Table 3.
Sensitivity and specificity of HtLAMP-Pg/Pf for the detection of P. falciparum
| Origin | Assay | Diagnostic accuracy | No. of samples | Type of sample | PCR technique used for speciation | Pf | Pv | Pm | Pk | Po spp | Mixed infections | Negatives | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Papua New Guinea | 42 | Filter paper | Multiplex PCR | 12 | 9 | 0 | 0 | 0 | 5 (Pf/Pv) | 16 | |||
| HtLAMP-Pg | Sensitivity | 77 % (20/26) 95 % CI 56–91 |
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| Specificity | 81 % (13/16) 95 % CI 54–96 |
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| HtLAMP-Pf | Sensitivity | 76 % (13/17) 95 % CI 50–93 |
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| Specificity | 100 % (25/25) 95 % CI 86–100 |
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| Sabah, Malaysia | 145 | Filter paper | Multiplex PCR and nested PCR (Pk) | 17 | 64 | 7 | 56 | 0 | 1 (Pv/Pk) | 0 | |||
| HtLAMP-Pg | Sensitivity | 100 % (145/145) 95 % CI 97–100 |
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| HtLAMP-Pf | Sensitivity | 100 % (17/17) 95 % CI 80–100 |
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| Specificity | 95 % (123/128) 95 % CI 90–98 |
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| The Gambia | 97 | Whole blood | Nested PCR | 94 | NA | 1 | NA | 0 | 0 | 2 | |||
| HtLAMP-Pg | Sensitivity | 100 % (95/95) 95 % CI 96–100 |
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| Specificity | 100 % (2/2) 95 % CI 16–100 |
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| HtLAMP-Pf | Sensitivity | 100 % (94/94) 95 % CI 96–100 |
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| Specificity | 100 % (3/3) 95 % CI 29–100 |
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| TOTAL | 284 | 124 | 73 | 8 | 56 | 0 | 6 | 18 | |||||
| HtLAMP-Pg | Sensitivity | 98 % (260/266) 95 % CI 95–99 |
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| Specificity | 83 % (15/18), 95 % CI 59–96 |
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| PPV | 99 %, 95 % CI 97–100 | ||||||||||||
| NPV | 71 %, 95 % CI 48–89 | ||||||||||||
| HtLAMP-Pf | Sensitivity | 97 % (124/128) 95 % CI 92–99 |
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| Specificity | 96 % (151/157) 95 % CI 92–99 |
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| PPV | 95 %, 95 % CI 90–98 | ||||||||||||
| NPV | 97 %, 95 % CI 94–99 |
This table summarizes the features of each of the 3 sample sets, from Papua New Guinea, Sabah Malaysia and The Gambia, and a composite sensitivity and specificity of HtLAMP-Pg/Pf for the detection of P. falciparum