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Malaria P.f/P.v Antigen Rapid Test Cassette (WB)

Overview

The Malaria P.f/P.v Antigen Rapid Test Cassette is a lateral flow immunoassay for the qualitative detection of Histidine-Rich Protein II (HRP-II) of Plasmodium falciparum (P.f) and plasmodium lactate dehydrogenase (pLDH) of Plasmodium vivax (P.v) in human whole blood. It provides aid in the diagnosis of infection with Malaria.

Contents Include

  • Test cassette

  • Package insert

  • Buffer

  • Dropper

Storage and Stability

  • Store as packaged in the sealed pouch at temperature (4-30°C or 40-86°F). The kit is stable within the expiration date printed on the labeling.

  • Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environments will cause product deterioration.

  • The LOT and the expiration date were printed on the labeling.

Specimen

  • The test can be used to test human whole blood.

  • Collect blood specimens (containing EDTA, citrate or heparin) by vein puncture following standard laboratory procedures.

  • Store specimens at 2-8°C (36-46°F) if not tested immediately. Store specimens at 2-8°C for up to 7 days. The specimens should be frozen at -20°C (-4°F) for longer storage.

  • Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Procedure

Allow the test device and specimens to equilibrate to temperature (15-30°C or 59-86°F) prior to testing.

  1. Remove the test cassette from the sealed pouch.

  2. Hold the dropper vertically and transfer 1 full drop (approximately 10 μL) of the specimen to the “S” well of the test cassette, add 3 drops of buffer (approximately 70 μL) to the “S” well after the specimen is added, and then begin timing. See the illustration below.

  3. Wait for the colored line(s) to appear. Interpret the test results at 15 minutes. Do not read the results after 20 minutes.

Notes: Applying a sufficient amount of specimen is essential for a valid test result. If migration (the wetting of the membrane) is not observed in the test window after one minute, add one more drop of buffer to the specimen well.

 

Results Interpretation

  • Positive: The control line and at least one test line appear on the membrane. The appearance of P.f test line indicates the P.f positive. The appearance of P.v test line indicates the P.v positive. And if both P.v and P.f line appear, it indicates that the presence of both P.f and P.v positive.

  • Negative: One colored line appears in the control region (C). No line appears in the test region (T). This negative result indicates the absence of P.f antigen and P.v antigen.

  • Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Limitations

  • The Malaria P.f/P.v Antigen Rapid Test Cassette is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antigen in the blood.

  • The results obtained from this test are intended to be an aid in diagnosis only. Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.

  • A negative test result indicates that antigens to Malaria are either not present or at levels undetectable by the test.

Contents required but not included

  • Specimen collection container

  • Timer
     

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