Round 1 - Foundation for Innovative New Diagnostics

10.3. Phase 2 - Wild type P. falciparum
and P. vivax and Plasmodium spp.
negative samples
10.3.1. P. falciparum detection rate
Compared to the P. falciparum cultured parasite panel,
P. falciparum detection rates of wild type samples were
generally higher, reflecting the increased antigen content
of wild type samples. As in Phase 1, the majority of tests
(35; 85%) detected ≥ 95% of P. falciparum samples at high
parasite densities but only 6 tests (15%) had this high level
of detection at low parasite density (200 parasites/μl). All
of these 6 products targeted HRP2; however 3 products
targeting pLDH detected > 60% of P. falciparum samples.
(Figure 8).
Table 4a illustrates detection rates at low and high
parasite densities based on a delayed second reading if it
was specifically indicated in the package insert following
initial negative results at the specified reading time. At the
low parasite density (200 parasites/μl), the P. falciparum
detection rate increased for 5 of the 7 products, based on
the delayed reading.
Figure 8: Phase 2 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000)
parasite density (parasites/μl) according to target antigen type (HRP2 or pLDH) †
100
75
50
Detection rate (%)
25
200 (HRP2)
200 (pLDH)
2000 (HRP2)
2000 (pLDH)
0
First Response Malaria Ag Combo (PLDH/HRP2)
First Response Malaria Ag HRP2
CareStart Malaria HRP2 (Pf)
Advantage P.f. Malaria Card
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
SD BIOLINE Malaria Ag Pf
SD BIOLINE Malaria Ag Pf/Pan
Immunoquick Malaria +4
CareStart Malaria pLDH (PAN)
Malaria Plasmodium falciparum Rapid test Device (Whole blood)
Binax Now Malaria
Immunoquick Malaria Falciparum
Malaria Rapid Combo
ICT Malaria Combo Cassette Test (ML02)
ICT Malaria Pf Cassette Test (ML01)
Parahit-f DIPSTICK FOR FALCIPARUM MALARIA
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device
Malaria Rapid Dual
Paracheck Pf Rapid test for P.falciparum Malaria (Dipstick)
Malaria P.F/Vivax
Advantage Pan Malaria Card
Malaria Rapid Pf
ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)
Malascan Rapid Test for Malaria Pf/Pan (Device)
Advantage Mal Card
Wondfo One Step Malaria Pf/Pan Whole Blood Test
OnSight – ParaQuick (Pan)
ADVANCED QUALITY TM MALARIA (p.f) POCT
Paracheck Pf Rapid test for P. falciparum Malaria (Device)
Parascreen Rapid Test for Malaria Pan/Pf (Device)
FirstSign – ParaView-2 (Pv + Pf) Card Test
Hexagon Malaria Combi
Hexagon Malaria
Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA
OptiMAL-IT
Parahit-Total Device Rapid test for P. falciparum and Pan malarial species.
FirstSign – Malaria Pf Card Test
SD BIOLINE Malaria Ag
One Step Malaria Antigen Strip
Parabank Rapid Test for Malaria Pan (Device)
Quickstick Malaria Antigen Test
†
- Phase 2 Evaluation Panel included 79 blood samples containing wild type P. falciparum. RDTs - 2 tests x 2 lots at 200 parasites/μl and
1 test x 2 lots at 2000 parasites/μl
Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
21