The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study

BMC Medicine

Research Article

Zaw Win Htet¹  Tint Tint Kyi²  Nicholas M. Anstey³  David A. Cooper⁴  Mark A. Boyd⁵  Htin Aung Saw⁶  Ne Myo Aung⁷  Mar Mar Kyi⁷  Swe Swe Thit⁷  Josh Hanson⁸ 

[1] Insein General Hospital, Yangon, Myanmar;Insein General Hospital, Yangon, Myanmar;Department of Medical Care, Ministry of Health, Nay Pyi Taw, Myanmar;Menzies School of Health Research, Charles Darwin University, Darwin, Australia;The Kirby Institute, University of New South Wales, Sydney, Australia;University of Adelaide, Lyell McEwin Hospital, Adelaide, Australia;The Kirby Institute, University of New South Wales, Sydney, Australia;University of Medicine 2, Yangon, Myanmar;University of Medicine 2, Yangon, Myanmar;Insein General Hospital, Yangon, Myanmar;University of Medicine 2, Yangon, Myanmar;The Kirby Institute, University of New South Wales, Sydney, Australia;Menzies School of Health Research, Charles Darwin University, Darwin, Australia;

关键词: Human immunodeficiency virus;    Tuberculosis;    Diagnostic test;    Clinical management;    Myanmar;    Lipoarabinomannan;   

DOI  :  10.1186/s12916-017-0888-3

 received in 2017-01-24, accepted in 2017-06-06,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe use of the point-of-care lateral flow lipoarabinomannan (LF-LAM) test may expedite tuberculosis (TB) diagnosis in HIV-positive patients. However, the test’s clinical utility is poorly defined outside sub-Saharan Africa.MethodsThe study enrolled consecutive HIV-positive adults at a tertiary referral hospital in Yangon, Myanmar. On enrolment, patients had a LF-LAM test performed according to the manufacturer’s instructions. Clinicians managing the patients were unaware of the LF-LAM result, which was correlated with the patient’s clinical course over the ensuing 6 months.ResultsThe study enrolled 54 inpatients and 463 outpatients between July 1 and December 31, 2015. On enrolment, the patients’ median (interquartile range) CD4 T-cell count was 270 (128–443) cells/mm3. The baseline LF-LAM test was positive in 201/517 (39%). TB was confirmed microbiologically during follow-up in 54/517 (10%), with rifampicin resistance present in 8/54 (15%). In the study’s resource-limited setting, extrapulmonary testing for TB was not possible, but after 6 months, 97/201 (48%) with a positive LF-LAM test on enrolment had neither died, required hospitalisation, received a TB diagnosis or received empirical anti-TB therapy, suggesting a high rate of false-positive results. Of the 97 false-positive tests, 89 (92%) were grade 1 positive, suggesting poor test specificity using this cut-off. Only 21/517 (4%) patients were inpatients with TB symptoms and a CD4 T-cell count of < 100 cells/mm3. Five (24%) of these 21 died, three of whom had a positive LF-LAM test on enrolment. However, all three received anti-TB therapy before death — two after diagnosis with Xpert MTB/RIF testing, while the other received empirical treatment. It is unlikely that knowledge of the baseline LF-LAM result would have averted any of the study’s other 11 deaths; eight had a negative test, and of the three patients with a positive test, two received anti-TB therapy before death, while one died from laboratory-confirmed cryptococcal meningitis. The test was no better than a simple, clinical history excluding TB during follow-up (negative predictive value (95% confidence interval): 94% (91–97) vs. 94% (91–96)).ConclusionsThe LF-LAM test had limited clinical utility in the management of HIV-positive patients in this Asian referral hospital setting.

【 授权许可】

CC BY   
© The Author(s). 2017