肯尼亚Cepheid GeneXpert HIV-1定性和定量检测的性能和可用性

数据集获取（Figshare）

• 源站标题：Performance and usability of Cepheid GeneXpert HIV-1 qualitative and quantitative assay in Kenya
• DOI：10.1371/journal.pone.0213865
• 发布日期：2019-03-22
• 文件数：3 个
• 文件总体积：461.32 KB
• 源站页面：https://plos.figshare.com/articles/dataset/Performance_and_usability_of_Cepheid_GeneXpert_HIV-1_qualitative_and_quantitative_assay_in_Kenya/7881533

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curl -L -o "pone.0213865.s001.pdf" "https://ndownloader.figshare.com/files/14672447"
curl -L -o "pone.0213865.s002.pdf" "https://ndownloader.figshare.com/files/14672453"
curl -L -o "pone.0213865.s003.pdf" "https://ndownloader.figshare.com/files/14672456"

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• pone.0213865.s001.pdf（171.33 KB）
• pone.0213865.s002.pdf（275.70 KB）
• pone.0213865.s003.pdf（14.28 KB）

文件总体积 461.32 KB（源站 API 实测）。

数据说明

Background
In Kenya, access to early infant diagnosis and viral load monitoring services for HIV patients on ART is significantly hampered by sample transportation challenges and long turnaround times. Near patient care testing technologies have the potential to obviate such constraints. The Cepheid GeneXpert was launched in 2010 as a TB assay and in 2014 as a potential point of care HIV viral load assay. Whereas it is widely is used for TB in Kenya, its utility for HIV testing has not been evaluated.
Objective
To investigate the performance and usability characteristics of the GeneXpert HIV-1 qualitative and quantitative assay.
Methods
This was a cross sectional study among 911 HIV Exposed infants and 310 HIV positive adults. Existing machines used for routine TB diagnosis were used in this study. The diagnostic accuracy of the qualitative assay was assessed using Roche CAP/CTM while the quantitative assay was assessed using with Abbott m2000 as the reference assays respectively. Statistical analysis was done using Stata/MP Version 14 for Mac. Concordance values and misclassification were calculated at the clinical cutoff of 1000 cp/ml.
Results
The sensitivity, specificity and accuracy of the GeneXpert HIV-1 qualitative assay were 99.23% (95% CI 97.24–99.90%), 98.91% (95% CI 97.76–99.55%) and 99.00% respectively. For the quantitative assay, they were 92.50% (95% CI 79.61–98.43%), 100.00% and 97.00% respectively. All 30 (100%) users reported that the GeneXpert machine was easy to use, workflow was simple and TB diagnosis was not negatively affected. In our hands, the median turn-around time for an individual qualitative and quantitative test was 90 minutes. A total of 58 (4.34%) errors and 28 (2.10%) invalid outcomes were experienced; 44 (3.29%) tests did not run to completion due to power outages.
Conclusion
GeneXpert HIV-1 qualitative and quantitative assay is an accurate test for the diagnosis of HIV in infants and for viral load monitoring. At the point of care, the GeneXpert machine’s simple work flow, ease of use and short test turnaround time present the potential to improve access to HIV testing and viral load monitoring. To integrate HIV diagnosis into

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CC BY 4.0

引用

学术使用请引用 DOI 10.1371/journal.pone.0213865（source: https://plos.figshare.com/articles/dataset/Performance_and_usability_of_Cepheid_GeneXpert_HIV-1_qualitative_and_quantitative_assay_in_Kenya/7881533）。