Serial follow-up of repeat voluntary blood donors reactive for anti-HCV ELISA

Abstract

Background:Voluntary non-remunerated repeat blood donors are perceived to be safer than the first time blood donors. This study was planned for follow-up of previous hepatitis C virus (HCV) test results of anti-HCV enzyme-linked immunosorbent assay (ELISA) reactive repeat blood donors. The aim was to suggest a protocol for re-entry of the blood donors who are confirmed HCV negative by nucleic acid test (NAT) and recombinant immunoblot assay (RIBA). A group of repeat voluntary donors were followed retrospectively who became reactive on a cross sectional study and showed HCV reactivity while donating blood regularly.Material and Methods:A total of 51,023 voluntary non remunerated blood donors were screened for anti-HCV ELISA routinely. If anybody showed positivity, they were tested by two ELISA kits (screening and confirmatory) and then confirmed infection status by NAT and or RIBA. The previous HCV test results of repeat donors reactive by anti-HCV ELISA were looked back from the records. Data of donors who were repeat reactive with single ELISA kit (in the present study) were analyzed separately from those reactive with two ELISA kits (in the present study).Results:In this study, 140 (0.27%) donors who were reactive by anti HCV ELISA were included. Out of them, 35 were repeat voluntary donors and 16 (11.43%) were reactive with single ELISA kit. All 16 donors were reactive by single ELISA kit occasionally in previous donations. Their present ELISA positive donations were negative for HCV NAT and RIBA. A total of 19 (13.57%) donors were reactive with two ELISA kits. In their previous donations, the donors who were reactive even once with two ELISA kits were consistently reactive by the same two ELISA kits in their next donations also.Conclusion:Donor sample reactive by only single ELISA kit may not be considered as infectious for disposal as they were negative by NAT and or RIBA. One time ELISA positivity was found probably due to ELISA kit specificity and sensitivity. Donors reactive with two ELISA kit should be discarded as there is a high positivity with NAT/ RIBA. However, donors reactive by two ELISA kits and negative by NAT and RIBA should be followed up and may not be deferred permanently.

Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

“…Indeed, 41% of initially reactive samples which could be analyzed were not reproduced when retested with the same reagent. Repeat testing is known to improve specificity (Choudhury et al, 2011; Piro et al, 2008). …”

“…Several solutions have been proposed. One could test simultaneously with two assays and exclude donors reactive with both since these subjects have the highest probability to be positive with NAT and/or Immunoblot (Choudhury et al, 2011). Nevertheless, two tests increase the cost of the screening unless a sequential screening strategy is used (Seed et al, 2003).…”

Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays

“…Studies in different population groups found varying prevalence rates [ Table 1 ]. [ 10 11 12 13 14 15 16 17 18 19 ]…”

Diverse Genotypes of Hepatitis C Virus in Voluntary Blood Donors in Shanghai, China

“…The low detection rate could be generally interpreted by different dynamics of antibody and viral nucleic acid, such as spontaneous clearance of HCV or resolved HCV RNA in blood specimens (20)(21)(22)(23). However, no partial sequence was amplified in the specimens negative for anti-HCV while positive by NAT.…”