UJI GENE-XT BERBASIS RT-LAMP SEBAGAI SISTEM DETEKSI VIRUS SARS-COV-2 PADA APLIKASI KLINIS

Background: So far, SARS-CoV-2 has been detected using Reverse Transcription – Real Time Polymerization Chain Reaction (RT-qPCR) as the Gold Standard. Although this method is used as the basis for virus discovery by WHO, it has several limitations. Therefore, a faster virus and simpler detection method is needed. The method is Reverse Transcription – Loop Mediated Isothermal Amplification (RTLAMP). The purpose of this study was to determine whether the results obtained from the detection of SAR-CoV-2 using RT-LAMP-based GENE-XT in clinical samples compared to RT-qPCR are in agreement. Materials and Methods: This study used samples from swab specimens positive and negative for SARS-CoV-2. To find out the agreement of results, amplification was performed using ReverseTranscriptase Polymerase Chain Reaction (RT-qPCR). Then the amplification was carried out with Reverse Transcription – Loop Mediated Isothermal Amplification (RT-LAMP). Next, analysis of method’s sensitivity, specificity, Predictive Value (+/-), Likelihood Ratio (LR +/) and Cohen's Kappa Coefficient were carried out. Results: Sensitivity 93.3%, Specificity 100%, PPV 100%, NPV 93.75%, LR (+) infinity, LR (-) 0.0067, Kappa Cohen coefficient K=0.934. Conclusion: There is an almost perfect agreement between the positive and negative SARS-CoV-2 specimens tested by RT-qPCR and RT-LAMP.