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Description
The Fastvue Malaria Pf/Pv Antigen Rapid Diagnostic Test Kit is a chromatographic immunoassay designed for the qualitative detection and differentiation of antigens from Plasmodium falciparum (P.f.) and Plasmodium vivax (P.v.) in human whole blood. This screening tool aids in the diagnosis of malaria infection by identifying the presence of specific parasite proteins. It is intended for in vitro diagnostic use by trained professionals in laboratory or point-of-care settings.
Dual Detection: Simultaneously detects and differentiates between Plasmodium falciparum (P.f.) and Plasmodium vivax (P.v.) malaria parasites.
Rapid Results: Provides a visual result within 15 to 20 minutes, allowing for timely assessment.
Whole Blood Specimen: Requires only a small sample of whole blood (5µL) for testing.
User-Friendly Design: The cassette format is straightforward to use, requiring minimal training.
Room Temperature Storage: The kit can be conveniently stored at room temperature (2-30°C), eliminating the need for refrigeration.
Q: What is this test kit used for?
A: The Fastvue Malaria Pf/Pv Antigen Rapid Diagnostic Test Kit is an in-vitro diagnostic tool for the qualitative detection and differentiation of Plasmodium falciparum (P.f.) and Plasmodium vivax (P.v.) antigens in human whole blood. It is intended for professional use as an initial screening test.
Q: How does this rapid test work?
A: This test is a chromatographic immunoassay that detects specific antigens produced by malaria parasites. It uses antibodies to identify Histidine-Rich Protein II (HRP-II) specific to P. falciparum and lactate dehydrogenase (pLDH) from P. vivax in a blood sample.
Q: How are the results interpreted?
A: A control line (C) must appear for the test to be valid. If only the C line appears, the result is negative. If the C line and the T1 (Pf) line appear, it indicates a P. falciparum infection. If the C line and T2 (Pv) line appear, it indicates a P. vivax infection. The appearance of all three lines (C, T1, and T2) suggests a mixed infection.
Q: Is a rapid test result sufficient for a final diagnosis?
A: No, this test is for initial screening. A positive result should be confirmed by a supplemental method like microscopy. It is also advised that diagnosis should consider the test result in conjunction with the patient's clinical condition.
Q: What is included in one test kit?
A: Typically, a kit contains individually foil-pouched test cassettes with a desiccant, a buffer solution, disposable specimen droppers, and a package insert with instructions for use.
The Fastvue Malaria Pf/Pv Antigen Rapid Diagnostic Test Kit is a chromatographic immunoassay designed for the qualitative detection and differentiation of antigens from Plasmodium falciparum (P.f.)...
Key Benefits
Aids in the rapid and qualitative diagnosis of malaria, specifically identifying infections caused by P. falciparum and P. vivax.
Facilitates prompt diagnostic screening, which is a critical step in managing malaria.
Offers a convenient point-of-care testing option, suitable for use in clinics and laboratories without extensive equipment.
Allows for the differentiation between the two common malaria species, P.f. and P.v., with a single test.
Aids in the rapid and qualitative diagnosis of malaria, specifically identifying infections caused by P. falciparum and P. vivax.
Facilitates prompt diagnostic screening, which is a critical st...
Direction for Use/Dosage
Ensure the test kit and specimen are at room temperature before starting.
Clean the fingertip with the provided alcohol swab and allow it to dry.
Puncture the skin with the sterile lancet and wipe away the first drop of blood.
Using the provided dropper, collect the blood sample up to the marked line (approximately 5µL).
Add the collected whole blood into the sample well (S) of the test cassette.
Add 2 drops of the assay buffer into the buffer well.
Read the results between 15-20 minutes. Do not interpret the results after 30 minutes.
Ensure the test kit and specimen are at room temperature before starting.
Clean the fingertip with the provided alcohol swab and allow it to dry.
Puncture the skin with the sterile lancet a...
Safety Information/Precaution
For professional in vitro diagnostic use only.
Do not use the kit beyond its expiration date.
Handle all blood specimens as if they contain infectious agents.
Wear protective clothing, such as gloves and a lab coat, when handling specimens.
Dispose of used test materials according to local regulations for biohazardous waste.
Do not eat, drink, or smoke in the area where specimens and kits are handled.
Humidity and temperature can affect the results; store the kit as recommended.
Consult a healthcare professional for diagnosis and before starting any treatment.
For professional in vitro diagnostic use only.
Do not use the kit beyond its expiration date.
Handle all blood specimens as if they contain infectious agents.
Wear protective clothing, ...
Other Information
Each kit contains individually sealed foil pouches with a test cassette and a desiccant, a buffer bottle, and blood transfer devices.
Store the kit at a temperature between 2-30°C (36-86°F).
Do not freeze the test kit.
The test device should remain in its sealed pouch until ready for use.
The test is intended for screening and all positive results should be confirmed with further laboratory testing.
Each kit contains individually sealed foil pouches with a test cassette and a desiccant, a buffer bottle, and blood transfer devices.
Store the kit at a temperature between 2-30°C (36-86°F).

