タイトルまたは説明

One step Malaria Pf/Pv Rapid Test Casette
Specimen : Whole Blood

Intended Use
 
One-Step Malaria Pf/Pv Antigen Test Kit is a rapid and convenient immunochromato-graphic assay for the qualitative detection of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in whole blood samples. It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum infections from Plasmodium vivax infections. This assay provides only a preliminary result and all positive specimens should be confirmed with other qualified assays.

Summary And Principle Of The Assay
Malaria is one of the most prevalent parasitic diseases across the world. Four species of the Plasmodium parasites are responsible for malaria infections in human, i.e. P. falciparum, P.vivax, P.ovale and P.malariae. Of these, P. falciparum and P. vivax are the most prevalent. The disease is transmitted by the Anopheles mosquito or in rare cases, by transfusion. The parasites mature in hepatocytes and release merozoites into the blood. Merozoites multiply within red blood cells, inducing symptoms like fever, chills, flu-like illness and anemia, and in severe cases, coma and death.
 
One-Step Malaria Pf/Pv Antigen Test Kit is an antigen-capture immunochromatographic assay, detecting the presence of specific soluble proteins, histidine-rich protein II (HRP-II) specific for Plasmodium falciparum and lactate dehydrogenase (pLDH) specific for Plasmodium vivax, in blood samples. HRP-II and pLDH are present in, and released from, infected red blood cells in P.f and P.v infections, respectively. Monoclonal antibodies specifically against pLDH and HRP-II are 1) conjugated with colloidal gold and deposited on the conjugate pad and 2) immobilized on the test lines T1 and T2 on the nitrocellulose membrane. When a blood sample is added, it rehydrates the gold-antibody conjugate and the HRP-II or pLDH, if any in the samples, interact with the gold conjugated antibodies. The antigen-antibody-gold complex will
migrate towards the test window until the Test Zone (T) where they are captured by immobilized antibodies, forming a visible pink line (Test band, indicating a positive result). If HRP-II or pLDH
are absent in the sample, no pink line will appear in the Test Zone (T).
 
To serve as an internal process control, a control band should always appear after the test is completed. Absence of a pink control line in the control region is an indication of an invalid result.
The detection limit of One-Step Pf/Pv test is *0 parasite/μl for P. falciparum, and **0 parasite/μl for P. vivax in whole blood sample.