| | |
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.