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RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and UPDATED COCHRANE REVIEW ASSESSES COVID-19 RAPID TEST Cochrane, a global independent network that gathers and summarizes the best evidence from research to help informed health decision-making, published an updated systematic review assessing rapid tests for the detection of SARS-CoV-2 infection (COVID-19).The review shows that rapid antigen tests are better at correctly identifying cases of COVID-19 in people with symptoms than in ORTHO LAUNCHES FIRST QUANTITATIVE COVID-19 IGG SPIKE Ortho Clinical Diagnostics, Raritan, N.J., launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test.. Ortho is the only company that offers laboratories in the United States a quantitative test in combination with a nucleocapsid test. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. CHOOSING REFERENCE STANDARDS FOR MOLECULAR ASSAY Figure 2. Cell line-derived reference standards provide a reproducible, renewable resource to routinely monitor molecular assay performance from sample extraction to analysis. In the analytical step, it is recommended to choose controls with multiple known variants at low allele frequencies to establish and verify assay sensitivity. The New CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
CLPMAG - CLINICAL LAB PRODUCTSINFORMATION TECHNOLOGYADVERTISETERMS OF SERVICEAUTOMATIONEQUIPMENTCONTACT US CLP is the only magazine that focuses exclusively on products and technology for the clinical lab industry. Every month, CLP's editorial provides 45,000 pathologists, lab managers, administrators and technologists with comprehensive coverage of new products andtechnology.
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and UPDATED COCHRANE REVIEW ASSESSES COVID-19 RAPID TEST Cochrane, a global independent network that gathers and summarizes the best evidence from research to help informed health decision-making, published an updated systematic review assessing rapid tests for the detection of SARS-CoV-2 infection (COVID-19).The review shows that rapid antigen tests are better at correctly identifying cases of COVID-19 in people with symptoms than in ORTHO LAUNCHES FIRST QUANTITATIVE COVID-19 IGG SPIKE Ortho Clinical Diagnostics, Raritan, N.J., launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test.. Ortho is the only company that offers laboratories in the United States a quantitative test in combination with a nucleocapsid test. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. CHOOSING REFERENCE STANDARDS FOR MOLECULAR ASSAY Figure 2. Cell line-derived reference standards provide a reproducible, renewable resource to routinely monitor molecular assay performance from sample extraction to analysis. In the analytical step, it is recommended to choose controls with multiple known variants at low allele frequencies to establish and verify assay sensitivity. The New CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV ROBOTIC SYSTEM FOR ULTRA-HIGH-THROUGHPUT COVID-19 TESTING Robotic System for Ultra-High-Throughput Covid-19 Testing. Ziath, Cambridge, UK, collaborated with the Hubrecht Institute in Utrecht, Netherlands, to help the new Strip-1 automated test robot process up to 20,000 samples for covid-19 testing in just 24 hours. This makes it much faster than all other automated SARS-CoV-2 testing systems usedto
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. AMP PROVIDES RECOMMENDATIONS FOR CLINICAL CYP2D6 The Association for Molecular Pathology (AMP) has published consensus recommendations to aid in the design and validation of clinical CYP2D6 assays, promote standardization of testing across different laboratories, and improve patient care.The manuscript, “Recommendations for Clinical CYP2D6Genotyping Allele Selection: A Joint Consensus Recommendation of the Association COVID-19 TESTING: SALIVA CAN BE MORE EFFECTIVE THAN The collection of nasopharyngeal swab (NPS) samples for COVID-19 diagnostic testing poses challenges including exposure risk to healthcare workers and supply chain constraints.LIS/MIDDLEWARE
SoftLab, the LIS solution from SCC Soft Computer, Clearwater, Fla, provides quantifiable improvements in clinical outcomes, workflow efficiencies, and return on investment. SoftLab helps clients reach top productivity. This application is designed to accommodate hospitals, IDNs (integrated delivery networks), and labs of everysize.
