Malaria Pf/Pv Antigen Rapid Test Kit (Colloidal Gold)

For in vitro diagnostic use: qualitative detection and differentiation of P. falciparum and P. vivax malaria in patients with suspected malaria (febrile illness) [1][2][3]. Useful for rapid, point-of-care diagnosis where reliable microscopy is not immediately available, including remote and community-level settings; WHO recommends prompt parasite-based diagnosis in all suspected cases before treatment [1][2]. The kit is an aid to diagnosis; microscopy remains the gold standard and should be used to confirm RDT results, identify species and quantify parasitaemia wherever feasible [1][2].

Specimen: fresh finger-prick capillary blood or fresh anticoagulated whole blood (EDTA, heparin or oxalate); do not use clotted, haemolysed or contaminated samples [3]. If testing is not immediate, store the whole blood specimen at 2-8 °C for up to 72 hours; do not freeze [3]. Bring kit and specimen to room temperature; open the foil pouch, collect about 5 µL of blood with the sample loop (or micropipette) and apply it to the sample well, then add the buffer drops to the buffer well as stated in the insert [3]. Read the result within the time window given in the insert (typically 15-20 minutes); do not interpret the test beyond 30 minutes [3]. Operators should be trained and monitored on test preparation and interpretation; follow the local standard operating procedure and job-aids [1].

Sample volume: approximately 5 µL of whole blood per test; buffer volume as specified in the package insert (typically about 2 drops) [3]. Test results are qualitative; the Pv line may also be used to monitor the response of a stand-alone P. vivax infection to anti-malarial therapy [3].

For professional in vitro diagnostic use only; the device is not intended for self-testing by patients or the general public [2]. Do not use the test beyond the expiry date, if the pouch is damaged or opened, or if the desiccant is missing; use a new device for each test [3]. Store the kit at 4-30 °C (or per the approved label) until the expiry date; do not freeze; avoid exposure to high temperature and humidity during transport and storage [1][3]. The RDT may miss infections with very low parasite densities; sensitivity depends on parasite density. All negative results should be confirmed by microscopy when feasible [1][2]. All positive results should also be confirmed by microscopy to determine the species and parasitaemia, an important prognostic indicator [2]. False-negative results are possible with P. falciparum strains lacking pfhrp2/3 genes; selection should consider tests meeting WHO performance criteria (panel detection score, false-positive and invalid rates) [1]. Handle blood specimens with universal precautions; dispose of lancets, cassettes and specimens safely as biohazardous waste [3]. For full product information, refer to the approved package insert / labelling of the product concerned [1][2][3].