Table 1.

Shows malaria diagnosis for 115 retrospective samples by the illumigene malaria assay in comparison with standard microscopy, RDT and PCR

	Reference method (RDT, microscopy, PCR)		Illumigene malaria assay
	Results (n)	Range parasite density (asexual parasites/µL)	Results (n)	Performance
Total	108		108
Positive	74		74	Sensitivity (%) (95% CI)	100% (95.1–100%)
Negative	34		34	Specificity (%) (95% CI)	100% (89.7–100%)
Clinical samples	96
Pf	27	(1–372,117)	–*
Pv	14	(169–18,777)	–*
Pm	13	(106–9244)	–*
Po	12	(31–6461)	–*
Mixed	0
Negative	30
External quality controls	12
Pf	1	5	–*
Pv	1	5	–*
Pm	2	5	–*
Po	3	20	–*
Pk	1	10,000
Negative	4

The retrospective panel consisted of 103 clinical samples (96 diagnostic samples and 7 samples from patients who already received treatment for malaria infection) and 12 external quality controls. These 7 samples from patients who already received treatment (115 − 7 = 108) were excluded from the calculation of both sensitivity and specificity. Parasite density as quantified by microscopy on blood smear

RDT, rapid diagnostic test; PCR, four-primer real-time PCR; Pf, Plasmodium falciparum; Pm, Plasmodium malariae; Po, Plasmodium ovale; Pv, Plasmodium vivax; Pk, Plasmodium knowlesi; n, number of samples; –*, the illumigene malaria assay does not distinguish between Plasmodium species