Iranian journal of microbiology · 2025
Diagnostic value comparative analysis of the commercial kits for the detection of SARS-CoV-2 in clinical samples: a systematic review and meta-analysis.
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Kadivarian Sepide, Rostamian Mosayeb, Kooti Sara, Dashtbin Shirin, Hosseinabadi Somayeh, Abiri Ramin, Alvand Amirhooshang
Аннотация
BACKGROUND AND OBJECTIVES: Rapid and accurate identification of suspicious SARS-CoV-2 patients is essential in controlling the infection. Numerous commercial kits are developed which target diverse regions of the SARS-CoV-2 virus genome. This systematic review addresses the lack of comprehensive analyses comparing the diagnostic value of commercial kits for SARS-CoV-2 detection. We aimed to compare diagnostic value of commercial SARS-CoV-2 kits in clinical samples using a systematic review and meta-analysis method.
MATERIALS AND METHODS: A comprehensive search was conducted on main databases of Medline (PubMed), Embase, Web of Science and Scopus from 2019 to October 2021 using the appropriate keywords. Systematic Reviews and Meta-Analysis guideline PRISMA checklist was used to select eligible studies.
RESULTS: The most frequent introduced kits were from USA (33 cases) and China (27). Among all studies, 11, 9 and 7 papers had assessed FDA -CDC, Sansure and Allplex kits, respectively. The majority of the kits were based on RT-PCR (52 cases) and the most frequent genes target was N protein (63 cases). The overall sensitivity of the kits was 80.5%. The lowest sensitivity was reported for Daan Kit, while the highest sensitivity was seen for many kits. The specificity of the kits ranged from 87.9% to 99.8% and the overall specificity was 97.9%. Both PPV and NPV of the kits ranged from 87.9% to 99.8% for PPV and 82.9% to 99.8% for NPV.
CONCLUSION: Based on DOR obtained from three different formulas, GeneFinder, InBios, NxTAG, Simplexa and FDA-CDC kit have better detection performance. The GeneFinder Kit appears to be among the more suitable options regarding cost-effectiveness for each reaction.
MATERIALS AND METHODS: A comprehensive search was conducted on main databases of Medline (PubMed), Embase, Web of Science and Scopus from 2019 to October 2021 using the appropriate keywords. Systematic Reviews and Meta-Analysis guideline PRISMA checklist was used to select eligible studies.
RESULTS: The most frequent introduced kits were from USA (33 cases) and China (27). Among all studies, 11, 9 and 7 papers had assessed FDA -CDC, Sansure and Allplex kits, respectively. The majority of the kits were based on RT-PCR (52 cases) and the most frequent genes target was N protein (63 cases). The overall sensitivity of the kits was 80.5%. The lowest sensitivity was reported for Daan Kit, while the highest sensitivity was seen for many kits. The specificity of the kits ranged from 87.9% to 99.8% and the overall specificity was 97.9%. Both PPV and NPV of the kits ranged from 87.9% to 99.8% for PPV and 82.9% to 99.8% for NPV.
CONCLUSION: Based on DOR obtained from three different formulas, GeneFinder, InBios, NxTAG, Simplexa and FDA-CDC kit have better detection performance. The GeneFinder Kit appears to be among the more suitable options regarding cost-effectiveness for each reaction.