EVALUASI SENSITIFITAS DAN BATAS NILAI DETEKSI CT VALUE DARI 3 PRODUK KOMERSIAL TES CEPAT ANTIGEN SARS COV-2 TERHADAP RT-PCR
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Abstract
Latar Belakang: Infeksi SARS CoV-2 pertama kali dilaporkan pada tahun 2019, dan menjadi pandemic hingga saat ini. Pemeriksaan penunjang RT-PCR dengan CT value menjadi standar baku emas dalam penegakan diagnose. Keterbatasan pada pemeriksaan RT-PCR membuat tes cepat antigen menjadi alternatif pemeriksaan masal COVID-19. Secara umum, tes antigen cepat diperkirakan dapat bekerja baik pada pasien dengan kadar viral load yang tinggi (CT value <25), namum perlu adanya studi lebih lanjut mengenai nilai prediksi CT value terhadap antigen seiring dengan banyaknya produk komersial tes antigen cepat yang beredar. Hal ini membuat peneliti tertarik untuk meneliti hal tersebut.
Metode: Desain penelitian ini adalah potong lintang. Pengambilan data dilaksanakan di Klinik Citra Semanan dan Klinik Sukma pada peride Januari 2021 hingga November 2022. Sampel penelitian berupa nilai CT value pada ketiga alat jenis antigen yang disamarkan (Antigen A, B dan C) terhadap RT-PCR. Analisa statistik menggunakan independent t-test dan Mann Whitney, uji ROC Curve. Sebelum dilakukan pengujian statistic, dilakuka uji normalitas data menggunakan uji Kolmogorov-Smirnoc dan Shapiro Wilk serta pengujian vairan antar kelompok dengan uji Levene.
Hasil: Ketiga alat antigen memiliki sensitifitas yang berbeda-beda. Antigen A memiliki sensitifitas sebesar 68,9%, Antigen B memiliki sensitifitas sebesar 88,9% dan Antigen C memiliki sensitifitas sebesar 82.4%. Didapatkan CT value gen ORF pada ketiga jenis antigen 24,00 dan CT value gen ORF sebesar 22,68. Nilai median CT value gen ORF produk A 20,20 (11,01-30,20), B 22,09 (12,00-30,71), dan C 21,51 (10,20-29,58) dengan p-value 0,005. Nilai median dari CT value gen N pada produk A 18,89 (7,72-28,50), B 21,18 (10-50-30,56), dan C 20,59 (9,23-29,35) dengan p-value 0,004.
Kesimpulan: Nilai sensifitas ketiga alat tersebut sangatlah bervariasi dengan rentang 68,9% hingga 88,9%. Penelitian ini didapatkan bahwa ketiga antigen ini mampu mendeteksi dengan nilai CT value pada angka 24 untuk gen ORF dan 22,68 pada gen N. Hal ini dapat membantu tenaga kesehatan untuk menjelaskan kepada pasien yang mendapatkan hasil positif, memperkirakan lama hari paska infeksi, dan besarnya pasien untuk menularkan virus tersebut kepada orang lain.
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References
Baro, B., Rodo, P., Ouchi, D., Bordoy, A. E., Saya Amaro, E. N., Salsench, S. V., Molinos, S., Alemany, A., Ubals, M., Corbacho-Monné, M., Millat-Martinez, P., Marks, M., Clotet, B., Prat, N., Estrada, O., Vilar, M., Ara, J., Vall-Mayans, M., G-Beiras, C., … Mitjà, O. (2021). Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison. Journal of Infection, 82(6), 269–275. https://doi.org/10.1016/j.jinf.2021.04.009
Basu, A., Zinger, T., Inglima, K., Woo, K., Atie, O., Yurasits, L., See, B., & Aguero-Rosenfeld, M. E. (2020). 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. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.01136-20
Berger, A., Nsoga, M. T. N., Perez-Rodriguez, F. J., Aad, Y. A., Sattonnet-Roche, P., Gayet-Ageron, A., Jaksic, C., Torriani, G., Boehm, E., Kronig, I., Sacks, J. A., de Vos, M., Bausch, F. J., Chappuis, F., Renzoni, A., Kaiser, L., Schibler, M., & Eckerle, I. (2021). Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers. PLOS ONE, 16(3), e0248921. https://doi.org/10.1371/journal.pone.0248921
Centre for Disease Control. (2020). Overview of Testing for SARS-CoV-2, the virus that causes COVID-19 | CDC. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
Eshghifar, N., Busheri, A., Shrestha, R., & Beqaj, S. (2021). Evaluation of Analytical Performance of Seven Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus. International Journal of General Medicine, Volume 14, 435–440. https://doi.org/10.2147/IJGM.S297762
Feng, W., Newbigging, A. M., Le, C., Pang, B., Peng, H., Cao, Y., Wu, J., Abbas, G., Song, J., Wang, D.-B., Cui, M., Tao, J., Tyrrell, D. L., Zhang, X.-E., Zhang, H., & Le, X. C. (2020). Molecular Diagnosis of COVID-19: Challenges and Research Needs. Analytical Chemistry, 92(15), 10196–10209. https://doi.org/10.1021/acs.analchem.0c02060
Greub, G., Caruana, G., Schweitzer, M., Imperiali, M., Muigg, V., Risch, M., Croxatto, A., Opota, O., Heller, S., Albertos Torres, D., Tritten, M.-L., Leuzinger, K., Hirsch, H. H., Lienhard, R., & Egli, A. (2021). Multicenter Technical Validation of 30 Rapid Antigen Tests for the Detection of SARS-CoV-2 (VALIDATE). Microorganisms, 9(12), 2589. https://doi.org/10.3390/microorganisms9122589
Information, I. (2022). COVID-19 Pandemic Response , Laboratory Data Reporting : CARES Act Section 18115 A . Reporting Requirements Section 1 : Reporting Requirements by Entity and Type of Testing. Section 4, 1–9.
