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Nathavitharana, Ruvandhi R, Lederer, Philip, Chaplin, Martha, Bjerrum, Stephanie, Steingart, Karen and Shah, Maunank (2021) 'Impact of diagnostic strategies for tuberculosis using lateral flow urine lipoarabinomannan assay in people living with HIV'. Cochrane Database of Systematic Reviews, Vol 2021, Issue 8, CD014641.
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Abstract
Background
Tuberculosis is the primary cause of hospital admission in people living with HIV, and the likelihood of death in the hospital is unacceptably high. The Alere Determine TB LAM Ag test (AlereLAM) is a point‐of‐care test and the only lateral flow lipoarabinomannan assay (LF‐LAM) assay currently commercially available and recommended by the World Health Organization (WHO). A 2019 Cochrane Review summarised the diagnostic accuracy of LF‐LAM for tuberculosis in people living with HIV. This systematic review assesses the impact of the use of LF‐LAM (AlereLAM) on mortality and other patient‐important outcomes.
Objectives
To assess the impact of the use of LF‐LAM (AlereLAM) on mortality in adults living with HIV in inpatient and outpatient settings.
To assess the impact of the use of LF‐LAM (AlereLAM) on other patient‐important outcomes in adults living with HIV, including time to diagnosis of tuberculosis, and time to initiation of tuberculosis treatment.
Search methods
We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); Science Citation Index Expanded (Web of Science), BIOSIS Previews, Scopus, LILACS; ProQuest Dissertations and Theses; ClinicalTrials.gov; and the WHO ICTRP up to 12 March 2021.
Selection criteria
Randomized controlled trials that compared a diagnostic intervention including LF‐LAM with diagnostic strategies that used smear microscopy, mycobacterial culture, a nucleic acid amplification test such as Xpert MTB/RIF, or a combination of these tests. We included adults (≥ 15 years) living with HIV.
Data collection and analysis
Two review authors independently assessed trials for eligibility, extracted data, and analysed risk of bias using the Cochrane tool for assessing risk of bias in randomized studies. We contacted study authors for clarification as needed. We used risk ratio (RR) with 95% confidence intervals (CI). We used a fixed‐effect model except in the presence of clinical or statistical heterogeneity, in which case we used a random‐effects model. We assessed the certainty of the evidence using GRADE.
Main results
We included three trials, two in inpatient settings and one in outpatient settings. All trials were conducted in sub‐Saharan Africa and assessed the impact of diagnostic strategies that included LF‐LAM on mortality when the test was used in conjunction with other tuberculosis diagnostic tests or clinical assessment for clinical decision‐making in adults living with HIV.
Inpatient settings
In inpatient settings, the use of LF‐LAM testing as part of a tuberculosis diagnostic strategy likely reduces mortality in people living with HIV at eight weeks compared to routine tuberculosis diagnostic testing without LF‐LAM (pooled RR 0.85, 95% CI 0.76 to 0.94; 5102 participants, 2 trials; moderate‐certainty evidence). That is, people living with HIV who received LF‐LAM had 15% lower risk of mortality. The absolute effect was 34 fewer deaths per 1000 (from 14 fewer to 55 fewer).
In inpatient settings, the use of LF‐LAM testing as part of a tuberculosis diagnostic strategy probably results in a slight increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF‐LAM (pooled RR 1.26, 95% CI 0.94 to 1.69; 5102 participants, 2 trials; moderate‐certainty evidence).
Outpatient settings
In outpatient settings, the use of LF‐LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality in people living with HIV at six months compared to routine tuberculosis diagnostic testing without LF‐LAM (RR 0.89, 95% CI 0.71 to 1.11; 2972 participants, 1 trial; low‐certainty evidence). Although this trial did not detect a difference in mortality, the direction of effect was towards a mortality reduction, and the effect size was similar to that in inpatient settings.
In outpatient settings, the use of LF‐LAM testing as part of a tuberculosis diagnostic strategy may result in a large increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF‐LAM (RR 5.44, 95% CI 4.70 to 6.29, 3022 participants, 1 trial; low‐certainty evidence).
Other patient‐important outcomes
Assessment of other patient‐important and implementation outcomes in the trials varied. The included trials demonstrated that a higher proportion of people living with HIV were able to produce urine compared to sputum for tuberculosis diagnostic testing; a higher proportion of people living with HIV were diagnosed with tuberculosis in the group that received LF‐LAM; and the incremental diagnostic yield was higher for LF‐LAM than for urine or sputum Xpert MTB/RIF.
Authors' conclusions
In inpatient settings, the use of LF‐LAM as part of a tuberculosis diagnostic testing strategy likely reduces mortality and probably results in a slight increase in tuberculosis treatment initiation in people living with HIV. The reduction in mortality may be due to earlier diagnosis, which facilitates prompt treatment initiation. In outpatient settings, the use of LF‐LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality and may result in a large increase in tuberculosis treatment initiation in people living with HIV. Our results support the implementation of LF‐LAM to be used in conjunction with other WHO‐recommended tuberculosis diagnostic tests to assist in the rapid diagnosis of tuberculosis in people living with HIV.
| Item Type: | Article |
|---|---|
| Subjects: | WA Public Health > Statistics. Surveys > WA 950 Theory or methods of medical statistics. Epidemiologic methods WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General) WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1002/14651858.CD014641 |
| Depositing User: | Stacy Murtagh |
| Date Deposited: | 03 Sep 2021 10:53 |
| Last Modified: | 03 Sep 2021 10:53 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/18810 |
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