Rapid Diagnostic Test (RDT) Prototype Validation Test for SARS CoV-2 Antigen in Comparison With RT-PCR Assay
DOI:
https://doi.org/10.29303/jku.v11i4.866Keywords:
Key words : RDT SARS CoV-2 antigen, RT-PCR, sensitivity, specificity, accuracyAbstract
Background: The diagnosis of Coronavirus Disease-2019 (COVID-19) is established based on Real-time reverse transcription-polymerase chain reaction (RT-PCR). However, due to the availibity, high cost and length of time of RT-PCR, a reliable alternative is needeed. Rapid Diagnostic Test (RDT) costs cheaper, near-patient use, and if performed and interpreted correctly can be used in areas without RT-PCR or if immediate diagnosis is needed. Objective : To evaluate the quality of RDT SARS CoV-2 prototype compared to RT-PCR. Methods: The patients in this study were patients with RDT antigen and or RT-PCR SARS-CoV-2 examination at Mataram University Hospital who had approved to be research subject. Nasopharyngeal swab sample was used for RDT Antigen SARS-CoV-2 Prototype. Whereas, nasopharyngeal and oropharyngeal swab sampel were used for RT-PCR SARS-CoV-2. The value of sensitivity, specificity and accuray of RDT prototype were assessed based on the RT-PCR result. Results: Total of 124 samples were included in this study. Approximately 39 (31.4%) were positive and 85 (68.5%) were negative. The sensitivity, specificity and accuracy of the SARS CoV-2 RDT prototype were 92.31% (79.13 - 98.38 %, 95% CI), 97.65% (91.76 - 99.71%, 95% CI) and 97.63 % (93.16 - 99.52 %, 95% CI), respectively. There were 5 discrepancies in RDT prototype results compare to the RT-PCR result. Conclusion: The RDT SARS-CoV-2 Antigen prototype showed good sensitivity, specificity and accuracy. Hence, this RDT has the potential to be used for screening or diagnosis, especially in areas with high disease prevalence and low rescorce setting.
References
WHO. COVID-19 Weekly Epidemiological Update. 2021. (Cited 2021 March 6). Available from :https://reliefweb.int/sites/reliefweb.int/files/resources/20210302_Weekly_Epi_Update_29.pdf.
Germas. Grafik Perkembangan COVID-19 NTB. 2021. (Cited 2021 March 7). Available from :https://corona.ntbprov.go.id.
Dinkes NTB. Press Release COVID-19, 6 Maret 2021 - Sekretaris Daerah Provinsi Nusa Tenggara Barat. 2021. (Cited 2021 March 6). available from :https://corona.ntbprov.go.id/storage/dokumen/Press%20Release%20Update%20Covid-19%20-%206%20Maret%202021.pdf
Favresse J, Gillot C, Oliviera M, Cadrobi J, et al.. Heas-to-Head Comparison of Rapid and Automated Antigen G=Detection Test for the Diagnosis of SARS-CoV-2 Infection. 2021. J. Clin. Med. 10: 265. DOI : https://doi.org/10.3390/jcm10020265.
WHO. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassay. 2020. (Cited 2021 March 4). Available at : https://apps.who.int/iris/rest/bitstreams/1302653/retrieve.
Wu YC, Chen CS, Chan YJ. The Outbreak of COVID-19 : An overview. 2020. Journal of Chinese Medical Assosiation. 83 : 217-220. DOI : 10.1097/JCMA.0000000000000270.
Adams ER, Augustin Y, Byrne RL, et al. Rapid development of COVID-19 rapid diagnostics for low resource settings : accelerating delivery through trasparency, responsiveness, and open collaboration. 2020. DOI : https://doi.org/10.1101/2020.04.29.20082099.
PAHO. Implementation of COVID-19 rapid antigen detection test- Pilot. 2020. (Cited 2021 November 20). Available from: https://www.paho.org/en/documents/implementation-covid-19-rapid-antigen-detection-test-pilot.
Carter LJ, Garner LV, Smoot JW, et al. Assay Techniques and Tesr Development for COVID-19 Diagnosis. 2020. ACS Cent. Sci. 6, 591-605. DOI : https://dx.doi.org/10.1021/acscentsci.0c00501?ref=pdf.
PDS Patklin. Revisi Panduan Tata Laksana Pemeriksaan Rapid Test SARS-CoV-2. 2020. (Cited 2021 March 1). Available from : https://www.pdspatklin.or.id/assets/files/pdspatklin_2020_12_08_23_24_38.pdf.
Shreffler J, Huecker MR. Diagnostic Testing Accuracy : Sensitivity, Specificity, Predictive Values and Likehood Ratios. 2021. (Cited 2021 November 20). Available at : https://www.ncbi.nlm.nih.gov/books/NBK557491/?report=reader#_NBK557491_pubdet_.
MedCalc Software Ltd. Diagnostic test Evaluation calculator. Version 20.015. 2021. (Cited 2021 November 25). Available from : https://www.medcalc.org/calc/diagnostic_test.php.
Porte L, Lerraga P, Vollrath V, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiraorory samples. 2020. International Journal of Infectious Disease 99 : 328-333. DOI : https://doi.org/10.1016/j.ijid.2020.05.098.
Chaimayo C, Kaewnaphan B, Tanlieng N, 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. 2020. Virol J 17 :177. DOI : https://doi.org/10.1186/s12985-020-01452-5.
ECDC. Option for the use of Rapid Diagnostic Test Antigen (RDT-Ag) test for COVID-19 in the EU/EEA and the UK. 2020. Available from : https://www.ecdc.europa.eu/sites/default/files/documents/Options-use-of-rapid-antigen-tests-for-COVID-19.pdf
Favresse J, Gillot C, Oliviera M, Cadrobi J, et al. Heas-to-Head Comparison of Rapid and Automated Antigen G=Detection Test for the Diagnosis of SARS-CoV-2 Infection. 2021. J. Clin. Med. 10: 265. DOI : https://doi.org/10.3390/jcm10020265.
Eusebi P.Diagnostic Accuracy Measures. 2013. Cerebrovasc Dis. 36(4) : 267-72. DOI : 10.1159/000353863.
