COVID-19 test kits from Carolina Liquid Chemistries granted FDA EUA
Carolina Liquid Chemistries (CLC) is now offering test kits for COVID-19 that have been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Among the test kits are two RT-PCR test kits intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, and sputum from individuals suspected of COVID-19, according to a CLC press release.
CLC also offers manual and automated test kits intended for the qualitative detection of antibodies to SARS-CoV-2. In addition to these FDA EUA-granted tests, CLC also offers supplies such as swabs and viral transport media (VTM).
The DiaCarta RT-PCR QuantiVirus SARS-CoV-2 Test Kit targets three viral genes (Orf1ab, N and E) and has sensitivity of 100 copies per mL of SARS-CoV-2 with a 95 percent confidence. Clinical validation of the assay showed 96.7 percent sensitivity and a specificity of 100 percent, with no cross-reaction to different types of non-SARS-CoV-2 species.
Also available is an enhanced throughput version of this test kit called the QuantiVirus SARS-CoV-2 Multiplex Test Kit. The multiplex version has a level of detection of 50 copies per mL with a 95 percent confidence. Clinical validation of the assay showed 95 percent sensitivity and a specificity of 100 percent, with no cross-reaction to different types of non-SARS-CoV-2 species. The QuantiVirus SARS-CoV-2 Multiplex Test Kit increases throughput significantly to 93 samples in a 96-well plate or 381 samples in a 384-well plate.
The lateral flow COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It uses lateral flow chromatographic immunoassay for detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, serum, or plasma. This COVID-19 IgG/IgM Rapid Test cassette kit includes external positive and negative controls, as well as an internal control on the cassette, with results produced in 15 minutes.
