Performance Characteristics
Detection Limit : 1.0 ng/ mL ;
Linear Range: 1.0-1000.0 ng/ mL;
Linear correlation coefficient R ≥ 0.990;
Precision: within batch C.V. is ≤ 15%; between batches C.V. is ≤ 20%;
Accuracy: the relative deviation of the measurement results shall not exceed ± 15% when the accuracy calibrator prepared by P.F/PV(MALARIA) national standard or standardized accuracy calibrator are tested.
1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.
2. Store Aehealth Ferritin Rapid Quantitative test cassette at 2～30℃, shelf life is up to 18 months.
3. Test cassette should be used within 1 hour after opening the pack.
Malaria is a disease that can be transmitted to people of all ages. It is caused by parasites of the malaria parasite species and is transmitted from person to person through the bite of an infected mosquito. If left untreated, malaria can cause serious disease that is often fatal. Type: Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, and Plasmodium ovale. The most common are Plasmodium falciparum and Plasmodium vivax. Plasmodium falciparum is by far the deadliest form of malaria infection.
The Aehealth MALARIA Ag (P.F/P.V) Rapid Test is based on fluorescence immunoassay technolgy. The Aehealth MALARIA Ag (P.F/P.V) Rapid Test uses a sandwich immunodetection method, when sample is added to the sample well of the test Cassette, the fluorescence-labeled detector P.F/P.V antibody binds to P.F/P.V antigen in blood specimen. As the sample mixture migrates on the nitrocellulose matrix of test strip by capillary action, the complexes of detector antibody and P.F/ P.V are captured to P.F/P.V antibody that has been immobilized on test strip. Thus the more P.F/P.V antigen is in blood specimen, the more complexes are accumulated on test strip. Signal intensity of fluorescence of detector antibody reflects amount of P.F/P.V captured and Aehealth FIA Meter shows P.F/P.V qualitative test results in blood specimen.