Background
Methods
Study area and participants
Sample collection and processing
DNA extraction for the LAMP assay
LAMP assay
Reference PCR assay
Sample size calculation and data analysis
Results
Age group (years) | Male | Female | Total | Median parasite density (range) |
---|---|---|---|---|
<5 | 38 (11 %) | 54 (16 %) | 92 (27 %) | 192 (16–9120) |
5–14 | 81 (24 %) | 94 (28 %) | 175 (52 %) | 64 (16–41,280) |
≥15 | 22 (6 %) | 52 (15 %) | 74 (21 %) | 64 (16–65,600) |
Total | 141 (41 %) | 200 (59 %) | 341 |
Diagnostic performance characteristics
PCR +ve | PCR −ve | Total | ||
---|---|---|---|---|
LAMP +ve | 120 | 7 | 127 | Sn = 91.6 % (95 % CI 85.5–95.7); Sp = 96.7 % (95 % CI 93.3–98.7) |
LAMP −ve | 11 | 203 | 214 | PPV = 94.5 % (95 % CI 89.1–97.8); NPV = 94.9 % (95 % CI 91.1–97.4) |
κ = 0.91 (95 % CI 0.84-0.94) | ||||
Mx +ve | 102 | 2 | 104 | Sn = 77.9 % (95 % CI 70.1–84.7); Sp = 99.1 % (95 % CI 96.6–99.9) |
Mx −ve | 29 | 208 | 237 | PPV = 98.1 % (95 % CI 93.2–99.8); NPV = 87.8 % (95 % CI 82.9–91.7) |
κ = 0.80 (95 % CI 0.73-0.87) | ||||
RDT +ve | 100 | 26 | 126 | Sn = 76.3 % (95 % CI 68.1–83.3); Sp = 87.6 % (95 % CI 82.4–91.8) |
RDT −ve | 31 | 184 | 215 | PPV = 79.4 % (95 % CI 71.3–86.1); NPV = 85.6 % (95 % CI 80.2–90.1) |
κ = 0.64 (95 % CI 0.56-0.73) | ||||
Total | 131 | 210 | 341 |
Operational characteristics
Process | Time used (h) |
---|---|
Punching of DBS samples including decontamination after each sample | 1 |
DNA extraction | 1.25 |
LAMP assay and end point determination | 1.25 |
Turn-around-time | 3.5 |