Evaluation of In Vitro Diagnostic Technologies for Sars-Cov-2 Detection
DOI:
https://doi.org/10.29070/vtsvsr19Keywords:
SARS-CoV-2, COVID-19, In Vitro Diagnostics (IVD), Antigen Tests, Antibody Tests, Nucleic Acid-PCRAbstract
The World Health Organization's classification of SARS-CoV-2 as a pandemic on March 11, 2020, has had a lasting influence on global health systems, continuing until March 2025. This study evaluates in vitro diagnostic (IVD) technologies for SARS-CoV-2 detection, focusing on datasets from the Indian Council of Medical Research (ICMR) and the Web of Science (WoS) repository. Analysis covers 2,882 approved commercial devices and test kits manufactured by 1,257 companies, alongside 12,886 related research publications. Among assay categories, antigen-based kits dominated (44%), followed by antibody assays (31%) and nucleic acid-PCR tests (23%). Validation studies revealed Nucleic Acid-PCR as the gold standard, with clinical sensitivity of 98.6%±2.0% and specificity of 99.3%±1.2%, while antigen-based kits offered the fastest detection, returning results within 15–30 minutes. False result analysis showed antigen kits with lower false positives (2.3–4.1%) and antibody kits with slightly fewer false negatives (4.6%). Limit of detection (LOD) evaluation indicated that 90% of antigen kits and 80% of PCR kits successfully identified positives at 1,000 viral copies or higher. This study highlights India’s significant role in diagnostic innovation during the pandemic and underscores the need for harmonized validation metrics, rapid testing platforms, and regulatory preparedness to strengthen global readiness for future outbreaks such as Disease X
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