COVID-19 test kits offered by Carolina Liquid Chemistries granted FDA emergency use authorization

Carolina Liquid Chemistries, Corp. (CLC), an innovative leader in clinical diagnostics and drug screening, is now offering test kits for COVID-19 that have been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA), pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Among the test kits are two real-time RT-PCR (reverse transcriptase polymerase chain reaction) 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. 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).

As case numbers have increased, so has demand for testing and the importance of trustworthy supply sources. Carolina Liquid Chemistries has been sourcing and manufacturing diagnostic test kits for over 25 years. It made sense for us to leverage our product sourcing capability to fill this need in the healthcare supply chain.”

Phillip Shugart, Founder and CEO, Carolina Liquid Chemistries, Corp.

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% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, 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% confidence. Clinical validation of the assay showed 95% sensitivity and a specificity of 100%, 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, manufactured by Assure Tech. (Hangzhou) Co., Ltd., 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. Results are produced in 15 minutes.

CLC also now carries sample collection and transportation supplies, including ultra-thin nasal and nasopharyngeal flocked swabs and Bartels FlexTrans™ Medium, an FDA 510(k) cleared viral transport medium (VTM) intended to stabilize viruses and suppress microbial contamination during transport of clinical specimens from the point of collection to the testing site. Prior to use, Bartels FlexTrans™ VTM can be conveniently stored at room temperature.

COVID-19 test kits offered by Carolina Liquid Chemistries are for use in authorized laboratories only. These and other FDA EUA-granted test kits have not been FDA cleared or approved and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Refer to carolinachemistries.com for instructions for use, fact sheets, FDA EUA letters, clinical performance studies, and material safety data sheets.