Evaluation of HIV-1 rapid tests and identification of alternative testing algorithms for use in Uganda.
BMC Infect Dis
; 18(1): 93, 2018 02 27.
Article
em En
| MEDLINE
| ID: mdl-29482500
ABSTRACT
INTRODUCTION:
The World Health Organization recommends that countries conduct two phase evaluations of HIV rapid tests (RTs) in order to come up with the best algorithms. In this report, we present the first ever such evaluation in Uganda, involving both blood and oral based RTs. The role of weak positive (WP) bands on the accuracy of the individual RT and on the algorithms was also investigated.METHODS:
In total 11 blood based and 3 oral transudate kits were evaluated. All together 2746 participants from seven sites, covering the four different regions of Uganda participated. Two enzyme immunoassays (EIAs) run in parallel were used as the gold standard. The performance and cost of the different algorithms was calculated, with a pre-determined price cut-off of either cheaper or within 20% price of the current algorithm of Determine + Statpak + Unigold. In the second phase, the three best algorithms selected in phase I were used at the point of care for purposes of quality control using finger stick whole blood.RESULTS:
We identified three algorithms; Determine + SD Bioline + Statpak; Determine + Statpak + SD Bioline, both with the same sensitivity and specificity of 99.2% and 99.1% respectively and Determine + Statpak + Insti, with sensitivity and specificity of 99.1% and 99% respectively as having performed better and met the cost requirements. There were 15 other algorithms that performed better than the current one but rated more than the 20% price. None of the 3 oral mucosal transudate kits were suitable for inclusion in an algorithm because of their low sensitivities. Band intensity affected the performance of individual RTs but not the final algorithms.CONCLUSION:
We have come up with three algorithms we recommend for public or Government procurement based on accuracy and cost. In case one algorithm is preferred, we recommend to replace Unigold, the current tie breaker with SD Bioline. We further recommend that all the 18 algorithms that have shown better performance than the current one are made available to the private sector where cost may not be a limiting factor.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Kit de Reagentes para Diagnóstico
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Infecções por HIV
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Programas de Rastreamento
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HIV-1
Tipo de estudo:
Diagnostic_studies
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Evaluation_studies
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Prognostic_studies
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Screening_studies
Limite:
Adult
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Female
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Humans
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Male
País/Região como assunto:
Africa
Idioma:
En
Revista:
BMC Infect Dis
Assunto da revista:
DOENCAS TRANSMISSIVEIS
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Uganda