Carolina Liquid Chemistries Secures FDA Emergency Use Authorization for COVID-19 Test Kits

(CLC, Greensboro, NC, USA) has been granted FDA emergency use authorization for its COVID-19 test kits.

CLC’s COVID-19 test kits include two real-time reverse transcriptase polymerase chain reaction (RT-PCR) diagnostics, the DiaCarta RT-PCR QuantiVirus SARS-CoV-2 Test Kit and QuantiVirus SARS-CoV-2 Multiplex Test Kit. Both are 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.

The DiaCarta RT-PCR QuantiVirus SARS-CoV-2 Test Kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum. The sensitivity is 100 copies per mL of SARS-CoV-2 viral with a 95% confidence. The assay is highly specific without cross-reaction with different types of non-SARS-CoV-2 species tested, and clinical validation shows 96.7% sensitivity and 100% specificity. Three genes of the SARS-CoV-2 including N, Orf1ab and E, are targeted in the qRT-PCR assay and primers and Taqman probes are designed in the conserved region of the SARS- CoV-2 virus-specific genome region to allow sensitive and specific amplification and detection of the virus. The human RNase P gene is used as internal and extraction control to monitor viral RNA extraction efficacy and assess amplifiable RNA/DNA in the samples to be tested.

The QuantiVirus SARS-CoV-2 Multiplex Test Kit is an enhanced throughput version of the QuantiVirus SARS-CoV-2 Test Kit. Based on real-time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) technology, it is highly specific for the detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal, and sputum samples. The level of detection is 50 copies per mL of SARS-CoV-2 viral load with a 95% confidence. Clinical validation of the assay shows 95% sensitivity and 100% specificity, with no cross-reaction to different types of non-SARS-CoV-2 species. The QuantiVirus SARS-CoV-2 Multiplex Test Kit combines four genes into one reaction well and increases throughput significantly to 93 samples in a 96 well plate or 381 samples in a 384 well plate.

“As case numbers have increased, so has demand for testing and the importance of trustworthy supply sources,” said CLC founder and CEO Philip 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.”

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