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22nd November 2021  Content supplied by: various sources as indicated

COVID-19 Diagnostics - Nov 2021: Report

The US FDA has issued a recall of 2 million Ellume COVID-19 antigen tests after 35 false positives were reported to the agency's MedWatch portal. The manufacturing error has been identified but not made public; however, the US FDA says they are working closely with the company to assess their additional checks and corrective actions to resolve the matter.

EUROIMMUN has released a multiplex CE-marked EURORealTime assay to the SARS-CoV2 and Influenza diagnostics market. The test can simultaneously detect both A and B Flu lineages and also the virus that causes COVID-19. The assay targets ORF1ab and N genes of the SARS-CoV-2 genome and one single target for Influenza A and B. The test has been validated for all real-time PCR cycles. 

At OraSure Technologies' recent Q3 earnings summary, CEO Stephen Tang discussed contracts worth $314 million with the Department of Defense to supply their Intelliswab test and to expand their manufacturing capacity. OraSure has also secured a BARDA contract to ensure Intelliswab obtains full FDA authorization post-pandemic. The majority of questions from stakeholders related to OraSure's failure to fulfill almost $400 million worth of customer orders (Walmart, Walgreens, and Fortune 500 companies). Stephen Tang said the delay and complications were due to a change from a manual manufacturing process to a more automated one.

Takara Bio Europe (TBE) has launched its SARS-CoV-2 Direct PCR detection kit in Europe with recently acquired CE-marking. The test doesn't require RNA extraction, and crude samples such as saliva or nasopharyngeal swabs can be tested quickly with their streamlined protocol that returns results in 60 minutes. The test detects N1 and N2 nucleocapsid genes (CDC) and contains a human RNase P (RP) gene as an internal control.

Celltrion (South Korea) has obtained FDA-EUA for its Diatrust™ COVID-19 antigen test for home use. The test is lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor-binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2 and returns results in 15 minutes. 

InBios International has received FDA-EUA for its SCoV-2 Ag Detect Rapid Self-Test, an over-the-counter SARS-CoV-2 antigen test designed for use at home. The test detects the nucleoprotein antigen and returns results in 20 minutes. It has been authorized for both symptomatic and asymptomatic individuals, when tested twice over three days and at least 24 hours and no more than 48 hours between tests.



Date Published: 22nd November 2021

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