EVALUASI VALIDITAS KIT RAPID DIAGNOSTIC TEST ANTIGEN (RDT-Ag) SARS-CoV-2
DOI:
https://doi.org/10.33992/meditory.v10i2.2274Abstract
The COVID-19 pandemic is still ongoing around the world. The rapid and easy development and validation of diagnostic methods is a top priority in response to the handling of the COVID-19 pandemic. The study aimed to evaluate the performance of the SARS-CoV-2 Antigen Rapid Diagnostic Test (RDT-Ag). The RDT-Ag kits evaluated in the study were RDT-Ag VD, RDT-Ag GB kits, and RDT-Ag TS kits that included sensitivity and specificity values. rRT-PCR and RDT-Ag tests use 90 samples of the same nasopharyngeal or oropharyngeal swab. The samples included 30 positive samples (Ct ≤ 25), 30 positive samples (Ct > 25), and 30 negative samples. Then, the results of rRT-PCR are used as a standard reference for RDT-Ag evaluation. RDT-Ag VD kit obtained 80% sensitivity in the positive sample group with a Ct value of ≤25, and 10% in the positive sample group with a Ct value of >25 with 93.3% specificity. The RDT-Ag GB kit obtained 70% sensitivity in the positive sample group with a Ct value of ≤ 25, and 10% in the positive sample group with a Ct value of > 25 with 100% specificity. The RDT-Ag TS kit obtained 93.3% sensitivity in the positive sample group with a Ct value of ≤25, and 20% in the positive sample group with a Ct value of >25 with 100% specificity. The sensitivity of RDT-Ag compared to the rRT-PCR results increased in the sample with a Ct value of ≤25 (> 70%) and its sensitivity decreased dramatically in the sample with a Ct value of >25 (< 20%).
References
Kementerian Kesehatan RI. Pedoman Pencegahan dan Pengendalian Corona Virus deases (Covid-19) [Internet]. Vol. 5, Kementrian Kesehatan. 2020. p. 178. Available from: https://covid19.go.id/storage/app/media/Protokol/REV-05_Pedoman_P2_COVID-19_13_Juli_2020.pdf
Centers for Disease Control and Prevention (CDC). Coronavirus Disease [Internet]. Coronavirus Disease. 2022. Available from: https://www.cdc.gov/coronavirus/2019-ncov/index.html
Agustiningsih, Arie Ardiansyah Nugraha, Daryanto, Hana Apsari Pawesri, Hartanti Dian Ikawati, Herna Harianja, Holy Arif Wibowo, Ida Susanti ILI. Pedoman Pemeriksaan PCR SARS-COV-2 Bagi Petugas Laboratorium. Vol. 1, Lembaga Penerbit BALITBANGKES. Jakarta: Lembaga Penerbit Badan Penelitian dan Pengembangan Kesehatan; 2020. 1–251 p.
WHO. WHO Corona Virus Data [Internet]. World Health Organization . 2022. Available from: https://covid19.who.int/
Satuan Tugas Penanganan COVID-19. Data COVID-19 Indonesia [Internet]. 2021. Available from: https://covid19.go.id/
World Health Organization. SARS-CoV-2 antigen-detecting rapid diagnostic tests: an implementation guide. Ctry Tech Guid - Coronavirus Dis [Internet]. 2020;1–48. Available from: https://www.who.int/publications/i/item/9789240017740
WHO. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays [Internet]. World Health Organization. World Health Organization; 2020. Available from: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
Saeed U, Uppal SR, Piracha ZZ, Rasheed A, Aftab Z, Zaheer H, et al. Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy. Virol J. 2021;18(1):1–5.
WHO. Advice on the use of point-of-care immunodiagnostic tests for COVID-19 [Internet]. Vol. 1, COVID-19: Laboratory and diagnosis. World Health Organization; 2020. Available from: https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19%0Ahttps://www.who.int/publications/i/item/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19-scientific-brief
European Centre for Disease Prevention and Control (ECDC). Option for The Use Rapid Antigen Test for COVID-19 in The EU/EEA and The UK Technical Report. [Internet]. 2020. Available from: https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk
Liotti FM, Menchinelli G, Lalle E, Palucci I, Marchetti S, Colavita F, et al. Performance of a novel diagnostic assay for rapid SARS-CoV-2 antigen detection in nasopharynx samples. Clin Microbiol Infect. 2021;27(3):487–8.
Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020;99:328–33.
Nalumansi A, Lutalo T, Kayiwa J, Watera C, Balinandi S, Kiconco J, et al. Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples. Int J Infect Dis. 2021;104:282–6.
Trevethan R. Sensitivity, Specificity, and Predictive Values: Foundations, Pliabilities, and Pitfalls in Research and Practice. Front Public Heal. 2017;5:307.
Rahbari R, Moradi N, Abdi M. rRT-PCR for SARS-CoV-2: Analytical considerations. Clin Chim Acta. 2021;516:1.
Downloads
Published
Issue
Section
Citation Check
License
- Articles published in Meditory are licensed under a Creative Commons Attribution-ShareAlike 4.0 International license. You are free to copy, transform, or redistribute articles for any lawful purpose in any medium, provided you give appropriate credit to the original author(s) and Meditory, link to the license, indicate if changes were made, and redistribute any derivative work under the same license.
- Copyright on articles is retained by the respective author(s), without restrictions. A non-exclusive license is granted to Meditory to publish the article and identify itself as its original publisher, along with the commercial right to include the article in a hardcopy issue for sale to libraries and individuals.
- By publishing in Meditory, authors grant any third party the right to use their article to the extent provided by the Creative Commons Attribution-ShareAlike 4.0 International license.
