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. 2014 May;2(5):e278-84.
doi: 10.1016/S2214-109X(14)70195-0.

Urine lipoarabinomannan testing for diagnosis of pulmonary tuberculosis in children: a prospective study

Mark P Nicol, Veronica Allen, Lesley Workman, Washiefa Isaacs, Jacinta Munro, Sandra Pienaar, Faye Black, Layla Adonis, Widaad Zemanay, Yonas Ghebrekristos, Heather J Zar

Urine lipoarabinomannan testing for diagnosis of pulmonary tuberculosis in children: a prospective study

Mark P Nicol et al. Lancet Glob Health. 2014 May.

Abstract

Background: Urine tests for mycobacterial lipoarabinomannan might be useful for point-of-care diagnosis of tuberculosis in adults with advanced HIV infection, but have not been assessed in children. We assessed the accuracy of urine lipoarabinomannan testing for the diagnosis of pulmonary tuberculosis in HIV-positive and HIV-negative children.

Methods: We prospectively recruited children (aged ≤ 15 years) who presented with suspected tuberculosis at a primary health-care clinic and paediatric referral hospital in South Africa, between March 1, 2009, and April 30, 2012. We assessed the diagnostic accuracy of urine lipoarabinomannan testing with lateral fl ow assay and ELISA, with mycobacterial culture of two induced sputum samples as the reference standard. Positive cultures were identified by acid-fast staining and tested to confirm Mycobacterium tuberculosis and establish susceptibility to rifampicin and isoniazid.

Findings: 535 children (median age 42.5 months, IQR 19.1 – 66.3) had urine and two induced specimens available for testing. 89 (17%) had culture-confirmed tuberculosis and 106 (20%) had HIV. The lateral fl ow lipoarabinomannan test showed poor accuracy against the reference standard, with sensitivity of 48.3% (95% CI 37.6 – 59.2), specificity of 60.8% (56.1 – 65.3), and an area under the receiver operating characteristic curve of 0.53 (0.46 – 0.60) for children without HIV and 0.64 (0.51 – 0.76) for children with HIV. ELISA had poor sensitivity in children without HIV (sensitivity 3.0%, 95% CI 0.4 – 10.5) and children with HIV (0%, 0.0 – 14.3); overall specificity was 95.7% (93.4 – 97.4).

Interpretation: Urine lipoarabinomannan tests have insufficient sensitivity and specificity to diagnose HIV-positive and HIV-negative children with tuberculosis and should not be used in this patient population.

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Figures

Figure 1
Figure 1
Study profile
Figure 2
Figure 2
Receiver operating characteristic curve for lipoarabinomannan lateral flow assay with different band intensities (stratified by HIV status), with mycobacterial culture as the reference standard ROC=receiver operating characteristic.
Figure 3
Figure 3
Children with a positive ELISA test, by lateral flow assay band intensity p<0·0001, test for trend.
See this image and copyright information in PMC

References

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