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2024, Cilt 54, Sayı 3, Sayfa(lar) 176-181
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Evaluation of Low Positive and Borderline Values of Anti-HCV Antibody in the Serological Diagnosis of Hepatitis C Using Two Different Enzyme Immunoassay Methods
Mehmet Soylu1, Ayça Aydın Uysal1, Ayşin Zeytinoğlu2
1Ege Üniversitesi Tıp Fakültesi, Tıbbi Mikrobiyoloji Anabilim Dalı, İzmir, Türkiye
2İzmir Ekonomi Üniversitesi, Tıp Fakültesi, Tıbbi Mikrobiyoloji Anabilim Dalı, İzmir, Türkiye
Keywords: Hepatitis C, Enzyme immunoassay, Polymerase chain reaction

Objective: Hepatitis C virus (HCV) is the leading cause of acute and chronic hepatitis. Diagnosis primarily relies on detecting anti-HCV antibodies, measuring alanine transaminase (ALT) levels, and evaluating HCV-RNA positivity. This study focused on patients with borderline or weakly positive results in two enzyme immunoassaybased blood tests: enzyme-linked fluorescence assay (ELFA) and chemiluminescent immunoassay (CLIA). It compared their anti-HCV antibody index values against their ALT and HCV-RNA outcomes.

Methods: The research included serum samples from 59 patients, collected between October 2018 and November 2019, evaluated using the Signal/Cut-off (S/CO) values in the CLIA system and the Test Value (TV) values in the ELFA system.

Results: The mean S/CO and TV values for HCV antibodies obtained from serum samples were determined as 2.78TV for ELFA test and 2.32 S/CO for CLIA test. Mean ALT level of all serum samples was determined as 28.7U/L. Weak positive results were obtained with CLIA in serum samples of 17 patients (11 Female-6 Male, mean age: 42.2) who had negative results with ELFA, and mean ELFA value was 0.24 TV, and the mean CLIA value was 1.74 S/CO. The mean of borderline cases in ELFA was 0.82TV; mean CLIA was 1.97 S/CO in same group.

Conclusion: The study underscores the importance of validating HCV antibody results obtained from one assay with another system, preferably alongside HCV-RNA testing, and suggests revising the “1 S/CO” and “1 TV” thresholds for positivity in future research to ensure accuracy in diagnosis.


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