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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