Pre-marketing Evaluation of real-time RT PCR Test Kits for SARS-CoV-2 Detection: Thailand Emergency Use Authorization
Keywords:
SARS-CoV-2, real-time PCR, Test Kit EvaluationAbstract
During the outbreak of SARS-CoV-2 in Thailand, molecular testing by real-time RT-PCR was crucial for diagnosis and disease surveillance. Several commercial PCR test kits for SARS-CoV-2 diagnosis were available. Pre-marketing evaluation for Emergency Use Authorization (EUA) of those test kits was necessary for marketing in the country. The process is consisted of reviewing a dossier including a package insert and performing laboratory evaluation. The laboratory was performed using a panel of 5 positive RNA samples derived from SARS-CoV-2 cultured cells for analytical sensitivity and 5 negative SARS-CoV-2 samples for analytical specificity. All samples were extracted and serially-diluted for target gene testing, N, ORF1a/ab, E, RdRp and S, according to each test kit. A total of 41 test kits were examined. Thirty-six test kits (88%) passed the evaluation. Three (7%) and two (5%) test kits failed for analytic sensitivity and analytic specificity as compared with the target sensitivity and specificity of 80% and 99.8%, respectively. Analysis on variability of a cycle threshold (Ct) retrieved from all testing found no difference for any target genes. It is, therefore, important for laboratory personnel to carefully consider details of each test kit prior to testing for achieving accurate results.
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