Jaringan Laboratorium Medis

Vol. 7 No. 2 (2025): November 2025
Original Articles

Sensitivity and Specificity of Human Immunodeficiency Virus (HIV) Antibody Testing Using the Immunochromatography Method Rapid Test Compared to ECLIA (Electro Chemiluminescence Immuno Assay)

PDF
  • Resmi Aini,
  • Adira Padmarini,
  • Andhy Sulistyo
DOI: https://doi.org/10.31983/jlm.v7i2.13620

Published 2025-10-27

Keywords

  • HIV,
  • Immunochromatography Rapid Test,
  • ECLA

How to Cite

Aini, R., Padmarini, A., & Sulistyo, A. (2025). Sensitivity and Specificity of Human Immunodeficiency Virus (HIV) Antibody Testing Using the Immunochromatography Method Rapid Test Compared to ECLIA (Electro Chemiluminescence Immuno Assay). Jaringan Laboratorium Medis, 7(2), 119–126. https://doi.org/10.31983/jlm.v7i2.13620

Copyright (c) 2025 Jaringan Laboratorium Medis

Creative Commons License

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Abstract

The requirement for HIV reagents using the Immunochromatographic Rapid Test method must comply with the WHO prequalification standards and evaluation by the National Evaluator Agency to ensure their quality and safety; therefore, their sensitivity and specificity were tested against the ECLIA method as the gold standard. To determine the sensitivity and specificity of HIV testing using the Immunochromatographic Rapid Test compared with ECLIA at UDD PMI Yogyakarta City. The study population consisted of all blood donor samples undergoing screening for transfusion-transmissible infections (TTI). Sampling was conducted using the Systematic Random Sampling technique, by determining a random starting point with a Random Number Generator and subsequently selecting samples at fixed intervals until 30 samples were obtained. These samples were then tested using both ECLIA and the Rapid Test. The study design was observational analytic with a cross-sectional approach to evaluate the correlation between Rapid Test results and the ECLIA method as the gold standard, and to calculate sensitivity, specificity, PPV, and NPV accurately. A total of 30 blood donor samples were examined. Based on the ECLIA results, 4 samples were identified as HIV-reactive and 26 samples were non-reactive. The Immunochromatographic Rapid Test detected only 2 of the 4 ECLIA-confirmed reactive cases. The test showed high specificity (100%) but relatively low sensitivity (50%). ECLIA detected 4 (13.3%) reactive and 26 (86.3%) non-reactive samples. The sensitivity of the Immunochromatographic Rapid Test compared to ECLIA was 50%, while the specificity was 100%. These results indicate that the Rapid Test does not meet the requirements stated in the 2018 CPOB guidelines, particularly regarding HIV screening, which requires a specificity of more than 98%.

