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RT-PCR

Compared with RT-PCR testing, Abbott's BinaxNow test had a sensitivity of 64 percent for samples from symptomatic people and nearly 36 percent for asymptomatic people.

Released by the Pandemic Response Accountability Committee, the report looks at data on test volume, turnaround, cost, and usage at six federal agencies.

The pace of development for CRISPR-based infectious disease assays increased as the pandemic progressed, more funding became available, and collaboration accelerated. 

The two new tests, which have the capability to quantify a patient's viral load, have been designed without external RNA extraction or amplification steps.

The agency also helped fund the development of the Revogene SARS-CoV-2 assay, which detects RNA targets directly from viral transport media without pre-dilution.

The panel simultaneously tests for SARS-CoV-2 and influenza viruses A and B, while a second analysis detects for human respiratory syncytial virus and human metapneumovirus.

The PCR-based kit allows laboratories to test for the diseases, which share clinical symptoms, in approximately three hours.

The EUA from FDA is the first for a diagnostic test for at-home, self-collection of patient samples for detecting the coronavirus and the flu.

The company plans to increase the capacity of its CLIA-certified laboratory to about 100,000 SARS-CoV-2 tests per day by the end of 2020.

The firm's new application of its BCR-ABL test will be able to detect p190 transcripts and is currently for research use only.

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