Development, validation and evaluation of a rapid PCR-nucleic acid lateral flow immuno-assay for the detection of Plasmodium and the differentiation between Plasmodium falciparum and Plasmodium vivax

Table 6 Sensitivity, specificity and agreement of the different diagnostic tests in Thailand

Detection line	Sensitivity (95% CI)	Specificity (95% CI)	Positive Predictive Value (95% CI)	Negative Predictive Value (95% CI)	Kappa
*Overall pan-Plasmodium*
SD-Bioline vs Microscopy (n = 377)	0.813 (0.723-0.879)	0.985 (0.960-0.995)	0.956 (0.884-0.986)	0.930 (0.892-0.956)	0.83
Microscopy vs PCR-NALFIA (n = 381)	0.869 (0.787-0.924)	0.949 (0.914-0.970)	0.869 (0.787-0.924)	0.949 (0.914-0.971)	0.82
SD-Bioline vs PCR-NALFIA (n = 377)	0.822 (0.734-0.887)	0.989(0.965-0.997)	0.967 (0.900-0.991)	0.934(0.897-0.958)	0.85
*P. falciparum*
SD-Bioline vs Microscopy (n = 377)	1 (0.874-1)	0.985 (0.964-0.994)	0.872 (0.718-0.952)	1 (0.986-1)	0.92
Microscopy vs PCR-NALFIA (n = 381)	0.773 (0.617- 0.880)	1 (0.986-1)	1 (0.874-1)	0.971 (0.946-985)	0.88
SD-Bioline vs PCR-NALFIA (n = 377)	0.796 (0.642-0.897)	0.988 (0.967-0.996)	0.898 (0.748-0.967)	0.973 (0.948-0.987)	0.84
P. vivax*
SD-Bioline vs Microscopy (n = 338)	0.722 (0.602-0.818)	1 (0.982-1)	1 (0.914-1)	0.930 (0.892-0.956)	0.78
Microscopy vs PCR-NALFIA (n = 381)	0.845 (0.735-0.916)	0.951 (0.920-0.972)	0.80 (0.689-0.880)	0.964 (0.935-0.981)	0.78
SD-Bioline vs PCR-NALFIA (n = 338)	0.754 (0.633-0.846)	1 (0.982-1)	1 (0.914-1)	0.941 (0.905-0.964)	0.82

*Because the pLDH line on the SD-bioline RDT also detects P. falciparum, all P. falciparum samples were excluded from the analysis with SD-Bioline.

ISSN: 1475-2875