Malaria P.F/Pan Antigen Rapid Test Cassette

For in vitro diagnostic use: screening and aid in the diagnosis of malaria infection in patients with suspected malaria [3][4]. Simultaneously detects and differentiates P. falciparum infection from non-falciparum infection (P. vivax, P. ovale, P. malariae) [3][4]. Useful for rapid point-of-care testing where reliable microscopy is unavailable; WHO recommends parasite-based diagnosis in all suspected cases before treatment [1]. An aid to diagnosis only; microscopy remains the gold standard and should confirm RDT results, species and parasitaemia wherever feasible [1][2].

Specimen: fresh finger-prick capillary blood or venous whole blood (EDTA, citrate or heparin); do not use clotted or contaminated samples [3][4]. If not tested immediately, store whole blood at 2-8 °C for up to 3 days, or freeze at -20 °C for longer storage; bring to room temperature before use and avoid repeated freeze-thaw [4]. Bring device, specimen and buffer to room temperature (15-30 °C); open the pouch immediately before testing [3][4]. Transfer about 5 µL of whole blood to the sample well (S) without air bubbles, then immediately add the buffer (about 2-3 drops, 50-120 µL) to the buffer well (B) as stated in the insert [3][4]. Read the result at 20-30 minutes after adding the specimen and buffer; do not interpret the test beyond 30 minutes [3][4]. Operators should be trained and monitored; follow the package insert and local standard operating procedure [1][3].

Sample volume: about 5 µL of whole blood per test; buffer volume as specified in the package insert [3][4]. Results are qualitative; parasite density is not determined [3][4]

For professional in vitro diagnostic use only; the cassette is intended for healthcare professionals and is not for self-testing by patients or the general public [2][3][4]. Do not use after the expiry date or if the pouch is damaged or opened; the device is single-use and must be discarded after reading [3][4]. Store at 2-30 °C (not above 30 °C); do not freeze; keep sealed until use, as humidity and temperature can adversely affect results [3][4]. Handle all specimens as potentially infectious; follow universal precautions and dispose of devices and specimens as biohazardous waste [4]. The result should not be the sole criterion for diagnosis; a definitive diagnosis should be made by a physician after all clinical and laboratory findings are evaluated [3][4]. A negative result does not preclude malaria infection; if symptoms persist, additional testing with other methods is recommended [3][4]. The RDT may miss infections with very low parasite densities; negative and positive results should be confirmed by microscopy when feasible. False negatives are possible with P. falciparum strains lacking pfhrp2/3 genes [1][2]. Haemolytic, lipaemic or icteric samples and rheumatoid factor may impair results; a Pf-positive/Pan-negative pattern may occur after treatment, when retesting after 2 days is advised [3][4]. For full product information, refer to the approved package insert / labelling of the product concerned [1][2][3][4].