Table 2.
Change in panel detection score and clean negative false positivity rate for voluntarily and compulsorily resubmitted products (rounds 1–8)
| Product | Catalogue number | Type of submission | First test | Last test | Change between first and last test | Met all WHO procurement criteria | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rd | Pf PDS (%) | Pv PDS (%) | FP (%) | Rd | Pf PDS (%) | Pv PDS (%) | FP (%) | Pf PDS (%) | Pv PDS (%) | FP (%) | 1st test | Last test | |||
| Advanced Quality™ One Step Malaria Pf Test | ITP11002TC1/TC40 | C | 1 | 57.0 | N/A | 16.1 | 5 | 53.0 | N/A | 7.7 | − 4.0 | N/A | − 8.4 | No | No |
| Advanced Quality™ One Step Malaria Pf Test | ITP11002TC1/TC40 | V | 5 | 53.0 | N/A | 7.7 | 7 | 93.0 | N/A | 0.4 | 40.0 | N/A | − 7.3 | No | Yes |
| Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood) | ITP11003 TC40 | V | 3 | 86.9 | 0.0 | 18.5 | 7 | 92.0 | 97.1 | 0.4 | 5.1 | 97.1 | − 18.1 | No | Yes |
| Advantage Mal Card | IR221025 | C | 1 | 62.0 | 100.0 | 4.2 | 5 | 30.0 | 94.3 | 0.4 | − 32.0 | − 5.7 | − 3.8 | No | No |
| Advantage P.f. Malaria Card | IR016025 | C | 1 | 97.5 | N/A | 0.0 | 5 | 89.0 | N/A | 0.0 | − 8.5 | N/A | 0.0 | Yes | Yes |
| Advantage Pan Malaria Card | IR013025 | C | 1 | 72.2 | 100.0 | 1.8 | 5 | 77.0 | 100.0 | 0.4 | 4.8 | 0.0 | − 1.4 | No | Yes |
| Asan Easy Test® Malaria Pf/Pan Ag | AM4650-K | V | 5 | 81.0 | 34.3 | 0.4 | 7 | 88.0 | 100.0 | 1.3 | 7.0 | 65.7 | 0.9 | No | Yes |
| BIONOTE MALARIA P.f. Ag Rapid Test Kit | RG19-11 | V | 3 | 85.9 | N/A | 2.0 | 6 | 88.0 | N/A | 0.5 | 2.1 | N/A | − 1.5 | Yes | Yes |
| BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit | RG19-08 | V | 3 | 93.9 | 88.6 | 3.0 | 6 | 83.0 | 68.6 | 0.5 | − 10.9 | − 20.0 | − 2.5 | Yes | No |
| BioTracer™ Malaria P.f/PAN Rapid Card | 17,012 | V | 5 | 77.0 | 77.1 | 0.4 | 7 | 96.0 | 97.1 | 0.9 | 19.0 | 20.0 | 0.5 | Yes | Yes |
| CareStart™ Malaria HRP2 (Pf) | RMOM-02571b | C | 1 | 98.7 | N/A | 2.4 | 5 | 91.0 | N/A | 0.9 | − 7.7 | N/A | − 1.5 | Yes | Yes |
| CareStart™ Malaria HRP2 (Pf) | RMOM-02571b | V | 5 | 91.0 | N/A | 0.9 | 8 | 92.0 | N/A | 0.0 | 1.0 | N/A | − 0.9 | Yes | Yes |
| CareStart™ Malaria HRP2/pLDH Pf | RMPM-02571e | C | 2 | 98.0 | N/A | 3.0 | 6 | 91.0 | N/A | 0.0 | − 7.0 | N/A | − 3.0 | Yes | Yes |
| CareStart™ Malaria HRP2/pLDH Pf | RMPM-02571e | V | 6 | 91.0 | N/A | 0.0 | 8 | 96.0 | N/A | 0.0 | 5.0 | N/A | 0.0 | Yes | Yes |
| CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO | RMRM-02571d | C | 1 | 97.5 | 90.0 | 3.0 | 5 | 90.0 | 94.3 | 0.4 | − 7.5 | 4.3 | − 2.6 | Yes | Yes |
| CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO | RMRM-02571d | V | 5 | 90.0 | 94.3 | 0.4 | 8 | 87.0 | 94.3 | 0.0 | − 3.0 | 0.0 | − 0.4 | Yes | Yes |
| CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO | RMVM-02571a | V | 2 | 90.0 | 90.0 | 0.5 | 8 | 87.0 | 100.0 | 0.0 | − 3.0 | 10.0 | − 0.5 | Yes | Yes |
| CareStart Malaria HRP2/pLDH (Pf/VOM) COMBO | RMWM-02571c | V | 2 | 89.0 | 80.0 | 0.5 | 4 | 89.8 | 91.2 | 0.0 | 0.8 | 11.2 | − 0.5 | Yes | Yes |
| CareStart Malaria HRP2/pLDH (Pf/VOM) COMBO | RMWM-02571c | C | 4 | 89.8 | 91.2 | 0.0 | 8 | 87.0 | 100.0 | 0.0 | − 2.8 | 8.8 | 0.0 | Yes | Yes |
| CareStart™ Malaria pLDH (PAN) | G0111 | C | 1 | 92.4 | 100.0 | 6.6 | 5 | 84.0 | 88.6 | 0.0 | − 8.4 | − 11.4 | − 6.6 | Yes | Yes |
| CareStart™ Malaria Pf/PAN (pLDH) Ag RDT | RMLM-05071f | C | 3 | 88.9 | 91.4 | 0.5 | 7 | 73.0 | 0.0 | 1.7 | − 15.9 | − 91.4 | − 0.5 | Yes | No |
| CareStart™ Malaria Pf/PAN (pLDH) Ag RDT | RMLM-05071f | V | 7 | 73.0 | 0.0 | 1.7 | 8 | 83.0 | 97.1 | 1.0 | 10.0 | 97.1 | − 0.7 | No | Yes |
| CareStart™ Malaria Screen RDT | RMAM-05071 g | C | 3 | 86.9 | 88.6 | 2.5 | 7 | 93.0 | 94.3 | 0.0 | 6.1 | 5.7 | − 2.5 | Yes | Yes |
| CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-line RDT | RMSM-XXX7X | V | 7 | 94.0 | N/A | 0.4 | 8 | 82.0 | N/A | 0.5 | − 12.0 | N/A | 0.1 | Yes | Yes |
| diagnosticks—Malaria (Pf)Cassette WB | KMFC6001 | V | 2 | 59.0 | N/A | 7.0 | 5 | 88.0 | N/A | 0.9 | 29.0 | N/A | − 6.1 | No | Yes |
| EzDx™ Malaria Pan/Pf Rapid Test Detection kit | RK MAL 001 | V | 4 | 76.5 | 11.8 | 3.5 | 6 | 78.0 | 88.6 | 1.4 | 1.5 | 76.8 | − 2.1 | No | Yes |
| Falcivax Rapid Test for Malaria Pv/Pf (device) | 503010025j | V | 2 | 92.0 | 45.0 | 4.5 | 8 | 95.0 | 100.0 | 0.5 | 3.0 | 55.0 | − 3.0 | No | Yes |
| First Response® Malaria Ag Combo (pLDH/HRP2) | I16FRC30 | V | 1 | 100.0 | 75.0 | 3.6 | 5 | 85.0 | 74.3 | 0.0 | − 15.0 | − 0.7 | − 3.6 | Yes | No |
| First Response Malaria Ag P. falciparum (HRP2) Card | I13FRC30 | C | 1 | 100.0 | N/A | 3.0 | 5 | 95.0 | N/A | 0.4 | − 5.0 | N/A | − 2.6 | Yes | Yes |
| First Response® Malaria Ag. P.f./P.v. Card test | PI19FRC25 | V | 6 | 85.0 | 71.4 | 0.5 | 8 | 94.0 | 100.0 | 1.0 | 9.0 | 28.6 | 0.5 | No | Yes |
| FirstSign™—ParaView (Pan + Pf) Malaria Test | 2101 CB-25 | V | 2 | 85.0 | 80.0 | 25.5 | 4 | 87.8 | 61.8 | 2.6 | 2.8 | − 18.2 | − 22.9 | No | No |
| Humasis Malaria P.f/Pan Antigen Test | AMAL-7025 | V | 4 | 100.0 | 0.0 | 97.8 | 5 | 90.0 | 91.4 | 0.9 | − 10.0 | 91.4 | − 96.9 | No | Yes |
| ICT Malaria Dual Test | ML03 | V | 3 | 78.8 | 60.0 | 0.5 | 7 | 85.0 | 31.4 | 1.3 | 6.2 | − 28.6 | 0.8 | No | No |
| ICT Malaria Pf Cassette Test | ML01 | V | 1 | 82.3 | N/A | 0.6 | 3 | 86.9 | N/A | 0.0 | 4.6 | N/A | − 0.6 | Yes | Yes |
| ICT Malaria Pf Cassette Test | ML01 | C | 3 | 86.9 | N/A | 0.0 | 7 | 94.0 | N/A | 1.7 | 7.1 | N/A | 1.7 | Yes | Yes |
