评估用于检测 HIV 感染的 MAGLUMI HIV Ab/Ag 组合检测试剂盒。

IF 4 3区医学 Q2 VIROLOGY Virology Journal Pub Date : 2024-11-13 DOI:10.1186/s12985-024-02565-x

Chunling Wang, Jie Rao, Zhonggang Fang, Hongwei Zhang, Jun Yin, Tinghua Li, Chen Zhang

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引用次数: 0

摘要

背景：人类免疫缺陷病毒（HIV）感染筛查和诊断是控制 HIV 流行的关键。检测血液样本中的抗 HIV 抗体（Ab）和抗原（Ag）是筛查潜在感染者的第一步。本研究旨在评估 MAGLUMI HIV Ab/Ag Combi 检测 HIV 抗体和抗原的性能：我们使用残留样本对 MAGLUMI HIV Ab/Ag Combi 的诊断特异性和灵敏度进行了回顾性评估。所有符合检测标准的样本都按照制造商的说明使用 MAGLUMI HIV Ab/Ag Combi 进行了检测。将 MAGLUMI HIV Ab/Ag Combi 检测结果与 Architect HIV Ag/Ab Combo 检测结果进行比较：结果：在 5,057 位未经挑选的献血者和 213 位住院病人样本中，MAGLUMI HIV Ab/Ag Combi 检测试剂盒的特异性分别为 99.85%和 100.00%。在 614 份 HIV-1 Ab、HIV-1 Ag 或 HIV-2 Ab 阳性样本中，检测灵敏度为 100.00%。从 30 个检测组的结果来看，MAGLUMI HIV Ab/Ag Combi 和 Architect 检测法的血清转换灵敏度相当：结论：MAGLUMI HIV Ab/Ag Combi 检测试剂盒的反应性与 Architect HIV Ag/Ab Combo 检测试剂盒相当。

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Evaluation of the MAGLUMI HIV Ab/Ag combi test for the detection of HIV infection.

Background: Human immunodeficiency virus (HIV) infection screening and diagnosis are critical to control the HIV epidemic. Testing for anti-HIV antibodies (Ab) and antigens (Ag) in blood samples is the first step to screen people who have been potentially exposed to the virus. This study aimed to evaluate the performance of the MAGLUMI HIV Ab/Ag Combi for detection of HIV antibodies and antigens.

Methods: We used residual samples to assess the diagnostic specificity and sensitivity of the MAGLUMI HIV Ab/Ag Combi retrospectively. All samples that met the test criteria were tested with the MAGLUMI HIV Ab/Ag Combi according to manufacturer's instruction. Results of the MAGLUMI HIV Ab/Ag Combi were compared with the Architect HIV Ag/Ab Combo test.

Results: The specificity of the MAGLUMI HIV Ab/Ag Combi was 99.85% in 5,057 unselected blood donors and 100.00% in 213 hospitalized patient samples, respectively. The sensitivity of the Test in 614 HIV-1 Ab, HIV-1 Ag or HIV-2 Ab positive samples was 100.00%. Seroconversion sensitivity from results of 30 panels was comparable between the MAGLUMI HIV Ab/Ag Combi and the Architect assay.

Conclusions: The reactivity of the MAGLUMI HIV Ab/Ag Combi test is comparable to the Architect HIV Ag/Ab Combo assay.

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来源期刊

Virology Journal 医学-病毒学

CiteScore

7.40

自引率

2.10%

发文量

186

审稿时长

1 months

期刊介绍： Virology Journal is an open access, peer reviewed journal that considers articles on all aspects of virology, including research on the viruses of animals, plants and microbes. The journal welcomes basic research as well as pre-clinical and clinical studies of novel diagnostic tools, vaccines and anti-viral therapies. The Editorial policy of Virology Journal is to publish all research which is assessed by peer reviewers to be a coherent and sound addition to the scientific literature, and puts less emphasis on interest levels or perceived impact.