Summary of June 2021 LabCoP Extended ECHO Session: Implementation of the Lateral-Flow Urine LAM Assay

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00:00:00 - 01:00:00

The June 2021 LabCoP Extended ECHO Session focused on the implementation of the Lateral-Flow Urine LAM Assay for tuberculosis (TB) diagnosis, particularly in advanced HIV disease contexts. The session began with introductions and an overview of the webinar's structure, highlighting the Global Laboratory Initiative's mission to improve TB diagnostics. Key speakers discussed the advantages of the LAM assay, which offers rapid testing with significant benefits for HIV-positive patients, and the importance of updating guidelines based on recent studies. Following presentations, the discussion emphasized practical considerations for implementing the assay, such as quality assurance and training, and addressed challenges related to different patient populations and regional disease burdens. Participants engaged in a Q&A addressing topics like the assay's sensitivity, the need for complementing tests, and the importance of clarifying program budgets to support implementation efforts. Overall, the session underscored the ongoing need for research and adaptation of testing approaches to enhance TB diagnosis in diverse healthcare settings.

00:00:00 In this section, the session begins with introductions and an overview of the webinar's structure, which includes presentations followed by a question and answer segment. The hosts emphasize the availability of French language interpretation and encourage participants to stay on their chosen language channel. Kathleen England, a laboratory and diagnostics specialist, outlines the mission of the Global Laboratory Initiative (GLI) as a collaborative platform to enhance tuberculosis (TB) diagnostic networks. She explains the significance of the lateral-flow urine LAM assay in diagnosing TB, especially in severely ill, immunocompromised patients who cannot produce sputum samples. The presentation also highlights ongoing research aimed at improving the accuracy and utility of these assays, along with updates on the TB LAM guidelines and related HIV care packages. Participants are encouraged to submit their questions via chat throughout the session.
00:05:00 In this section, the presenters outline the purpose of the session, which focuses on the implementation of the Lateral-Flow Urine LAM Assay for TB and HIV programs, and introduce the first speaker, Dr. Martinez. She discusses the LAM biomarker's role in TB diagnosis, emphasizing that it is present in various sample types, with urine being particularly beneficial due to its ease of collection and lower biosafety requirements. Dr. Martinez explains that LAM concentrations are higher in urine from patients co-infected with TB and HIV, potentially due to immunosuppression and kidney infections. The current rapid test available for TB diagnosis using LAM is the Alere Determine TB LAM Antigen Test, which provides quick results in just 25 minutes and is especially sensitive in populations living with HIV, making it a potentially cost-effective and decentralizable tool for diagnosis, despite its lower sensitivity compared to other tests like Xpert.
00:10:00 In this section, the discussion emphasizes the significant advantages of using the lateral flow urine LAM assay in tuberculosis (TB) diagnosis, particularly for individuals living with HIV. Evidence has shown that this diagnostic tool facilitates same-day diagnoses and can reduce mortality, especially in symptomatic patients within inpatient settings. The effectiveness of the assay varies based on patient characteristics, such as HIV status, symptom presentation, and CD4 count, with increased sensitivity noted in those with severe immunosuppression. Following recent studies, the World Health Organization updated its policy guidance in 2019, enhancing recommendations for the assay's use and expanding the eligible target populations. Practical guidelines have also been developed to assist national TB and HIV programs in implementing these protocols effectively in routine clinical settings.
00:15:00 In this section, the speaker discusses the essential elements for the introduction and implementation of the lateral-flow urine LAM assay for tuberculosis (TB) diagnosis, emphasizing quality assurance, procurement, and laboratory standard operating procedures (SOPs). Key recommendations are provided for both inpatient and outpatient settings, where the lateral-flow LAM is advised for patients with TB signs and symptoms or advanced HIV disease, with specific CD4 count thresholds noted for different contexts. The importance of developing national diagnostic algorithms is stressed, along with the necessity of forming a working group consisting of TB and HIV experts to ensure a coordinated introduction plan that is tailored to local healthcare settings. Additionally, the speaker mentions that while template algorithms exist, adaptations are crucial for effective implementation.
00:20:00 In this section, the discussion focuses on the implementation of the lateral-flow urine LAM assay, emphasizing the necessity to report its results as bacteriologically confirmed, regardless of the test's biomarker nature. It highlights the significance of addressing practical considerations such as training for both laboratory and clinical staff, ensuring privacy during sample collection, and implementing safe disposal methods for urine samples. The guidance also covers crucial aspects of the test performance, including sample collection, storage conditions, and result interpretation, underscoring the importance of referencing specific materials for accuracy. Furthermore, it details procurement processes and available resources through the Global Drug Facility and acknowledges the contributions of various stakeholders in developing the guidance. The session concludes with an introduction to the next speaker, Dr. Nathan, who will provide further insights related to the topic.
