Comparative Evaluation of Different SARS-CoV-2 Rapid Point-of-Care Antigen Tests with SARS-CoV-2 PCR for Diagnosis of COVID-19

Ghada Ismail; Dalia H. Abdelhamid; Rania Abdel Halim; Marwa Salah Mostafa; Hossam Abdelghaffar; Noha Alaa Eldin Fahim; Ahmed Elshafei; Menna Asker; Nashwa Naguib Omar

doi:10.3889/oamjms.2022.10335

Authors

Ghada Ismail Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Director of Reference Laboratory of the Egyptian University Hospitals, Cairo, Egypt
Dalia H. Abdelhamid Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Rania Abdel Halim Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Marwa Salah Mostafa Department of Medical Microbiology and Immunology, Faculty of Medicine, Cairo University, Cairo, Egypt https://orcid.org/0000-0002-8906-8938
Hossam Abdelghaffar Department of ENT, Faculty of Medicine, Helwan University, Helwan, Egypt; Secretary General of the Supreme Council for University Hospitals, Ministry of Higher Education and Scientific Research, Giza, Egypt https://orcid.org/0000-0002-2607-2518
Noha Alaa Eldin Fahim Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt https://orcid.org/0000-0001-6388-3857
Ahmed Elshafei Theodor Belharz Research Institute, Ministry of Higher Education and Scientific Research, Giza, Egypt
Menna Asker Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Nashwa Naguib Omar Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt https://orcid.org/0000-0002-2607-2518

DOI:

https://doi.org/10.3889/oamjms.2022.10335

Keywords:

SARS-CoV-2, Point of care, Rapid antigen tests, SARS-CoV-2 PCR, COVID-19

Abstract

BACKGROUND: Detection of positive 2019-nCoV nucleic acids by real-time reverse transcriptase-polymerase chain reaction (rRT-PCR)-based assays performed on the upper and lower respiratory samples remains the gold standard for the diagnosis of COVID-19. However, antigen-detecting rapid diagnostic tests can offer a faster (15–30 min) and less expensive way to diagnose active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection than nucleic acid amplification tests.

AIM: Hence, the present study aimed to compare and evaluate the results of different SARS-CoV-2 rapid point-of-care antigen tests with SARS-CoV-2 PCR as a reference method.

METHODS: Sixty-five nasopharyngeal swab specimens were collected from attendees of the Reference Laboratory of Egyptian university hospitals. The samples were placed in viral transport medium for RNA extraction. The remaining part of the suspension was stored at −70°C until use for COVID-19 antigen testing. All samples were processed for the COVID-19 Ag rapid test and RT-PCR simultaneously.

RESULTS: RT-PCR assay revealed 46 (70.8%) positive samples and 19 (29.2%) negative samples for COVID-19. All eight rapid antigen assays indicated specificity and positive predictive value of 100% each. As for the other parameters, the sensitivity, negative predictive value (NPV), and accuracy ranged from 43.8 to 93.8, 33.3 to 90, and 60 to 96, respectively. Biozak exhibited the best performance with the highest sensitivities 91.3, 81.8, and 93.75, respectively, while Viro and Standard Q were the worst among the tested kits with sensitivity, NPV, and accuracy of 50, 33.3, and 60 each. Regarding the relationship between the viral load of COVID-19 detected by RT-PCR and the results of the eight rapid antigen tests (RAT), we deduced that the higher the viral load, the better the sensitivity observed.

CONCLUSION: The RATs used, in our study, exhibited heterogeneous diagnostic performance, where some of them showed very promising results in comparison to the reference RT-PCR assay.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Plum Analytics Artifact Widget Block

References

Payne S. Family coronaviridae. Viruses. 2017;6:149-58. https://doi.org/10.1016/B978-0-12-803109-4.00017-9 PMid:7149805 DOI: https://doi.org/10.1016/B978-0-12-803109-4.00017-9

Afar Y, Fauquier N, Anwar S, Hosen MJ. SARS-CoV-2: A new dimension to our understanding of coronaviruses. Int Microbial. 2020;24(1):19-24. https://doi.org/10.1007/s10123-020-00152-y PMid:33231780 DOI: https://doi.org/10.1007/s10123-020-00152-y

