Table 2. Stratified analysis of parasitaemia comparing DBS and WB HTP-LAMP against nPCR with a cut-off at 2 p/μL.
Parasitaemia >2 p/μL | PCR(+) | PCR(-) | Sensitivity(95% CI) | Specificity(95% CI) | PPV, % | NPV,% | Parasites/μLa (Geometric mean) | Plasmodium species distribution |
DBS-HTP-LAMP vs. nPCR n = 688 | ||||||||
DBS HTP-LAMP (+) | 60 | 0 | 100 | 100 | 100 | 100 | 2.0–912896.0 | n = 57, P. falciparum from ≥ 4 p/μL |
DBS HTP-LAMP (-) | 0 | 628 | (711.5) | n = 2, P. vivax each at 2 p/μL;n = 1, P. ovale at 2 p/μL | ||||
WB-HTP-LAMP vs. nPCR n = 688 | ||||||||
WB-HTP-LAMP (+) | 60 | 0 | 100 | 100 | 100 | 100 | 2.0–912896.0 | n = 57, P. falciparum from ≥ 4 p/μL |
WB-HTP-LAMP (-) | 0 | 628 | (711.5) | n = 2, P. vivax each at 2 p/μL;n = 1, P. ovale at 2 p/μL | ||||
Parasitaemia < 2p/μL | PCR (+) | PCR (-) | Sensitivity(95% CI) | Specificity (95% CI) | PPV, % | NPV, % | Parasites/μLa (Geometric mean) | Plasmodium species distribution |
DBS-HTP-LAMP vs. nPCR n = 639 | ||||||||
DBS HTP-LAMP (+) | 7 | 0 | 77.8 | 100 | 100 | 99.7 | undetected-1.5 | n = 5, P. falciparum from 0.5–1.5 p/μL |
DBS HTP-LAMP (-) | 2 | 630 | (54.3–100) | (1.03) | n = 2, P. falciparum, P. ovale (undetected by qPCRb, DBS positive) n = 1, P. falciparum at 0.8 p/μL, | |||
(DBS negative) | ||||||||
n = 1, P. falciparum (undetected by qPCRb; DBS negative) | ||||||||
WB-HTP-LAMP vs. nPCR n = 639 | ||||||||
WB-HTP-LAMP (+) | 8 | 2 | 88.9 | 99.7 | 80 | 99.8 | undetected-1.5 | n = 5, P. falciparum from 0.5–1.5 p/μL |
WB-HTP-LAMP (-) | 1 | 628 | (71.1–100) | (99.2–100) | (1.03) | n = 2, P. falciparum (undetected by qPCRb, WB positive) n = 1, P. ovale (undetected by qPCRb, WB positive)n = 1, P. falciparum at 0.8 p/μL, (WB negative) |
a Range of parasite densities for PCR positive results
b Parasite density could not be quantified due to negative qPCR results.