Reliable resolution of ambiguous hepatitis C virus genotype 1 results with the Abbott HCV Genotype Plus RUO assay

V Saludes1,2,3, A Antuori1, B Reinhardt4

  • 1Microbiology Department, Laboratori Clínic Metropolitana Nord, Hospital Universitari Germans Trias i Pujol; Genetics and Microbiology Department, Universitat Autònoma de Barcelona, Badalona, Spain.

Scientific Reports
|March 8, 2019
PubMed

Insights

Accurate hepatitis C virus genotype 1 (HCV-1) subtyping is crucial. The Abbott HCV Genotype Plus (GT Plus) assay effectively resolved ambiguous results, improving overall subtyping accuracy in clinical samples.

Area of Science:

  • Virology
  • Clinical Diagnostics
  • Molecular Biology

Background:

  • Accurate subtyping of hepatitis C virus genotype 1 (HCV-1) is essential for clinical and epidemiological purposes.
  • Existing methods can yield ambiguous results, necessitating improved diagnostic approaches.

Purpose of the Study:

  • To evaluate the Abbott HCV Genotype Plus (GT Plus) assay as a reflex test for resolving ambiguous HCV-1 subtypes.
  • To assess the reliability and efficiency of the GT Plus assay in a clinical setting.

Main Methods:

  • The GT Plus assay was tested on 198 HCV-1 specimens, including those with ambiguous results from the Abbott RealTime Genotype II (GT II) assay.
  • Sanger sequencing and comparison with LiPA 2.0 were used for validation.
  • Performance was evaluated based on successful subtyping rates and concordance with reference methods.

Main Results:

  • The GT Plus assay successfully assigned subtypes in 88.8% (142/160) of previously un-subtyped samples.
  • Overall subtyping concordance between GT Plus and reference methods (sequencing or LiPA 2.0) was high at 98.6% (140/142).
  • The combined use of GT II and GT Plus assays reduced ambiguous HCV-1 results, achieving 98.9% successful subtyping.

Conclusions:

  • The combined use of Abbott GT II and GT Plus assays provides a reliable and simple strategy to significantly reduce ambiguous HCV-1 results.
  • This approach enhances the overall efficiency and accuracy of HCV-1 subtyping in clinical diagnostics.

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