00:25:00 In this section, Nathan Ford from WHO summarizes the organization's recommended package of care for advanced HIV disease, which was informed by a systematic review of hospital admissions and mortality among HIV-positive individuals. The review identified tuberculosis, cryptococcal meningitis, and severe bacterial infections as major causes of these issues. Ford highlights two significant randomized trials, REMSTART and REALITY, that established effective strategies—diagnostic-driven and prophylactic approaches—for reducing mortality in patients with advanced disease. Following the evidence from these trials, WHO published a guideline in 2017 advocating for a comprehensive package of interventions, including screening, treatment, rapid antiretroviral therapy initiation, and support for adherence. He notes a positive trend in the adoption of these guidelines, with an increase in the number of countries prioritizing care for advanced HIV disease, and outlines WHO's future plans to revise the package components and focus on reducing mortality from severe bacterial infections.
00:30:00 In this section, the discussion focuses on the adaptations needed for the implementation of the Lateral-Flow Urine LAM Assay, particularly considering regional differences in disease burden, such as in Latin America and Southeast Asia. The speaker introduces Martin, the head of the tuberculosis program at FIND, who discusses upcoming LAM assays, specifically the FujiLAM test. Martin explains the complex procedure of the FujiLAM test, which utilizes a small laboratory within a plastic chip to enhance analytical sensitivity. He highlights the test's efficiency, presenting clinical data that show a marked improvement in sensitivity compared to earlier assays, particularly among vulnerable HIV-positive populations. Additionally, he emphasizes the need for further advancements to enable effective urine-based rapid testing in non-HIV-infected patients.
00:35:00 In this section, the speaker discusses a study comparing the sensitivity of various tuberculosis diagnostic tests, including the Fujilam and ECL LAM assays, across two cohorts from Peru and South Africa. The analysis reveals variations in sensitivity, with higher rates in Peru likely due to more advanced disease among patients there. The discussion highlights the importance of bacterial load in improving test sensitivity, particularly for pediatric populations, where current diagnostic tools are inadequate. Results indicate the Fujilam demonstrates significantly better sensitivity than the LAM assay, especially in children. The speaker emphasizes ongoing studies to evaluate the Fujilam's performance in diverse scenarios and notes that future tests aim for even higher analytical sensitivity to improve diagnostics across different patient populations, particularly for those with HIV.
00:40:00 In this section, the speaker discusses the challenges associated with analyzing the LAM assay, comparing the target molecule's structure to broccoli and emphasizing the complexity of capturing it from urine samples. The speaker explains that once the bacteria are eliminated, the LAM molecule degrades and binds to proteins in the bloodstream before being excreted in the urine, making quantification difficult. The focus is on developing more sensitive antibodies and methods to concentrate urine to enhance detection capabilities. Various approaches are outlined, including improved reagents, sample concentration techniques, and the use of advanced readers for enhanced analytical sensitivity. The speaker concludes by highlighting the critical role of the LAM test in diagnosing severely ill patients with HIV, particularly when sputum samples are challenging to obtain, and expresses optimism for future advancements in LAM testing as manufacturers innovate toward higher sensitivity diagnostics.
00:45:00 In this section, the speakers engage with questions regarding the implementation and usage of the Lateral-Flow Urine LAM Assay. Kathleen highlights the importance of focusing the test in HIV clinics, as these represent key entry points for people living with HIV, although there is a concern about its potential misapplication in broader populations due to its rapid, urine-based nature. Lisa emphasizes that the LFLAM should be used as an add-on test in conjunction with other diagnostic tools, while a positive LFLAM result can be considered sufficient to initiate tuberculosis (TB) treatment. Further discussions touch on the bacterial confirmation aspect of tuberculosis diagnosis and the essential guidelines provided by WHO. Additionally, Martina discusses the quality assurance measures outlined in the guidance, acknowledging the absence of validated panels while offering a methodology to validate the tests using properly stored samples.
00:50:00 In this section, the discussion focuses on the implementation of lateral-flow urine LAM assays in detecting advanced HIV disease and the associated challenges and variances in sensitivity between inpatient and outpatient cohorts. It is clarified that while there are currently no standardized panels for external quality assessment purposes, combining LAM tests with other molecular tests can enhance detection sensitivity. The conversation emphasizes the importance of confirmatory tests to assess drug resistance and explores strategies to improve the uptake of these tests in clinical settings through initiatives related to advanced HIV disease management. Participants also highlight the role of organizations like PEPFAR in increasing awareness and intervention capacity for advanced HIV disease, aiming to reduce mortality associated with HIV-related conditions.
00:55:00 In this section, the discussion focuses on the recent guidance surrounding the implementation of the lateral flow LAMP assay for HIV management and the challenges faced in its uptake. It emphasizes the need for clear budgeting and program allocation, noting that indecision about which program should incorporate the test has hindered its financial support. The conversation also touches on the performance of the assay in various populations, highlighting its limited sensitivity in children and HIV-negative individuals. Presenters mention significant performance variations in studies from different countries, suggesting the necessity for further research to establish conclusive data on the test's effectiveness across diverse demographics. Finally, there is confirmation that the session's PowerPoint slides and video recordings will be made available on the ASLM website.

01:00:00 - 01:00:00

In the concluding section of the "June 2021 LabCoP Extended ECHO Session," the speaker thanks the attendees and presenters for their participation, wishing them a pleasant evening or afternoon. They provide information about a certificate code available on the screen for download from the ASLM Academy. The session wraps up with a reminder to reconvene the following week, ending on a note of well wishes and farewells.