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Peer-reviewedCC BY-NC-ND 4.0Journal of Clinical Laboratory Analysis

Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO‐LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?

  1. 1Institute for Transfusiology and Haemobiology Military Medical Academy Belgrade Serbia
  2. 2Institute for Medical Research, National Institute of Republic of Serbia University of Belgrade Belgrade Serbia
  3. 3Faculty of Medicine, Military Medical Academy University of Defence Belgrade Serbia

Abstract

Background: The objective of this study is to evaluate whether the rapid lateral flow immunochromatography Geenius HCV Supplemental Assay (ICH) can serve as an alternative to INNO‐LIA HCV Score Confirmatory western blot (WB) assay in a population of blood donors.

Methods: Sera of 60 blood donors, anti‐HCV antibodies repeatedly reactive after first line screening with Architect anti‐HCV chemiluminescent immunoassay, (ABBOTT, Wiesbaden, Germany) (ICL) were evaluated for anti‐HCV antibodies with Geenius HCV Supplemental assay (Bio‐Rad. Marnes‐la‐Coquette—France) (ICH) and Inno‐LIA HCV Score (Inogenetics NV. Gent. Belgium) (Inno‐LIA WB). The level of agreement between ICH and WB results was determined by kappa statistics.

Results: Out of 60 samples identified as anti‐HCV antibodies repeatedly reactive by ICL, ICH identified 32% samples as reactive and 2% as indeterminate. WB identified 35% samples as positive and 20% as indeterminate. Kappa analysis detected moderate agreement between ICH and WB in detecting anti‐HCV antibodies (kappa = 0.60). Moderate to almost very good agreement is acknowledged between ICH and WB in reactivity with individual HCV antigens.

Conclusion: Given the limited number of samples analyzed in this study we can summarize that Geenius HCV Supplemental and Inno‐LIA WB assays are comparable pertaining to anti‐HCV positive samples, but with discrepancy in results occurring in the area of samples classified with WB assay as indeterminate. However, there is very good agreement between Inno‐LIA WB and Geenius ICH positivity/reactivity with individual HCV antigens. Our findings indicate that Geenius ICH Supplemental test cannot replace anti‐HCV Inno‐LIA WB in confirming anti‐HCV antibodies.

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BibTeX
@article{kozic2026geenius,
  title = {{Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO‐LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?}},
  author = {Zorana P. Kozić and Irina S. Maslovarić and Ivana T. Drvenica and Marijana V. Kovačić and Dragana C. Marković and Vesna Lj. Ilić and Dušan D. Vučetić},
  journal = {Journal of Clinical Laboratory Analysis},
  year = {2026},
  month = oct,
  doi = {10.1002/jcla.70367},
  url = {https://doi.org/10.1002/jcla.70367},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO‐LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?
AU  - Zorana P. Kozić
AU  - Irina S. Maslovarić
AU  - Ivana T. Drvenica
AU  - Marijana V. Kovačić
AU  - Dragana C. Marković
AU  - Vesna Lj. Ilić
AU  - Dušan D. Vučetić
PY  - 2026
DA  - 2026/10/09
JO  - Journal of Clinical Laboratory Analysis
DO  - 10.1002/jcla.70367
UR  - https://doi.org/10.1002/jcla.70367
AB  - Background: The objective of this study is to evaluate whether the rapid lateral flow immunochromatography Geenius HCV Supplemental Assay (ICH) can serve as an alternative to INNO‐LIA HCV Score Confirmatory western blot (WB) assay in a population of blood donors.  Methods: Sera of 60 blood donors, anti‐HCV antibodies repeatedly reactive after first line screening with Architect anti‐HCV chemiluminescent immunoassay, (ABBOTT, Wiesbaden, Germany) (ICL) were evaluated for anti‐HCV antibodies with Geenius HCV Supplemental assay (Bio‐Rad. Marnes‐la‐Coquette—France) (ICH) and Inno‐LIA HCV Score (Inogenetics NV. Gent. Belgium) (Inno‐LIA WB). The level of agreement between ICH and WB results was determined by kappa statistics.  Results: Out of 60 samples identified as anti‐HCV antibodies repeatedly reactive by ICL, ICH identified 32% samples as reactive and 2% as indeterminate. WB identified 35% samples as positive and 20% as indeterminate. Kappa analysis detected moderate agreement between ICH and WB in detecting anti‐HCV antibodies (kappa = 0.60). Moderate to almost very good agreement is acknowledged between ICH and WB in reactivity with individual HCV antigens.  Conclusion: Given the limited number of samples analyzed in this study we can summarize that Geenius HCV Supplemental and Inno‐LIA WB assays are comparable pertaining to anti‐HCV positive samples, but with discrepancy in results occurring in the area of samples classified with WB assay as indeterminate. However, there is very good agreement between Inno‐LIA WB and Geenius ICH positivity/reactivity with individual HCV antigens. Our findings indicate that Geenius ICH Supplemental test cannot replace anti‐HCV Inno‐LIA WB in confirming anti‐HCV antibodies.
SN  - 0887-8013
SN  - 1098-2825
ER  -