PDF

References

  1. Abbott Laboratories. (2022). HIV Ag/Ab Combo Reagen Kit Alinity. In Abbott Laboratories (Ed.), Abbott Laboratories.
  2. BPOM. (2018). Petunjuk Operasional Penerapan Pedoman Cara Pembuatan Obat Yang Baik Di Unit Transfusi Darah Dan Pusat Plasmaferesis. РОРР СРОB Di UTD Dan Pusat Plasmaferesis. In Jakarta.
  3. Carvajal, D. N., & Rowe, P. C. (2010). Sensitivity, specificity, predictive values, and likelihood ratios. Pediatrics in Review, 31(12), 511–513. https://doi.org/10.1542/pir.31-12-511
  4. Deswiani, P., Marliana, N., Abror, Y. K., Kesehatan, P., & Kesehatan, K. (2024). Perbandingan Hasil HBsAg dan Anti HBs Metode Chemiluminescent Microparticle Immunoassay ( CMIA ) Antara Alat Alinity-I Dan Architect-i2000SR. Jurnal Kesehatan Siliwangi, 4(3), 929–936.
  5. Erawati, Siska Kusumawardani, L. A. P. S. (2023). Prevalensi Kejadian Infeksi HIV Sebagai Screening Test Deteksi AIDS Dengan Metode Imunokromatografi Pada Komunitas Homoseksual. Journal Syifa Sciences and Clinical Research, 5(1), 31–36. https://doi.org/10.37311/jsscr.v5i1.17164
  6. Fung, A. W. S., Knauer, M. J., Blasutig, I. M., Colantonio, D. A., & Kulasingam, V. (2017). Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer. F1000Research, 6(0), 1832. https://doi.org/10.12688/f1000research.12775.1
  7. Haq, F. A. H., Amelia, R., Sari, E. M., & Luhulima, D. E. J. (2024). Prevalensi Deteksi Antibodi Human Immunodeficiency Virus (HIV) Pada Kelompok Lelaki Seks Lelaki (LSL). Medicra (Journal of Medical Laboratory Science Technology), 7(2), 69–75. https://doi.org/10.21070/medicra.v7i2.1764
  8. Harti, A. S., Agustin, A., Mardiyah, S., Estuningsih, & Kusumawati, H. N. (2014). Periksaan HIV 1 dan 2 Metode Imunokromatografi Rapid Test Sebagai Screening Test Deteksi AIDS. Jurnal KESMADASKA, 55–59. http://jurnal.ukh.ac.id/index.php/JK/article/view/52
  9. Kemenkes. (2015). Peraturan Menteri Kesehatan Republik Indonesia Nomor 91 Tahun 2015 Tentang Standar Pelayanan Transfusi Darah (Vol. 3, Issue 2). http://hukor.kemkes.go.id/uploads/produk_hukum/PMK_No._91_ttg_Standar_Transfusi_Pelayanan_Darah_.pdf
  10. Kemenkes. (2019). Pedoman Nasional Pelayanan Kedokteran Tata Laksana HIV Nomor HK.01.07/MENKES/90/2019 (Vol. 7, Issue 2, pp. 56–62). https://medicra.umsida.ac.id/index.php/medicra/article/view/1764/2135
  11. Mukaromah. (2017). Variasi Sampel Terhadap Hasil Tes Rapid Anti HIV. (Universitas Muhammadiyah Semarang (ed.)).
  12. Ni’mah, A. M., Prasetyowati, I., & Bumi, C. (2024). Seroepidemiologi Antibodi Anti HIV berdasarkan Karakteristik Demografi pada Pendonor Darah di UDD PMI Kabupaten Probolinggo. Jurnal Epidemiologi Kesehatan Komunitas, 9(1), 13–19. https://doi.org/10.14710/jekk.v9i1.7165
  13. OMS. (2019). Consolidated Guidelines on HIV Testing Services 2019. In World Health Organization. https://www.who.int/publications/i/item/978-92-4-155058-1
  14. Praharaj, A. K., Angadi, K., Kalghatgi, A. T., Tripathy, S., Sawhney, M. P. S., & Nagendra, A. (2003). Early diagnosis of human immunodeficiency virus infection by p24 antigen detection. Medical Journal Armed Forces India, 59(4), 313–315. https://doi.org/10.1016/S0377-1237(03)80143-0
  15. Putri W.R. (2022). Keamanan Produk Darah: “Deteksi Imltd Menggunakan Metode Chemiluminescence Assay (Clia)” Blood Product Safety: Chemiluminescence Assay (Clia) Methods for Transfusion-Related Infectious Disease Detection. JMLS) Journal of Medical Laboratory and Science, 2(2), 2022. https://doi.org/10.36086/medlabscience.v2i2
  16. Rajagukguk, M., Loesnihari, R., Amelia, S., Aman Nasution, T., & Sanuddin, O. (2013). Global Medical and Health Communication Karakteristik Pendonor Darah dengan HIV Reaktif Positif Melalui Rapid Test HIV Tiga Metode. Universitas Methodist Indonesia. Jl. Setia Budi-Tanjung Sari Psr, 2(April), 34–41. http://dx.doi.org/10.29313/gmhc.v6i1.2418
  17. Roche Diagnostics. (2020). Electrochemiluminescence Immunoassay (ECLIA) for HIV Detection (Technical Report (ed.)).
  18. Sugiyono. (2016). Metode Penelitian Kuantitatif, Kualitatif, dan R&D (Alfabeta (ed.)).
  19. Triatmojo, B. (2020). Gambaran Hasil Pemeriksaan HIV pada Darah Donor Overview of HIV Test Results on Donor Blood. Jurnal Laboratorium Medis, 2(01), 0–4. https://ejournal.poltekkes-smg.ac.id/ojs/index.php/JLM/
  20. Yanti, Y., Parwati, I., Indrati, A. R., & Alam, A. (2016). Validitas Pemeriksaan Antigen P24 HIV Metode Rapid Immunochromatography Terhadap Viral Load RNA HIV Metode PCR. Sari Pediatri, 16(5), 347. https://doi.org/10.14238/sp16.5.2015.347-50