Abstract:
INTRODUCTION:Viral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis is performed using nucleic-acid testing in children under 18 months. Resource-limited health systems face severe challenges to scale-up both viral load and early infant diagnosis to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an early infant diagnosis assay in children younger than 18 months. METHODS:This study was an observational, prospective study, including children between one and 18 months of age who were born to HIV-positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and VL testing using the Roche CAP/CTM HIV-1 Qualitative v2 and Roche CAP/CTM HIV-1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard. RESULTS:A total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994. CONCLUSIONS:The comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional early infant diagnosis testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.
journal_name
J Int AIDS Socjournal_title
Journal of the International AIDS Societyauthors
Vubil A,Nhachigule C,Loquiha O,Meggi B,Mabunda N,Bollinger T,Sacks JA,Jani I,Vojnov Ldoi
10.1002/jia2.25422subject
Has Abstractpub_date
2020-01-01 00:00:00pages
e25422issue
1issn
1758-2652journal_volume
23pub_type
杂志文章abstract:INTRODUCTION:Since June 2016, the national HIV programme in Malawi has adopted Universal Test and Treat (UTT) guidelines requiring that all persons who test HIV positive will be referred to start antiretroviral therapy (ART). Although there is strong evidence from clinical trials that early initiation of ART leads to r...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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abstract:INTRODUCTION:Most clinical trials for new antiretroviral (ARV) agents are conducted among narrowly defined adult populations. Only after safety and efficacy have been clearly demonstrated among adults living with HIV are trials including adolescents, children and infants conducted. This approach contributes to signific...
journal_title:Journal of the International AIDS Society
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abstract:BACKGROUND:Traditional medication adherence measures do not account for the pharmacokinetic (PK) properties of the drugs, potentially misrepresenting true therapeutic exposure. METHODS:In a population of HIV-infected Kenyan children on antiretroviral therapy including nevirapine (NVP), we used a one-compartment model ...
journal_title:Journal of the International AIDS Society
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doi:10.7448/IAS.20.1.21157
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abstract:INTRODUCTION:Treat-all is being implemented in several African settings, in accordance with 2015 World Health Organisation guidelines. The factors known to undermine adherence to antiretroviral therapy (ART) may change in the context of Treat-all, where people living with HIV (PLHIV) increasingly initiate ART at earlie...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25220
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.7448/IAS.18.7.20236
更新日期:2015-12-02 00:00:00
abstract:INTRODUCTION:There are limited data characterizing the burden of HIV among men who have sex with men (MSM) in Malawi. Epidemiologic research and access to HIV prevention, treatment and care services have been traditionally limited in Malawi by criminalization and stigmatization of same-sex practices. To inform the deve...
journal_title:Journal of the International AIDS Society
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doi:10.7448/IAS.16.4.18742
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journal_title:Journal of the International AIDS Society
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doi:10.7448/IAS.18.1.19385
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abstract::Eastern Europe and Central Asia have the largest drug epidemic globally and the fastest and still expanding HIV epidemic. The Russian Federation and Ukraine together account for over 90% of the reported AIDS cases in the region. If small in absolute numbers, the epidemics are however significant in prevalence rate in ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19501
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pub_type: 杂志文章,评审
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,meta分析,评审
doi:10.7448/IAS.19.1.20992
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journal_title:Journal of the International AIDS Society
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doi:10.7448/IAS.18.1.19954
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journal_title:Journal of the International AIDS Society
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pub_type: 杂志文章,多中心研究
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-13-29
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.7448/IAS.16.1.17980
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.1.19310
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journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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更新日期:2014-11-02 00:00:00
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25169
更新日期:2018-07-01 00:00:00
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25109
更新日期:2018-04-01 00:00:00
abstract:INTRODUCTION:Linkage from HIV testing and counselling (HTC) to initiation of antiretroviral therapy (ART) is suboptimal in many national programmes in sub-Saharan Africa, leading to delayed initiation of ART and increased risk of death. Reasons for failure of linkage are poorly understood. METHODS:Semi-structured qual...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.15.2.18020
更新日期:2012-12-31 00:00:00
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19776
更新日期:2014-11-02 00:00:00
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,随机对照试验
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abstract:INTRODUCTION:Evidence suggests that people who inject drugs often begin their drug use and injecting practices in adolescence, yet there are limited data available on the HIV epidemic and the responses for this population. The comprehensive package of interventions for the prevention, treatment and care of HIV infectio...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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