Clinical evaluation of Xpert HIV Qual XC assay in diverse HIV-1 subtypes circulating in China

IF 3.4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-07-26 DOI:10.1016/j.jcv.2025.105844

Jiafeng Zhang , Xiaobei Ding , Qin Fan , Xinghui Gao , Mingli Zhu , Wenjie Luo , Yan Xia , Yiwei Tang , Chengliang Chai , Jianmin Jiang

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引用次数: 0

Abstract

Background

Early and accurate HIV-1 diagnosis is crucial for timely treatment initiation and transmission prevention. This study evaluated the clinical performance of the Xpert HIV Qual XC assay in detecting HIV-1 across diverse subtypes in China.

Methods

A total of 242 whole blood samples (215 HIV-1-positive, 15 negative, plus 12 with non-HIV pathogens) were tested. Sensitivity, specificity, kappa coefficient, and correlations between Ct values and log₁₀ viral loads were analyzed. Operational performance was compared to the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0 (referred to as the COBAS system) regarding turnaround time (TAT) and reagent usage efficiency.

Results

The Xpert assay demonstrated a high sensitivity of 99.07 % and a specificity of 100.00 %, with an overall agreement of 99.18 % with clinical diagnoses. The detection rates varied by viral load and achieved 100.00 % accuracy for samples with viral loads above 50 copies/mL, but decreased to 84.62 %(11/13) for samples with extremely low viral loads (<50 copies/mL). The assay successfully detected a wide range of HIV-1 subtypes, including CRF07_BC, CRF01_AE, and CRF08_BC, which reflects the genetic diversity in China. Additionally, the Xpert assay provides rapid results within 90 min and requires fewer reagents than COBAS system, making it a viable point-of-care testing option.

Conclusions

The Xpert HIV Qual XC assay shows excellent performance across diverse HIV-1 subtypes and is well-suited for decentralized diagnostic settings, supporting improved early diagnosis of HIV and treatment efforts.

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Xpert HIV quality XC检测在中国不同HIV-1亚型流行中的临床评价

背景：早期和准确的HIV-1诊断对于及时开始治疗和预防传播至关重要。本研究评估了Xpert HIV quality XC检测在中国检测不同亚型HIV-1的临床表现。方法：对242份全血进行检测，其中hiv -1阳性215份，阴性15份，非hiv病原体12份。分析了Ct值与log₁0病毒载量之间的敏感性、特异性、kappa系数和相关性。将操作性能与COBAS AmpliPrep/COBAS TaqMan HIV-1定性测试v2.0（简称COBAS系统）在周转时间（TAT）和试剂使用效率方面进行比较。结果：Xpert分析的灵敏度为99.07%，特异性为100.00%，与临床诊断的总体一致性为99.18%。病毒载量不同，检出率也不同，对于病毒载量大于50拷贝/mL的样品，检出率达到100.00%，但对于病毒载量极低的样品，检出率降至84.62%（11/13）。结论：Xpert HIV quality XC检测在不同的HIV-1亚型中表现出色，非常适合分散的诊断环境，支持改进HIV的早期诊断和治疗工作。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)