Evaluating diagnostic accuracies of Panbio™ test and RT-PCR for the detection of SARS-CoV-2 in Addis Ababa, Ethiopia using Bayesian Latent-Class Models (BLCM)

Abstract

Background Rapid diagnostics are vital for curving the transmission and control of the COVID-19 pandemic. Although many commercially available antigen-based rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 are recommended by the WHO, their diagnostic performance has not yet been assessed in Ethiopia. So far, the vast majority of studies assessing diagnostic accuracies of rapid antigen tests considered RT-PCR as a reference standard, which inevitably leads to bias when RT-PCR is not 100% sensitive and specific. Thus, this study aimed to evaluate the diagnostic performance of Panbio™ jointly with the RT-PCR for the detection of SARS-CoV-2. Methods A prospective cross-sectional study was done from July to September 2021 in Addis Ababa, Ethiopia, during the third wave of the pandemic involving two health centers and two hospitals. Diagnostic sensitivity and specificity of Panbio™ and RT-PCR were obtained using Bayesian Latent-Class Models (BLCM). Results 438 COVID-19 presumptive clients were enrolled, 239 (54.6%) were females, of whom 196 (44.7%) had a positive RT-PCR and 158 (36.1%) were Panbio™ positive. The Panbio™ and RT-PCR had a sensitivity (95% CrI) of 99.6 (98.4–100) %, 89.3 (83.2–97.6) % and specificity (95% CrI) of 93.4 (82.3–100) %, and 99.1 (97.5–100) %, respectively. Most of the study participants, 318 (72.6%) exhibited COVID-19 symptoms; the most reported was cough 191 (43.6%). Conclusion As expected the RT-PCR performed very well with a near-perfect specificity and a high, but not perfect sensitivity. The diagnostic performance of Panbio™ is coherent with the WHO established criteria of having a sensitivity ≥80% for Ag-RDTs. Both tests displayed high diagnostic accuracies in patients with and without symptoms. Hence, we recommend the use of the Panbio™ for both symptomatic and asymptomatic individuals in clinical settings for screening purposes.

COVID‐19 in Morocco's region: Observational study of prevalence in symptomatic adults using the PANBIOS® rapid antigen test September 2021

“…Others studies of symptomatic patients in the Netherlands and Spain found similar test sensitivity (respectively, 72% and 71%) and specificity (respectively, 100% and 99%) 11,12 . In contrast, a study made in Ethiopia shows better sensitivity 99.6% and a specificity of 99.1% using Bayesian latent‐class models 13 . This difference could be explained by the size of our sample and the fact that we only specify symptomatic patients.…”

“…11,12 In contrast, a study made in Ethiopia shows better sensitivity 99.6% and a specificity of 99.1% using Bayesian latent-class models. 13 This difference could be explained by the size of our sample and the fact that we only specify symptomatic patients.…”

“…indeed, studies have shown that the rapid PANBIOS ® test was more effective during the first 5 days after disease onset and the number of false negative tests in RDT increases with time after the onset of clinical symptoms and low Ct value, especially after more than 1-2 weeks. 13,[16][17][18][19] In some cases, however, antigen tests can give false-positive results: The result is positive when there is no viral infection.…”

“… 11 , 12 In contrast, a study made in Ethiopia shows better sensitivity 99.6% and a specificity of 99.1% using Bayesian latent‐class models. 13 This difference could be explained by the size of our sample and the fact that we only specify symptomatic patients. Another hypothesis could be the methods used, we used different tools to evaluate the performance of the rapid PANBIOS®, and a medical decision using JAMOVI was made.…”

“…Our study showed limits, and we found 4% false negative and 30% false positive in symptomatic patients; this difference may be due to several factors, the early or late onset of COVID‐19 disease; indeed, studies have shown that the rapid PANBIOS® test was more effective during the first 5 days after disease onset and the number of false negative tests in RDT increases with time after the onset of clinical symptoms and low Ct value, especially after more than 1–2 weeks. 13 , 16 , 17 , 18 , 19 …”