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The prescription-only test from Symbiotica is designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick.
The test runs on DiaSorin's Liaison XL Analyzer and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.
Quidel also announced it has been named the official diagnostics partner of the San Diego Padres Major League Baseball team.
Of the 31 companies in the index, 11 firms saw their stock prices increase, while 20 saw their share prices decline.
The latest US Food and Drug Administration Emergency Use Authorizations allow the tests to be used for serial testing in asymptomatic individuals.
Amazon said that it will use its test for employees and other individuals who enter its facilities as part of its COVID-19 preparedness and response program.
The chemiluminescent immunoassay may be used by laboratories CLIA-certified to perform moderate- or high-complexity tests, the FDA said.
The hybridization-based test may provide better detection of emerging COVID-19 variants of concern, due to a higher tolerance for probe mismatches than in PCR.
The test measures IgG antibodies directed to the spike protein of the virus and has demonstrated 99.9 percent specificity and 98.9 percent sensitivity.
A prescription-only version of the test was first authorized last year for the detection of three SARS-CoV-2 genes in a range of samples.