Efficacy, Acceptability and Feasibility of the FujiLAM Diagnostic Test for Tuberculosis in Patients Living with HIV
Study design
Quantitative and qualitative study
Context
Development of rapid biomarker-based tests that can diagnose tuberculosis (TB) using non-sputum samples is a priority for TB control. Urine point-of-care TB-LAM tests are crucial for TB diagnosis in people living with HIV (PLHIV). At the launch of the study, AlereLAM was the WHO-recommended test for diagnosing tuberculosis in HIV-positive patients, providing results in less than 25 minutes, and had been shown to be feasible to use at point-of-care in low-resource areas.
Despite 2015 recommendations to use AlereLAM by the World Health Organization, its well documented diagnostic value, ease of use, and affordability, uptake at point of care in resource limited settings has been very low mainly due to budget limitations and lack of local operational research studies to inform implementation.
The newer FujiLAM test promises greater diagnostic sensitivity compared to the AlereLAM in HIV positive patients, and may have a diagnostic value in HIV-negative patients. However, it involves more steps, and has a longer results turnaround time of one hour.
Successful implementation of new diagnostic tests may depend on various factors that are context specific. Thus, it is important to explore and understand operational characteristics at the level of intended use.
Our role
Coordination
Partners
- Mbarara University of Science and Technology (MUST)
- Ministries of Health of Uganda, Kenya, Mozambique and South Africa
- Funder: ANRS Maladies infectieuses émergentes
Study objectives
- to compare the diagnostic accuracy of the novel FujiLAM assay with the WHO-recommended Abbott TB-LAM assay in urine of PLHIV,
- to evaluated the association between mortality and AlereLAM and FujiLAM test results.
- to assess the feasibility of using the FujiLAM test at point-of-care, and the test acceptability by healthcare workers performing the FujiLAM test as well as healthcare workers in management roles.
Methodology
This prospective study compared the effectiveness of the FujiLAM and AlereLAM tests against microbiological and clinical reference tests (symptoms, chest X-ray, microscopic examination of sputum, and culture) for diagnosing tuberculosis in two groups of outpatients living with HIV:
- those presenting with at least one symptom of tuberculosis (without a CD4 count),
- those with advanced HIV disease without symptoms of tuberculosis.
The study was conducted at four sites with high prevalence of HIV and tuberculosis:
- Mbarara Regional Hospital (Uganda),
- Homa Bay District Hospital (Kenya),
- Alto Maé Health Centre (Maputo, Mozambique),
- Eshowe Clinic and Eshowe Hospital (KwaZulu-Natal, South Africa).
A complementary study also assessed the feasibility and acceptability of the FujiLAM test amongst healthcare staff and patients through questionnaires, individual interviews and focus group discussions.
Key findings
Diagnostic sensitivity of FujiLAM and AlereLAM compared with the microbiological reference standard in patients with HIV
The study found that FujiLAM had a sensitivity of 60 per cent compared with the microbiological reference test, compared with 40 per cent for AlereLAM. The difference in sensitivity was consistent across all CD4 count thresholds. Among patients with a CD4 count of less than 200 cells per μL, the sensitivity of FujiLAM was 69 per cent, compared with 52 per cent for AlereLAM. Among patients with a CD4 count of 200 cells per μL or more, the sensitivity of FujiLAM was 47 per cent, compared with 24 per cent for AlereLAM. Both tests demonstrated similar specificity, at 86 per cent and 87 per cent respectively.
Feasibility and acceptability amongst staff (technicians, nurses, clinicians, health workers)
94 per cent found the FujiLAM test ‘easy/very easy’ to carry out, and the majority of them found interpreting the results ‘easy/very easy’. Furthermore, the FujiLAM test is viewed positively by users compared with AlereLAM in particular, due to its good performance.
The main difficulty mentioned is the number of steps involved and the 40-minute incubation time, raising the question of who should carry out the test, depending on the setting in which it is used.
Patient acceptability and perception
Positive factors:
- Urine sample: easy, quick, painless, less stigmatising than sputum collection
- Same-day results, reducing the stress and costs associated with a return to hospital
- Free testing and treatment
Requirements
- Clean, private toilets
Limitations
- Waiting times to access toilets
- Increased mistrust of urine tests for tuberculosis, as patients are less likely to associate the urinary tract with the disease.
In summary, the FujiLAM test is
- Quick: results available within 1 hour
- Easy to carry out
- Requires only a urine sample; no sputum sample is needed
- Can be carried out close to where patients are, without the need for electricity or a laboratory
- Has greater sensitivity than the AlereLAM test currently recommended by the WHO
