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 evaluated the clinical performance of the Newlink One Step HIV 1.2 and HIV p24 Combo Test (Whole Blood/Serum/Plasma, REF: L11-HIBG02C4), a rapid, fourth-generation immunochromatographic assay designed for the simultaneous, qualitative detection of antibodies to HIV-1/2 and the HIV-1 p24 antigen. Using commercial enzyme-linked immunosorbent assay/chemiluminescent immunoassay (ELISA/CLIA) as the reference standard, the test was evaluated across a substantial cohort of clinical specimens. For HIV-1/2 antibody detection, 2023 specimens (406 positive, 1617 negative) were tested, yielding a relative sensitivity of 99.8% (95% CI: 98.6%-100%), a relative specificity of 99.7% (95% CI: 99.3%-99.9%), and an overall accuracy of 99.7% (95% CI: 99.4%-99.9%), with a Kappa statistic of 0.99 indicating almost perfect agreement. For HIV-1 p24 antigen detection, 1081 specimens (90 positive, 991 negative) were tested, yielding a relative sensitivity of 82.2% (95% CI: 72.7%-89.5%), a relative specificity of 98.8% (95% CI: 97.9%-99.4%), and an overall accuracy of 97.4% (95% CI: 96.3%-98.3%), with a Kappa statistic of 0.83 indicating substantial agreement. Subgroup analyses by gender and age showed consistent performance. The test demonstrated excellent precision (>99% correct identification in within-run and between-run studies) and no cross-reactivity with a panel of common interfering substances and infectious agents. In conclusion, the One Step HIV 1.2 and HIV p24 Combo Test is a highly accurate, reliable, and rapid point-of-care diagnostic tool, particularly for HIV-1/2 antibody detection, while also providing valuable early detection capability for HIV-1 infection through p24 antigen detection, making it suitable for diverse clinical and screening settings.

KEYWORDS

Human Immunodeficiency Virus (HIV); HIV-1/2 Antibody; HIV-1 p24 Antigen; Fourth-Generation HIV Test; Rapid Diagnostic Test; Point-of-Care Testing; Immunochromatographic Assay; ELISA/CLIA

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Clinical Performance Assessment of a Dual-Target Rapid Immunoassay: The Newlink One Step HIV 1.2 and HIV p24 Combo Test (Ref: L11-HIBG02C4) in a Multicenter Evaluation. MEDS Clinical Medicine (2025) Vol. 6: 162-166. DOI: http://dx.doi.org/10.23977/medsc.2025.060523.

REFERENCES

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