CITYHEALTH INTRODUCES COVID-19 HAWAII DROP-OFF TEST KIT San Francisco-based CityHealth, the leading provider of urgent care in the San Francisco Bay area and Trusted Testing Partner for the State of Hawaii, has a new testing option for Hawaii-bound travelers, the Hawaii Drop-Off Test Kit. The Hawaii Drop-Off Test Kit allows travelers the opportunity to collect their own nasal swab sample at home, under the supervision of a certified CityHealth XMATRX INFINITY EXPANDS POSSIBILITIES FOR CLINICAL Xmatrx Infinity from Fremont, Calif.-based BioGenex Laboratories is designed for life science research and drug discovery and development. The system adapts and completely automates any manual protocol including baking, deparaffinization, antigen retrieval, probe denaturation, probe hybridization, stringency washes, counter stain, and final coverslip. STUDY: UNIVERSAL DX COLORECTAL CANCER TEST HIGHLY ACCURATE Universal Diagnostics (UDX), a Cambridge, Mass.-based bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, announced the results of an international multicenter observational cohort study: Colorectal cancer detection at 92% sensitivity and 97% specificity was achieved using single targeted sequencing analysis of multi-omics markers, advanced SELUX DIAGNOSTICS RECEIVES $14.6M IN BARDA FUNDING AFTER Boston-based Selux Diagnostics, Inc., which focuses on personalized diagnostics to combat superbug infections and fight antibiotic resistance, has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human NEUTRALIZING ANTIBODIES TO SARS-COV-2 Neutralizing Antibodies to SARS-CoV-2. The virus that causes covid-19, SARS-CoV-2, uses the spike protein (S) to bind to the receptor on host cells to trigger cell entry and infection. S protein consists of S1 and S2 subunits, and S1 interacts with the host cells via the receptor binding domain (RBD). 8 Monoclonal antibodies to S1 protein that NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots CEREBROSPINAL FLUID TESTING It is commonly accepted that red blood cells (RBCs) should not be present in normal CSF. RBCs in the CSF may be indicative of hemorrhage or the result of a traumatic lumbar puncture. 5 A significant decrease in color between the first and last collection tubes is the first indication that RBCs in CSF may be due to a traumatic tap. In the case of a hemorrhage, all tubes are likely to be the XBC - CLINICAL LAB PRODUCTS - CLPMAG A new blood analyzer from Chempaq recently launched in Denmark, the Chempaq XBC (eXpress Blood Counter), brings a portion of blood cell analysis to the point of care, eliminating intermediate steps and reading results in 3 minutes. The product is expected to receive US FDA 510 (k) clearance this year. Counting with the Coulter Principle.ADEZA BIOMEDICAL
Adeza Biomedical. Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. The company was recently acquired by Cytyc Corp, which is well aligned with Adeza’s area of expertise as a provider of surgical and diagnostic productsSEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
NEUTRALIZING ANTIBODIES TO SARS-COV-2 Neutralizing Antibodies to SARS-CoV-2. The virus that causes covid-19, SARS-CoV-2, uses the spike protein (S) to bind to the receptor on host cells to trigger cell entry and infection. S protein consists of S1 and S2 subunits, and S1 interacts with the host cells via the receptor binding domain (RBD). 8 Monoclonal antibodies to S1 protein that NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots CEREBROSPINAL FLUID TESTING It is commonly accepted that red blood cells (RBCs) should not be present in normal CSF. RBCs in the CSF may be indicative of hemorrhage or the result of a traumatic lumbar puncture. 5 A significant decrease in color between the first and last collection tubes is the first indication that RBCs in CSF may be due to a traumatic tap. In the case of a hemorrhage, all tubes are likely to be the XBC - CLINICAL LAB PRODUCTS - CLPMAG A new blood analyzer from Chempaq recently launched in Denmark, the Chempaq XBC (eXpress Blood Counter), brings a portion of blood cell analysis to the point of care, eliminating intermediate steps and reading results in 3 minutes. The product is expected to receive US FDA 510 (k) clearance this year. Counting with the Coulter Principle.ADEZA BIOMEDICAL
Adeza Biomedical. Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. The company was recently acquired by Cytyc Corp, which is well aligned with Adeza’s area of expertise as a provider of surgical and diagnostic productsSEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and ORTHO LAUNCHES FIRST QUANTITATIVE COVID-19 IGG SPIKE Ortho Clinical Diagnostics, Raritan, N.J., launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test.. Ortho is the only company that offers laboratories in the United States a quantitative test in combination with a nucleocapsid test. COVID-19 TESTING: SALIVA CAN BE MORE EFFECTIVE THAN The collection of nasopharyngeal swab (NPS) samples for COVID-19 diagnostic testing poses challenges including exposure risk to healthcare workers and supply chain constraints. CITYHEALTH INTRODUCES COVID-19 HAWAII DROP-OFF TEST KIT San Francisco-based CityHealth, the leading provider of urgent care in the San Francisco Bay area and Trusted Testing Partner for the State of Hawaii, has a new testing option for Hawaii-bound travelers, the Hawaii Drop-Off Test Kit. The Hawaii Drop-Off Test Kit allows travelers the opportunity to collect their own nasal swab sample at home, under the supervision of a certified CityHealth AMP PROVIDES RECOMMENDATIONS FOR CLINICAL CYP2D6 The Association for Molecular Pathology (AMP) has published consensus recommendations to aid in the design and validation of clinical CYP2D6 assays, promote standardization of testing across different laboratories, and improve patient care.The manuscript, “Recommendations for Clinical CYP2D6Genotyping Allele Selection: A Joint Consensus Recommendation of the Association XMATRX INFINITY EXPANDS POSSIBILITIES FOR CLINICAL Xmatrx Infinity from Fremont, Calif.-based BioGenex Laboratories is designed for life science research and drug discovery and development. The system adapts and completely automates any manual protocol including baking, deparaffinization, antigen retrieval, probe denaturation, probe hybridization, stringency washes, counter stain, and final coverslip. STUDY: UNIVERSAL DX COLORECTAL CANCER TEST HIGHLY ACCURATE Universal Diagnostics (UDX), a Cambridge, Mass.-based bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, announced the results of an international multicenter observational cohort study: Colorectal cancer detection at 92% sensitivity and 97% specificity was achieved using single targeted sequencing analysis of multi-omics markers, advanced SELUX DIAGNOSTICS RECEIVES $14.6M IN BARDA FUNDING AFTER Boston-based Selux Diagnostics, Inc., which focuses on personalized diagnostics to combat superbug infections and fight antibiotic resistance, has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human THERMO SCIENTIFIC LAUNCHES INTERFACE TO ENHANCE MASS Scientists in clinical research laboratories can benefit from a new differential ion mobility interface from Waltham, Mass.-based Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows.Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows. ANALYZER SELECTION AND IMPLEMENTATION For many years, a large midwestern hospital lab used a dry chemistry analyzer from Ortho-Clinical Diagnostics, Inc. (OCD). When their contract was due to expire, they put together a lab committee for assessing new analyzers with the goals of decreasing costs and consolidating workstations. The team represented all areas affected bythe
CLPMAG - CLINICAL LAB PRODUCTSINFORMATION TECHNOLOGYADVERTISETERMS OF SERVICEAUTOMATIONEQUIPMENTCONTACT US CLP is the only magazine that focuses exclusively on products and technology for the clinical lab industry. Every month, CLP's editorial provides 45,000 pathologists, lab managers, administrators and technologists with comprehensive coverage of new products andtechnology.