Koczula, K. M., & Gallotta, A. (2016). Lateral flow assays. Essays in Biochemistry, 60(1), 111–120. https://doi.org/10.1042/EBC20150012
Kyosei, Y., Yamura, S., Namba, M., Yoshimura, T., Watabe, S., & Ito, E. (2021). Antigen tests for COVID-19. Biophysics and Physicobiology, 18, bppb-v18.004. https://doi.org/10.2142/biophysico.bppb-v18.004
Lambert-Niclot, S., Cuffel, A., Le Pape, S., Vauloup-Fellous, C., Morand-Joubert, L., Roque-Afonso, A. M., Le Goff, J., & Delaugerre, C. (2020). Evaluation of a rapid diagnostic assay for detection of sars-cov-2 antigen in nasopharyngeal swabs. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.00977-20
Loho, T., & Widodo, D. (2021). Rapid Antigen Detection Test for Severe Acute Respiratory Syndrome Coronavirus 2: How to Use It Properly? Acta Medica Indonesiana, 53(1), 119–131. https://actamedindones.org/index.php/ijim/article/view/1680
OECD. (2020). Testing for COVID-19: How to best use the various tests? OECD Policy Responses to Coronavirus (COVID-19), December, 1–14. https://read.oecd-ilibrary.org/view/?ref=1036_1036993-cfmlc0vov2&title=Test
Parvu, V., Gary, D. S., Mann, J., Lin, Y.-C., Mills, D., Cooper, L., Andrews, J. C., Manabe, Y. C., Pekosz, A., & Cooper, C. K. (2021). Factors that Influence the Reported Sensitivity of Rapid Antigen Testing for SARS-CoV-2. Frontiers in Microbiology, 12. https://doi.org/10.3389/fmicb.2021.714242
Peto, T., Affron, D., Afrough, B., Agasu, A., Ainsworth, M., Allanson, A., Allen, K., Allen, C., Archer, L., Ashbridge, N., Aurfan, I., Avery, M., Badenoch, E., Bagga, P., Balaji, R., Baldwin, E., Barraclough, S., Beane, C., Bell, J., … Zinyama, R. (2021). COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing. EClinicalMedicine, 36, 100924. https://doi.org/10.1016/j.eclinm.2021.100924
Sethuraman, N., Jeremiah, S. S., & Ryo, A. (2020). Interpreting Diagnostic Tests for SARS-CoV-2. JAMA, 323(22), 2249. https://doi.org/10.1001/jama.2020.8259
Setiadi, W., Rozi, I. E., Safari, D., Daningrat, W. O. D., Johar, E., Yohan, B., Yudhaputri, F. A., Lestari, K. D., Oktavianthi, S., Myint, K. S. A., Malik, S. G., & Soebandrio, A. (2022). Prevalence and epidemiological characteristics of COVID-19 after one year of pandemic in Jakarta and neighbouring areas, Indonesia: A single center study. PLOS ONE, 17(5), e0268241. https://doi.org/10.1371/journal.pone.0268241
Sisay, A., Abera, A., Dufera, B., Endrias, T., Tasew, G., Tesfaye, A., Hartnack, S., Beyene, D., & Desta, A. F. (2022). Diagnostic accuracy of three commercially available one step RT-PCR assays for the detection of SARS-CoV-2 in resource limited settings. PLoS ONE, 17(1 January). https://doi.org/10.1371/journal.pone.0262178
Sun, J., He, W.-T., Wang, L., Lai, A., Ji, X., Zhai, X., Li, G., Suchard, M. A., Tian, J., Zhou, J., Veit, M., & Su, S. (2020). COVID-19: Epidemiology, Evolution, and Cross-Disciplinary Perspectives. Trends in Molecular Medicine, 26(5), 483–495. https://doi.org/10.1016/j.molmed.2020.02.008