Uji Validitas Metode Immunochromatographic Test ANTI-HCV Dalam Skrining Infeksi Menular Lewat Transfusi Darah: Studi Cross-Sectional Di UDD PMI Provinsi Lampung

Mutiara Salsabila, Mulat Muliasih, Zulhafis Mandala, Hidayat Hidayat, Akhmad Kheru Darmawan

Sari


Hepatitis C Virus (HCV) merupakan agen IMLTD utama yang menyebabkan penyakit hati kronis hingga sirosis dan karsinoma hepatoseluler. Permenkes RI No. 91 Tahun 2015 menetapkan standar minimal sensitivitas 99,5% dan spesifisitas 98% untuk metode skrining IMLTD. Penelitian observasional diagnostik cross-sectional ini menganalisis 100 sampel darah donor secara consecutive sampling di UDD PMI Provinsi Lampung (Desember 2025–Maret 2026). CLIA menggunakan Roche Cobas e402 sebagai standar baku; ICT menggunakan kit Biocare Combo 4 dilakukan oleh peneliti yang di-blinding terhadap hasil CLIA. CLIA mendeteksi 8 sampel reaktif (8,0%; 95% CI 4,1–15,0%); ICT hanya mendeteksi 1 (1,0%), berbeda bermakna secara statistik (uji eksak McNemar, p = 0,016). Validitas ICT: sensitivitas 12,5% (95% CI: 2,2–47,1%), spesifisitas 100% (96,0–100%), NPP 100%, NPN 92,9%, LR− 0,875, akurasi 93,0%. Seluruh 7 negatif palsu memiliki titer S/CO CLIA 1,09–8,55, mencerminkan keterbatasan analitik inheren visualisasi membran nitroselulosa dibandingkan amplifikasi photomultiplier CLIA. ICT tidak memenuhi ambang batas sensitivitas regulasi dan tidak dapat digunakan sebagai metode tunggal skrining IMLTD; transisi ke CLIA atau EIA sangat direkomendasikan.


Kata Kunci


Anti-HCV; CLIA; ICT; Infeksi Menular Lewat Transfusi Darah; Uji Validitas

Teks Lengkap:

PDF

Referensi


Ali, N., Batool, Z., Noor, A., Aurangzeb, Arif Khan, S., and Basharat, S. (2018). Immunochromatography and chemiluminescence for detection of anti-HCV antibodies in diagnosis of hepatitis C infection among healthy blood donors. Jurnal Medical Science, 26, 268–271.

Harlan, J., and Sutjiati, R. (2018). Metodologi Penelitian Kesehatan (Edisi Kedua). Depok: Penerbit Gunadarma.

Irshad, R., Farooq, U., Ullah, I., Farooq, A., Shah, T., Gul, A., and Badshah, A. (2023). Comparative evaluation and accuracy of ICT, CLIA and NAT for the detection of hepatitis B, C and HIV in blood donors. Journal of Ayub Medical College, 35(4), 654–657.

Kementerian Kesehatan RI. (2023). Petunjuk Teknis Pencegahan Infeksi Menular Lewat Transfusi Darah (IMLTD). Jakarta: Kemenkes RI.

Lemeshow, S., Hosmer, D. W., Klar, J., and Lwanga, S. K. (1990). Adequacy of Sample Size in Health Studies. Chichester: John Wiley & Sons, for the World Health Organization.

Lukita Ariani, N., Luh Putu Eka Sudiwati, N., Panggayuh, A., and Widuri, S. (2024). Prevalensi IMLTD darah donor di UDD PMI Kota Surabaya. Care: Jurnal Ilmiah Ilmu Kesehatan, 12(1), 153–165.

Mahajan, S., Agarwal, R., Rawat, V., Kumar, G., Sharma, M. K., and Gupta, E. (2019). Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody. VirusDisease, 30(3), 373–379.

Maldarelli, M. E., Bonin, J. E., Shah, A., Dave, S., Mazzeffi, M. A., Boswell, K., Madathil, R. J., Tabatabai, A., and Ghneim, M. H. (2022). An oxygen balancing act: a narrative review of red blood cell transfusion in extracorporeal membrane oxygenation. Annals of Blood, 7.

Mandal, S., Gupta, D., and Patra, S. (2018). A comparative study on chemiluminescent immunoassay with immunochromatography test in the screening process of hepatitis B and hepatitis C. Journal of Applied Biology and Laboratory Medicine.

McPherson, R. A., and Pincus, M. R. (2022). Henry's Clinical Diagnosis and Management by Laboratory Methods (24th ed.). Amsterdam: Elsevier.

Muche, Y., Gelaw, Y., Atnaf, A., and Getaneh, Z. (2023). Blood transfusion complications and associated factors among blood-transfused adult patients at Debre Markos Comprehensive Specialized Hospital, Ethiopia. Journal of Blood Medicine, 14, 389–398.

Sallam, M., and Khalil, R. (2024). Contemporary insights into hepatitis C virus: A comprehensive review. Microorganisms, 12(6).

Stroffolini, T., and Stroffolini, G. (2024). Prevalence and modes of transmission of HCV infection: A historical worldwide review. Viruses, 16(7).

Tang, W., Chen, W., Amini, A., Boeras, D., Falconer, J., Kelly, H., Easterbrook, P. (2017). Diagnostic accuracy of tests to detect hepatitis C antibody: A meta-analysis. BMC Infectious Diseases, 17.

Wedemeyer, H., Mauss, S., Berg, T., Keitel, V., Rockstroh, J., & Sarrazin, C. (Eds.). (2025). Hepatology: A clinical textbook (11th ed.). German: hepatologytextbook.com.

World Health Organization. (2018). Blood Donor Counselling: Implementation Guidelines. Geneva: WHO.




DOI: https://doi.org/10.33024/jikk.v13i8.25762

Refbacks

  • Saat ini tidak ada refbacks.


##submission.copyrightStatement##

##submission.license.cc.by-nc4.footer##

Pendidikan Dokter Universitas Malahayati Lampung


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