Comparison of samples found positive by anti-HCV screening test with line immunoassay and determination of threshold value.

Abstract

This study aimed to compare the serum samples found reactive (≥1-≤20 signal-to-cutoff ratio) with Elecsys antibodies to hepatitis C virus screening test with innogenetics-line immunassay hepatitis C Virus Score test and to determine the most appropriate threshold value for our country, since positive results close to the cutoff value cause serious problems in routine diagnostic laboratories. Antibodies to hepatitis C virus-positive samples from 687 different patients were included in the study. Antibodies to hepatitis C virus antibody detection was performed using Elecsys antibodies to hepatitis C virus II kits (Roche Diagnostics, Germany), an electrochemiluminescence method based on the double-antigen sandwich principle, on the Cobas e601 analyzer (Roche Diagnostics) in accordance with the recommendations of the manufacturer. Samples that were initially identified as reactive were studied again. Samples with ≥1-≤20 signal-to-cutoff ratio reagents as a result of retest were included in the study to be validated with the third-Generation Line immunassay kit (innogenetics-line immunassay hepatitis C Virus, Belgium). A total of 687 samples with antibodies to hepatitis C virus positive and levels between 1-20 S/Co were found to be 56.1% negative, 14.8% indeterminate, and 29.1% positive by innogenetics-line immunassay hepatitis C Virus confirmation test. When the cases with indeterminate innogenetics-line immunassay hepatitis C Virus test results were accepted as positive, the signal-to-cutoff ratio value for antibodies to hepatitis C virus was determined as 5.8 (95% confidence interval) in distinguishing the innogenetics-line immunassay hepatitis C Virus negative and positive groups. It was concluded that with further studies on this subject, each country should determine the most appropriate S/Co value for its population, and thus it would be beneficial to reduce the problems such as test repetition and cost increase.