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News : clinical, Aug 2020

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Effective Buccal Swab RNA Extraction for COVID-19 Diagnostic Testing

RNA Extraction Buccal Swab Porvair COVID SARS
SARS-CoV-2
31 Aug 2020
The Chromatrap® Homogeniser Spin Column from Porvair Sciences has been adapted for COVID-19 to ensure an improved yield and quality of viral RNA from nasal and throat swab samples. 

Abbott's Affordable BinaxNOW™ COVID-19 Antigen Test Receives FDA Authorization

COVID SARS Antigen Rapid ABBOTT FDA EUA
Lateral Flow AssaysSARS-CoV-2
31 Aug 2020
Abbott's new antigen test to detect an active infection of SARS-CoV-2 in patients has been granted an FDA-EUA. Abbott claim the test has shown excellent diagnostic accuracy in studies and is very affordable at just $5 per test. A digital health pass (QR code) is available as standard. 

Flu, RSV and SARS-CoV-2 Winter Test Panel Now Available in Europe

SARS influenza RSV CE Primer Genesig Novacyt
InfluenzaRespiratory Syncytial Virus (RSV)SARS-CoV-2
31 Aug 2020
The genesig® Winterplex Test panel can distinguish between SARS-CoV-2, Influenza A & B and RSV, requiring just one sample from the patient. Primerdesign's original SARS-CoV-2 assay was one of the first to be recommended by WHO to detect the virus. 

Yale and NBA Team-up for COVID-19 Game Changer

Image not available
SARS-CoV-2
24 Aug 2020
Yale University has been granted EUA from the US FDA for its SalivaDirect COVID-19 testing protocol. The method is seen as a game-changer by many, as it avoids the use of reagents prone to global shortages and is a non-invasive technique, requiring only a saliva specimen. 

New High Capacity Square Anaerobic Jar

nox 18 SY Lab easiest high sample anaerobic jar
Anaerobic/Microaerophilic Environments
19 Aug 2020
Small footprint – high sample capacity - nox.18 - the new square jar - making anaerobic incubation much simpler!

A Faster & Improved Microbiology Workflow Now Available in Europe 

BD Kiestra InoquIA Synapsys
BioinformaticsLaboratory AutomationLiquid Handling
17 Aug 2020
The BD Kiestra™ InoqulA system is now available in Europe. This automated standalone microbiology workflow allows users to switch seamlessly between two modes to process liquid and non-liquid samples, and with the BD Synapsys™ informatics solution provides complete traceability. 

RT-PCR & MALDI-TOF COVID-19 Assay Receives FDA Authorization

Ethos COVID SARS 2 MALDI TOF RT PCR
MALDI-TOFSARS-CoV-2
17 Aug 2020
Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay has received FDA-EUA. The test utilizes both RT-PCR and ionization technology for the qualitative detection of viral RNA from a swab sample. The test is also authorized to take samples from Ethos At-home-Collection-kit. 

UK Completes Assessment of COVID-19 Lateral-Flow IgG Kits

UK Antibody IgG COVID 19
SARS-CoV-2
14 Aug 2020
The UK Government has published a peer-reviewed study on lateral-flow immunoassay (LFIA) COVID-19 kits that detect IgG only. LFIA were shown to have inferior sensitivity to ELISA but had high specificity, and were shown to be used competently by general public. 

WHO Look to Improve COVID-19 Test Evaluation

WHO COVID 19 survey
SARS-CoV-2
13 Aug 2020
The World Health Organization has drafted new criteria on high volume and near-patient antibody and viral detection COVID-19 assays. The purpose of which is to improve its assessment of test kits on a case-by-case basis. Deadline for comments is 19 August. 

New Mouse-Derived Monoclonal Antibodies for COVID-19 Research 

Image not available
AntibodiesAssay DevelopmentSARS-CoV-2
10 Aug 2020
ViroStat has developed and released a set of new monoclonal antibodies to the nucleocapsid of the COVID-19 virus. These final 5 antibodies were selected from an initial group of 60 based upon highest binding affinity and best ELISA pairing for detection of native viral antigen.

