Malaria Pf Pv Rapid Diagnostic Test Kit
OEM / ODM
SUMMARY AND EXPLANATION OF THE TEST
Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P. ovale, and P. malariae.
The Malaria Pf/Pv Ag Rapid Test utilizes antibodies specific to P. falciparum Histidine Rich Protein-II (pHRP-II) and to P. vivax Lactate Dehydrogenase (Pv-LDH) to simultaneously detect and differentiate infection with P. falciparum and P. vivax-5. The test can be performed by untrained or minimally skilled personnel, without laboratory equipment
|Product Name||Malaria Pf/Pv Ag Rapid Test|
|Brand Name||GOLDEN TIME , OEM-Buyer’s logo|
|Shelf time||24 months|
|Storage||2℃ to 30℃|
The Malaria Pf/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay. The strip test components consist of: 1) a burgundy colored conjugate pad containing mouse anti-Pv-LDH antibody conjugated with colloid gold (Pv-LDH-gold conjugates) and mouse anti-pHRP-II antibody conjugated with colloid gold (pHRP-II-gold conjugates), 2) a nitrocellulose membrane strip containing two test bands (Pv and Pf bands) and a control band (C band). The Pv band is pre-coated with another mouse anti-Pv-LDH specific antibody for the detection of Pv infection, the Pf band is pre-coated with polyclonal anti-pHRP-II antibodies for the detection of Pf infection, and the C band is coated with goat anti-mouse IgG.
REAGENTS AND MATERIALS PROVIDED
1.Each kit contains 25 test devices, each sealed in a foil pouch with three items inside:
a. One cassette device.
b. One desiccant.
2. 25 x 5 µL mini plastic droppers
3. Blood Lysis buffer (1 bottle, 10 mL)
4.One package insert (instruction for use).
STORAGE AND SHELF-LIFE
1. Store the test device packaged in sealed foil pouch at 2-30℃(36-86F).Do not freeze.
2. Shelf-life: 24 months from manufacturing date.
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen.
Mix the specimen well prior to assay once thawed. Blood will be hemolyzed after thawing.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device
on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Fill in the mini plastic dropper with the blood specimen not to exceed the specimen line as shown in the following image. The volume of the specimen is around 5 µL.
Holding the dropper vertically, dispense all of the specimen into the center of the sample well making sure that there are no air bubbles.
Then add 3 drops (about 100-150 µL) of Lysis Buffer immediately.
Step 5: Set up timer.
Step 6: Results can be read in 20 to 30 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 result.
INTERPRETATION OF RESULTS
1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color in the both test bands (Pv and Pf) indicates that no anti-plasmodium antigens are detected. The result is negative.
2. POSITIVE RESULT:
2.1In addition to the presence of C band, if only Pv band is developed, the test indicates for the presence of Pv-LDH antigen. The result is Pv positive.
2.2 In addition to the presence of C band, if only Pf band is developed, the test indicates for the presence of pHRP-II antigen. The result is Pf positive.
2.3In addition to the presence of C band, both Pv and Pv bands are developed, the test indicates for the presence of both Pv-LDH and pHRP-II antigens. The result is both Pv and Pf positive.
3. INVALID: If no C band is developed, the assay is invalid regardless of any burgundy color in the test bands as indicated below. Repeat the assay with a new device.