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
SEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
CLPMAG - CLINICAL LAB PRODUCTSINFORMATION TECHNOLOGYADVERTISETERMS OF SERVICEAUTOMATIONEQUIPMENTCONTACT US CLP is the only magazine that focuses exclusively on products and technology for the clinical lab industry. Every month, CLP's editorial provides 45,000 pathologists, lab managers, administrators and technologists with comprehensive coverage of new products andtechnology.
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
SEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
ORTHO LAUNCHES FIRST QUANTITATIVE COVID-19 IGG SPIKE Ortho Clinical Diagnostics, Raritan, N.J., launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test.. Ortho is the only company that offers laboratories in the United States a quantitative test in combination with a nucleocapsid test. CITYHEALTH INTRODUCES COVID-19 HAWAII DROP-OFF TEST KIT San Francisco-based CityHealth, the leading provider of urgent care in the San Francisco Bay area and Trusted Testing Partner for the State of Hawaii, has a new testing option for Hawaii-bound travelers, the Hawaii Drop-Off Test Kit. The Hawaii Drop-Off Test Kit allows travelers the opportunity to collect their own nasal swab sample at home, under the supervision of a certified CityHealth AMP PROVIDES RECOMMENDATIONS FOR CLINICAL CYP2D6 The Association for Molecular Pathology (AMP) has published consensus recommendations to aid in the design and validation of clinical CYP2D6 assays, promote standardization of testing across different laboratories, and improve patient care.The manuscript, “Recommendations for Clinical CYP2D6Genotyping Allele Selection: A Joint Consensus Recommendation of the Association HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic THERMO SCIENTIFIC LAUNCHES INTERFACE TO ENHANCE MASS Scientists in clinical research laboratories can benefit from a new differential ion mobility interface from Waltham, Mass.-based Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows.Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows. THREE STARBRIGHT DYES FOR FLOW CYTOMETRY INTRODUCED Bio-Rad Laboratories, Inc., has introduced three StarBright Dyes designed for flow cytometry applications. StarBright Violet 570, 670, and 710 Dyes offer improved brightness and precise excitation and emission spectra, making them suitable for use in multicolor flowcytometry panels.
CYTOSMART LAUNCHES 2 FLUORESCENCE LIVE-CELL IMAGING CytoSmart Technologies, Eindhoven, the Netherlands, has announced the launch of two new fluorescence live-cell imaging systems – the Lux3 FL Duo Kit and the Multi Lux3 FL.The CytoSmart Lux3 FL Duo Kit is a compact and cost-effective imaging system consisting of two fluorescence microscopes designed for side-by-side comparison of cellcultures.
STUDY: UNIVERSAL DX COLORECTAL CANCER TEST HIGHLY ACCURATE Universal Diagnostics (UDX), a Cambridge, Mass.-based bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, announced the results of an international multicenter observational cohort study: Colorectal cancer detection at 92% sensitivity and 97% specificity was achieved using single targeted sequencing analysis of multi-omics markers, advanced LABORATORY AUTOMATION Laboratory automation expert and consultant Robin A. Felder, PhD, professor of pathology and associate director of clinical chemistry at the University of Virginia School of Medicine, says that most clinical laboratory errors—and more than half of all laboratory costs—are associated with preanalytical and postanalytical processing ofspecimens.
GENE LINKED TO CONGENITAL HEART DISEASE IDENTIFIED New insight on the link between a gene called SORBS2 and congenital heart disease has been published in eLife, with findings that may help explain the cause of the disease in some patients. Some people with congenital heart disease are missing part of the long arm of chromosome 4, also known as chromosome 4q. CLPMAG - CLINICAL LAB PRODUCTSINFORMATION TECHNOLOGYADVERTISETERMS OF SERVICEAUTOMATIONEQUIPMENTCONTACT US CLP is the only magazine that focuses exclusively on products and technology for the clinical lab industry. Every month, CLP's editorial provides 45,000 pathologists, lab managers, administrators and technologists with comprehensive coverage of new products andtechnology.
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
SEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
CLPMAG - CLINICAL LAB PRODUCTSINFORMATION TECHNOLOGYADVERTISETERMS OF SERVICEAUTOMATIONEQUIPMENTCONTACT US CLP is the only magazine that focuses exclusively on products and technology for the clinical lab industry. Every month, CLP's editorial provides 45,000 pathologists, lab managers, administrators and technologists with comprehensive coverage of new products andtechnology.
RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
SEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
CITYHEALTH INTRODUCES COVID-19 HAWAII DROP-OFF TEST KIT San Francisco-based CityHealth, the leading provider of urgent care in the San Francisco Bay area and Trusted Testing Partner for the State of Hawaii, has a new testing option for Hawaii-bound travelers, the Hawaii Drop-Off Test Kit. The Hawaii Drop-Off Test Kit allows travelers the opportunity to collect their own nasal swab sample at home, under the supervision of a certified CityHealthRAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
AMP PROVIDES RECOMMENDATIONS FOR CLINICAL CYP2D6 The Association for Molecular Pathology (AMP) has published consensus recommendations to aid in the design and validation of clinical CYP2D6 assays, promote standardization of testing across different laboratories, and improve patient care.The manuscript, “Recommendations for Clinical CYP2D6Genotyping Allele Selection: A Joint Consensus Recommendation of the Association HOME PAGE – CLINICAL LAB PRODUCTS MEDIA KIT Clinical Lab Products delivers in-depth coverage of product and technology trends for the clinical laboratory community—and reaches more than 60,000 key decision makers and influencers.As one of healthcare’s most important data companies, we facilitate the development and rapid adoption of diagnostic tests and instruments into clinical settings, helping to improve testing and diagnostic THERMO SCIENTIFIC LAUNCHES INTERFACE TO ENHANCE MASS Scientists in clinical research laboratories can benefit from a new differential ion mobility interface from Waltham, Mass.-based Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows.Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows. THREE STARBRIGHT DYES FOR FLOW CYTOMETRY INTRODUCED Bio-Rad Laboratories, Inc., has introduced three StarBright Dyes designed for flow cytometry applications. StarBright Violet 570, 670, and 710 Dyes offer improved brightness and precise excitation and emission spectra, making them suitable for use in multicolor flowcytometry panels.
CYTOSMART LAUNCHES 2 FLUORESCENCE LIVE-CELL IMAGING CytoSmart Technologies, Eindhoven, the Netherlands, has announced the launch of two new fluorescence live-cell imaging systems – the Lux3 FL Duo Kit and the Multi Lux3 FL.The CytoSmart Lux3 FL Duo Kit is a compact and cost-effective imaging system consisting of two fluorescence microscopes designed for side-by-side comparison of cellcultures.
STUDY: UNIVERSAL DX COLORECTAL CANCER TEST HIGHLY ACCURATE Universal Diagnostics (UDX), a Cambridge, Mass.-based bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, announced the results of an international multicenter observational cohort study: Colorectal cancer detection at 92% sensitivity and 97% specificity was achieved using single targeted sequencing analysis of multi-omics markers, advanced SELUX DIAGNOSTICS RECEIVES $14.6M IN BARDA FUNDING AFTER Boston-based Selux Diagnostics, Inc., which focuses on personalized diagnostics to combat superbug infections and fight antibiotic resistance, has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human GENE LINKED TO CONGENITAL HEART DISEASE IDENTIFIED New insight on the link between a gene called SORBS2 and congenital heart disease has been published in eLife, with findings that may help explain the cause of the disease in some patients. Some people with congenital heart disease are missing part of the long arm of chromosome 4, also known as chromosome 4q.DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
CEREBROSPINAL FLUID TESTING It is commonly accepted that red blood cells (RBCs) should not be present in normal CSF. RBCs in the CSF may be indicative of hemorrhage or the result of a traumatic lumbar puncture. 5 A significant decrease in color between the first and last collection tubes is the first indication that RBCs in CSF may be due to a traumatic tap. In the case of a hemorrhage, all tubes are likely to be the CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
ADEZA BIOMEDICAL
Adeza Biomedical. Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. The company was recently acquired by Cytyc Corp, which is well aligned with Adeza’s area of expertise as a provider of surgical and diagnostic productsSEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. PAYING FOR MOLECULAR DIAGNOSTICS Despite the uncertain reimbursement landscape, new molecular diagnostic tests are being released at a dizzying pace. A 2018 report found that, on average, 14 new genetic tests come onto the market every day. 2 At the time the report was released, more than 74,000 genetic tests were commercially available in the United States.DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
CEREBROSPINAL FLUID TESTING It is commonly accepted that red blood cells (RBCs) should not be present in normal CSF. RBCs in the CSF may be indicative of hemorrhage or the result of a traumatic lumbar puncture. 5 A significant decrease in color between the first and last collection tubes is the first indication that RBCs in CSF may be due to a traumatic tap. In the case of a hemorrhage, all tubes are likely to be the CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
ADEZA BIOMEDICAL
