Screening Test Of Immunochromatographic Test Biocare Method Compared To Chemiluminescence Immunoassay As The Reference Standard In Syphilis Examination Of Blood Donors At Pmi Lampung Province In 2026
DOI:
https://doi.org/10.30872/Keywords:
syphilis, blood donors, immunochromatographic test, chemiluminescence immunoassay, diagnostic testAbstract
Syphilis is one of the transfusion-transmitted infections (TTIs) that can be transmitted through blood transfusion if not detected during donor screening. Immunochromatographic Test (ICT) is still used as a screening method because it is rapid, simple, and cost-effective; however, its diagnostic performance compared with Chemiluminescence Immunoassay (CLIA) as the reference standard requires evaluation. This study aimed to assess the diagnostic performance of ICT Biocare against CLIA for syphilis screening among blood donors at the Indonesian Red Cross (PMI) of Lampung Province. An observational analytic study with a cross-sectional diagnostic test design was conducted on 100 donor serum samples selected using consecutive sampling. Diagnostic performance was evaluated using a 2×2 contingency table to determine sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. The results showed 25 discordant findings between ICT and CLIA, consisting of 24 false-negative and 1 false-positive cases. ICT Biocare demonstrated a sensitivity of 52%, specificity of 98%, PPV of 96.3%, NPV of 67.1%, and an overall accuracy of 75%. Although ICT Biocare exhibited high specificity, its relatively low sensitivity indicates the potential for false-negative results. Therefore, CLIA is recommended to improve blood transfusion safety and minimize the risk of transfusion-transmitted syphilis
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