Table 1.
Product information, target antigens and clinical data for the ten rapid diagnostic tests evaluated for P. knowlesi detection.
| Malaria rapid diagnostic tests | Manufacturer | Catalogue number | Lot number | WHO reference number | WHOPre-qualified | Test read interval (minutes) | Target antigens* | P. knowlesi cases tested† | Malaria negative controls tested | Limit of detection (PkA1-H.1) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pan-pLDH based tests | |||||||||||
| First Response® Malaria Ag. pLDH/HRP2 Combo Card Test | Premier Medical Corporation Ltd. Mumbai, India | PI16FRC2 | 75J1019S | PQDx 0285-010-00 | Yes | 20 | Pan-pLDH | 103 | 19 | Yes | |
| Pf-HRP2 | |||||||||||
| CareStart™ Malaria PAN (pLDH) Ag RDT | Access Bio, Inc. New Jersey, USA | G0111 (RMNM-02571) |
MN19L61 | PQDx 0234-049-00 | Yes | 20 | Pan-pLDH | 103 | 19 | Yes | |
| STANDARD Q Malaria Pf/Pan Ag Test | SD Biosensors Inc., Republic of Korea | 09MAL30B | QML3019014 | PQDx 0347-117-00 | Yes | 15 | Pan-pLDH | 143 | 21 | Yes | |
| Pf-HRP2 | |||||||||||
| CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo | Access Bio, Inc. New Jersey, USA | G0131 (RMRM-02571) |
MR19K66 | PQDx 0136-049-00 | Yes | 20 | Pan-pLDH | 102 | 19 | Yes | |
| Pf-HRP2 | |||||||||||
| Parascreen® Rapid test for Malaria Pan/Pf | Zephyr Biomedicals, Tulip Diagnostics (P) Ltd. Goa, India | 503030025 | 101334 | PQDx 0291-025-00 | Yes | 20 | Pan-pLDH | 102 | 19 | Yes | |
| Pf-HRP2 | |||||||||||
| careUS™ Malaria PAN (pLDH) Ag | WELLS BIO. Inc., Republic of Korea | RMR-M02582 | RMR 19F261 | – | No | 20 | Pan-pLDH | 133 | 21 | No | |
| Pf-HRP2 | |||||||||||
| SD BIOLINE Malaria Ag Pf/Pan | Standard Diagnostics Gyeonggi-do, Republic of Korea | 05FK60 | 05EDE027C | PQDx 0030-012-01 | Yes | 15 | Pan-pLDH | 145 | 22 | Yes | |
| Pf-HRP2 | |||||||||||
| One Step test for Malaria Pf/Pan Ag MERISCREEN Malaria Pf/Pan Ag | Meril Diagnostics Pvt. Ltd., Gujarat, India | MHLRPD-02 | MI 111830 | PQDx 0330-074-00 | Yes | 20 | Pan-pLDH | – | – | Yes | |
| Pf-HRP2 | – | – | |||||||||
| P. vivax-pLDH tests | |||||||||||
| Biocredit™ Malaria Ag Pf/Pv (pLDH/pLDH) | RapiGEN Inc., Republic of Korea | C60RHA25 | H016004 | PQDx 0470-074-00 (World Health Organization, 2022a) | #Under review | 30 | Pv-pLDH | 135 | 20 | Yes | |
| Pf-pLDH | |||||||||||
| FalciVax Rapid Test for Malaria Pv/Pf | Zephyr Biomedicals, Tulip Diagnostics (P) Ltd. Goa, India | 503010025 | 81284 | PQDx 0290-025-00 | Yes | 20 | Pv-pLDH | 138 | 18 | Yes | |
| Pf-HRP2 | |||||||||||
*pLDH (parasite lactate dehydrogenase); Pan (all malaria species – Plasmodium sp.); Pv (P. vivax); Pf (P. falciparum); Pf-HRP2 (P. falciparum histidine-rich-protein-2); PkA1-H.1 (cultured P. knowlesi A1 H.1 clone).
†Includes patients tested either before or after antimalarial treatment.
#Expert Review Panel for Diagnostics (ERPD Risk Category 2 until 14 Jul 2022).