【Cochrane简语概要】通过即时HIV核酸检测诊断18个月及以下婴幼儿HIV-1或HIV-2感染

改进HIV感染诊断为何如此重要？

据估计，每年仍有150万婴儿感染HIV。如不及时治疗，大约50%~60%的HIV感染患儿将在两岁前死亡，出生前死亡的风险非常高。虽然艾滋病无法治愈，但可以通过抗逆转录病毒药物 （antiretroviral therapy, ART）抑制HIV。早期诊断后，可以通过服用这种药物预防HIV相关感染导致的严重疾病和死亡。因此，在患者床旁或附近快速准确地检测HIV病毒遗传分子的方法（即时检测（POC））可增加早期恰当治疗的机会，并最大限度地避免那些未检测到HIV的患者错过治疗。

（图片来自healthproblemsnews.com）

本综述的目的是什么?

明确即时分子检测在18个月及以下的婴幼儿中诊断HIV-1和（或）HIV-2感染的准确性。

本综述研究了什么？

基于已发表文献对比即时分子检测与实验室金标准的结果。

本综述的主要结果是什么？

12项研究比较了用于诊断HIV感染的即时分子检测，涉及15项评估和15120名受试者。

本综述的优势和局限性是什么？

本综述纳入了足够多的研究和受试者。所有研究都开展于撒哈拉以南的非洲地区，因此，本研究的结果非常适用于HIV高发地区和拟开展HIV控制计划的地区。然而，三分之一的即时检测评估在实验室进行，而非患者床旁，但不同环境之间的检测准确性没有差异。

本综述的结果适用于哪些群体？

暴露于HIV感染的18个月及以下的婴幼儿。

本综述的意义是什么？

理论上，在1000名18个月及以下的婴幼儿中，当100人感染HIV时，100名儿童的即时分子检测结果呈阳性，其中1人并未感染（假阳性）；900名儿童的即时分子检测呈阴性，但其中1人确实存在HIV感染（假阴性）。

本综述的时效性如何？

证据检索截至2021年2月2日。

作者结论: 

对于暴露于HIV感染的18个月及以下的婴幼儿，使用POC NAT检测进行HIV-1和（或）HIV-2感染诊断的灵敏度和特异度均较高。

作者:Ochodo EA, Guleid F, Deeks JJ, Mallett S；译者：吴守媛，Cochrane中国协作网成员单位，兰州大学健康数据科学研究院；审校：史乾灵，Cochrane中国协作网成员单位，兰州大学健康数据科学研究院；编辑排版：索于思，北京中医药大学循证医学中心

相关文章链接

【Cochrane Plain Language Summary】Point-of-care tests for detecting HIV viral molecules in infants and children aged 18 months or less

Why is improving the diagnosis of HIV infection important?

It is estimated that 1.5 million infants are still exposed to HIV every year. If left untreated, about 50% to 60% of HIV-infected infants will die by the age of two years. Children infected before birth are especially at high risk of death. HIV is incurable; however, there are medications that suppress HIV, known as antiretroviral drugs (ART). When HIV is detected early, severe illness and death from HIV-related infections can be prevented by taking this medication. A test that detects HIV viral genetic molecules quickly and accurately at or near the patient's side (point-of-care) therefore can increase access to early appropriate treatment and minimize missing treatments in those whose HIV remains undetected.

What is the aim of this review?

To determine the accuracy of molecular point-of-care tests for detecting the main types of HIV infection (HIV-1/HIV-2) in infants and children aged 18 months or less.

What was studied in this review?

Published reports of molecular point-of-care tests with results measured against laboratory viral-based tests (benchmark).

What are the main results of this review?

Twelve studies which completed 15 evaluations involving 15,120 participants compared molecular point-of-care tests for diagnosing HIV infection.

What are the strengths and limitations of this review?

The review included sufficient studies and participants. All studies were conducted in sub-Saharan Africa, making the results highly applicable for use in communities where the disease is regularly found and where disease control programmes are often targeted. However, one in three included evaluations of the molecular point-of-care tests were conducted in a laboratory setting and not near the patient but there was no difference in the test accuracy between settings.

To whom do the results of this review apply?

Infants and children aged 18 months or less who were exposed to HIV infection.

What are the implications of this review?

In theory, for a population of 1000 children aged 18 months or less where 100 have HIV infection, 100 children will be positive with the molecular point-of-care test, of which one will not have the infection (false-positive result), and 900 will be negative with the molecular point-of-care test, of which one will indeed have the infection (false-negative result).

How up-to-date is this review?

The evidence is current to 2 February 2021.

Authors' conclusions: 

For the diagnosis of HIV-1/HIV-2 infection, we found the sensitivity and specificity of POC NAT tests to be high in infants and children aged 18 months or less who were exposed to HIV infection.

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