Title
Evaluation of the SMARTCHEK Genesystem RT-qPCR assay for the detection of SARS-CoV-2 in clinical samples
Date Issued
01 December 2022
Access level
open access
Resource Type
journal article
Publisher(s)
BioMed Central Ltd
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.
Volume
22
Issue
1
Language
English
OCDE Knowledge area
Biotecnología relacionada con la salud Bioquímica, Biología molecular
Scopus EID
2-s2.0-85127463119
PubMed ID
Source
BMC Infectious Diseases
ISSN of the container
14712334
Sponsor(s)
This work was supported by the Instituto Nacional de Salud under the Project "Platform for the genotyping of SARS-CoV-2 virus" (D.R. No. 191-2020-OGITT/INS).
Sources of information: Directorio de Producción Científica Scopus