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News : clinical, Jul 2020

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Paris Airport Rapid PCR Testing Feverish Travellers

credo diagnostics vita pcr sars cov 2 ce ivd paris airport
PCRSARS-CoV-2
30 Jul 2020
For the past month, the VitaPCR™ rapid test has been used on feverish passengers arriving at Roissy Airport. The test uses PCR to amplify a region within the nucleocapsid gene and provides airport authorities with a result within 20 minutes with just two minutes hands-on-time. 

Allentown's Washing and Contamination Control Products Now Benefit from NESA Sales and Aftercare

Image not available
CleanroomWorkstations
29 Jul 2020
New England Scientific Associates (NESA) has partnered with Allentown, LLC. for exclusive representation in the New England & upstate New York areas.

Two Clinical Trials Show 100% Diagnostic Accuracy for COVID-19 Multiplex qPCR Assay 

COVID 19 qPCR multiplex Bruker Fluorotype SARS CoV 2
SARS-CoV-2
29 Jul 2020
Bruker's FluoroType® SARS-CoV-2 multiplex qPCR assay has demonstrated 100% accuracy in two clinical trials. The test is CE-IVD marked, detects two regions on SARS-CoV-2, differentiates between 4 other coronaviruses and has been validated on common RT-PCR thermocyclers. 

India Council Release Data on High Volume COVID-19 Antigen Testing Regime

SD Biosensor CE ANVISA STANDARD Q ANTIGEN COVID 19
Lateral Flow AssaysSARS-CoV-2
29 Jul 2020
SD Biosensor's Standard Q Ag rapid antigen test is now used as the first test to be deployed in hotspot areas as part of several country's testing regimes. The lateral-flow test gives a result within 15 minutes, and SD Biosensor has supplied 15 million kits to India over the last 3 weeks.

Viral RNA Extraction Kit Promises Superior Detection Over Solid-Phase Extraction

PHASIFY RNA COVID19 extraction
SARS-CoV-2
28 Jul 2020
Phase Scientific has received CE-marking for its  PHASIFY™  VIRAL RNA extraction kit, which claims to facilitate higher SARS-CoV-2 RNA yields, can enable a 3-6 cycle threshold reduction and increases true positive detection compared to conventional solid-phase extraction.

Bioeasy COVID-19 Antigen Test Still Tops WHO's List

antigen ce mark bioeasy COVID 19
SARS-CoV-2
23 Jul 2020
FIND/WHO's resource of clinical performance data of COVID-19 diagnostics is growing, and many developers have put forward their test for independent evaluation. The introduction of rapid antigen tests is seen as a step forward by testing regimes, and its performance data is under the spotlight. 

Under Ten Dollar Test Detects Five Regions of SARS-CoV-2 in Single Reaction

Agena iPLEX Pro SARSCoV2 Panel
Quantitative PCR (qPCR)SARS-CoV-2
22 Jul 2020
Agena Biosciences has launched an FDA-EUA qualitative test for SARS-CoV-2. The iPLEX Pro SARS-CoV-2 Panel detects five regions of the virus, and if used with Agena's MassARRAY® instrument a lab can run 6000 samples a day. Each sample costs under ten dollars to run. 

Pooling Samples for COVID-19 May be Best Step Forward

Pool biocomma pathogen dx quest rt qpcr covid FDA
SARS-CoV-2Specimen TransportSwabs with Transport Medium
21 Jul 2020
Asymptomatic people are a puzzle for testing regimes that want rapid testing in place to mitigate the economic effects of a pandemic. But pooling asymptomatic individuals samples on high-throughput qPCR systems is now encouraged after successful pooling regimes in Europe and Asia. 

Does Your Lab Need a Super Efficient Anaerobic Workstation?

Video about Baker Ruskinn Workstations
Anaerobic/Microaerophilic EnvironmentsWorkflow OptimizationWorkstations
21 Jul 2020
Baker Ruskinn anaerobic and microaerophilic workstations have been developed with the user in mind with a host of features to help you deliver consistent results.

CDC COVID-19 Test Kit is Error-Prone Says Director of US Public Health Lab

COVID 19 CDC RT PCR Sequencing Milford Sin Hang Lee
Reverse Transcription PCR (RT-PCR)SARS-CoV-2
20 Jul 2020
A recently published peer-reviewed article reported significant errors with CDC's COVID-19 RT-PCR test. Author Sin Hang Lee, director at Connecticut's Milford Molecular Diagnostics Laboratory is offering to re-test samples from high-death toll nursing homes using his protocol. 

