Adoption and uptake of the lateral flow urine LAM test in countries with high tuberculosis and HIV/AIDS burden: current landscape and barriers

Abstract

Background: Since 2015, the World Health Organization (WHO) has recommended a commercially available lateral-flow urine LAM test (Alere-LAM) to assist in the diagnosis of tuberculosis (TB) in severely ill people living with HIV (PLHIV). The test can rapidly detect TB in severely ill PLHIV and can identify PLHIV most at-risk of death, leading to mortality reductions. However, its uptake in countries with high burdens of TB and HIV has been slow. To assess the current use landscape and identify barriers to the adoption of Alere-LAM, we conducted a questionnaire-based study in 31 high TB and HIV/AIDS burden countries. Methods: Between November 2018 and December 2019, we collected responses to a semi-structured questionnaire that had been emailed to staff and affiliates of National TB Programs or HIV/AIDS Programs, Ministries of Health, and TB or HIV institutes of 31 high TB/HIV burden countries. Questions concerned country policies, adoption, and current use of Alere-LAM testing, as well as testing algorithms and barriers preventing Alere-LAM uptake. Results: We received questionnaire responses from 24 out of 31 (77%) high TB/HIV burden countries. Of these 24 countries, 11 (46%) had adopted Alere-LAM policies, with only five (21%) countries currently using Alere-LAM testing. Testing algorithms were generally aligned with WHO recommendations. Fifteen countries (63%) said they were planning to implement Alere-LAM testing in the near future. The most commonly cited constraint to adoption and implementation was budget limitations. Additional barriers to Alere-LAM implementation included lack of country-specific data and piloting, administrative hurdles such as regulatory agency approval, lack of coordination between National TB and HIV programs, and small perceived patient population. Conclusion: Responses to our questionnaire demonstrate the persistent gap between country-level policy and real-world use of Alere-LAM, as well as specific barriers that must be addressed to scale-up testing in PLHIV.

Advances in Molecular Diagnosis of Tuberculosis

“…A 2018 study showed that despite high diagnostic accuracy and quick time to results, the ratio of smear microscopy tests to Xpert tests performed in 17 high TB burden countries was six to one (11). A similar trend of low uptake of new TB tests has also been reported for urine lipoarabinomannan (LAM) testing (12).…”

Diagnostic accuracy of a novel tuberculosis point-of-care urine lipoarabinomannan assay for people living with HIV: A meta-analysis of individual in- and outpatient data

“…In 2019, over 5 years after the establishment of the WHO policy on LF-LAM, a survey of 31 countries with high TB/HIV burden, with responses obtained from 24, showed that only 11 countries had LF-LAM policies in place, with only 5 countries currently using LF-LAM [10]. Limited budgets, lack of country-specific data, administrative hurdles such as local regulatory approval, lack of coordination between national TB and HIV programs, and small perceived patient population size were the most commonly cited constraints on LF-LAM adoption [10]. There is real potential for a broader and simpler WHO recommendation for SILVAMP-LAM given its higher sensitivity, and this could help to overcome some of these implementation barriers.…”

“…The commercially available Alere Determine TB LAM lateral flow assay (LF-LAM; Abbott, Chicago, US; in previous studies also called AlereLAM) is a rapid, inexpensive POC TB test [7]. While its use is associated with a mortality benefit in severely ill and immunocompromised PLHIV [2,3], it has only moderate sensitivity in patients with a low CD4 count and has had low programmatic uptake [8][9][10]. We have already reported on the novel Fujifilm SILVAMP TB LAM (SILVAMP-LAM; Fujifilm, Tokyo, Japan; in previous studies also called FujiLAM) assay.…”

Getting to the point in point-of-care diagnostics for tuberculosis

“…Despite this WHO recommendation, a recent study found that uptake of AlereLAM was limited to only 21% of high-burden TB countries. Respondents cited budget constraints, limited countryspecific data, administrative barriers, insufficient coordination between TB and HIV programs, and perceived small eligible population as primary limitations (14). The recommendation to use urine LAM assays only in patients with HIV substantially limits the test's utility, as HIV-negative patients with pulmonary TB account for over 90% of the global TB burden (15).…”