Abstract
Background: The COVID-19 pandemic remains the main public health problem, due to the quick and easy dissemination of the causal agent, SARS-CoV-2 virus, around the world. Since the beginning of the pandemic, an opportune laboratory diagnosis has been critical to respond this emergency, and RT-qPCR has been used as reference molecular tests for detection of SARS-CoV-2.
Methods: In this study, we performed the evaluation of a RT-qPCR SMARTCHEK platform (SMARTCHEK, Genesystem) for SARS-CoV-2 detection based on the amplification of RdRp and N gene markers. The platform was evaluated with nasopharyngeal swab samples corresponding to 360 suspected cases of COVID-19 which were remitted to Instituto Nacional de Salud in Peru. This quick method was compared with conventional RT-qPCR as gold standard.
Results: The RT-qPCR SMARTCHEK showed a 98.1% sensitivity (CI: 93.3-99.8%), a 98.8% specificity (CI: 96.6-99.8%), a 97.2% positive predictive value (CI: 92-99.4%) and a 99.2% negative predictive value (CI: 97.2-99.9%). The assay demonstrated a strong agreement between the RT-qPCR SMARTCHEK and conventional RT-qPCR (kappa value ≥ 0.966).
Conclusion: The RT-qPCR SMARTCHEK is a platform that gives reliable and fast results, with high sensitivity and specificity for the detection of SARS-CoV-2, and it will be considered a suitable alternative to COVID-19 diagnosis in low-resource settings.
Keywords: COVID-19; Molecular diagnosis; RT-qPCR; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, RT-qPCR, Molecular diagnosis, 【초록키워드】 public health, SARS-CoV-2, pandemic, COVID-19 pandemic, Diagnosis, SARS-CoV-2 virus, Predictive value, Laboratory, Nasopharyngeal swab, amplification, SARS-CoV-2 detection, sensitivity, specificity, RT-qPCR, Positive predictive value, Molecular diagnosis, Sensitivity and specificity, qPCR, COVID-19 diagnosis, gold, RdRP, laboratory diagnosis, N gene, dissemination, Critical, platform, Molecular tests, Nasopharyngeal swab samples, Negative predictive value, health problem, gold standard, molecular test, nasopharyngeal swab sample, performed, evaluated, demonstrated, respond, 【제목키워드】 SARS-CoV-2, clinical sample,