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Multicenter Study
. 2023 Jan 25;18(1):e0277657.
doi: 10.1371/journal.pone.0277657. eCollection 2023.

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

Jack Karuga Irungu  1 , Peninah Munyua  2 , Caroline Ochieng  3 , Bonventure Juma  2 , Patrick Amoth  4 , Francis Kuria  4 , John Kiiru  4 , Lyndah Makayotto  4 , Ahmed Abade  1 , Marc Bulterys  2 , Elizabeth Hunsperger  2 , Gideon O Emukule  2 , Clayton Onyango  2 , Taraz Samandari  2 , Beth A Tippett Barr  2 , Victor Akelo  2 , Herman Weyenga  2 , Patrick K Munywoki  2 , Godfrey Bigogo  3 , Nancy A Otieno  3 , Jackton Azenga Kisivuli  5 , Edwin Ochieng  6 , Rufus Nyaga  6 , Noah Hull  6 , Amy Herman-Roloff  2 , Rashid Aman  4
Affiliations
Multicenter Study

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

Jack Karuga Irungu et al. PLoS One. .

Abstract

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, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97%.

Methods: This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention's (CDC) rRT-PCR test.

Results: We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8-26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4-50.9%), specificity 98.5% (95% CI: 97.8-99.0%), PPV 90.8% (95% CI: 86.8-93.9%) and NPV 85.0% (95% CI: 83.4-86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3-66.7%) and specificity was 98.1% (95% CI: 96.7-99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3-40.4%) and specificity was 98.7% (95% CI: 97.8-99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2-74.3%), and 53.3% (95% CI: 40.0-66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9-91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30.

Conclusion: The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow diagram of enrolment of study participants and distribution by clinical status and test results in the field evaluation of the Panbio™ Ag RDT in Kenya, 2021.
Ag RDT, +ve, +ve, positive; -ve negative; antigen rapid diagnostic test; rRT-PCR–real time reverse transcriptase polymenrase chain reaction.
Fig 2
Fig 2. Distribution of Cycle threshold (Ct) values for rRT-PCR positive samples by Ag RDT result and by presence/absence of symptoms, Kenya 2021 (n = 551).
Ag RDT, antigen rapid diagnostic test; Ct, cycle threshold; n, number of; rRT-PCR–real time reverse transcriptase polymenrase chain reaction.
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