Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Table 3 Overview of the RDT kits evaluated in the present study

			Evidence of GMP
RDT format	Plasmodium antigens targeted	Number	CE mark	WHO list^†	Total
Two band	HRP-2	7	4	5	7
	pan-pLDH	1	1	0	1
	Pv-pLDH	1	1	0	1
Three band	HRP-2, pan-pLDH	11	5	7	9
	HRP-2, aldolase^‡	5	5*	5	5
	HRP-2, Pv-pLDH	4	1	1	2
	Pf-pLDH, pan-pLDH	6	5	6	6
Four band	HRP-2, Pv-pLDH, pan-pLDH	7	3	5	6

* One three-band test (HRP-2, aldolase) is FDA approved.
^† WHO list of ISO:13485:2003 certified manufacturers and their RDT products (list of known commercially available antigen detecting malaria RDTs) [12].
^‡ One of these RDTs used both aldolase and pan-pLDH as pan-malarial antigen.