As part of Hytest North America’s continued commitment to supporting infectious disease diagnostics, we are pleased to announce the launch of Cat. #8HC59. This new antigen expands our HCV product portfolio and provides assay developers with an additional tool for the detection of antibodies against HCV.

Cat. #8HC59 represents an immunodominant fragment of the HCV core protein and is produced in E. coli. It contains an artificially introduced methionine residue at the N-terminus and a C-terminal 10×His tag connected via a GSGS linker to facilitate affinity purification.

Performance in a CLIA prototype

The antigen is manufactured to provide high purity and reliable lot-to-lot consistency. The performance of Cat. #8HC59 was evaluated in an indirect chemiluminescent immunoassay (CLIA) prototype using clinical samples. The prototype demonstrated:

• • 100.0% clinical sensitivity with 125 HCV-positive samples
• • 99.96% clinical specificity with 4,709 clinical samples

The prototype assay fulfilled the applicable performance requirements specified in Commission Implementing Regulation (EU) 2022/1107. Although Cat. #8HC59 was evaluated in an indirect CLIA prototype, its potential applications are not limited to this assay format. The antigen may also be suitable for double-antigen sandwich assays for anti-HCV antibody detection, subject to assay-specific evaluation and optimization.

Expanding Hytest’s HCV antigen portfolio

Together with Hytest’s existing recombinant HCV antigen portfolio — HCV core (Cat. # 8HC55, Cat. # 8HC56), NS3 (Cat. # 8HC53), and NS4 (Cat. # 8HC51, Cat. # 8HC52) — Cat. #8HC59 gives assay developers greater flexibility in selecting and combining antigens for different serological assay designs.

For further information about Cat. #8HC59, including the product Datasheet, please visit the Cat. #8HC59 product page. Background on the development of anti-HCV antibody assays using Hytest antigens is available in the HCV Technote.

For details, please contact the Hytest North America Sales team.