Belgium FAMPH Recommends Novatec's COVID-19 ELISA Test

GSD NovaLisa NovaPrime ELISA
ELISASARS-CoV-2
20 Jul 2020
After excellent clinical performances during its first external validation at an acute care hospital in Brussels (Belgium),  the NovaLisa COVID-19 IgG and IgA ELISA test has been recommended for use by Belgium's Health Products Agency (FAMHP). 

A Small Workstation with Big Ideas

Don Whitley A20 Workstation
Anaerobic/Microaerophilic EnvironmentsWorkstations
14 Jul 2020
Time to step up from using anaerobic jars to using an anaerobic workstation? The A20 is compact, incredibly efficient and cheaper to operate than it is to use jars.

A Simple Colorimetric Alternative to Gold-Standard COVID-19 Testing 

LAMP COVID 19
LAMP/Isothermal AmplificationSARS-CoV-2
14 Jul 2020
New England Biolabs has launched a SARS-CoV-2 Rapid Colorimetric LAMP Assay kit (RUO) that produces visually read results in 30 minutes, by a simple color change due to a pH drop. The kit needs only a heat source to run and could be useful in low resource point-of-care settings. 

Fully-Automated COVID-19 Serology Test Gets FDA Green Light

Diazyme IgG COVID 19
SARS-CoV-2
14 Jul 2020
Diazyme has received FDA-EUA for its fully automated DZ-Lite SARS-CoV-2 IgG CLIA test. Diazyme state it has no cross-reactivity with the four most common coronavirus strains. The test uses both S and N proteins to pick up IgG specific for SARS-CoV-2.

CANARY Migrates From Anthrax Detection to SARS-CoV-2

Image not available
SARS-CoV-2
13 Jul 2020
PathSensors can now develop a COVID-19 diagnostic kit using CANARY™ technology after an agreement with MIT to expand its license for clinical use. CANARY is a biosensor initially developed after 9/11 to detect anthrax.

Every Stage of SARS-CoV-2 Infection Covered With GBC Test Kits

GB SARS CoV 2 RT PCR
Lateral Flow AssaysSARS-CoV-2
09 Jul 2020
General Biologicals has developed a quick RT-PCR test, rapid antigen test and an ELISA antibody test for the diagnosis of COVID-19. The RT-PCR kit has been approved in India, Taiwan and Australia and is also in use hard-hit countries Mexico and Indonesia. 

Large-Scale Manufacturer Ready for Orders for Highly Accurate FDA-EUA COVID-19 Serology Test

Access IgG COVID 19 FDA Beckman Coulter
SARS-CoV-2
07 Jul 2020
Beckman Coulter has received FDA-EUA for its COVID-19 serology test, the Access SARS-CoV-2 igG test. The test has 100% confirmed sensitivity and 99.6% specificity. The company says it can produce up to 30 million test a month. 

Return-to-Work Safely Program Includes PCR and Antibody COVID-19 Test

employee COVID19 screening
SARS-CoV-2
06 Jul 2020
Lung disease diagnostics firm Biodesix has developed a post-COVID-19 lockdown customized return to work service for employers. The WorkSafe™ Program consists of two tests kits;  Bio-Rad Laboratories SARS-CoV-2 ddPCR Test (molecular) and the Platelia SARS-CoV-2 Total Ab Test (antibody).
 

Cepheid Announce Development of Next-Generation Multiplex COVID-19, Flu and RSV Test 

Cepheid COVID19 Flu RSV Xpert
InfluenzaQuantitative PCR (qPCR)Respiratory Syncytial Virus (RSV)
06 Jul 2020
Cepheid plan to pursue FDA-EUA for the Xpert® Xpress SARS-CoV-2/Flu/RSV four-in-one test. The test is designed for use on a single sample using the GeneXpert® System with results expected in as little as 35 minutes.

Border Screening Firm Acquire Pathogen Detection Specialists

smith detection Pathsensors
Ebola virusFrancisella tularensisSalmonella
06 Jul 2020
Smiths Detection, a leader in threat detection at border screenings, has acquired PathSensors; a provider of high-speed, high sensitivity pathogen detection and threat prevention solutions. This expands its sensing capabilities across the CBRNE spectrum to respond quickly to emerging threats.

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