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China. N Engl J Med. 2020;382(8):727-33. https://doi.org/10.1056/NEJMoa2001017 PMid:31978945 DOI: https://doi.org/10.1056/NEJMoa2001017

Cucinotta D, Vanilla M. WHO declares COVID-19 a pandemic. Act Biomed. 2020;91(1):157-60. https://doi.org/10.23750/abm.v91i1.9397 PMid:32191675

Ismail G, Mustafa M, Abdelghaffar H, Halim R, Omar N, Fahim N. Current status and a future perspective of COVID19 in Egypt: Egyptian reference laboratory experience. J Pure Appl Microbiol. 2021;15(3):1257-65. https://doi.org/10.22207/JPAM.15.3.15 DOI: https://doi.org/10.22207/JPAM.15.3.15

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet. 2020;395(10223):507-13. https://doi.org/10.1016/S0140-6736(20)30211-7 PMid:3200714 DOI: https://doi.org/10.1016/S0140-6736(20)30211-7

Plebani M, Laposata M, Lippi G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta. 2019;489:49-52. https://doi.org/10.1016/j.cca.2018.11.021 PMid:30445032 DOI: https://doi.org/10.1016/j.cca.2018.11.021

Eftekhari A, Alipour M, Chodari L, Dizaj S, Ardalan M, Samiei M, et al. A Comprehensive review of detection methods for SARSCoV-2. Microorg. 2021;9(2):232. https://doi.org/10.3390/microorganisms9020232 PMid:33499379 DOI: https://doi.org/10.3390/microorganisms9020232

Alpdagtas S, Ilhan E, Uysal E, Sengor M, Ustundag CB, Gunduz O. Evaluation of current diagnostic methods for COVID-19. APL Bioeng. 2020;4(4):041506. https://doi.org/10.1063/5.0021554 PMid:33305162 DOI: https://doi.org/10.1063/5.0021554

Carter L, Garner L, Smoot J, Li Y, Zhou Q, Saveson C, et al. Assay techniques and test development for COVID-19 diagnosis. ACS Cent Sci. 2020;6(5):591-605. https://doi.org/10.1021/acscentsci.0c00501 PMid:32382657 DOI: https://doi.org/10.1021/acscentsci.0c00501

Liu W, Liu L, Kou G, Zheng Y, Ding Y, Ni W, et al. Evaluation of nucleocapsid and spike protein-based ELISAs for detecting antibodies against SARS-CoV-2. J Clin Microbiol. 2020;58(6):e00461-20. https://doi.org/10.1128/JCM.00461-20 PMid:32229605 DOI: https://doi.org/10.1101/2020.03.16.20035014

Kujawski S, Wong K, Collins J, Epstein L, Killerby M, Midgley C, et al. Clinical and virologic characteristics of the first 12 patients with coronavirus disease 2019 (COVID-19) in the United States. Nat Med. 2020;26(6):861-8. https://doi.org/10.1038/s41591-020-0877-5 PMid:32327757 DOI: https://doi.org/10.1038/s41591-020-0877-5

Dankova Z, Novakova E, Skerenova M, Holubekova V, Lucansky V, Dvorska D, et al. Comparison of SARS-CoV-2 detection by rapid antigen and by three commercial RT-qPCR tests: A study from Martin University hospital in Slovakia. Intern J Env R Public H. 2021;18:7037. https://doi.org/10.3390/ijerph18137037 PMid:34280974 DOI: https://doi.org/10.3390/ijerph18137037

World Health Organization. (2021). Antigen-detection in the Diagnosis of SARS-CoV-2 Infection: Interim Guidance. (No. WHO/2019-nCoV/Antigen_Detection/2021.1). Geneva: World Health Organization; 2021. Available from: https://apps.who.int/iris/handle/10665/345948.