Adeza Biomedical. Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. The company was recently acquired by Cytyc Corp, which is well aligned with Adeza’s area of expertise as a provider of surgical and diagnostic productsSEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. PAYING FOR MOLECULAR DIAGNOSTICS Despite the uncertain reimbursement landscape, new molecular diagnostic tests are being released at a dizzying pace. A 2018 report found that, on average, 14 new genetic tests come onto the market every day. 2 At the time the report was released, more than 74,000 genetic tests were commercially available in the United States. RESEARCHERS DEVELOP METHOD FOR ACCURATE, RAPID VIRUS Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have developed a new method for rapid and accurate detection of viral nucleic acids — a breakthrough that can be easily adapted to detect different RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and THERMO SCIENTIFIC LAUNCHES INTERFACE TO ENHANCE MASS Scientists in clinical research laboratories can benefit from a new differential ion mobility interface from Waltham, Mass.-based Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows.Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows. ROBOTIC SYSTEM FOR ULTRA-HIGH-THROUGHPUT COVID-19 TESTING Robotic System for Ultra-High-Throughput Covid-19 Testing. Ziath, Cambridge, UK, collaborated with the Hubrecht Institute in Utrecht, Netherlands, to help the new Strip-1 automated test robot process up to 20,000 samples for covid-19 testing in just 24 hours. This makes it much faster than all other automated SARS-CoV-2 testing systems usedto
INVITAE OPENS EARLY ACCESS TO LIQUID BIOPSY-BASED Invitae Corporation, a San Francisco-based medical genetics company, has begun offering early access to its new personalized cancer monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory.The service employs a novel combination of a tumor profile, blood tests, and personalized assays based on a patient’s tumor with the goal of detecting circulating CEREBROSPINAL FLUID TESTING When we think about cerebrospinal fluid (CSF) analysis, it helps to first step back for a historical overview. CSF was first described in the 1700s by several scientists, including Emanuel Swedenborg, Albrecht von Haller, Francois Magendie, and Thomas Willis. 1 And later, in the late 1800s, Heinrich Quincke showed the ability to access CSF and popularized collection of the fluid through AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
SEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
RHEUMATOID FACTOR ASSAY Rheumatoid factor, an autoantibody produced against the Fc fragment of human IgG, is an antibody found in rheumatoid arthritis patients. It is used in the diagnosis and prognosis of disease. This RF immunoturbidimetric technology uses latex reagent, which includes a suspension of polystyrene latex particles of uniform size coated withhuman IgG.
ANALYZER SELECTION AND IMPLEMENTATION For many years, a large midwestern hospital lab used a dry chemistry analyzer from Ortho-Clinical Diagnostics, Inc. (OCD). When their contract was due to expire, they put together a lab committee for assessing new analyzers with the goals of decreasing costs and consolidating workstations. The team represented all areas affected bythe
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causescovid-19.
CEREBROSPINAL FLUID TESTING When we think about cerebrospinal fluid (CSF) analysis, it helps to first step back for a historical overview. CSF was first described in the 1700s by several scientists, including Emanuel Swedenborg, Albrecht von Haller, Francois Magendie, and Thomas Willis. 1 And later, in the late 1800s, Heinrich Quincke showed the ability to access CSF and popularized collection of the fluid through CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lotsADEZA BIOMEDICAL
Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
PAYING FOR MOLECULAR DIAGNOSTICS Figure 1. Providing details about how a test positively affects care decisions can be crucial to a reimbursement decision or appeal. Here a lab technician processes a sample for the Luminex multiplexed nucleic acid xTAG gastrointestinal pathogen panel, which provides results for more than 90% of causative gastroenteritis agents in as little as 5hours.
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories.SEPSIS - CLPMAG.COM
Developer of lateral-flow and rapid diagnostic technologies, services, and products, Mologic, Thurleigh, UK, has begun a major clinical trial with University College London Hospitals (UCLH) to evaluate the company’s point-of-care diagnostic for the early detection ofsepsis.
DIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causescovid-19.
CEREBROSPINAL FLUID TESTING When we think about cerebrospinal fluid (CSF) analysis, it helps to first step back for a historical overview. CSF was first described in the 1700s by several scientists, including Emanuel Swedenborg, Albrecht von Haller, Francois Magendie, and Thomas Willis. 1 And later, in the late 1800s, Heinrich Quincke showed the ability to access CSF and popularized collection of the fluid through CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lotsADEZA BIOMEDICAL
Adeza Biomedical, Sunnyvale, Calif, founded 20 years ago to focus on women’s reproductive health care, is behind a test and testing unit for women at risk of preterm birth. QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
PAYING FOR MOLECULAR DIAGNOSTICS Figure 1. Providing details about how a test positively affects care decisions can be crucial to a reimbursement decision or appeal. Here a lab technician processes a sample for the Luminex multiplexed nucleic acid xTAG gastrointestinal pathogen panel, which provides results for more than 90% of causative gastroenteritis agents in as little as 5hours.
REAGENT VARIATION
The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco. NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories.SEPSIS - CLPMAG.COM
Developer of lateral-flow and rapid diagnostic technologies, services, and products, Mologic, Thurleigh, UK, has begun a major clinical trial with University College London Hospitals (UCLH) to evaluate the company’s point-of-care diagnostic for the early detection ofsepsis.
