Abstract

BackgroundUp to one third of HIV-infected individuals with suspected TB are sputum-scarce. The Alere Determine™ TB LAM Ag lateral flow strip test can be used to diagnose TB in HIV-infected patients with advanced immunosuppression. However, how urine LAM testing should be incorporated into testing algorithms and in the context of specific patient sub-groups remains unclear.MethodsThis study represents a post hoc sub-group analysis of data from a randomized multi-center parent study. The study population consisted of hospitalized HIV-infected patients with suspected TB who were unable to produce sputum and who underwent urine LAM testing. The diagnostic utility of urine LAM for TB in this group was compared to the performance of urine LAM in patients who did produce a sputum sample in the parent study.ResultsThere were a total of 187 and 2341 patients in the sputum-scarce and sputum-producing cohorts, respectively. 80 of the sputum-scarce patients underwent testing with urine LAM. In comparison to those who did produce sputum, sputum-scarce patients had a younger age, a lower Karnofsky performance score, and a lower weight and BMI at admission. A greater proportion of sputum-scarce patients were urine LAM positive, compared to those who were able to produce sputum (31% vs. 21%, p = 0.04). A higher proportion of sputum-scarce patients died within 8 weeks of admission (32% vs. 24%, p = 0.013). We inferred that 19% of HIV-infected sputum-scarce patients suspected of TB were diagnosed with tuberculosis by urine LAM testing, with an estimated positive predictive value of 63% (95% CI 43–82%).ConclusionsUrine LAM testing can effectively identify tuberculosis in HIV-infected patients who are at a higher risk of mortality yet are unable to generate a sputum sample for diagnostic testing. Our findings support the use of urine LAM testing in sputum-scarce hospitalized HIV-infected patients, and its incorporation into diagnostic algorithms for this patient population.

Highlights

  • IntroductionThe Alere DetermineTM TB LAM Ag lateral flow strip test can be used to diagnose TB in human immunodeficiency virus (HIV)-infected patients with advanced immunosuppression

  • Up to one third of human immunodeficiency virus (HIV)-infected individuals with suspected TB are sputum-scarce

  • Patients Of the 2528 patients enrolled in the study, a total of 222 patients did not have a sputum result. 35 of these patients generated a sputum sample but no result was recorded; these patients were not included in the sputum-scarce cohort

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Summary

Introduction

The Alere DetermineTM TB LAM Ag lateral flow strip test can be used to diagnose TB in HIV-infected patients with advanced immunosuppression. Current diagnostic tests for pulmonary TB rely on generation of a sputum sample. The World Health Organization (WHO) advocates for the Xpert MTB/RIF test, an automated real-time polymerase chain reaction assay for detection of M. tuberculosis and rifampicin resistance, [3] as the initial diagnostic test for all adults and children with suspected TB [4]. Despite allowing for more rapid diagnostic results as well as information on first line drug resistance, the Xpert MTB/RIF assay requires the patient to generate a sputum sample of adequate quality and volume for this test to yield a result

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