Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed hiv-infected adults: a prospective, clinic-based study

BMC Infectious Diseases

Ingrid V Bassett²  Kenneth A Freedberg⁶  Rochelle P Walensky⁶  Jeffrey N Katz⁶  Douglas Ross⁵  Janet Giddy¹  Sharon M Coleman⁴  Elena Losina⁴  Paul K Drain³ 

[1] McCord Hospital, Durban, South Africa;Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, USA;Medical Practice Evaluation Center, Department of Medicine, Massachusetts General Hospital, 50 Staniford St, #943, Boston, MA 02114, USA;Boston University School of Public Health, Boston, USA;St. Mary’s Hospital, Durban, South Africa;Brigham and Women’s Hospital, Boston, USA

关键词: South Africa;    Screening;    Diagnostic testing;    Urine;    Lipoarabinomannan (LAM);    HIV/AIDS;    Tuberculosis;   

Others  :  1134461
DOI  :  10.1186/1471-2334-14-110

 received in 2013-10-10, accepted in 2014-02-19,  发布年份 2014

【 摘 要 】

Background

A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting.

Methods

We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count.

Results

Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm³. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm³, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm³. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7).

Conclusions

In this prospective, clinic-based study with trained nurses, a rapid urine LAM test had low sensitivity for TB screening among newly-diagnosed HIV-infected adults, but improved sensitivity when combined with sputum smear microscopy.

【 授权许可】

   
2014 Drain et al.; licensee BioMed Central Ltd.

【 图 表 】

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