Table 6 Results of the clinical validation of both RLEP DRB LAMP formats (in-house and ready-to-use)
From: RLEP LAMP for the laboratory confirmation of leprosy: towards a point-of-care test
RLEP qPCR positive samples | RLEP qPCR negative samples | ||||
|---|---|---|---|---|---|
High positive samples of MB leprosy patients | Medium positive samples of MB leprosy patients | Low positive samples of MB leprosy patients | Samples from endemic controls | Samples from healthy non-exposed controls | |
In-house RLEP DRB LAMP | |||||
Positive result | 30 | 30 | 23 | 0 | 0 |
Negative result | 0 | 0 | 7 | 30 | 30 |
Proportion | 100% pos | 100% pos | 77% pos | 100% neg | 100% neg |
95%-CI | – | – | 62; 92 | – | – |
Ready-to-use RLEP DRB LAMP | |||||
Positive result | 30 | 28 | 13 | 0 | 0 |
Negative result | 0 | 2 | 17 | 30 | 30 |
Proportion | 100% pos | 93% pos | 43% pos | 100% neg | 100% neg |
95%-CI | – | 84; 100 | 26; 61 | – | – |