Leprosy ML Flow assay
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The ML Flow test is a simple assay for the detection of IgM antibodies to M.leprae phenolic glycolipid-I (PGL-I). The test can be performed using human serum or blood. The ML Flow test is simple to perform, requires no specialized equipment and results can be read in 5 (whole blood) or 10 (serum) minutes. The ingredients are highly stable and can be stored at ambient temperature. All these features make the ML Flow test very suitable for use in the field.
Application for patients
Several studies have shown that the presence of antibodies to the M. leprae-specific phenolic glycolipid-I (PGL-I) correlates with the bacterial load of a leprosy patient: only 15-40% of paucibacillary (PB) patients are seropositive, compared to 80-100% of the multibacillary (MB) patients. Detection of these antibodies may thus be a useful tool for confirming the diagnosis of MB disease for treatment purposes. When tested on sera from leprosy patients and negative controls from a leprosy endemic area the sensitivity and the specificity of the assay were found to be similar to those of the ELISA, which is the standard test for the detection of M. leprae-specific IgM antibodies.
Application for contacts
It has long been known that contacts of leprosy patients run an increased risk of developing leprosy. It was found that seropositive contacts of leprosy patients have a higher risk to develop clinical leprosy (either PB or MB) compared to seronegative leprosy contacts. These findings indicate that serology can be used to identify people with an increased risk of developing clinical leprosy.
Approach
As part of the development and evaluation of the ML Flow test, we performed a study into the feasibility and acceptability of serological testing with the ML Flow test under health workers and leprosy patients and their contacts in three countries with totally different social and cultural contexts, namely in Brazil, Nepal and Nigeria.
The main conclusion was that the implementation of the ML Flow test is acceptable and feasible from the perspective of health workers, patients and contacts.
Projects
Publications
- Buhrer-Sekula, S. - Simple and fast lateral flow test for classification of leprosy patients and identification of contacts with high risk of developing leprosy.
- Oskam, L. - Serology: recent developments, strengths, limitations and prospects: a state of the art overview.
- Oskam, L. - A strategy to improve the ML Flow test for detection of anti-phenolic glcolipid-1 antibodies: Reply
- Schuring, R.P. - Association between anti-PGL-I IgM and clinical and demographic parameters in leprosy.
- Buhrer-Sekula, S. - The ML flow test as a point of care test for leprosy control programmes: potential effects on classification of leprosy patients.