RESEARCHERS DEVELOP METHOD FOR ACCURATE, RAPID VIRUS Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have developed a new method for rapid and accurate detection of viral nucleic acids — a breakthrough that can be easily adapted to detect different THERMO SCIENTIFIC LAUNCHES INTERFACE TO ENHANCE MASS Scientists in clinical research laboratories can benefit from a new differential ion mobility interface from Waltham, Mass.-based Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows.Thermo Scientific that increases productivity and data quality for qualitative and quantitative workflows. RAPID COVID-19 DIAGNOSTIC TEST DELIVERS FAST, ACCURATE A low-cost, rapid diagnostic test for COVID-19 developed by Penn Medicine provides COVID-19 results within four minutes with 90% accuracy. A paper published this week in Matter details the fast and inexpensive diagnostic test, called Real-time Accurate Portable Impedimetric Detection prototype 1.0 or RAPID 1.0. Compared to existing methods for COVID-19 detection, RAPID is inexpensive and INVITAE OPENS EARLY ACCESS TO LIQUID BIOPSY-BASED Invitae Corporation, a San Francisco-based medical genetics company, has begun offering early access to its new personalized cancer monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory.The service employs a novel combination of a tumor profile, blood tests, and personalized assays based on a patient’s tumor with the goal of detecting circulating ROBOTIC SYSTEM FOR ULTRA-HIGH-THROUGHPUT COVID-19 TESTING Ziath, Cambridge, UK, collaborated with the Hubrecht Institute in Utrecht, Netherlands, to help the new Strip-1 automated test robotprocess up to
CEREBROSPINAL FLUID TESTING When we think about cerebrospinal fluid (CSF) analysis, it helps to first step back for a historical overview. CSF was first described in the 1700s by several scientists, including Emanuel Swedenborg, Albrecht von Haller, Francois Magendie, and Thomas Willis. 1 And later, in the late 1800s, Heinrich Quincke showed the ability to access CSF and popularized collection of the fluid through AMP, APC CALL ON CONGRESS TO PASS THE VERIFIED INNOVATIVE The Association for Molecular Pathology (AMP) and the Association of Pathology Chairs (APC) have voiced their support for the VerifiedInnovative Testing
RHEUMATOID FACTOR ASSAY This latex-enhanced immunoturbidimetric assay for rheumatoid factor (RF) chemistry analyzers provides a quantitative result. The standard curve range is 0-60 IU/mL.SEPSIS - CLPMAG.COM
Developer of lateral-flow and rapid diagnostic technologies, services, and products, Mologic, Thurleigh, UK, has begun a major clinical trial with University College London Hospitals (UCLH) to evaluate the company’s point-of-care diagnostic for the early detection ofsepsis.
ANALYZER SELECTION AND IMPLEMENTATION By Mary V. Barba, MT(ASCP) Reduced budgets, staffing, and reimbursement—coupled with increased regulations and physician expectations — have forced laboratory personnel at all levels to seek nontraditional approaches for meeting customVIROLOGY TESTING
Chakkaphak offers the recent example of a critical situation that developed in the health system’s newborn nursery. Clinicians required same-day testing of all the infants in the nursery to determine whether they were witnessing an outbreak of respiratory syncytial virus (RSV) infection and, if so, which babies wereinfected.
EMERGING TECHNOLOGIES Vitek MS is a mass spectrometry system intended for the identification of pathogenic organisms in clinical laboratory applications. FDA granted 510 (k) de novo clearance for the system in August 2013, making it the first clinical mass spectrometry system to be cleared for the US market. Speed, accuracy, and breadth are all hallmarks ofthe new
RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NASA CREATES BREATH ANALYZER TO DIAGNOSE MULTIPLE NASA Creates Breath Analyzer to Diagnose Multiple Illnesses. The National Aeronautics and Space Administration (NASA) representatives presented new medical diagnostic technology, the E-Nose Breathalyzer, to members of David Grant USAF Medical Center Oct. 21, 2020, at Travis Air Force Base. The E-Nose Breathanalyzer, under development at NASASEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
EMERGING TECHNOLOGIES PROMISE REVOLUTIONARY DIAGNOSTIC TOOLS A new and unique pocket-sized lab could provide doctors immediate test results, reduce costs for budget-strapped clinical laboratories, and serve as a lab-testing tool for doctors working in remote areas. “Lab-on-a-chip” (LOC) technology is the result of nearly 2 decades of development. The latest advance is the result of turning loose CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
PSA TEST MORE RELIABLE IN MEN TAKING DUTASTERIDE The PSA screening test for prostate cancer is not perfect. It can indicate cancer when none is present and miss life-threatening tumors. But a new study published in the January issue of the Journal of Urology. suggests the test is more reliable in men taking dutasteride (Avodart®), a drug widely prescribed to shrink an enlarged prostategland.
VIROLOGY TESTING
Chakkaphak offers the recent example of a critical situation that developed in the health system’s newborn nursery. Clinicians required same-day testing of all the infants in the nursery to determine whether they were witnessing an outbreak of respiratory syncytial virus (RSV) infection and, if so, which babies wereinfected.
EMERGING TECHNOLOGIES Vitek MS is a mass spectrometry system intended for the identification of pathogenic organisms in clinical laboratory applications. FDA granted 510 (k) de novo clearance for the system in August 2013, making it the first clinical mass spectrometry system to be cleared for the US market. Speed, accuracy, and breadth are all hallmarks ofthe new
RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NASA CREATES BREATH ANALYZER TO DIAGNOSE MULTIPLE NASA Creates Breath Analyzer to Diagnose Multiple Illnesses. The National Aeronautics and Space Administration (NASA) representatives presented new medical diagnostic technology, the E-Nose Breathalyzer, to members of David Grant USAF Medical Center Oct. 21, 2020, at Travis Air Force Base. The E-Nose Breathanalyzer, under development at NASASEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
EMERGING TECHNOLOGIES PROMISE REVOLUTIONARY DIAGNOSTIC TOOLS A new and unique pocket-sized lab could provide doctors immediate test results, reduce costs for budget-strapped clinical laboratories, and serve as a lab-testing tool for doctors working in remote areas. “Lab-on-a-chip” (LOC) technology is the result of nearly 2 decades of development. The latest advance is the result of turning loose CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
PSA TEST MORE RELIABLE IN MEN TAKING DUTASTERIDE The PSA screening test for prostate cancer is not perfect. It can indicate cancer when none is present and miss life-threatening tumors. But a new study published in the January issue of the Journal of Urology. suggests the test is more reliable in men taking dutasteride (Avodart®), a drug widely prescribed to shrink an enlarged prostategland.
NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
RESEARCHERS DEVELOP METHOD FOR ACCURATE, RAPID VIRUS Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have developed a new method for rapid and accurate detection of viral nucleic acids — a breakthrough that can be easily adapted to detect differentDIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. RESEARCHERS IDENTIFY NEW 'MEXICAN VARIANT' OF COVID-19 A research group at the University of Bologna has identified a new SARS-CoV-2 variant that is spreading mostly in Mexico.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
PAYING FOR MOLECULAR DIAGNOSTICS Despite the uncertain reimbursement landscape, new molecular diagnostic tests are being released at a dizzying pace. A 2018 report found that, on average, 14 new genetic tests come onto the market every day. 2 At the time the report was released, more than 74,000 genetic tests were commercially available in the United States. STUDY: INCREASED TUBERCULOSIS TESTING NEEDED IN IRISH Investigators from Trinity College Dublin, the Irish Mycobacteria Reference Laboratory, St. James’s Hospital, and the Department of Public Health HSE East believe tuberculosis (TB) care in Irish Prisons should be supported, considering the findings of their study which is published in the International Journal of Tuberculosis and Lung Disease.. The study describes an investigation into a NOVEL URINE SCREENING TEST CAN DETECT NEW AND RECURRENT A study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc., examined a new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker, and revealed the test can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine. DIAGNOSING NEURODEGENERATION MAY BE A BLOOD TEST AWAY Levels of a protein called neurofilament light chain (NfL) in the blood can identify those who might have neurodegenerative diseases such as Down’s syndrome dementia, motor neuron disease (ALS), and frontotemporal dementia, when clinical symptoms are not definitive. INVITAE OPENS EARLY ACCESS TO LIQUID BIOPSY-BASED Invitae Corporation, a San Francisco-based medical genetics company, has begun offering early access to its new personalized cancer monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory.The service employs a novel combination of a tumor profile, blood tests, and personalized assays based on a patient’s tumor with the goal of detecting circulatingVIROLOGY TESTING
Chakkaphak offers the recent example of a critical situation that developed in the health system’s newborn nursery. Clinicians required same-day testing of all the infants in the nursery to determine whether they were witnessing an outbreak of respiratory syncytial virus (RSV) infection and, if so, which babies wereinfected.
EMERGING TECHNOLOGIES Vitek MS is a mass spectrometry system intended for the identification of pathogenic organisms in clinical laboratory applications. FDA granted 510 (k) de novo clearance for the system in August 2013, making it the first clinical mass spectrometry system to be cleared for the US market. Speed, accuracy, and breadth are all hallmarks ofthe new
RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NASA CREATES BREATH ANALYZER TO DIAGNOSE MULTIPLE NASA Creates Breath Analyzer to Diagnose Multiple Illnesses. The National Aeronautics and Space Administration (NASA) representatives presented new medical diagnostic technology, the E-Nose Breathalyzer, to members of David Grant USAF Medical Center Oct. 21, 2020, at Travis Air Force Base. The E-Nose Breathanalyzer, under development at NASASEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
EMERGING TECHNOLOGIES PROMISE REVOLUTIONARY DIAGNOSTIC TOOLS A new and unique pocket-sized lab could provide doctors immediate test results, reduce costs for budget-strapped clinical laboratories, and serve as a lab-testing tool for doctors working in remote areas. “Lab-on-a-chip” (LOC) technology is the result of nearly 2 decades of development. The latest advance is the result of turning loose CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
PSA TEST MORE RELIABLE IN MEN TAKING DUTASTERIDE The PSA screening test for prostate cancer is not perfect. It can indicate cancer when none is present and miss life-threatening tumors. But a new study published in the January issue of the Journal of Urology. suggests the test is more reliable in men taking dutasteride (Avodart®), a drug widely prescribed to shrink an enlarged prostategland.
VIROLOGY TESTING
Chakkaphak offers the recent example of a critical situation that developed in the health system’s newborn nursery. Clinicians required same-day testing of all the infants in the nursery to determine whether they were witnessing an outbreak of respiratory syncytial virus (RSV) infection and, if so, which babies wereinfected.
EMERGING TECHNOLOGIES Vitek MS is a mass spectrometry system intended for the identification of pathogenic organisms in clinical laboratory applications. FDA granted 510 (k) de novo clearance for the system in August 2013, making it the first clinical mass spectrometry system to be cleared for the US market. Speed, accuracy, and breadth are all hallmarks ofthe new
RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
QUANTUMDX SCALES UP TO MASS MANUFACTURE Q-POC QuantuMDx, Newcastle Upon Tyne, UK, has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC and disposable test cassette, to mass manufacture.QuantuMDx accelerated development, scale-up, and manufacture of Q-POC—its rapid point-of-care testing system—in 2020 in response to the covid-19pandemic.
