Round 1 - Foundation for Innovative New Diagnostics

Tables
Table 1:
Table 2:
Manufacturers and products accepted into Round 1 of WHO-FIND Malaria RDT Evaluation Programme
Characteristics of Plasmodium spp. negative specimens
Table 3: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000
or 5000) parasite densities (parasites/μl)
Table 3a: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000
or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table 4:
Summary performance of malaria RDTs against wild type P. falciparum and P. vivax samples at low (200) and
high (2000 or 5000) parasite densities (parasites/μl) and Plasmodium spp. negative samples
Table 4a: Summary performance of malaria RDTs against wild type P. falciparum at low (200) and high (2000 or 5000)
parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table 5:
Table 6:
Heat stability testing results for 41 malaria RDTs on a cultured P. falciparum sample at low (200) and high
(2000 or 5000) parasite densities (parasites/μl) . Positivity rate at baseline, and after 60 days incubation at
35°C and 45°C
Ease of use description of 41 malaria RDTs
Table A3.1: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000)
parasite densities (parasites/μl)
Table A3.1a: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000)
parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table A3.2:
Table A3.3:
Detection rate of 20 P. falciparum culture lines at low and high parasite densities based on initial reading
according to manufacturers instructions and a delayed second reading performed within 1 hour.
Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200) and
high (2000 or 5000) parasite densities (parasites/μl)
Table A3.3a: Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200)
and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the
manufacturer.
Table A4.1:
Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or
5000) parasite densities (parasites/μl)
Table A4.1a: Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or
5000) parasite densities (parasites/μl) based on delayed readings when specified by the manufacturer
Table A4.2:
Table A4.3:
Reader variability in detection rate of P. falciparum samples (n=79) based on an initial reading according to
manufacturers instructions and a second reading within 1 hour
Reader variability in detection rate for P. vivax samples (n=20) based on an initial reading according to
manufacturers instructions and a second reading within 1 hour
Table A4.4: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200)
and high (2000 or 5000) parasite densities (parasites/μl)
Table A4.4a: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200)
and high (2000 or 5000) parasite densities (parasites/μl) based on delayed readings when specified by the
manufacturer
Table A4.5:
Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low and high parasite
densities (parasites/μl) samples
Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
III