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Performance evaluation of BD FACSPresto™ point of care CD4 analyzer to enumerate CD4 counts for monitoring HIV infected individuals in Nigeria.

Identifieur interne : 000B31 ( Ncbi/Merge ); précédent : 000B30; suivant : 000B32

Performance evaluation of BD FACSPresto™ point of care CD4 analyzer to enumerate CD4 counts for monitoring HIV infected individuals in Nigeria.

Auteurs : Olubunmi Ruth Negedu-Momoh [Nigeria] ; Feyisayo Ebenezer Jegede [Nigeria] ; Ali Yakubu [Nigeria] ; Oluseyi Balogun [Nigeria] ; Musa Abdullahi [Nigeria] ; Titilope Badru [Nigeria] ; Edward Adekola Oladele [Nigeria] ; Chinedu Agbakwuru [Nigeria] ; Hadiza Khamofu [Nigeria] ; Kwasi Torpey [Nigeria]

Source :

RBID : pubmed:28542359

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English descriptors

Abstract

Despite the upsurge in support and intervention of donor agencies in HIV care and treatment programing in Sub-Sahara African, antiretroviral (ART) programs are still confronted with access and coverage challenges which influence enrolment of new patients. This study investigated the validity of point of care BD FACSPresto™ CD4 analyzer for CD4+ cell count, overall agreement, correlation, sensitivity, and specificity in comparison to a reference standard flow cytometry method. We also assessed the feasibility of use among non-laboratorians.

DOI: 10.1371/journal.pone.0178037
PubMed: 28542359

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pubmed:28542359

Le document en format XML

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<div type="abstract" xml:lang="en">Despite the upsurge in support and intervention of donor agencies in HIV care and treatment programing in Sub-Sahara African, antiretroviral (ART) programs are still confronted with access and coverage challenges which influence enrolment of new patients. This study investigated the validity of point of care BD FACSPresto™ CD4 analyzer for CD4+ cell count, overall agreement, correlation, sensitivity, and specificity in comparison to a reference standard flow cytometry method. We also assessed the feasibility of use among non-laboratorians.</div>
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<ArticleTitle>Performance evaluation of BD FACSPresto™ point of care CD4 analyzer to enumerate CD4 counts for monitoring HIV infected individuals in Nigeria.</ArticleTitle>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Despite the upsurge in support and intervention of donor agencies in HIV care and treatment programing in Sub-Sahara African, antiretroviral (ART) programs are still confronted with access and coverage challenges which influence enrolment of new patients. This study investigated the validity of point of care BD FACSPresto™ CD4 analyzer for CD4+ cell count, overall agreement, correlation, sensitivity, and specificity in comparison to a reference standard flow cytometry method. We also assessed the feasibility of use among non-laboratorians.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Blood samples from 300 HIV infected individuals were analyzed for CD4+ T cell and CD4%, using finger prick capillary sample from 150 PMTCT clients and 150 ART clients at Murtala Mohammed Specialist Hospital, Kano, Nigeria. Their venous samples were compared on a flow cytometry reference method using BD FACSCount CD4+ count system. The accuracy of the BD FACSPresto machine in comparison to BD FACSCount was evaluated. Statistical analysis was carried out using STATA (version 12). Bland-Altman method and correlation analysis were used to analyze agreement between both measurements. In addition, sensitivity and specificity of both measurements were determined. Statistical significance was set at p-value <0.05.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The mean bias and limit of agreement for CD4+ count between BD FACSPresto and BD FACS count machine were 7.49 (95% CI: 2.44 to 12.54) and -8.14 to 96.39 respectively. Further analysis revealed close agreement between BD FACSPresto and BD FACSCount with no significant difference between the two methods (p = .0.95). Using a threshold of 500 cells/μL, sensitivity and specificity of BD FACSPresto were 95.1% and 97.1% respectively, compared to BD FACSCount. There was no statistically significant difference in the misclassification between BD FACSPresto and BD FACSCount results (p = 0.23). Furthermore, sensitivity and specificity were similar when BD FACSPresto machine was operated by a nurse or laboratory scientist, there was no substantial difference in testing variability observed between laboratory and non-laboratory operators using the BD FACSPresto analyzer.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Overall, BD FACSPresto Point of Care CD4+ count finger stick capillary blood results is a reliable method in comparison to venous sample cytometry method and no significant difference variability observed between laboratory personnel and non-laboratory operators. The BD FACSPresto is simple, more robust and easy to use equipment without significant variability in reliability by non-laboratory health care workers hence will be a valuable instrument in increasing access and coverage of CD4 estimations in developing countries. The introduction of the BD FACSPresto POC analyzer has a high potential in reducing patients waiting time and improving the overall quality of ART service and clients' satisfaction especially in rural settings.</AbstractText>
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<LastName>Jegede</LastName>
<ForeName>Feyisayo Ebenezer</ForeName>
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