Comparison of RT-PCR Kits Currently in use for Covid-19 infection Diagnosis in Mongolia

Abstract

Background: 380 commercial kits have been developed and commercialized worldwide. In Mongolia we use Chinese, Russian, German, American, Korean and own country’s Kits for detection of Covid -19 infection. Only few studies are done for sensitivity and specificity analysis for commercial RT-PCR kits in our country. Aim: To evaluate specificity and sensitivity of commercial RT-PCR kits currently in use in our country. Materials and Methods: Commercially available 7 SARS-CoV-2 detection RT-PCR Kits were used for comparison and 94 participants, who are referred to National Center for Communicable Disease for detection of Covid-19 infections, included. Nasopharyngeal swab collected within 1-2 days after patient diagnosis. SARS-CoV-2 stock solution was diluted in 2 mL 0.9% NaCl solution for detection of RNA dependent screening. Samples were diluted by sequential dilution technique. Each dilution sample were tested by RT-PCR assays and determined Ct values. Results: Sensitivity and specificity of 7 RT-PCR Kits (Seegene “AllplexTM SARS-CoV-2 Assay” (Seegene), XABT “Multiple Real-Time PCR Kit for Detection of 2019-CoV” (Xabt), WANTAI “SARS-CoV-2 RT-PCR Kit” (Wantai), 3D MED “ANDIS SARS-CoV-2 and influenza A/B, RT-qPCR Detection Kit” (3D MED), CHOROS MNG “SARSCoV-2 RT-qPCR” (Choros MNG), BGI “Real-time fluorescent RT-PCR kit detecting 2019-nCoV” (BGI), SD Sensor “STANDART M nCoV Real-Time Detection kit” (SD Sensor)) currently in use were used for comparison. At least 6 positive results indicates “Positive” result. At least 6 negative results indicate “negative” result. 4 Kits (57.1%) detected all positive 62 cases as positive. 1 Kit (14.3%) detected 61 cases positive. 1 kit (14.3%) detected 58 cases as positive. 4 kits (57.1%) detected all 32 negative cases as negative. 2 Kits (28.6%) detected 30 cases as negative. 1 Kit (14.3%) detected 28 cases as negative. Sensitivity and specificity using 2x2 table showed 100% sensitivity is detected in Seegene, Wantai, Choros MNG, SD Sensor Kits, 98.38% in BGI Kit, 98.13% in 3D MED Kit, 93.54% in Xabt kit respectively. While high 100% specificity is detected in Xabt, Wantai, 3D MED, BGI Kits, 93.75% in Seegene, SD Sensor, 87.5% in Chorus MNG Kit. According to the negative and positive predictive value analysis Xabt, Wantai, 3D MED, BGI had 100% PPV, Seegene, Wantai, Choros MNG, SD Sensor Kits had 100% NPV. Conclusion: The sensitivity and specificity of the RT-PCR tests used in our country for the detection of COVID-19 infection differed. Seegene, Wantai, Choros MNG, and SD Sensor had high sensitivity, while Xabt, Wantai, 3D MED, and BGI had high specificity.