Table 1 Number, type and origin of samples used for technical validation of the RLEP DRB LAMP (n = 65)
From: RLEP LAMP for the laboratory confirmation of leprosy: towards a point-of-care test
Purpose | No | Obtained from | Sample type (No) | Origin (No) |
|---|---|---|---|---|
“Must detect RLEP” samples (n = 25) | 25 | Clinical samples from Leprosy patients (RLEP qPCR confirmed; seven samples additionally confirmed by direct DNA sequencing) | Nasal swab (14) | INHa (10) |
DITMb (4) | ||||
Slit skin smear (10) | INHa (8) | |||
DITMb (2) | ||||
Skin biopsy (1) | DITMb (1) | |||
“Must not detect RLEP” samples (n = 40) | 12 | Closely related mycobacterial species (confirmed by direct DNA sequencing): Mycobacterium avium; M. chelonae; M. fortuitum; M. gordonae; M. intracellulare; M. kansasii; M. lentiflavum; M. marinum; M. smegmatis; M. szulgai; M. tuberculosis; M. xenopi | Culture extract (12) | National Reference Centre for Mycobacteria Borstel Germany (12) |
2 | Cultures from patients with Buruli ulcer disease (Mycobacterium ulcerans) | Culture extract (2) | DITMb (2) | |
4 | Clinical samples derived from qPCR confirmed patients with Buruli ulcer disease (BUD) | Nasal swab (2) | KCCRc (2) | |
Fine needle aspirate (FNA) (2) | KCCRc (1) | |||
INHa (1) | ||||
4 | Clinical samples from patients with PCR confirmed cutaneous leishmaniasis: Leishmania braziliensis; L. donovani complex; L. mexicana; L. tropica | Skin biopsy (3) | DITMb (3) | |
Skin scraping (1) | DITMb (1) | |||
12 | Endemic controls: clinical samples from suspected leprosy cases, RLEP qPCR negative | Nasal swab (5) | INHa (4) | |
DITMb (1) | ||||
Buccal swab (2) | INHa (2) | |||
Slit skin smear (4) | INHa (4) | |||
Skin biopsy (1) | DITMb (1) | |||
6 | Healthy, non-exposed controls: Clinical samples from non-exposed individuals (DITM laboratory staff) | Nasal swab (5) | DITMb (5) | |
Buccal swab (1) | DITMb (1) |