Comparative Performance of Four Nucleic Acid Amplification Tests for SARS-CoV-2 Virus

BACKGROUND: COVID-19 is caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), which was discovered in 2019 and spread around world a short time. SARS-CoV-2 nucleic acid amplification tests (NAATs) have been rapidly developed quickly applied to clinical testing of COVID-19. Aim this study evaluate performance four NAAT assays. METHODS: Limit detection (LOD), precision, accuracy, analytical specificity interference studies on NAATs (Daan, Sansure, Hybribio, Bioperfectus) were performed according Clinical Laboratory Standards Institute protocols guidelines. The compared using 46 samples. RESULTS: LOD N gene for Daan, Hybribio 500 copies/mL, that Bioperfectus 1,000 copies/mL. ORF1ab Bioperfectus, 3,000 Sansure 2,000 A good precision shown at concentration above 20% all NAATs, with individual coefficients variation below 3.6%. Satisfactory results also observed specificity, tests. comparison test showed could detect samples 100% (30/30) sensitivity (16/16), whereas detected 81.25% (13/16). However, no significant difference found between three other (p > 0.05). CONCLUSIONS: comparable performance, lower than gene.