Evaluation of Panbio \(^{TM}\) COVID-19 Ag Rapid Test as a Point of Care for Triage of Symptomatic Patients at the Entry Points of a Public Hospital in Gabon

Abstract

Aims: Rapid antigen testing plays a crucial role in COVID-19 triage, particularly in settings where access to molecular diagnostics is limited. The aim of this study was to evaluate the performance of the PanbioTM COVID-19 Ag Rapid Diagnostic Test in symptomatic patients for the diagnosis of SARS-CoV-2 infection using RT-PCR as a reference technique in Gabon. Study Design: A cross-sectional incongruence study. Place and Duration of Study: Patients: Centre Hospitalier Universitaire d’Owendofrom February to June 2021. Methodology: Symptomatic patients aged 6 to 75 years old, presenting within six days of symptom onset were consecutively enrolled. Two nasopharyngeal swabs were collected from each participant: one was tested using the PanbioTM COVID-19 Rapid Diagnostic Test, and the second was analyzed by RT-PCR (Sansure Biotech) as the reference method. Sensitivity, specificity, positive and negative predictive values, as well as likelihood ratios, were calculated to assess the diagnostic performance of the PanbioTM RDT compared with RT-PCR. Results: Overall, 431 patients were included: 33.6% (n=145) tested positive by RT-PCR and by PanbioTMCOVID-19 Ag RDT (P=.9). The sensitivity of the test was 95.2% [90-98] and the specificity was 97.5% [95-99]. PanbioTMCOVID-19 Ag RDT showed a Sensitivity of 95.5% [90-98] among the participants with mild COVID-19 form while it was 90.9% [62.7-98.5] in those with moderate to severe form (P=.03). Conclusion: PanbioTM COVID-19 Ag RDT kit met the WHO cut-off standards for patients screening for COVID-19 when compared to the RT-PCR reference methods. This test is a good alternative for the screening, rapid clinical management of suspected COVID-19 patients. Future studies are needed to assess its diagnostic performance in asymptomatic individuals, who constitute an important reservoir for SARS-CoV-2 transmission.