COVID-19 Testing Lab is Granted FDA-EUA for Speedy Viral RNA Extraction Technique

Quest COVID 19 Viral RNA extraction
Nucleic Acid Extraction
10 Aug 2020
Quest Diagnostics has received FDA-EUA for a new viral RNA extraction technique that will increase its testing capacity to 185,000 per day. The method extracts RNA with the Mag-Bind Viral RNA Xpress Kit (Omega Bio-Tek) and the Hamilton MagEx STAR.

Dried Blood Spot Test Alleviates Constraints With COVID-19 Testing Says Perkin Elmer 

Perkin Elmer dried blood spot covid 19 gsp delfia igG
SARS-CoV-2
10 Aug 2020
Perkin Elmer has launched a dried blood spot test for COVID-19 serology IgG testing. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing. The product is CE-IVD marked and planned for US FDA-EUA.

High-Throughput COVID-19 Testing Enabled by Fluent Liquid Handling 

Thermo Fisher COVID 19 Amplitude
Liquid HandlingSARS-CoV-2
10 Aug 2020
Thermo Fisher Scientific has introduced a new highly-automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources.

Collect and Preserve Clinical Specimens Containing Viruses, Including SARS-CoV-2 (COVID-19)

Viral Transport Medium
ChlamydiaMycoplasmaSARS-CoV-2
06 Aug 2020
Liofilchem VTM is suitable for the collection and preservation of clinical specimens containing viruses, including SARS-CoV-2 (COVID-19), Chlamydia spp., Mycoplasma spp. and Ureaplasma spp.

Quantitative RUO COVID-19 ELISA Will Help Vaccine Developers

RUO COVID-19 ELISA for Vaccine Developers
ELISASARS-CoV-2
04 Aug 2020
COVID-SeroIndex test kit is an ELISA assay, designed to measure the presence or absence of anti-COVID-19 antibodies in addition to measuring the titer of antibodies a person has produced.  It utilizes not one, but two virus antigens: the full-length spike protein, and its receptor binding domain.

LabVantage COVID-19 LIMS Solution Implemented for Onsite Workplace Health and Safety

COVID-19 LIMS solution
LIMSSARS-CoV-2
04 Aug 2020
The COVID-specific LIMS solution incorporates LabVantage’s deep knowledge of laboratory workflows, along with numerous features designed to make it easy for laboratories to perform coronavirus testing using RT-PCR, isothermal nucleic acid amplification, and serology methods.

FDA Recommendations for COVID-19 Diagnostics for Use In Non-Lab Settings

COVID-19 Diagnostics for Non-Lab Settings
Lateral Flow AssaysSARS-CoV-2
04 Aug 2020
The FDA has posted a new template for commercial developers to help them submit EUA requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

RT-LAMP With Nanosequencing - LamPORE COVID-19 Testing to be Rolled Out by UK Government

LamPORE SARSCoV2 assays
LAMP/Isothermal AmplificationSARS-CoV-2
03 Aug 2020
LamPORE is a precise, rapid, low-cost and highly scalable assay for the detection of SARS-CoV-2, designed to test saliva and swab RNA samples from either symptomatic or asymptomatic people. Using RT-LAMP to amplify specific viruses and nanopore sequencing to identify the amplified viruses.

Microbiologics Expands Viral Capabilities for SARS-CoV-2 With New BSL-3 Laboratory

BSL3 Virology Testing Service
Assay DevelopmentSARS-CoV-2
03 Aug 2020
With new virology services capabilities, Microbiologics has launched a menu of cell-based services for SARS-CoV-2 to assist assay developers, evaluate therapeutic solutions and vaccines, and provide inactivated intact virus to researchers and diagnostic companies.

Self-Collected Saliva-based COVID-19 RT-PCR Test Receives FDA EUA

Image not available
Contract Service LaboratorySARS-CoV-2
03 Aug 2020
The test, shown in CRL's EUA studies to be more sensitive and accurate than the standard COVID-19 anterior nasal swab test, detects the presence of coronavirus in the saliva of the test taker.

Detect 3 Different SARS-CoV-2 Antigens With xMAP® Multi-Antigen IgG Assay - FDA EUA

Image not available
SARS-CoV-2
03 Aug 2020
The xMAP SARS-CoV-2 Multi-Antigen IgG Assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for both human serum and plasma (>14 days post-symptom onset) in clinical studies.

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