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评价伯乐公司的 Multispot HIV-1/HIV-2 快速检测试剂盒作为 Western blot 检测的替代方法,用于确认 HIV 感染。

Evaluation of the Bio-Rad Multispot HIV-1/HIV-2 Rapid Test as an alternative to Western blot for confirmation of HIV infection.

机构信息

Clinical Virology Laboratory and Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.

Clinical Virology Laboratory and Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.

出版信息

J Clin Virol. 2013 Dec;58 Suppl 1:e97-e103. doi: 10.1016/j.jcv.2013.08.021. Epub 2013 Aug 30.

DOI:10.1016/j.jcv.2013.08.021
PMID:24113294
Abstract

BACKGROUND

In the United States, a new HIV diagnostic algorithm has been proposed that uses an HIV-1/HIV-2 antibody differentiation immunoassay instead of Western blot or immunofluoresence for confirmatory testing.

OBJECTIVES

To evaluate the Multispot HIV-1/HIV-2 Rapid Test (Multispot) as an alternative to Western blot analysis for confirmation of HIV infection.

STUDY DESIGN

A series of 205 serum and plasma specimens positive for HIV-1 or HIV-2 were used to compare the performance of Multispot to a standard HIV-1 Western blot. Positive samples included 63 specimens from patients>18 months of age, 33 proficiency survey specimens, and 109 specimens from nine commercial seroconversion and performance panels. In addition, 63 specimens from 51 HIV-exposed, uninfected children≤18 months of age in various stages of seroreversion and 192 HIV-negative samples were tested. Specimens were initially screened using a 4th generation HIV Ag/Ab Combo assay.

RESULTS

Multispot readily discriminated between individuals with HIV-1 or HIV-2 infection and those who were uninfected. Of the 205 samples repeatedly reactive by the 4th generation screening assay, infection status was correctly confirmed by Multispot in 83.9% (172/205) compared to 68.8% (141/205) for Western blot. Multispot detected HIV-1 earlier in 27.6% of low-titer antibody specimens called indeterminate by Western blot, and effectively reduced the number of indeterminate results in seroreverting HIV-1 exposed, uninfected infants and for HIV-2 infections misinterpreted as indeterminate or positive by HIV-1 Western blot.

CONCLUSIONS

Multispot offers speed and simplicity over Western blot and has an excellent performance for differentiation and confirmation of antibodies to HIV-1 and HIV-2.

摘要

背景

在美国,提出了一种新的 HIV 诊断算法,该算法使用 HIV-1/HIV-2 抗体区分免疫测定法代替 Western blot 或免疫荧光法进行确认检测。

目的

评估 Multispot HIV-1/HIV-2 快速检测(Multispot)作为 Western blot 分析替代方法,用于确认 HIV 感染。

研究设计

使用一系列 205 份血清和血浆标本,这些标本对 HIV-1 或 HIV-2 呈阳性,以比较 Multispot 与标准 HIV-1 Western blot 的性能。阳性样本包括 63 份来自年龄>18 个月的患者的样本、33 份熟练度调查样本和来自九个商业血清转换和性能面板的 109 份样本。此外,还检测了 63 份来自 51 名处于血清转换各阶段的 HIV 暴露、未感染的<18 个月大的儿童和 192 份 HIV 阴性样本。标本最初使用第四代 HIV Ag/Ab Combo 检测进行筛选。

结果

Multispot 可轻松区分 HIV-1 或 HIV-2 感染者和未感染者。在 205 份通过第四代筛选检测反复呈阳性的样本中,Multispot 正确确认感染状态的比例为 83.9%(172/205),而 Western blot 为 68.8%(141/205)。Multispot 在 Western blot 称为不确定的 27.6%低抗体滴度标本中更早地检测到 HIV-1,并有效减少了血清转换 HIV-1 暴露、未感染婴儿中不确定结果的数量,以及 HIV-2 感染被错误地解释为不确定或阳性的 HIV-1 Western blot。

结论

Multispot 提供了比 Western blot 更快和更简单的速度,并且在区分和确认 HIV-1 和 HIV-2 抗体方面具有出色的性能。

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