Screening Test Of Immunochromatographic Test Biocare Method Compared To Chemiluminescence Immunoassay As The Reference Standard In Syphilis Examination Of Blood Donors
DOI:
https://doi.org/10.30872/Keywords:
syphilis, blood donors, immunochromatographic test, chemiluminescence immunoassay, diagnostic testAbstract
Syphilis is a sexually transmitted infection that may be transmitted through blood transfusion if not detected during donor screening. The immunochromatographic test (ICT) is widely used because it is rapid, simple, and cost-effective; however, its sensitivity requires evaluation against chemiluminescence immunoassay (CLIA) as the reference method. This study aimed to evaluate the diagnostic performance of the Biocare ICT compared with CLIA for syphilis screening in blood donors at the Indonesian Red Cross (PMI) in Lampung Province. An observational analytical study with a cross-sectional diagnostic test design was conducted using 100 donor serum samples selected through consecutive sampling. A 2 × 2 contingency table was used to determine sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. The results showed 25 discordant results between ICT and CLIA, comprising 24 false-negative and one false-positive result. The Biocare ICT demonstrated a sensitivity of 52%, specificity of 98%, PPV of 96.3%, NPV of 67.1%, and accuracy of 75%. It can be concluded that the Biocare ICT has high specificity but relatively low sensitivity compared with CLIA, indicating a potential risk of false-negative results. CLIA is therefore recommended to support blood transfusion safety and minimize the risk of syphilis-infected blood donations being missed during screening
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Copyright (c) 2026 Ovi Hawila Tivena Rini, Mulat Muliasih, Veronica Ela Rimawati, and Muhammad Nur. Published by Jurnal Sains dan Kesehatan, Faculty of Pharmacy, University of Mulawarman, Samarinda, Indonesia.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
