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According to College of American Pathologists, "Analytic performance of many SARS-CoV-2 diagnostic PCR tests approaches 100% at 500-5000 copies/mL; however, clinical performance of testing depends on biology and pre-analytic factors and only approaches 80% sensitivity and 98-99% specificity."
Bioperfectus Real-Time PCR Kit approaches 94.9% clinical sensitivity and 98.7% clinical specificity at 350 copies/mL with nearly 1,000 samples in clinical trials, which is applicable and well-recognized in the PCR laboratories around the world.
