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Lancet Infect Dis. 2017 Dec;17(12):1285-1292. doi: 10.1016/S1473-3099(17)30488-7. Epub 2017 Aug 25.

Point-of-care C-reactive protein-based tuberculosis screening for people living with HIV: a diagnostic accuracy study.

Author information

1
Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA. Electronic address: christina.yoon@ucsf.edu.
2
Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Makerere University Joint AIDS Program, Kampala, Uganda.
3
Makerere University-University of California, San Francisco Research Collaboration, Mulago Hospital Complex, Kampala, Uganda.
4
Makerere University Joint AIDS Program, Kampala, Uganda.
5
Johns Hopkins University School of Medicine, Baltimore, MD, USA.
6
Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Makerere University-University of California, San Francisco Research Collaboration, Mulago Hospital Complex, Kampala, Uganda.
7
Department of Epidemiology, Division of Infectious Disease Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
8
School of Medicine, Department of Medicine, Pulmonary, Critical Care, and Sleep Medicine Section, Yale University, New Haven, CT, USA; Department of Epidemiology of Microbial Diseases, Yale University, School of Public Health, New Haven, CT, USA.
9
Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA; Department of Medicine, HIV/AIDS, Infectious Diseases and Global Medicine, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA; Makerere University-University of California, San Francisco Research Collaboration, Mulago Hospital Complex, Kampala, Uganda.
10
Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA; Curry International Tuberculosis Center, University of California, San Francisco, Oakland, CA, USA.

Abstract

BACKGROUND:

Symptom-based screening for tuberculosis is recommended for all people living with HIV. This recommendation results in unnecessary Xpert MTB/RIF testing in many individuals living in tuberculosis-endemic areas and thus poor implementation of intensified case finding and tuberculosis preventive therapy. Novel approaches to tuberculosis screening are needed to help achieve global targets for tuberculosis elimination. We assessed the performance of C-reactive protein (CRP) measured with a point-of-care assay as a screening tool for active pulmonary tuberculosis.

METHODS:

For this prospective study, we enrolled adults (aged ≥18 years) living with HIV with CD4 cell count less than or equal to 350 cells per μL who were initiating antiretroviral therapy (ART) from two HIV/AIDS clinics in Uganda. CRP concentrations were measured at study entry with a point-of-care assay using whole blood obtained by fingerprick (concentration ≥10 mg/L defined as screen positive for tuberculosis). Sputum samples were collected for Xpert MTB/RIF testing and culture. We calculated the sensitivity and specificity of point-of-care CRP and WHO symptom-based screening in reference to culture results. We repeated the sensitivity analysis with Xpert MTB/RIF as the reference standard.

FINDINGS:

Between July 8, 2013, and Dec 15, 2015, 1237 HIV-infected adults were enrolled and underwent point-of-care CRP testing. 60 (5%) patients with incomplete or contaminated cultures were excluded from the analysis. Of the remaining 1177 patients (median CD4 count 165 cells per μL [IQR 75-271]), 163 (14%) had culture-confirmed tuberculosis. Point-of-care CRP testing had 89% sensitivity (145 of 163, 95% CI 83-93) and 72% specificity (731 of 1014, 95% CI 69-75) for culture-confirmed tuberculosis. Compared with WHO symptom-based screening, point-of-care CRP testing had lower sensitivity (difference -7%, 95% CI -12 to -2; p=0·002) but substantially higher specificity (difference 58%, 95% CI 55 to 61; p<0·0001). When Xpert MTB/RIF results were used as the reference standard, sensitivity of point-of-care CRP and WHO symptom-based screening were similar (94% [79 of 84] vs 99% [83 of 84], respectively; difference -5%, 95% CI -12 to 2; p=0·10).

INTERPRETATION:

The performance characteristics of CRP support its use as a tuberculosis screening test for people living with HIV with CD4 count less than or equal to 350 cells per μL who are initiating ART. HIV/AIDS programmes should consider point-of-care CRP-based tuberculosis screening to improve the efficiency of intensified case finding and increase uptake of tuberculosis preventive therapy.

FUNDING:

National Institutes of Health; President's Emergency Plan for AIDS Relief; University of California, San Francisco, Nina Ireland Program for Lung Health.

Comment in

PMID:
28847636
PMCID:
PMC5705273
DOI:
10.1016/S1473-3099(17)30488-7
[Indexed for MEDLINE]
Free PMC Article

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