The Malaria Pf/Pv Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-II) and Malaria P.vivax specific lactate dehydrogenase(Pv-LDH) in human blood specimen as an aid in the diagnosis of Malaria infection. It's for In-Vitro Diagnostic use only.
Malaria Pf/Pv Rapid Test Cassette
1. Product Details
Product Name: The Malaria Pf/Pv Rapid Test Cassette
Test Item: Malaria P.falciparum specific histidine rich protein-2(Pf HRP-II) and Malaria P.vivax specific lactate dehydrogenase(Pv-LDH)
Specimen: Whole Blood
The Malaria Pf/Pv Rapid Test Cassette (Whole Blood) contains a membrane strip, which is precoated with mouse monoclonal antibodies specific HRP-II of P.falciparum on test line Pf(T2) region and with mouse monoclonal antibodies specific to lactate dehydrogenase of P.vivax species on test line Pv(T1) region respectively. Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold, which are specific to P.falciparum histidine rich protein-2 (Pf HRP-II) and specific to the lactate dehydrogenase of P.vivax.
During the assay, an adequate volume of the blood specimen is dispensed into the sample well (S) of the test cassette, a lysis buffer is added to the buffer well(B). The buffer contains a detergent that lyses the red blood cells and releases various antigens, which migrate by capillary action across the strip held in the cassette. Pv-LDH if presents in the specimen will bind to the Pv-LDH-gold conjugates. The immunocomplex is then captured on the membrane by the precoated anti-Pv-LDH antibody, forming a burgundy colored Pv(T1) band, indicating a Pv positive test result.
Alternatively, pHRP-II if presents in the specimen will bind to the pHRP-II-gold conjugates. The immunocomplex is then captured on the membrane by the precoated anti pHRP II antibodies, forming burgundy colored Pf(T2) band, indicating a Pf positive result.
Absence of any T bands suggests a negative result.
3. Directions for Use
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C)prior to testing.
(1) Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
(2) Place the test cassette on a clean and level surface.
(3) With a 5μL mini plastic dropper provided, draw whole blood specimen to exceed the specimen line as showed in the following image and then transfer drawn whole blood into the sample well (S). Then add 3 drops (about 120μL) of Lysis Buffer to the buffer well(S) immediately.
(4) Set up timer
If preferred, after 5 minutes of adding specimen and buffer, you may add one more drop of lysis buffer to help the background become clearer.
(5) Results can be read in 20 to30 minutes. It may take more than 20 minutes to have the background become clearer. Don't read results after 30 minutes. To avoid confusion, discard the test device after interpreting the results.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China