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News : clinical, May 2020

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AFYS3G Offers a Unique Solution for the Ultimate Traceability of Labware

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31 May 2020
AFYS3G has a unique way to guarantee the absolute traceability of your laboratory consumables: laser-based marking systems.

Studies Say Abbott's  ID NOW™ COVID-19 Test Works Best at Acute Stage of Infection

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LAMP/Isothermal AmplificationSARS-CoV-2
29 May 2020
Abbott has released an interim analysis from independent studies being carried out on its ID NOW™ COVID-19 test, as per FDA instructions. Results, so far show the test has a high sensitivity and specificity in the early days of symptoms onset. 

FDA Aids Development and Evaluation of COVID-19 Diagnostic Tests

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SARS-CoV-2
29 May 2020
The U.S. FDA is supporting the agency’s evaluation of diagnostic tests for COVID-19 by providing a SARS-CoV-2 reference panel. The panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

Accelerating Pandemic Response Means Accelerating Release Testing

Charles River rapid sterility
PDA TR 33Ph. Eur 5.1.6Assay Validation
27 May 2020
The world needs pharma and biotech organizations to respond to public health crises faster than ever. As production timelines shorten and approvals are fast-tracked, the industry must be able to release products as quickly and safely as possible. 

Textile Moguls Attain Rights to Direct-to-Consumer Rapid Antigen COVID-19 Test 

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SARS-CoV-2
27 May 2020
Avacta has partnered with Cytiva (formerly GE Healthcare Life Sciences) to develop a rapid lateral flow assay to detect antigens of SARS-CoV-2, for the consumer market. Sales, marketing and distribution firm Medusa19, say they see the kit being used at airports and businesses looking to reopen. 

FDA Clampdown on Non-Compliant COVID-19 Serology Test Manufacturers 

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SARS-CoV-2
25 May 2020
The US FDA has instructed a large cohort of COVID-19 serology test manufacturers not to distribute kits until they have complied with mandatory guidelines, which include submitting an FDA-EUA application, within a certain time-frame and/or not addressing issues on tests validaity.

Thermo Fisher's US Contract Will See 8 Million COVID-19 VTM-Filled Tubes Per Week

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SARS-CoV-2Specimen Transport
25 May 2020
Thermo Fisher produces Viral Transport Media (VTM)  that complies with US requirements for COVID-19 sample collection and have signed a contract with the government, allowing Thermo Fisher to expand and scale-up production capacity to 8 million per week. 

EKF Secures COVID-19 Novel Sample Collection Kit Manufacturing and Supply Contracts

PrimeStore VTM COVID19
Sample CollectionSpecimen TransportSwabs
22 May 2020
The PrimeStore® MTM COVID-19 sample collection device that inactivates viral RNA is in high demand and its manufacturer EKF Diagnostics has secured contracts and have doubled manufacturing capacity in the US and repurposed EU plants to meet demand. 

Baker Donates a SterilGARD® e3 to Support Medical Virologist in Their COVID-19 Response

Baker SterilGARD
Biological Safety CabinetsSARS-CoV-2
21 May 2020
Baker have donated a SterilGARD® e3 biological safety cabinet to Seeding Labs to support the public health efforts of Malawi University of Science and Technology (MUST) in Malawi's COVID-19 response.

Puritan - 4 Reasons They’re Not Your Ordinary Drugstore Swab

Puritan COVID Flock Swabs
Swabs Molecular AssaySwabs Virology
20 May 2020
Puritan’s 'FDA Preferred' HydraFlock® and PurFlock Ultra® swabs are highly sophisticated diagnostic tools. Their tips, handles and materials are ideally suited for COVID-19 testing. Puritan's foam and polyester swabs are also FDA listed as substitutes for flock.

Bioreagents Related to SARS-CoV-2 (COVID-19) Vaccine Development

Sino GeoVax COVID Vaccine
Assay Development
20 May 2020
To address this global public health crisis, unprecedented efforts are being made to study the culprit virus, SARS-CoV-2. Sino Biological is working to develop rapid diagnostic reagents, vaccines, and therapies against this virus.

Reliable COVID-19 Diagnostics with PCR and ELISA Tests from EUROIMMUN

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ELISAPCRSARS-CoV-2
19 May 2020
EUROIMMUN offers the EURORealTime SARS-CoV-2 for sensitive direct virus detection, as well as ELISAs based on spike protein domain S1 (IgG, IgA) or modified nucleocapsid protein (IgG). The IgG ELISAs demonstrate specificities of 99.6% and 99.8%.

Microbiologics Introduces New IVD & RUO SARS-CoV-2 Controls

QC and RUO IVD Controls for SARS-CoV-2
QC Molecular StandardsSARS-CoV-2
19 May 2020
Validate all stages of a molecular assay - extraction, reverse transcription, amplification, and detection with Microbiologics' new SARS-CoV-2 Process Control (RUO). An IVD control with the RdRp, S, E, and N gene targets is also now available.

Sample Collection and Swab Types for COVID-19 Testing

What to do if you dont have any nasopharyngeal swabs
SwabsSwabs with Transport Medium
19 May 2020
In this video, Norman Sharples, COPAN Diagnostics’ CEO runs through alternatives to collecting a nasopharyngeal specimen with a flocked swab for COVID-19 diagnosis.

SOLIScript® 1-step RT-qPCR CoV Kit for High Throughput COVID-19 Detection

SOLIScript 1-step RT-qPCR CoV Kit
Assay DevelopmentSARS-CoV-2
19 May 2020
SOLIScript® 1-step CoV Kit from Solis BioDyne is optimized for highly sensitive detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA by one-step real-time RT-PCR (RT-qPCR). Reagents are stable at room temperature enabling easy ice-free shipping and reaction set-up.

