EFFICACY OF PANBIOTM COVID-19 AG RAPID TEST IN SARS-COV-2 DETECTION: COMPARISON WITH RT-PCR TEST

Authors

  • Shabana Asif Margalla Hospital, Taxila
  • Aashi Ahmed HITEC, IMS, NUMS, Rawalpindi
  • Ambreen Gul HITEC Institute of Medical sciences(IMS, Taxila) NUMS,Rawalpindi
  • Tariq Abbasi Ayub teaching hospital, Abbottabad

DOI:

https://doi.org/10.55519/JAMC-04-S4-10113

Keywords:

SARS-CoV-19, COVID-19, Rapid antigen detection, Reverse transcriptase polymerase chain reaction, sensitivity, Specificity

Abstract

Background: Evidence on performance of Rapid Antigen Detection Tests to recognize SARS-CoV-2 symptomatic patients in our context is limited. This study was aimed to evaluate Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) in identifying SARS-CoV-2 infection in comparison with RT-PCR test. Methods: This cross-sectional validation study was carried out at Margalla Hospital, Taxila from October, 2020 to March, 2021. Three hundred and eighty-two participants of both gender and all ages, symptomatic for 3–4 days were included in this study. For each participant, two nasopharyngeal swabs were collected by trained lab technicians according to SOPs, one for Rapid Antigen Test and other for RT-PCR.Covid-19 antibodies were checked 4-6 weeks after symptoms among 77 randomly selected participants to further evaluate the performance of Rapid Antigen Test. Data was analyzed using SPSS-26. Results: The mean age of the participants was 43.1 years (SD= 15.9). More than half of participants were males (n=213%=55.8) and 169 (44.2%) were females. Sensitivity of Rapid Antigen Test was calculated to be 94.3%, whereas the specificity was 39.7%. Out of 34 RT-PCR negatives that were initially detected positive on Rapid Antigen Test, 33 demonstrated presence of COVID-19 antibodies. Conclusion: Panbio™ COVID-19 Ag Rapid Test was found to have 93.4% overall sensitivity and relatively low overall specificity (37.9%). Rapid antigen testing using Panbio™ COVID-19 Ag Rapid Test Device can be effectively used to scale up mass testing to interrupt transmissibility of COVID-19 infection by generating quick result.

Author Biographies

Shabana Asif, Margalla Hospital, Taxila

Dr Shabana Asif Consultant Pathologist Margalla Hospital, Taxila

Aashi Ahmed, HITEC, IMS, NUMS, Rawalpindi

Dr Aashi Mughal Associate Professor Department of Community Medicine

Ambreen Gul, HITEC Institute of Medical sciences(IMS, Taxila) NUMS,Rawalpindi

Assistant ProfessorBiochemistry department

Tariq Abbasi, Ayub teaching hospital, Abbottabad

Tariq Abbasi FCPS Chairperson; Anesthesia department Ayub teaching hospital, Abbottabad

References

Shrestha LB, Pokharel K. Standard operating procedure for specimen collection, packaging and transport for diagnosis of SARS-CoV-2. J Nepal Med Assoc 2020;58(228):627–9.

Olearo F, Nörz D, Heinrich F, Sutter JP, Roedl K, Schultze A, Wiesch JSZ, Braun P, Oestereich L, Kreuels B, Wichmann D, Aepfelbacher M, Pfefferle S, Lütgehetmann M. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. J Clin Virol 2021; 137: 104782.

Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ 2020;369:m1808.

Chaimayo C, Kaewnaphan B, Tanlieng N, Athipanyasilp N, Sirijatuphat R, Chayakulkeeree M, et al. Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. Virol J 2020;17(1):177.

Möckel M, Corman VM, Stegemann MS, Hofmann J, Stein A, Jones TC, et al. SARS-CoV-2 antigen rapid immunoassay for diagnosis of COVID-19 in the emergency department. Biomarkers 2021;26(3):213–20.

Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol 2020;42(1):13–21.

Pavelka M, Van-Zandvoort K, Abbott S, Sherratt K, Majdan M, Jarčuška P, et al. The impact of population-wide rapid antigen testing on SARS-CoV-2 prevalence in Slovakia. medRxiv 2020;2020:20240648.

Toptan T, Eckermann L, Pfeiffer AE, Hoehl S, Ciesek S, Drosten C, et al. Evaluation of a SARS-CoV-2 rapid antigen test: Potential to help reduce community spread? J Clin Virol 2021;135:104713.

Linares M, Pérez-Tanoira R, Carrero A, Romanyk J, Pérez-García F, Gómez-Herruz P, Arroyo T, Cuadros J. Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms. J Clin Virol 2020;133:104659.

Torres I, Poujois S, Albert E, Colomina J, Navarro D. Evaluation of a rapid antigen test (PanbioTM COVID-19 Ag rapid test device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients. Clin Microbiol Infect 2021;27(4):636.e1–636.e4.

Bujang MA, Adnan TH. Requirements for minimum sample size for sensitivity and specificity analysis. J Clin Diagn Res 2016;10(10):YE01–6.

Gremmels H, Winkel BMF, Schuurman R, Rosingh A, Rigter NAM, Rodriguez O, et al. Real-life validation of the PanbioTM COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection. EClinicalMedicine 2021;31:100677.

Krüttgen A, Cornelissen CG, Dreher M, Hornef MW, Imöhl M, Kleines M. Comparison of the SARS-CoV-2 Rapid antigen test to the real star Sars-CoV-2 RT PCR kit. J Virol Methods 2021;288:114024.

Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Domen J, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, McInnes MD, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 2021;3(3):CD013705

Bulilete O, Lorente P, Leiva A, Carandell E, Oliver A, Rojo E, et al. PanbioTM rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care. J Infect 2021;82(3):391–8.

Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, Martínez M, Poujois S, Forqué L, Valdivia A, Solano de la Asunción C, Ferrer J, Colomina J, Navarro D. Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect 2021(3):472.e7–472.e10.

Wagenhäuser I, Knies K, Rauschenberger V, Eisenmann M, McDonogh M, Petri N, et al. Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR. EBioMedicine 2021;69:103455.

Mistry DA, Wang JY, Moeser ME, Starkey T, Lee LY. A systematic review of the sensitivity and specificity of lateral flow 1 devices in the detection of SARS-CoV-2 2 3 4 Running Title: 5 Lateral Flow Devices for SARS-CoV-2. BMC Infect Dis 2021;21(1):1–4.

Downloads

Published

2022-10-11