Optimizing HIV testing: Comparing diagnostic signatures and assay performance in ART-treated and general screening populations

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Clinica Chimica Acta Pub Date : 2025-02-21 DOI:10.1016/j.cca.2025.120207

Qian Liu , Xinru Liu , Le Chang , Huimin Ji , Huizhen Sun , Ying Yan , Junjie Xu , Lunan Wang

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Abstract

Introduction

Accurate and early HIV detection is crucial for improving outcomes and controlling transmission. This study compares HIV marker patterns and evaluates detection assay performance in general screening and ART-treated populations to enhance diagnostic accuracy and public health.

Methods

A total of 196 blood donor samples that were initially reactive in blood center screening were collected across 17 provinces in China, along with 126 ART samples from people living with HIV (PLWH). HIV RNA, Ag/Ab, and western blot were conducted in both groups. CD4 T cell counts were assessed in PLWH. The performance of two antigen detection kits (Wantai, Livzon) and eight Ag/Ab kits (Roche, Abbott, KHB, InTec, Wantai, Livzon, Murex, Bio-rad) were evaluated.

Results

In the ART group, all samples were Ag/Ab positive, with 32.5 % (41/126) having undetectable viral loads; NAT-positive samples showed a higher rate of complete bands in western blot compared to NAT-negative group (42.5 % vs 15.4 %, P = 0.021), while p17, p39, and p31 bands were often absent. 90.8 % (178/196) of blood donors were NAT-positive and Ag/Ab-positive. 4.6 % (9/196) of blood donors were NAT-positive but Ag/Ab-negative, these samples were also tested as NAT-only reactive in screening at blood centers, often showing only a p24 band or negative result in WB, indicating early acute infection. 3.6 % (7/196) of blood donors were confirmed as NAT-negative but Ag/Ab-positive, hinting that a small group on ART might attempt to donate blood. HIV serological kits showed 100 % positivity in the ART group. Fourth-generation kits, particularly the Roche Ag/Ab kit, showed the highest sensitivity (95.2 %) for NAT-positive donors.

Discussion

This study highlights critical differences in HIV detection between ART-treated individuals and general screening populations, emphasizing the need for tailored diagnostic strategies to ensure blood transfusion safety.

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优化HIV检测：比较art治疗人群和普通筛查人群的诊断特征和检测性能。

准确和早期的艾滋病毒检测对于改善结果和控制传播至关重要。本研究比较了HIV标记物模式，并评估了检测方法在普通筛查和抗逆转录病毒治疗人群中的表现，以提高诊断准确性和公共卫生。方法：在中国17个省份共收集了196份在血液中心筛查中初步反应的献血者样本，以及来自艾滋病毒感染者（PLWH）的126份ART样本。两组均进行HIV RNA、Ag/Ab、western blot检测。检测PLWH患者的CD4 t细胞计数。对2种抗原检测试剂盒（Wantai、Livzon）和8种Ag/Ab试剂盒（Roche、Abbott、KHB、InTec、Wantai、Livzon、Murex、Bio-rad）的性能进行评价。结果：ART组所有样本均为Ag/Ab阳性，32.5 %（41/126）的病毒载量检测不到；与nat阴性组相比，nat阳性样品在western blot中显示出更高的完整条带率（42.5 % vs 15.4 %,P = 0.021），而p17， p39和p31条带通常不存在。90.8 %（178/196）的献血者为nat阳性和Ag/ ab阴性。4.6 %（9/196）的献血者nat阳性但Ag/ ab阴性，这些样本在血液中心筛查时也被检测为nat阳性，通常仅显示p24带或WB阴性，表明早期急性感染。3.6% %（7/196）的献血者被确认为nat阴性，但Ag/ ab阳性，这暗示一小部分接受抗逆转录病毒治疗的人可能会尝试献血。ART组HIV血清学试剂盒阳性率为100% %。第四代试剂盒，特别是罗氏Ag/Ab试剂盒，对nat阳性供者的敏感性最高（95.2% %）。讨论：这项研究强调了接受抗逆转录病毒治疗的个体和一般筛查人群在艾滋病毒检测方面的关键差异，强调需要制定量身定制的诊断策略以确保输血安全。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.