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BillionToOne's assay detects SARS-CoV-2 in samples from nasal, nasopharyngeal, and oropharyngeal swabs and has a testing capacity of 1 million tests per day.
The test, which is also CE marked, is designed to run on the company's MosaiQ platform for blood grouping and transfusion-transmitted infection screening.
The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.
The lateral flow immunoassay is designed to rapidly detect and differentiate immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma.
The nanopore sequencing-based test is designed to both diagnose SARS-CoV-2 infection, as well as monitor mutations that may affect efforts to combat the virus.
The FDA has authorized the Assure COVID-19 IgG/IgM Rapid Test Device for use on fingerstick blood samples.
If the lateral flow assay receives US regulatory approval, it would be the first antigen test for use in both symptomatic and asymptomatic individuals.
Both of the RT-PCR-based tests use healthcare provider-collected samples and may be used by any lab CLIA-certified to perform high-complexity tests.
The test is designed to detect two regions within the virus' nucleocapsid gene in upper respiratory specimens, according to the Puerto Rico-based company.
One of the revisions specifies that the ID Now test is for use with specimens collected within the first week of symptom onset.