Point-of-care HIV testing best practice for early infant diagnosis: an implementation study
Point-of-care HIV testing best practice for early infant diagnosis: an implementation study
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DOI：
10.1186/s12889-019-6990-z
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发表时间：
2019-06-11
影响因子：
4.5
通讯作者：
Coutsoudis, Anna
中科院分区：
文献类型：
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作者：
Spooner, Elizabeth;Govender, Kerusha;Coutsoudis, Anna
背景随着全民健康覆盖和以人为本的综合医疗保健，精简的卫生系统和尊重的护理是必要的。南非在预防母婴传播（PMTCT）方面取得了很大进展，但由于艾滋病毒的巨大负担，每年出生的估计360，000名艾滋病毒暴露婴儿需要至少进行出生和10周的艾滋病毒PCR检测，这带来了许多挑战，包括延迟结果和失访。护理点（POC）艾滋病毒检测的婴儿很好地解决了这些挑战，并有利于启动艾滋病毒感染的婴儿迅速诊断后，最佳的临床outcomes.MethodsObjectives是确定的准确性，可行性和可接受性的POC测试相比，标准的护理（SOC）中心实验室检测。纳入了在南非德班的医院（n=323）和初级卫生保健诊所（n=117）进行出生PCR检测的HIV暴露婴儿。基线情况分析审查了登记册，并在干预前打电话给艾滋病毒暴露婴儿的母亲。将Aleeq HIV-1/2 Detect POC检测（50分钟内处理足跟穿刺标本）的有效性实施研究与SOC进行了比较，并向母亲和工作人员进行了问卷调查。Stata 14被用于analysis.ResultsAt基线2%的出生艾滋病毒检测被错过，只有40%的母亲可以联系，17%没有收到出生检测结果，19%没有10周的测试，39%没有收到10周的结果。住院患儿中检出HIV感染者5例（1.5%），HIV阴性者318例（98.5%），门诊患儿均为阴性。所有阳性婴儿在出院前开始抗逆转录病毒治疗。最终，POC和SOC具有完美的一致性，但对于10个SOC测试，研究人员积极追踪结果或重复测试。SOC测试的周转时间平均为8天（IQR 6 -10天），POC测试的周转时间为0天。POC错误率为9.6%，重复时均给出结果。大多数母亲（92%）更喜欢POC测试，7%没有偏好。没有工作人员首选SOC检测与79%的首选POC和21%没有preference.ConclusionsPoint-of-care艾滋病毒检测EID是准确的，可行的和可接受的，早期ART的好处，所有阳性婴儿在出生设施。我们建议将其视为EID的最佳实践。试验注册ISRCTN 38911104于2018年1月9日注册-回顾性注册。
BackgroundWith Universal Health Coverage and Integrated People-centred Health Care, streamlined health-systems and respectful care are necessary. South Africa has made great strides in prevention of mother-to-child transmission (PMTCT) but with the great burden of HIV, a minimum of birth and 10-week HIV-PCR testing are required for the estimated 360,000 HIV-exposed infants born annually which presents many challenges including delayed results and loss to follow-up. Point-of-care (POC) HIV testing of infants addresses these challenges well and facilitates initiation of HIV-infected infants rapidly after diagnosis for best clinical outcomes.MethodsObjectives were to determine accuracy, feasibility and acceptability of POC testing compared to standard-of-care (SOC) central-laboratory testing. HIV-exposed infants for birth PCR testing in hospital (n=323) and follow-up at a primary health care clinic (n=117) in Durban, South Africa were included. A baseline situational-analysis reviewed registers and phoned mothers of HIV-exposed infants prior to the intervention. An effectiveness-implementation study of the Alereq HIV-1/2 Detect POC test (heel-prick specimen processed in 50min) was compared with SOC with questionnaires to mothers and staff. Stata 14 was used for analysis.ResultsAt baseline 2% of birth HIV tests were missed; only 40% of mothers could be contacted; 17% did not receive birth test result; 19% did not have a 10-week test; 39% had not received the 10-week results. There were 5(1.5%) HIV-infected and 318(98.5%) HIV-negative infants detected in hospital with all clinic babies negative. All positive infants commenced ART before discharge. Ultimately POC and SOC had perfect concordance but for 10 SOC tests researchers actively tracked-down results or repeated tests. Turn around times for SOC tests were on average 8-days (IQR6-10 days) and for POC testing was 0-days. The POC error-rate was 9,6% with all giving a result when repeated. The majority of mothers (92%) preferred POC testing with 7% having no preference. No staff preferred SOC testing with 79% preferring POC and 21% having no preference.ConclusionsPoint-of-care HIV testing for EID is accurate, feasible and acceptable, with benefits of early ART for all positive infants at birth facilities. We recommend that it be considered best practice for EID.Trial registrationISRCTN38911104 registered 9 January 2018 - retrospectively registered.