Round 1 - Foundation for Innovative New Diagnostics

Detection rate ‡ (%) False positive rates (%) False positive rates (%)
Total false
positive rates*
(%)
Product Manufacturer
200 parasites/µl
2000 or 5000
parasites/µl
200 parasites/μl 2000 or 5000 parasites/μl Clean Negative
samples
Pf samples Pv samples Pf samples Pv samples
Invalid
rate (%)
Pf samples
(n=79)
Pv samples
(n=20)
Pf samples
(n=79)
Pv samples
(n=20)
False positive
non Pf
infection †
(n=316)
False positive
Pf infection ◊
(n=80)
False positive
non Pf
infection †
(n=158)
False positive
Pf infection ◊
(n=40)
False positive
Plasmodium
spp. infection
(n=168)
Pf & Pan/Pf & Pv
Advantage Mal Card J. Mitra & Co. Pvt. Ltd. 62.03 100 100 100 2.53 0 0 0 4.17 0
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test
Device
AZOG, Inc. 77.22 30 100 95 1.9 0 0 2.5 9.52 0
Binax Now Malaria Inverness Medical Innovations, Inc. 91.14 10 100 85 0.32 3.8 0 (157) 5 0.00 0.34
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO Access Bio, Inc. 97.47 90 100 95 0.32 1.25 0 2.5 2.98 0
First Response Malaria Ag Combo (PLDH/HRP2) Premier Medical Corporation Ltd. 100 75 100 65 0 3.75 0 20 3.57 0
FirstSign – ParaView-2 (Pv + Pf) Card Test Unimed International, Inc. 48.1 0 98.73 85 0.95 3.75 0 5 0.00 0
Hexagon Malaria Combi Human GmbH 46.84 0 97.47 50 0 0 0 (157) 2.63 (38) 2.99 0.67
ICT Malaria Combo Cassette Test (ML02) ICT Diagnostics 86.08 0 100 95 0.32 3.75 0 5 0.6 0
Immunoquick Malaria +4 Biosynex 93.67 30 98.73 100 0 (314) 0 0 (157) 0 0.60 0
Malaria P.F/Vivax
Diagnostic Automation / Cortez
Diagnostics, Inc.
73.58 (53) 0 (15) 94.87 (39) 30.77 (13) 1.03 (97) 0 (30) 2.08 (48) 0 (18) 1.56 67.51
Malaria Rapid Combo Vision Biotech (Pty) Ltd. 87.34 10 100 90 0.32 7.5 0 7.5 7.74 0
Malaria Rapid Dual Vision Biotech (Pty) Ltd. 75.95 5 98.73 90 1.27 0 0 0 10.12 0
Malascan Rapid Test for Malaria Pf/Pan (Device) Zephyr Biomedicals 63.29 0 97.47 75 0.63 6.25 0 17.5 5.36 0
One Step Malaria Antigen Strip IND Diagnostic Inc. 1.27 0 67.09 60 2.22 3.75 1.9 0 1.80 0
OnSight – ParaQuick (Pan, Pf) Test Amgenix International, Inc. 59.49 50 100 100 0 1.25 0 0 0.00 0
OptiMAL-IT DiaMed AG 36.71 95 96.2 100 3.8 0 0.63 0 0.00 0
Parahit-Total Device Rapid test for P. falciparum and Pan
malarial species.
Span Diagnostics Ltd. 35.44 0 93.67 50 0 (315) 0 0 2.5 0.00 0.17
Parascreen Rapid Test for Malaria Pan/Pf (Device) Zephyr Biomedicals 50.63 25 100 95 0.63 3.8 0 0 1.19 0.17
Quickstick Malaria Antigen Test Innovatek Medical Inc. 1.27 0 67.09 60 2.22 3.75 1.9 1.80
SD BIOLINE Malaria Ag Standard Diagnostics, Inc. 29.11 50 96.2 100 0 1.25 0 0 1.79 0
SD BIOLINE Malaria Ag Pf/Pan Standard Diagnostics, Inc. 96.2 35 100 95 0 (310) 0 0 2.56 (39) 1.19 1.35
Wondfo One Step Malaria Pf/Pan Whole Blood Test Guangzhou Wondfo Biotech Co., Ltd 60.76 30 98.73 95 3.52 (312) 1.3 (77) 0 (155) 2.56 (39) 6.59 1.85
Pan only
Advantage Pan Malaria Card J. Mitra & Co. Pvt. Ltd. 72.15 100 100 100 N/A N/A N/A N/A 1.79 0
CareStart Malaria pLDH (PAN) Access Bio, Inc. 92.41 100 100 100 N/A N/A N/A N/A 6.55 0
Parabank Rapid Test for Malaria Pan (Device) Zephyr Biomedicals 1.27 30 87.34 100 N/A N/A N/A N/A 2.99 (167) 0
Pf - Plasmodium falciparum
Pv - Plasmodium vivax
pan - Plasmodium species
†
- For combination tests, Pan or Pv line, only, positive indicates a false positive non P. falciparum infection
‡
- A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
◊
- Pf line positive indicates a false positive P. falciparum infection
* - The total number of times a positive result for malaria was generated when it should not have been (Pf+; Pf +/Pan or Pv -; Pf+/Pan or Pv+; Pf-/Pan or Pv+)
Detection rate (%) ≥95 85-94 50-84 < 50
False positive rate (%) 10
Invalid rate (%)
5% of tests
conducted
Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
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