Covid-19 test kits from Carolina Liquid Chemistries (CLC), Greensboro, NC, have been granted FDA emergency use authorization. The kits include two real-time reverse transcriptase polymerase chain reaction (RT-PCR) diagnotics 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 as well as supplies such as swabs and viral transport media.
“As case numbers have increased, so has demand for testing and the importance of trustworthy supply sources,” says CLC founder and CEO Phillip Shugart. “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.”
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, China, 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 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 stored at room temperature.
For more information, visit Carolina Liquid Chemistries.