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Image: New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization (Photo courtesy of Visby Medical)

New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization

A new portable PCR COVID-19 test kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use in lab environments. More...
18 Sep 2020
Image: SARS-CoV-2 emerging from the surface of cells (Photo courtesy of NIAID)

New CRISPR-Based Rapid Test Detects as Many Cases as Standard COVID-19 Diagnostic

A newly-developed CRISPR-based test has shown improved sensitivity and can detect nearly as many cases as the standard COVID-19 diagnostic. More...
18 Sep 2020
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FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

The US Food and Drug Administration (FDA Silver Spring, MD, USA) has published comparative performance data for some authorized COVID-19 molecular diagnostic tests. More...
18 Sep 2020
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Self-Swab COVID-19 Collection Kit Receives FDA EUA for Use by CLIA-Certified Laboratories

The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to a new COVID-19 self-collection kit, enabling public health and large private labs to increase access to testing. More...
17 Sep 2020
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First-in-Class Rapid Diagnostic Test Measures COVID-19 Neutralizing Antibodies in Plasma and Serum

A new rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring the levels of functional SARS-CoV-2 neutralizing antibodies in a lateral flow assay format. More...
17 Sep 2020
Image: The cobas SARS-CoV-2 & Influenza A/B Test (Photo courtesy of Roche)

Roche Granted FDA Emergency Use Authorization for Cobas SARS-CoV-2 & Influenza A/B Test

Roche (Basel, Switzerland) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a rapid version of its Cobas SARS-CoV-2 & Influenza A/B test. More...
17 Sep 2020
Image: Histology of normal small intestinal mucosa in adequately treated celiac disease (A). Untreated coeliac disease shows the classic triad of infiltration of the epithelium with lymphocytes, crypt hyperplasia and villous atrophy (B) (Photo courtesy of Professor Jason Tye-Din, MBBS PhD).

Unique Antibody Profile Differentiates Gluten Sensitivity from Celiac Disease

Until recently, many doctors often dismissed the complaints of people who claimed to be sensitive to foods containing gluten but did not have celiac disease, a well-documented autoimmune disease triggered by exposure to the dietary protein found in wheat, rye, and barley. More...
17 Sep 2020