Kost, G.J. The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses. Diagnostics2023, 13, 3223.
Kost, G.J. The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses. Diagnostics 2023, 13, 3223.
Kost, G.J. The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses. Diagnostics2023, 13, 3223.
Kost, G.J. The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses. Diagnostics 2023, 13, 3223.
Abstract
Abstract: A prevalence boundary (PB) marks the point in prevalence where the false omission rate, RFO=FN/(TN+FN), exceeds the tolerance limit for missed diagnoses. Objectives were to mathematically analyze rapid antigen test (RAgT) performance, determine why PBs are breeched, and evaluate the merits of testing three times over five days, now required by the US Food and Drug Administration for asymptomatic persons. Equations were derived to compare test performance patterns, calculate PBs, and perform recursive computations. An independent July 2023 FDA-university-commercial evaluation of RAgTs provided performance data used in theoretical calculations. Tiered sensitivity/specificity comprise: Tier-1) 90%, 95%; Tier-2) 95%, 97.5%; and Tier-3) 100%, ≥99%, respectively. Repeating a T2 test improves the PB from 44.6% to 95.2% (RFO 5%). In the FDA-university-commercial evaluation, RAgTs generated sensitivity of 34.4%, which improved to 55.3% when repeated, then 68.5% with the third test. With RFO=5%, PBs were 7.37/10.46/14.22%, respectively. PB analysis suggests RAgTs should achieve clinically proven sensitivity of 91.0-91.4%. When prevalence exceeds PBs, missed diagnoses can perpetuate virus transmission. Repeating low-sensitivity RAgTs delays diagnosis. In homes, high-risk settings, and hotspots, PB breaches may prolong contagion, defeat mitigation, facilitate new variants, and transform outbreaks into endemic disease. Molecular diagnostics can help avoid these potential vicious cycles
Keywords
Coronavirus disease-2019 (COVID-19); Emergency Use Authorization (EUA); false negative (FN); false omission rate (RFO); point-of-care testing (POCT); prevalence boundary (PB); rapid antigen test (RAgT); repeated testing; sensitivity and specificity; tier
Subject
Medicine and Pharmacology, Epidemiology and Infectious Diseases
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
