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

SUMMARY

OBJECTIVE:

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.

METHODS:

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).

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:
Hepatitis C virus antibodies; Enzyme immunoassay; Hepatitis C virus; Immunoassay