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Select target malaria species Panel detection score, 200 parasites/µl
Minimum panel detection score
"Panel detection score", termed "Detection rate" in the Round 1 Report, is defined as the frequency with which all RDTs tested on a sample in the evaluation panel were positive (2 RDTs from each of 2 lots positive against each 200 parasites/µl sample and 1 RDT from each lot positive against each 2000-5000 parasites/µl sample). If an invalid result occurred, this test was ignored in the result (but is reflected in the “Invalid rate”). Therefore, this index of performance is a measure of positivity rate and inter-test and inter-lot consistency.
 for P. falciparum (%) 		Panel detection score, 2000-5000 parasites/µl
Minimum panel detection score for P. vivax (%) Invalid rate
Maximum false positive rate
“False positive rate” is the frequency with which RDTs developed visible test lines when tested against samples of the ‘clean negative’ panel (samples with no malaria parasites and no known other infectious agents or blood abnormalities).
False positive rate
Maximum invalid test rate
“Invalid rate” is the frequency with which RDTs failed to develop a control line, (invalid result) when tested against the parasite-positive panel.
Heat stability, 200 parasites/µl
Test format Heat stability, 2000 parasites/µl

Table View Chart View
Product Manufacturer Product ID Panel detection scorea (%), 200 parasites/μl, P. falciparum samplesc Panel detection score (%), 200 parasites/μl, P. vivax samplesd
First Response Malaria Ag HRP2 Premier Medical Corporation Ltd. II3FRC30 100 N/A
First Response Malaria Ag Combo (PLDH/HRP2) Premier Medical Corporation Ltd. II6FRC30 100 75
CareStart Malaria HRP2 (Pf) Access Bio, Inc. G0141 99 N/A
CareStart™ Malaria HRP2/pLDH Pf test Access Bio, Inc. G0181 98 N/A
Advantage P.f. Malaria Card J. Mitra & Co. Pvt. Ltd. IR016025 97 N/A
SD BIOLINE Malaria Ag Pf Standard Diagnostics, Inc. 05FK50-02-4 97 N/A
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO Access Bio, Inc. G0131 97 90
SD BIOLINE Malaria Ag Pf/Pan Standard Diagnostics, Inc. 05FK60-02-3 96 35
SD BIOLINE Malaria Ag Pf/Pv Standard Diagnostics, Inc. 05FK80 96 95
Immunoquick Malaria +4 Biosynex 0506_K25 94 30
Paramax-3 Rapid Test for Malaria Pan/Pv/Pf (device) Zephyr Biomedicals 50320025 93 45
Malaria Plasmodium falciparum Rapid test Device (Whole blood) ACON Laboratories, Inc. IMA-402 92 N/A
CareStart Malaria pLDH (PAN) Access Bio, Inc. G0111 92 100
Falcivax Rapid Test for Malaria Pv/Pf (device) Zephyr Biomedicals 50300025 92 45
OnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test Amgenix International, Inc. 537-25-DB 92 37
Immunoquick Malaria Falciparum Biosynex 0502_K25 91 N/A
Binax Now Malaria Inverness Medical Innovations, Inc. IN660050 91 10
diagnosticks- Malaria (Pv/Pf) Cassette SSA Diagnostics & Biotech Systems KMVFC6002 91 45
CareStart™ Malaria HRP2/PLDH (Pf/Pv) COMBO Access Bio, Inc. G0161 90 90
CareStart™ Malaria HRP2/PLDH (Pf/VOM) COMBO Access Bio, Inc. G0171 89 80
FirstSign™ - ParaView-3 (Pan+Pv+Pf) Malaria Test Unimed International Inc. 2103 CB-25 89 45
Malaria Rapid Combo Vision Biotech (Pty) Ltd. VB011 87 10
HiSens Malaria Ag Pf HRP2 Card HBI Co., Ltd. HR3023 87 N/A
ICT Malaria Combo Cassette Test (ML02) ICT Diagnostics ML02 86 0
FirstSign™ - ParaView (Pan+Pf) Malaria Test Unimed International Inc. 2101 CB-25 85 80
First Response Malaria pLDH/HRP2 Combo Test Premier Medical Corporation Ltd. I16FRC30 84 75
HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card HBI Co., Ltd. HR2923 84 75
ICT Malaria Pf Cassette Test (ML01) ICT Diagnostics ML01 82 N/A
diagnosticks- Malaria (Pf) Dipstick SSA Diagnostics & Biotech Systems KMFD6007 80 N/A
Parahit-f DIPSTICK FOR FALCIPARUM MALARIA Span Diagnostics Ltd. 25977 78 N/A
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device AZOG, Inc. MFV-124R 77 30
Malaria Rapid Dual Vision Biotech (Pty) Ltd. VB020 76 5
Paracheck Pf Rapid test for P. falciparum Malaria (Dipstick) Orchid Biomedical Systems 30302025 75 N/A
OnSight™ - Malaria Pf Test Amgenix International, Inc. 511-25-DB 74 N/A
Malaria P.F/Vivax Diagnostic Automation / Cortez Diagnostics, Inc. 172110P-25 74 (53) 0 (15)
Advantage Pan Malaria Card J. Mitra & Co. Pvt. Ltd. IR013025 72 100
Malaria Rapid Pf Vision Biotech (Pty) Ltd. VB01 68 N/A
ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) InTec Products, Inc. ITP11002TC40 67 N/A
ParaHIT total (dipstick) Span Diagnostics Ltd 55IC201-10; 55IC201-50 64 10
Malascan Rapid Test for Malaria Pf/Pan (Device) Zephyr Biomedicals 50402025 63 0
Onsite Pf/Pan Ag Rapid Test CTK Biotech, Inc. R0113C 63 20
Advantage Mal Card J. Mitra & Co. Pvt. Ltd. IR2210025 62 100
Onsite Pf/Pv Ag Rapid Test CTK Biotech, Inc. R0112C 61 75
Wondfo One Step Malaria Pf/Pan Whole Blood Test Guangzhou Wondfo Biotech Co., Ltd W56-C (4.0 MM) 61 30
OnSight – ParaQuick (Pan, Pf) Test Amgenix International, Inc. 536-25DB 59 50
diagnosticks- Malaria (Pf) Cassette SSA Diagnostics & Biotech Systems KMFC6001 59 N/A
Onsite Pf Ag Rapid Test CTK Biotech, Inc. R0114C 59 N/A
ADVANCED QUALITY TM MALARIA (p.f) POCT InTec Products, Inc. ITP11002TC1 57 N/A
Paracheck Pf Rapid test for P. falciparum Malaria (Device) Orchid Biomedical Systems 30301025 54 N/A
Maleriscan Malaria Pf/Pv Bhat Bio-Tech India (P) Ltd MAT-50 52 0
Parascreen Rapid Test for Malaria Pan/Pf (Device) Zephyr Biomedicals 50310025 51 25
Rows returned: 51

Notes:
a A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
b The total number of times a positive result for malaria was generated when it should not have been
c Round 1, n=79; Round 2, n=100
d Round 1, n=20; Round 2, n=40
e For combination tests, Pan or Pv line, only, positive indicates a false positive P. falciparum infection (Round 1 n=316; Round 2, n=400)
f Pf line positive indicates a false positive P. falciparum infection (Round 1, n=80; Round 2, n=160)
g For combination tests, Pan or Pv line, only, positive indicates a false positive P. falciparum infection (Round 1, n=158, Round 2, n=200)
h Pf line positive indicates a false positive P. falciparum infection (Round 1, n=40; Round 2, n=80) i Round 1, n=168; Round 2, n=200