Diagnostic accuracy of induced sputum LAM ELISA for tuberculosis diagnosis in sputum-scarce patients

被引:22
|
作者
Peter, J. G. [1 ,2 ]
Cashmore, T. J. [1 ,2 ]
Meldau, R. [1 ,2 ]
Theron, G. [1 ,2 ]
van Zyl-Smit, R. [1 ,2 ]
Dheda, K. [1 ,2 ,3 ,4 ]
机构
[1] Univ Cape Town, Lung Infect & Immun Unit, Div Pulmonol, Lung Inst, ZA-7925 Cape Town, South Africa
[2] Univ Cape Town, Dept Med, ZA-7925 Cape Town, South Africa
[3] Univ Cape Town, Inst Infect Dis & Mol Med, ZA-7925 Cape Town, South Africa
[4] UCL, Sch Med, Ctr Infect Dis & Int Hlth, Dept Infect, London W1N 8AA, England
基金
新加坡国家研究基金会; 加拿大健康研究院; 英国医学研究理事会; 美国国家卫生研究院;
关键词
ELISA; detection; infectious disease; PULMONARY TUBERCULOSIS; LIPOARABINOMANNAN; UTILITY; URINE; ASSAY;
D O I
10.5588/ijtld.11.0614
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
OBJECTIVE: To examine whether a lipoarabinomannan (LAM) enzyme-linked immunosorbent assay (ELISA) that offers diagnostic utility using urine in patients with tuberculosis (TB) and human immunodeficiency virus (HIV) co-infection can be used in induced sputum to diagnose sputum-scarce patients with suspected TB. DESIGN: LAM was measured in induced sputum samples obtained from 61 consecutively recruited sputum-scarce TB suspects in a tertiary hospital respiratory clinic in South Africa. Liquid culture positivity for Mycobacterium tuberculosis was used as the reference standard. Receiver operating characteristic analysis was used to assess alternative LAM concentration cut-offs. RESULTS: A total of 87% (53/61) of study patients had a valid M. tuberculosis culture result; 49% (23/53) were HIV-infected and 17% (9/53) were culture-positive for M. tuberculosis. Induced sputum smear microscopy and LAM ELISA had an overall sensitivity of 56% (95%CI 27-81); however, the specificity of LAM ELISA was 48% (95%CI 34-62), while the positive and negative predictive values were respectively 18% (95%CI 8-36) and 84% (95%CI 65-94). An optimal rule-in cut-off selected by receiver operating characteristic (LAM concentration >5.73 ng/ml) increased test specificity to 98% and reduced sensitivity to 22%. Normalisation of the assay for sample total protein or cell count did not improve diagnostic accuracy. CONCLUSIONS: In this proof-of-concept study, the ELISA was not clinically useful for TB diagnosis using induced sputum.
引用
收藏
页码:1108 / 1112
页数:5
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