Diagnostic Performances of COVID-19 between Clinical Performance, False Omission Rate and Prevalence Boundaries of COVID-19 Rapid Diagnostic Kits using Visual Logistics
Diagnostic Performances of Covid-19 Rapid Diagnostic Kits using Visual Logistics
Keywords:
clinical performance, false omission rate, prevalence boundaries, rapid COVID-19 tests, antigenic tests (RAgTs), molecular tests (RMoTs)Abstract
Rapid diagnostic tests with good clinical performance are essential for effective infectious disease control. This study aimed to evaluate the utility of visual logistics in illustrating the clinical performance relationships of rapid COVID-19 test kits. Data on sensitivity and specificity for antigen tests (RAgTs) and molecular tests (RMoTs) were collected from the FIND and Thai FDA websites, covering reports from November 1, 2021, to June 30, 2022. The analysis categorized test kit performance into six groups: WHO criteria (9.0%), sub-tier level (7.0%), low-level (30.0%), Thai FDA criteria (26.3%), medium level at Tier 2 (24.4%), and high level at Tier 3 (3.3%). RAgTs showed low to medium clinical performance (sensitivity ≥ 94.2%, specificity ≥ 99.2%), while RMoTs exhibited moderate to high performance (sensitivity ≥ 98.4%, specificity ≥ 99.1%). Visual logistics revealed prevalence boundaries (PB) at 58.4%, 48.6%, 33.3%, 70.3%, 50.6%, and no boundary at a false omission rate (RFO) of 5%. RAgTs with moderate and high performance demonstrated acceptable positive predictive values (PPV) and negative predictive values (NPV) across various PB levels. In conclusion, visual logistics offers a practical tool for understanding clinical performance relationships of test kits and could be applied to other infectious diseases in the future.
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