A Collection of Antigens and Monoclonal Antibodies for SARS-CoV-2

Sino SARS 2 Antigens Antibody
Assay DevelopmentSARS-CoV-2
19 May 2020
To support COVID-19 Research, Sino Biological has developed a collection of antigens and monoclonal antibodies. These reagents have supported hundreds of research groups around the globe for their vaccine and antibody development works. 

FDA-Cleared Liofilchem MTS™ (MIC Test Strip) Lefamulin (LMU)

MIC test strip
Antibiotic ResistanceAntibiotic SensitivityMIC (Minimum Inhibitory Concentration
18 May 2020
Liofilchem has received clearance from the FDA to market in the United States the Lefamulin 0.016-256 MTS™ (MIC Test Strip), a quantitative assay for determining the Minimum Inhibitory Concentration (MIC) of Lefamulin.

Abbott Agrees With FDA To Perform Post-Market Study on Questionable COVID-19 Test

Abbott ID NOW FDA investigation
SARS-CoV-2
18 May 2020
Abbott's ID NOW™ COVID-19 test goes under FDA's microscope after the US regulatory body received 15 adverse event reports suggesting inaccuracies. Abbott will conduct the study, involving 150 COVID-19 positive samples from a variety of clinical settings and promise to improve the test.

First-In-The-World SARS-CoV-2 Serology Test to Detect Neutralizing Antibodies

cPass COVID19
SARS-CoV-2
18 May 2020
Duke-NUS Medical School, GenScript Biotech Corporation and the Diagnostics Development Hub (DxD) have developed a rapid high-throughput assay that can detect neutralizing antibodies in one hour, without the need of live biological materials and biocontainment facility.

CHROMagar™ Serratia, First Chromogenic Medium for Serratia marcescens

Chromogenic media Serratia marcescens
Chromogenic MediaEnvironmental MonitoringHospital Acquired Infection (HAI)
15 May 2020
Serratia marcescens are implicated in nosocomial infections. Continuous surveillance demands effective recovery of clinical isolates and environmental samples.  CHROMagar™ has developed CHROMagar™ Serratia, the first chromogenic medium designed specifically to detect Serratia marcescens.

Rapid Concentration of SARS-CoV-2 in Wastewater for COVID-19 Monitoring - White Paper

How to test for SARS-CoV-2 in wastewater
Microbial ConcentratorsSARS in Wastewater
15 May 2020
The Innovaprep white paper describes how the Concentrating Pipette (CP) Select™ can be used to concentrate SARS-CoV-2 virus from wastewater, detecting at very low concentrations from about 10 copies per 100 mls. of influent to 120 copies per 100 liters of effluent.

One Hour CRISPR-Based COVID-19 Test Gets FDA-EUA

SHERLOCK
SARS-CoV-2
12 May 2020
The Sherlock™ CRISPR SARS-CoV-2 kit can provide results in one hour and has recently been granted EUA from the FDA. The kit works by programming a CRISPR molecule to detect SARS-CoV-2 and when found its enzyme is activated and releases a detectable signal.

Gemini Bio Announces Its Dedicated Effort to Help Support COVID-19 Research

GeminiMoxi
SARS-CoV-2
12 May 2020
Gemini Bioproducts has announced its effort to help support COVID-19 research by prioritising products and services to assist its customers in four key areas: (1) cell culture, (2) viral harvesting and transport, (3) research tools, and (4) analytical instruments.

Identifying Targets for Development of COVID-19 Drugs & Vaccines

Lentivirus
Assay Development
11 May 2020
AMSBIO has extended its COVID-19 research portfolio with the introduction of a service to provide custom lentivirus pseudotyped with spike glycoprotein from SARS-CoV-2 to help researchers identify potential targets for the development of therapeutic drugs and vaccines.

Hands-Free LabElite Products Aid COVID-19 Efforts; Now Available with Fast-Ship Priority

LabElite
SARS-CoV-2Workflow Optimization
07 May 2020
As part of Hamiltons aid in fighting the SARS-CoV-2 pandemic; it is fast-tracking orders on products used to research the virus. They have now added the hands-free LabElite DeCapper and I.D. Capper products; which automate tube capping, protects users from infection and prevents contamination. 

A SARS-CoV-2 Extraction and Processing Workflow Without Delay

MagEx StARlet
SARS-CoV-2Workflow Optimization
07 May 2020
Hamilton's MagEx STARlet automated workstation has been pre-scripted with Zymo Research's Quick-DNA/RNA™ Viral MagBead Kit. This now provides a fully automated SARS-CoV-2 sample handling workflow which includes sample extraction, purification and processing. 

Roche COVID-19 CE-Marked Serology Test is Granted EUA by US FDA

Elecsys
SARS-CoV-2
05 May 2020
Roche’s Elecsys® Anti-SARS-CoV-2 immunoassay has a specificity higher than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation). It runs on cobas e analysers and can give a result in approx. 18 minutes for one single test, with a test throughput of up to 300 tests/hour.

Bio-Rad's SARS-CoV-2 Assay is First Total Antibody Test To Receive FDA-EUA

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SARS-CoV-2
01 May 2020
Bio-Rad's Platelia SARS-CoV-2 Total Ab assay has been granted FDA-EUA. Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 per cent and diagnostic sensitivity of 98 percent.

Creative Diagnostics Launches SARS-CoV-2 Antigens and Antibodies for Research Use

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AntibodiesAssay DevelopmentSARS-CoV-2
01 May 2020
Creative Diagnostics launches SARS-CoV-2 antigens and antibodies for global researchers.

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