TABLE 2 | Recommended reference test for the evaluation of an RDT for detection of active VL disease
From the following article:
Evaluation of rapid diagnostic tests: visceral leishmaniasis
Marleen Boelaert, Sujit Bhattacharya, François Chappuis, Sayda H. El Safi, Asrat Hailu, Dinesh Mondal, Suman Rijal, Shyam Sundar, Monique Wasunna & Rosanna W. Peeling
Nature Reviews Microbiology 5, S30-S39 (November 2007)
doi:10.1038/nrmicro1766
| Reference standard | Specimen(s) | Problems |
|---|---|---|
| Direct smears and culture of tissue aspirate, including splenic aspirate | Splenic aspirate, or lymph node or bone marrow aspirates | Splenic aspirates can only be carried out under controlled conditions (risk 0.1%) |
| Will yield only minor misclassification bias, which should be adjusted for | ||
| If splenic aspirates cannot be obtained, use latent class analysis, based on one or more of the following: other parasitology; validated serology (rK39, or DAT); response to treatment (if other markers available); specific clinical signs (pancytopenia, darkened skin) | Lymph node or bone marrow buffy coat; serum or capillary blood | Latent class analysis requires good prior knowledge of the markers included in the model or the inclusion of a sufficient number of markers for identifiability; response to narrow-spectrum drug and no drug resistance/ requires standardization of assessment |
| If splenic aspirates cannot be obtained, use a composite reference standard based on one or more of the following: other parasitology; validated serology (rK39 or DAT); response to treatment (if other markers available) | Lymph node or bone marrow buffy coat; serum or capillary blood | A composite reference standard requires good prior knowledge of the markers included and adjustment for the amount of misclassification bias; response to narrow-spectrum drug and no drug resistance/ requires standardization of assessment |
| DAT, direct agglutination test; VL, visceral leishmaniasis. | ||
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