Author(s)

Lei Zhang ¹, Feng Yang ², Junzhe Zhu ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang 310000, China

Corresponding Author

Lei Zhang

ABSTRACT

This study assessed the clinical performance of the Newlink One Step HBsAg and HCV Combo Test (Whole Blood/Serum/Plasma), a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) and antibodies to Hepatitis C Virus (HCV). Using commercial EIA/CMIA as the reference standard for HBsAg and EIA/ECLIA for HCV, accuracy was evaluated with human whole blood, serum, and plasma specimens. The validation included a large cohort: 2,926 specimens (669 HBsAg positive, 2,257 negative) for Hepatitis B and 2,062 specimens (540 HCV antibody positive, 1,522 negative) for Hepatitis C. The combo test demonstrated high diagnostic accuracy. For HBsAg detection, relative sensitivity was 99.7% (95% CI: 98.9%-100%), relative specificity was 99.8% (95% CI: 99.6%-100%), and overall accuracy was 99.8% (95% CI: 99.6%-99.9%). For HCV antibody detection, relative sensitivity exceeded 99.9% (95% CI: 99.3%-100%), relative specificity was 99.9% (95% CI: 99.6%-100%), and overall accuracy was >99.9% (95% CI: 99.7%-100%). No cross-reactivity was observed with a panel of potential interfering substances or other common infectious agents. The test also showed excellent within-run and between-run precision. In summary, the One Step HBsAg and HCV Combo Test is a reliable, accurate and practical point-of-care tool for simultaneous screening of Hepatitis B and C, supporting timely clinical management.

KEYWORDS

Hepatitis B surface antigen; Hepatitis C virus antibody; Rapid diagnostic test; Point-of-care testing; Immunochromatographic assay; Qualitative screening

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Performance Evaluation of the Newlink One Step HBsAg and HCV Combo Test (Whole Blood/Serum/Plasma, REF: L11-HBC02C4) via Clinical Validation. MEDS Clinical Medicine (2025) Vol. 6: 167-71. DOI: http://dx.doi.org/10.23977/medsc.2025.060524.

REFERENCES

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