Diagnostic accuracy of the Panbio COVID-19 antigen rapid test device for SARS-CoV-2 detection in Kenya, 2021: A field evaluation

• DOI: 10.1371/journal.pone.0277657
• Publication Date: 2023-01-25T23:06:34Z
• Authors: Jack Karuga Irungu; Peninah Munyua; Caroline Ochieng; Bonventure Juma; Patrick Amoth; Francis Kuria; John Kiiru; Lyndah Makayotto; Ahmed Abade; Marc Bulterys; Elizabeth Hunsperger; Gideon O. Emukule; Clayton Onyango; Taraz Samandari; Beth A. Tippett Barr; Victor Akelo; Herman Weyenga; Patrick K. Munywoki; Godfrey Bigogo; Nancy A. Otieno; Jackton Azenga Ki...; Edwin Ochieng; Rufus Nyaga; Noah Hull; Amy Herman-Roloff; Rashid Aman
• Keywords: 2019-20 coronavirus outbreak; Betacoronavirus

Background Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, a long turnaround time. Antigen RDTs provide feasible alternative to rRT-PCR since they are quick, relatively inexpensive, do not require laboratory. WHO that Ag have sensitivity ≥80% specificity ≥97%. Methods This evaluation was conducted at 11 health facilities Kenya between March July 2021. We enrolled persons any age with respiratory symptoms asymptomatic contacts confirmed COVID-19 cases. collected demographic clinical information two nasopharyngeal specimens from each participant for RDT testing rRT-PCR. calculated diagnostic performance Panbio ™ against US Centers Disease Control Prevention’s (CDC) test. Results evaluated 2,245 individuals where 551 (24.5%, 95% CI: 22.8–26.3%) tested positive by Overall 46.6% (95% 42.4–50.9%), 98.5% 97.8–99.0%), PPV 90.8% 86.8–93.9%) NPV 85.0% 83.4–86.6%). Among symptomatic individuals, 60.6% 54.3–66.7%) 98.1% 96.7–99.0%). 34.7% CI 29.3–40.4%) 98.7% 97.8–99.3%). In onset <5 days (594/876, 67.8%), 67.1% 59.2–74.3%), 53.3% 40.0–66.3%) among those >7 (157/876, 17.9%). highest 87.0% 80.9–91.8%) cycle threshold (Ct) values ≤30. Conclusion overall were much lower than expected. high satisfactory; therefore, result may confirmation kit be useful as rapid screening tool only patients high-risk settings limited access A negative should interpreted based on epidemiological retesting