Rapid Antigen Detection Test for Severe Acute Respiratory Syndrome Coronavirus 2: How to Use It Properly?

Tonny Loho, Djoko Widodo

Abstract


Cases of coronavirus disease 2019 (COVID-19) in Indonesia are still increasing and even higher in the last few weeks. Contact tracing and surveillance are important to locate cases in the community, including asymptomatic individuals. Diagnosis of COVID-19 depends on the detection of viral RNA, viral antigen, or indirectly, viral antibodies. Molecular diagnosis, using real time, reverse transcriptase polymerase chain reaction (RT-PCR), is the common standard method; however, it is not widely available in Indonesia and requires a high standard laboratory. Rapid, point-of-care antibody testing has been widely used as an alternative; however, interpretation of the results is not simple and now it is no longer used by the Indonesian government as a screening test for people travelling between locations. Thus, the rapid antigen detection test (Ag-RDT) is used by the Indonesian government as a screening test for travellers. As a result, many people buy the kit online and perform self-Ag-RDT at home. This raises the question of how safe and accurate it is to perform self-Ag-RDT at home. Before a test is applied, it is suggested to research its sensitivity and specificity, as compared to gold standard, and its limitations. In this article, laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is discussed, with an emphasis on Ag-RDT and the recommendation to use it properly in daily practice.


Keywords


SARS-CoV-2; COVID-19; antigen testing

References


Alanagreh L, Alzoughool F, Atoum M. The human coronavirus disease covid-19: Its origin, characteristics, and insights into potential drugs and its mechanisms. Vol. 9, Pathogens. MDPI AG; 2020.

Romano M, Ruggiero A, Squeglia F, et al. A structural view of SARS-CoV-2 RNA replication machinery: RNA synthesis, proofreading and final capping. Cells. 2020;9.

Kumar S, Nyodu R, Maurya VK SS. Morphology, genome organization, replication, and pathogenesis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). In: Saxena S, eds. Coronavirus disease 2019 (COVID-19). Medical Virolog - Se. Springer; 2019.

Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of Coronavirus disease 2019 (COVID-19): A review. JAMA. 2020;324:782–93.

Stelzer-Braid S, Walker GJ, Aggarwal A, et al. Virus isolation of severe acute respiratory syndrome coronavirus 2 (SARS-C0V-2) for diagnostic and research purposes. Pathology. 2020;52(7):760–3.

Sethuraman N, Jeremiah SS, Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA. 2020;323:2249–51.

Feng W, Newbigging AM, Le C, et al. Molecular diagnosis of COVID-19: Challenges and research needs. Analytical chemistry. Am Chemical Soc. 2020;92:10196–209.

Touma M. COVID-19: molecular diagnostics overview. J Mol Med. 2020;98: 947–54.

Basu A, Zinger T, Inglima K, 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).

CDC. Overview of testing for SARS-CoV-2 (COVID-19) [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2021 Jan 20]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

Bohn MK, Loh TP, Wang C Bin, et al. IFCC interim guidelines on serological testing of antibodies against SARS-CoV-2. Clinical Chemistry and Laboratory Medicine. 2020;58:2001–8.

Long QX, Liu BZ, Deng HJ, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020;26(6):845–8.

Montesinos I, Gruson D, Kabamba B, et al. Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. J Clin Virol. 2020;128.

Xia N, Wang G, Gong W. Serological test is an efficient supplement of RNA detection for confirmation of SARS-CoV-2 infection. 2020.

Xie J, Ding C, Li J, et al. Characteristics of patients with coronavirus disease (COVID-19) confirmed using an IgM-IgG antibody test. J Med Virol. 2020;92(10):2004–10.

Li Z, Yi Y, Luo X, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020;92(9):1518–24.

Diagnostics and testing - FIND [Internet]. [cited 2021 Jan 19]. Available from: https://www.finddx.org/covid-19/

Jacofsky D, Jacofsky EM, Jacofsky M. Understanding antibody testing for COVID-19. J Arthroplasty. 2020;35(7):S74–81.

Deeks JJ, Dinnes J, Takwoingi Y, et al. Diagnosis of SARS-CoV-2 infection and COVID-19: accuracy of signs and symptoms; molecular, antigen, and antibody tests; and routine laboratory markers. Cochrane Database Syst Rev. 2020;2020(4).

Lisboa Bastos M, Tavaziva G, Abidi SK, et al. Diagnostic accuracy of serological tests for covid-19: Systematic review and meta-analysis. BMJ. 2020;370.

Miller TE, Garcia Beltran WF, Bard AZ, et al. Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital. FASEB J. 2020;34(10):13877–84.

Theel ES, Slev P, Wheeler S, et al. The role of antibody testing for sars-cov-2: Is there one? J Clin Microbiol. 2020;58.

Wrapp D, Wang N, Corbett KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Prepr Serv Biol. 2020.

Chia WN, Tan CW, Foo R, et al. Serological differentiation between COVID-19 and SARS infections. Emerg Microbes Infect. 2020;9(1):1497–505.

Nicol T, Lefeuvre C, Serri O, et al. Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: Two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech). J Clin Virol. 2020;129.

Yee Wan W, Hoon Lim S, Hong Seng E. Cross-reaction of sera from COVID-19 patients with SARS-CoV assays. medRxiv. 2020.

Lv H, Wu NC, Tsang OTY, et al. Cross-reactive Antibody Response between SARS-CoV-2 and SARS-CoV Infections. Cell Rep. 2020;31(9).

Okba NMA, Müller MA, Li W, et al. Severe acute respiratory syndrome Coronavirus 2-specific antibody responses in Coronavirus disease patients. Emerg Infect Dis. 2020;26(7):1478–88.

Scohy A, Anantharajah A, Bodéus M, et al. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 2020;129:104455.

Mathuria JP, Yadav R, Rajkumar. Laboratory diagnosis of SARS-CoV-2 - A review of current methods. J Infect Publ Health. 2020;13:901–5.

Novel Coronavirus (COVID-19) [Internet]. Ottawa Public Health. [cited 2021 Jan 20]. Available from: https://www.ottawapublichealth.ca/en/public-health-topics/novel-coronavirus.aspx?_mid_=32064

McCulloch DJ, Kim AE, Wilcox NC, et al. Comparison of unsupervised home self-collected midnasal swabs with clinician-collected nasopharyngeal swabs for detection of SARS-CoV-2 infection. JAMA Netw open. 2020;3(7):e2016382.

WHO. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays Interim guidance, 11 September 2020. World Heal Organ. 2020.

CDC. Interim guidance for antigen testing for SARS-CoV-2 [Internet]. Centers for disease control and prevention. 2020 [cited 2021 Jan 20]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/php/open-america/testing.html.


Full Text: PDF

Refbacks

  • There are currently no refbacks.