A simple, high-throughput, colourimetric, field applicable loop-mediated isothermal amplification (HtLAMP) assay for malaria elimination

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
		Specificity	81 % (13/16) 95 % CI 54–96
	HtLAMP-Pf	Sensitivity	76 % (13/17) 95 % CI 50–93
		Specificity	100 % (25/25) 95 % CI 86–100
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
	HtLAMP-Pf	Sensitivity	100 % (17/17) 95 % CI 80–100
		Specificity	95 % (123/128) 95 % CI 90–98
The Gambia				97	Whole blood	Nested PCR	94	NA	1	NA	0	0	2
	HtLAMP-Pg	Sensitivity	100 % (95/95) 95 % CI 96–100
		Specificity	100 % (2/2) 95 % CI 16–100
	HtLAMP-Pf	Sensitivity	100 % (94/94) 95 % CI 96–100
		Specificity	100 % (3/3) 95 % CI 29–100
TOTAL				284			124	73	8	56	0	6	18
	HtLAMP-Pg	Sensitivity	98 % (260/266) 95 % CI 95–99
		Specificity	83 % (15/18), 95 % CI 59–96
		PPV	99 %, 95 % CI 97–100
		NPV	71 %, 95 % CI 48–89
	HtLAMP-Pf	Sensitivity	97 % (124/128) 95 % CI 92–99
		Specificity	96 % (151/157) 95 % CI 92–99
		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

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