Covid 19

Thomas Scientific Accelerates Investments in Molecular Diagnostics

The company’s new molecular diagnostics business unit is dedicated to serving the nation's independent testing and reference laboratories.

Covid 19

DiaSorin Molecular Gets More BARDA Funding to Submit Covid-19 Kits for FDA Clearance

The BARDA funding is for the validation and submission of the Simplexa Covid-19 Direct kit and the Simplexa Covid-19 & Flu A/B Direct kit for FDA 510(k) clearance.

Covid 19

Inside Track: The Virus That Took Over the World

COLA CEO Nancy Stratton offers a perspective on the impact covid-19 has had on clinical labs.

Quanterix Gets FDA EUA for Semi-Quantitative Covid-19 Antibody Test

Jan 8, 2021 | Covid 19

The covid-19 antibody test available on the Simoa HD-X Analyzer detects and quantitates IgG antibodies to SARS-CoV-2 in serum or EDTA plasma.

FDA Issues Alert to Clinical Laboratory Staff Regarding SARS-CoV-2 Viral Mutation

Jan 8, 2021 | Compliance, Covid 19, Molecular Diagnostics

The FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.

DxTerity Offers Covid-19 Tests for Sale on Amazon

Jan 8, 2021 | Covid 19, POC Reagents & Test Kits

The self-administered, noninvasive saliva kits are FDA authorized for use by both individuals with and without symptoms of covid-19.

Spectrum Solutions to Provide Saliva Collection Devices for British Covid-19 Testing Mandate

Jan 8, 2021 | Covid 19, Molecular Diagnostics

SDNA-1000 Saliva Collection Device will be used for an extensive countrywide mandate that includes testing every UK citizen once a week.

EUA for IL-6 Test to Help Assess Dysregulated Inflammation

Jan 8, 2021 | Clinical Chemistry Test Kits, Covid 19

Siemens Healthineers’ Advia Centaur Interleukin-6 test can be used to determine the risk of mechanical ventilation for hospitalized covid-19 patients.

Illumina, Helix to Assess Prevalence of New Covid-19 UK Variant in USA

Jan 6, 2021 | Covid 19

With support from the CDC, Illumina and Helix have already identified more than 50 cases of the new covid-19 variant in the United States.

NIH Develops Robust Covid-19 Serology ELISAs

Jan 5, 2021 | Covid 19, Hematology & Serology, Research

NIH researchers developed two covid-19 assays to detect the spike protein and receptor binding protein, achieving sensitivity of 100% and specificity of 100% using the Mitra Microsampler from Neoteryx.

Fulgent Genetics Awarded NYC Covid-19 School Testing Contract

Jan 5, 2021 | Covid 19

Through the agreement, Fulgent will provide covid-19 testing for thousands of students and employees at many K-12 schools in New York City on a daily basis.

Could a Breathalyzer Help Detect Covid-19? Indonesian Scientists Say They’ve Developed One

Jan 5, 2021 | Covid 19, Diagnostic Technologies

Researchers from Gadjah Mada University in Indonesia have developed a simple breathalyzer test that they say can electronically “smell’ coronavirus and detect infection in under 2 minutes.

FDA Issues Alert for Risk of False Results with Curative SARS-Cov-2 Test for Covid-19

Jan 4, 2021 | Covid 19

FDA issued a safety communication to alert patients and healthcare providers of the risk of false negative covid-19 results with the Curative SARS-Cov-2 test.