Ambrosi C, Prezioso C, Checconi P, Scribano D, Sarshar M, Capannari M, et al. SARS-CoV-2: Comparative analysis of different RNA extraction methods. J Virol Methods. 2021;287:114008. https://doi.org/10.1016/j.jviromet.2020.114008 PMid:33160015 DOI: https://doi.org/10.1016/j.jviromet.2020.114008

Sung H, Roh K, Hong K, Seong M, Ryoo N, Kim H, et al. COVID-19 molecular testing in Korea: Practical essentials and answers from experts based on experiences of emergency use authorization assays. Ann Lab Med. 2020;40:439-47. https://doi.org/10.3343/alm.2020.40.6.439 PMid:32539299 DOI: https://doi.org/10.3343/alm.2020.40.6.439

Hur K, Park K, Lim Y, Jeong Y, Sung H, Kim M. Evaluation of four commercial kits for SARS-CoV-2 real-time reverse-transcription polymerase chain reaction approved by emergency-useauthorization in Korea. Front Med (Lausanne). 2020;7:521. https://doi.org/10.3389/fmed.2020.00521 PMid:32903503 DOI: https://doi.org/10.3389/fmed.2020.00521

Harrington A, Cox B, Snowdon J, Bakst J, Ley E, Grajales P, et al. Comparison of abbott ID-NOW and abbott m2000 Methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. J Clin Microbiol. 2020;58(8):e00798-20. https://doi.org/10.1128/JCM.00798-20 PMid:32327448 DOI: https://doi.org/10.1128/JCM.00798-20

Sethuraman N, Jeremiah SS, Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA. 2020;323(22):2249-51. https://doi.org/10.1001/jama.2020.8259 PMid:32374370 DOI: https://doi.org/10.1001/jama.2020.8259

Chu V, Schwartz N, Donnelly M, Chuey M, Soto R, Yousaf A, et al. Comparison of home antigen testing with RT-PCR and viral culture during the course of SARS-CoV-2 infection. JAMA Intern Med. 2022; 33:e221827. https://doi.org/10.1001/jamainternmed.2022.1827 PMid:35486394 DOI: https://doi.org/10.1001/jamainternmed.2022.1827

Peña M, Ampuero M, Garcés C, Gaggero A, García P, Velasquez M, et al. Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals. Int J Infect Dis. 2021;107:201-4. https://doi.org/10.1016/j.ijid.2021.04.087 PMid:33945868 DOI: https://doi.org/10.1016/j.ijid.2021.04.087

Routsias J, Mavrouli M, Tsoplou P, Dioikitopoulou K, Tsakris A. Diagnostic performance of rapid antigen tests (RATs) for SARS-CoV-2 and their efficacy in monitoring the infectiousness of COVID-19 patients. Scien Rep. 2021;11(1):22863. https://doi.org/10.1038/s41598-021-02197-z PMid:34819567 DOI: https://doi.org/10.1038/s41598-021-02197-z

Landaas E, Storm M, Tollånes M, Barlinn R, Kran A, Bragstad K, et al. Diagnostic performance of a SARS-CoV-2 rapid antigen test in a large, Norwegian cohort. J Clin Virol. 2021;137:104789. https://doi.org/10.1016/j.jcv.2021.104789 PMid:33736946 DOI: https://doi.org/10.1016/j.jcv.2021.104789

Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, et al. Performance of abbott ID-NOW COVID-19 rapid nucleic acid amplification test using nasopharyngeal swabs transported in viral transport media and dry nasal swabs in a New York city academic institution. J Clin Microbiol. 2020;58(8):e01136-20. https://doi.org/10.1128/JCM.01136-20.e01136-20 PMid:32471894 DOI: https://doi.org/10.1128/JCM.01136-20

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. https://doi.org/10.1186/s12985-020-01452-5 PMid:33187528 DOI: https://doi.org/10.1186/s12985-020-01452-5

Kawasuji H, Takegoshi Y, Kaneda M, Ueno A, Miyajima Y, Kawago K, et al. Transmissibility of COVID-19 depends on the viral load around onset in adult and symptomatic patients. PLoS One. 2020;15(12):e0243597. https://doi.org/10.1371/journal.pone.0243597 PMid:33296437 DOI: https://doi.org/10.1371/journal.pone.0243597

Jegerlehner S, Suter-Riniker F, Jent P, Bittel P, Nagler M. Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in reallife clinical settings. Int J Infect Dis. 2021;109:118-22. https://doi.org/10.1016/j.ijid.2021.07.010 PMid:34242764 DOI: https://doi.org/10.1016/j.ijid.2021.07.010