NASA CREATES BREATH ANALYZER TO DIAGNOSE MULTIPLE NASA Creates Breath Analyzer to Diagnose Multiple Illnesses. The National Aeronautics and Space Administration (NASA) representatives presented new medical diagnostic technology, the E-Nose Breathalyzer, to members of David Grant USAF Medical Center Oct. 21, 2020, at Travis Air Force Base. The E-Nose Breathanalyzer, under development at NASASEPSIS - CLPMAG.COM
Sepsis survivors often have an impaired quality of life that may be permanent. The financial and societal burden of sepsis is thus highly significant. The chances of survival may improve if the condition is recognized early and treated promptly. However, early detection is difficult. Mologic is developing a novel, high-performancepoint-of-care
EMERGING TECHNOLOGIES PROMISE REVOLUTIONARY DIAGNOSTIC TOOLS A new and unique pocket-sized lab could provide doctors immediate test results, reduce costs for budget-strapped clinical laboratories, and serve as a lab-testing tool for doctors working in remote areas. “Lab-on-a-chip” (LOC) technology is the result of nearly 2 decades of development. The latest advance is the result of turning loose CLIA HAS MANDATED A CONTROL LOT VERIFICATION IN WHICH NEW CLIA has mandated a Control Lot Verification in which new controls have to be run as patients and compared to the values of the old Controls. This would be a precaution to know if the controls are indeed working and are suitable for use in the lab. Since the values of the new Control lots NEW TABLETOP HEMATOLOGY ANALYZER FOR SMALL AND MEDIUM LABS New Tabletop Hematology Analyzer for Small and Medium Labs. Beckman Coulter, Brea, Calif, has launched the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, userscan
PSA TEST MORE RELIABLE IN MEN TAKING DUTASTERIDE The PSA screening test for prostate cancer is not perfect. It can indicate cancer when none is present and miss life-threatening tumors. But a new study published in the January issue of the Journal of Urology. suggests the test is more reliable in men taking dutasteride (Avodart®), a drug widely prescribed to shrink an enlarged prostategland.
NEW METHOD OF RAPID, ACCURATE TESTING FOR COVID-19 New Method of Rapid, Accurate Testing for Covid-19 Antibodies. Researchers at University of California, Santa Cruz have developed a novel serological assay, using optical biosensor technology for the detection of antibodies to SARS-CoV-2, the coronavirus that causes covid-19. Rebecca DuBois, PhD, associate professor of biomolecularengineering
RESEARCHERS DEVELOP METHOD FOR ACCURATE, RAPID VIRUS Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have developed a new method for rapid and accurate detection of viral nucleic acids — a breakthrough that can be easily adapted to detect differentDIGITAL PATHOLOGY
The CytoSmart Multi Lux lets researchers carry out side-by-side comparisons between cell cultures, run long-term experiments, and monitor cells from home. RESEARCHERS IDENTIFY NEW 'MEXICAN VARIANT' OF COVID-19 A research group at the University of Bologna has identified a new SARS-CoV-2 variant that is spreading mostly in Mexico.RAPID ID SOFTWARE
Rapid ID software. ERIC software, which stands for Electronic RapID Compendium, is a Windows based update to the DOS based computerized code compendium currently available from this company. The software is for use with this company’s RapID Systems, which offer rapid biochemical identifications of bacteria and yeasts after 4 hours.There are
PAYING FOR MOLECULAR DIAGNOSTICS Despite the uncertain reimbursement landscape, new molecular diagnostic tests are being released at a dizzying pace. A 2018 report found that, on average, 14 new genetic tests come onto the market every day. 2 At the time the report was released, more than 74,000 genetic tests were commercially available in the United States. STUDY: INCREASED TUBERCULOSIS TESTING NEEDED IN IRISH Investigators from Trinity College Dublin, the Irish Mycobacteria Reference Laboratory, St. James’s Hospital, and the Department of Public Health HSE East believe tuberculosis (TB) care in Irish Prisons should be supported, considering the findings of their study which is published in the International Journal of Tuberculosis and Lung Disease.. The study describes an investigation into a NOVEL URINE SCREENING TEST CAN DETECT NEW AND RECURRENT A study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc., examined a new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker, and revealed the test can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine. DIAGNOSING NEURODEGENERATION MAY BE A BLOOD TEST AWAY Levels of a protein called neurofilament light chain (NfL) in the blood can identify those who might have neurodegenerative diseases such as Down’s syndrome dementia, motor neuron disease (ALS), and frontotemporal dementia, when clinical symptoms are not definitive. INVITAE OPENS EARLY ACCESS TO LIQUID BIOPSY-BASED Invitae Corporation, a San Francisco-based medical genetics company, has begun offering early access to its new personalized cancer monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory.The service employs a novel combination of a tumor profile, blood tests, and personalized assays based on a patient’s tumor with the goal of detecting circulating This website stores cookies on your computer. These cookies are used to improve your website and provide more personalized services to you, both on this website and through other media. To find out more about the cookies we use, see our Privacy Policy.Accept Decline
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