Ewha Med J.  2023 Jan;46(1):e2. 10.12771/emj.2023.e2.

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

• Chung HS
• Chung JS
• Lee YJ
• Lee S
• Jeong J
• So MK
• Lee M

• KMID: 2539443
• DOI: http://doi.org/10.12771/emj.2023.e2

Abstract

Objectives
The Panbio COVID-19 Ag Rapid Test Device (Panbio COVID-19 Ag, Abbott Rapid Diagnostics) is a lateral flow immunochromatographic assay targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein in nasopharyngeal specimens for the diagnosis of coronavirus disease 2019 (COVID-19). This study aimed to verify the performance of the Panbio COVID-19 Ag for implementation in clinical laboratories.
Methods
Sixty nasopharyngeal swab specimens (30 positive and 30 negative) dipped in transport medium, and COVID-19 was confirmed using real-time RT-PCR using Allplex SARS-CoV-2 assay (Seegene), were tested using the Panbio COVID-19 Ag. Reproducibility was evaluated using positive and negative control materials. Sensitivity and specificity were calculated based on the results of realtime RT-PCR as the standard test method.
Results
Reproducibility was confirmed by the consistent results of repeated tests of the quality control materials. The overall sensitivity and specificity of Panbio COVID-19 Ag were 50.0% and 100.0%, respectively. Panbio COVID-19 Ag demonstrated high sensitivity (88.2%) in analyzing the detection limit cycle threshold (Ct) value of 26.67 provided by the manufacturer as a positive criterion, and the sensitivity was 100.0% for the positive criterion of Ct values <25, although it was less sensitive for Ct ≥ 25.
Conclusion
Considering the high sensitivity for positive samples with Ct values <25 and the rapid turnaround of results, Panbio COVID-19 Ag can be used in clinical laboratories to diagnose COVID-19 in limited settings.

Keyword

COVID-19; Rapid antigen detection test; SARS-CoV-2; Sensitivity

Reference

References

1. Korean Society for Laboratory Medicine, Korea Disease Control and Prevention Agency. Guidelines for the laboratory diagnosis of COVID-19 in Korea [Internet]. Seoul (KR): Korean Society for Laboratory Medicine;c2021. [cited 2022 Dec 1]. Available from. https://www.kslm.org/rang_board/list.html?num=17518&start=225&code=covid19_press.

2. World Health Organization [WHO]. Antigen-detection in the diagnosis of SARS-CoV-2 infection [Internet]. Geneva (CH): WHO;c2021. [cited 2022 Dec 1]. Available from. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays.

3. Hong KH, Lee SW, Kim TS, Huh HJ, Lee J, Kim SY, et al. Guidelines for laboratory diagnosis of coronavirus disease 2019 (COVID-19) in Korea. Ann Lab Med. 2020; 40(5):351–360. DOI: 10.3343/alm.2020.40.5.351. PMID: 32237288. PMCID: PMC7169629.

4. Lee K. Laboratory diagnosis of COVID-19 in Korea. Ewha Med. J 2021; 44(1):1–10. DOI: 10.12771/emj.2021.44.1.1.

5. Lee MK. Challenges of scaling up SARS-CoV-2 rapid antigen tests. Ann Clin Microbiol. 2021; 24(4):111–114. DOI: 10.5145/ACM.2021.24.4.1.

6. Mattiuzzi C, Henry BM, Lippi G. Making sense of rapid antigen testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics. Diagnosis. 2020; 8(1):27–31. DOI: 10.1515/dx-2020-0131. PMID: 33554523.

7. Brümmer LE, Katzenschlager S, Gaeddert M, Erdmann C, Schmitz S, Bota M, et al. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis. PLoS Med. 2021; 18(8):e1003735. DOI: 10.1371/journal.pmed.1003735. PMID: 34383750. PMCID: PMC8389849.

8. Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2022; 7(7):CD013705. DOI: 10.1002/14651858.CD013705.pub3. PMID: 35866452. PMCID: PMC9305720.

9. Abbott Rapid Diagnostics Jena GmbH. Panbio COVID-19 Ag Rapid Test Device Nasopharyngeal instructions for use [Internet]. Jena (DE): Abbott Rapid Diagnostics Jena GmbH;c2021. [cited 2022 Dec 1]. Available from. https://www.globalpointofcare.abbott/en/product-details/panbio-covid-19-ag-antigen-test.html.

10. Merino P, Guinea J, Muñoz-Gallego I, González-Donapetry P, Galán JC, Antona N, et al. Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection. Clin Microbiol Infect. 2021; 27(5):758–761. DOI: 10.1016/j.cmi.2021.02.001. PMID: 33601009. PMCID: PMC7884234.

11. Caruana G, Croxatto A, Kampouri E, Kritikos A, Opota O, Foerster M, et al. Implementing SARS-CoV-2 rapid antigen testing in the emergency ward of a Swiss University Hospital: the INCREASE Study. Microorganisms. 2021; 9(4):798. DOI: 10.3390/microorganisms9040798. PMID: 33920307. PMCID: PMC8069749.

12. Castrejón-Jiménez NS, García-Pérez BE, Reyes-Rodríguez NE, Vega-Sánchez V, Martínez-Juárez VM, Hernández-González JC. Challenges in the detection of SARS-CoV-2: evolution of the lateral flow immunoassay as a valuable tool for viral diagnosis. Biosensors. 2022; 12(9):728. DOI: 10.3390/bios12090728. PMID: 36140114. PMCID: PMC9496238.

13. Boehringer HR, O'Farrell BJ. Lateral flow assays in infectious disease diagnosis. Clin Chem. 2021; 68(1):52–58. DOI: 10.1093/clinchem/hvab194. PMID: 34969115. PMCID: PMC9383164.

14. Bulilete O, Lorente P, Leiva A, Carandell E, Oliver A, Rojo E, et al. Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care. J Infect. 2021; 82(3):391–398. DOI: 10.1016/j.jinf.2021.02.014. PMID: 33592253. PMCID: PMC7881288.

15. Gremmels H, Winkel BMF, Schuurman R, Rosingh A, Rigter NAM, Rodriguez O, et al. Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection. EClinicalMedicine. 2021; 31:100677. DOI: 10.1016/j.eclinm.2020.100677. PMID: 33521610. PMCID: PMC7832943.

16. European Centre for Disease Prevention and Control [ECDC]. Options for the use of rapid antigen detection tests for COVID-19 in the EU/EEA – first update [Internet]. Stockholm (SE): ECDC;c2021. [cited 2022 Dec 1]. Available from. https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-first-update.