| ICT Malaria Combo Cassette Test | ML02 | V | 1 | 86.1 | 0.0 | 0.6 | 4 | 76.5 | 5.9 | 0.4 | − 9.6 | 5.9 | − 0.2 | No | No |
| IMMUNOQUICK® MALARIA falciparum | 0502_K25 | C | 1 | 91.1 | N/A | 0.6 | 5 | 72.0 | N/A | 5.1 | − 19.1 | N/A | 4.5 | Yes | No |
| Malaria pf (HRP II)/(PAN-LDH) Antigen Detection Test | MFV-124R | V | 1 | 77.2 | 30.0 | 9.5 | 3 | 95.0 | 0.0 | 5.5 | 17.8 | − 30.0 | − 4.0 | No | No |
| Malaria pf (pLDH)/PAN-pLDH Test Device | MFV-124 | V | 3 | 2.0 | 5.7 | 0.0 | 5 | 41.0 | 8.6 | 81.3 | 39.0 | 2.9 | 81.3 | No | No |
| Malaria P.f./Pan Rapid Test Cassette | IMPN-402 | V | 7 | 69.0 | 71.4 | 0.9 | 8 | 63.0 | 91.4 | 0.5 | − 6.0 | 20.0 | − 0.4 | No | No |
| Malaria Rapid Combo/Clearview® Malaria Combo | VB11 | V | 1 | 87.3 | 10.0 | 7.7 | 3 | 82.8 | 5.7 | 3.5 | − 4.5 | − 4.3 | − 4.2 | No | No |
| Malaria Rapid Dual/Clearview® Malaria Dual Test | VB20 | V | 1 | 76.0 | 5.0 | 10.1 | 5 | 89.0 | 60.0 | 12.7 | 13.0 | 55.0 | 2.6 | No | No |
| Malaria Rapid Pf/Clearview®Malaria Pf | VB01 | V | 1 | 68.4 | N/A | 0.6 | 5 | 84.0 | N/A | 5.1 | 15.6 | N/A | 4.5 | No | Yes |
| Malascan™ Device—Rapid test for Malaria Pf/Pan | 50,402,025 | V | 1 | 63.3 | 0.0 | 5.4 | 3 | 82.8 | 57.1 | 1.0 | 19.5 | 57.1 | − 4.4 | No | No |
| Maleriscan® Malaria P.f/PAN (Pv, Pm, Po) 3 Line Antigen Test | MAT-PF/PAN-50 | V | 4 | 84.7 | 0.0 | 1.3 | 5 | 84.0 | 62.9 | 3.0 | − 0.7 | 62.9 | 1.7 | No | No |
| NanoSign Malaria Pf/Pan Ag | RMAP10 | V | 3 | 77.8 | 0.0 | 0.5 | 4 | 92.9 | 97.1 | 0.4 | 15.1 | 97.1 | − 0.1 | No | Yes |
| One Step Malaria Pf Test (Cassette) | 522,352 | V | 2 | 37.0 | N/A | 0.5 | 4 | 94.9 | N/A | 1.3 | 57.9 | N/A | 0.8 | No | Yes |
| One Step Malaria P.f Test | W37-C | V | 3 | 60.6 | N/A | 0.0 | 7 | 93.0 | N/A | 0.0 | 32.4 | N/A | 0.0 | No | Yes |
| One Step Malaria P.f/P.v Whole Blood Test | W056-C | V | 5 | 87.0 | 28.6 | 2.1 | 7 | 92.0 | 65.7 | 1.3 | 5.0 | 37.1 | − 0.8 | No | Yes |
| One Step Malaria P.F/P.V Test (Cassette) | 523,352 | V | 4 | 50.0 | 0.0 | 1.3 | 5 | 92.0 | 100.0 | 77.1 | 42.0 | 100.0 | 75.8 | No | No |
| Onsite Pf Ag Rapid Test | R0114C | V | 2 | 59.0 | N/A | 0.0 | 6 | 75.0 | N/A | 0.0 | 16.0 | N/A | 0 | No | Yes |
| Onsite Malaria Pf/Pan Malaria Ag Rapid Test | R0113C | V | 2 | 63.0 | 20.0 | 0.0 | 6 | 78.0 | 85.7 | 0.0 | 15.0 | 65.7 | 0 | No | Yes |
| Onsite Malaria Pf/Pv Ag Rapid Test | R0112C | V | 2 | 61.0 | 75.0 | 0.5 | 6 | 74.0 | 80.0 | 0.0 | 13.0 | 5.0 | − 0.5 | No | No |
| OptiMAL-IT | 710,024 | V | 1 | 36.7 | 95.0 | 0.0 | 3 | 50.5 | 97.1 | 2.0 | 13.8 | 2.1 | 2.0 | No | No |
| Parabank™ Device—Rapid test for Malaria Pan | 50,301,025 | V | 1 | 1.3 | 30.0 | 3.0 | 3 | 17.2 | 62.9 | 0.5 | 15.9 | 32.9 | − 2.5 | No | No |
| Paracheck® Pf Device—Rapid test for P. falciparum Malaria (Ver. 3) | 302030025 k | V | 1 | 54.4 | N/A | 1.2 | 4 | 95.9 | N/A | 1.3 | 41.5 | N/A | 0.1 | No | Yes |
| Paracheck® Pf Device—Rapid test for P. falciparum Malaria (Ver. 3) | 302030025 k | C | 4 | 95.9 | N/A | 1.3 | 8 | 94.0 | N/A | 3.4 | − 1.9 | N/A | 2.1 | Yes | Yes |
| Paracheck® Pf Dipstick—Rapid test for P. falciparum Malaria (Ver.3) | 30,302,025 | V | 1 | 74.7 | N/A | 7.2 | 4 | 70.4 | N/A | 0.9 | − 4.3 | N/A | − 6.3 | No | No |
| ParaHIT®—f (Device) | 551C104-50 h | V | 1 | 39.2 | N/A | 0.0 | 3 | 84.9 | N/A | 0.0 | 45.7 | N/A | 0.0 | No | Yes |
| ParaHIT® - f (Device) | 551C104-50 h | C | 3 | 84.9 | N/A | 0.0 | 7 | 77.0 | N/A | 0.0 | − 7.9 | N/A | 0.0 | Yes | Yes |
| ParaHIT®—f (Dipstick) | 551C103-50i | V | 1 | 78.5 | N/A | 0.6 | 3 | 80.8 | N/A | 2.5 | 2.3 | N/A | 1.9 | Yes | Yes |
| ParaHIT®—f (Dipstick) | 551C103-50i | C | 3 | 80.8 | N/A | 2.5 | 7 | 74.0 | N/A | 0.0 | − 6.8 | N/A | − 2.5 | Yes | No |
| Parascreen™ Device—Rapid test for Malaria Pan/Pf | 503030025 l | V | 1 | 50.6 | 25.0 | 1.2 | 8 | 91.0 | 94.3 | 0.5 | 40.4 | 69.3 | − 0.7 | No | Yes |
| QuickProfileTM Malaria Pf/Pv Antigen Test | 71,050 | V | 6 | 78.0 | 25.7 | 0.0 | 7 | 79.0 | 88.6 | 22.9 | 1.0 | 62.9 | 22.9 | No | No |
| RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) | C32RHA25m | V | 5 | 77.0 | 77.1 | 4.7 | 7 | 91.0 | 100.0 | 3.9 | 14.0 | 22.9 | − 0.8 | Yes | Yes |
| SD BIOLINE Malaria Ag | 05FK40 | V | 1 | 29.1 | 50.0 | 1.8 | 3 | 16.2 | 97.1 | 0.0 | − 12.9 | 47.1 | − 1.8 | No | No |
| SD Bioline Malaria Ag P.f (HRP2/pLDH) | 05FK90 | V | 3 | 87.9 | N/A | 2.0 | 8 | 90.0 | N/A | 0.0 | 2.1 | N/A | − 2.0 | Yes | Yes |
| SD BIOLINE Malaria Ag P.f/P.f/P.v | 05FK120 | V | 6 | 85.0 | 91.4 | 0.0 | 8 | 89.0 | 97.1 | 0.0 | 4.0 | 5.7 | 0.0 | Yes | Yes |
| SD BIOLINE Malaria Ag P.f/Pan | 05FK60 | V | 1 | 96.2 | 35.0 | 1.2 | 5 | 94.0 | 91.4 | 0.0 | − 2.2 | 56.4 | − 1.2 | No | Yes |
| SD Bioline Malaria Ag P.f/P.v | 05FK80 | C | 2 | 96.0 | 95.0 | 3.5 | 6 | 92.0 | 94.3 | 1.9 | − 4.0 | − 0.7 | − 1.6 | Yes | Yes |
| SD BIOLINE Malaria Antigen | 05FK50 | C | 1 | 97.5 | N/A | 2.4 | 5 | 95.0 | N/A | 0.0 | − 2.5 | N/A | − 2.4 | Yes | Yes |
| Wondfo One Step Malaria Pf/Pan Whole Blood Test | W56-C | V | 1 | 60.8 | 30.0 | 6.6 | 3 | 37.4 | 85.7 | 4.1 | − 23.4 | 55.7 | − 2.5 | No | No |
First and last submissions of the same type are compared
PDS panel detection score, FP false positivity, Rd round, resubmission type: V voluntary, C compulsory, N/A not applicable. The following list is the former product codes which have since been updated as detailed in the table: aG0161/G0161-ET, bG0141/G0141-ET, cG0171/G0171-ET, dG0131/G0131-ET, eG0181/G0181-ET, fG0121, gG0231, h55IC102-10, I5 55IC101-10, j50,300,025, k30301025, l50310025, mC30RHA25