| Type: | IVD Reagent |
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| Certificate: | CE, ISO |
| Method: | Colloidal Gold Rapid Test |
| Warranty: | 3 Years |
| Material: | Medical Grade ABS Plastic |
| Package: | Single Pouch + Carton |
| Samples: |
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| Customization: |
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| SPECIFICATIONS | |
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INTENDED USE
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The Malaria Antigen P.f/Pan Rapid Test Cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) antigen and P. vivax, P. ovale or P. malariae (Pan) antigen in human Whole Blood. It provides an aid in the diagnosis of infection with Malaria.
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SUMMARY
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Malaria is caused by a protozoan which invades human red blood cells. 1Malaria is one of the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants and young children. Over half of the world's population lives in malarious areas. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and
defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology.
The Malaria Antigen P.f/Pan Rapid Test Cassette detect antigens to Malaria infection in human Whole Blood. It is a noninvasive method and does not use radioactive isotopes. The test is easy to perform and requires no specialized equipment. Visual interpretation provides an accurate qualitative result. It is a useful on-site aid in the diagnosis of Malaria infection.
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STORAGE AND STABILITY
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Store as packaged in the sealed pouch at temperature (4-30ºC or
40-86ºF). 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 environment will cause product
deterioration.
The LOT and the expiration date were printed on the labeling.
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TEST PROCEDURE
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Allow the test device and specimens to equilibrate to temperature (15-30ºC
or 59-86ºF) prior to testing.
1. Remove the test cassette from the sealed pouch.
2. Hold the dropper vertically and transfer 1 full drop of
specimen to the "S" well of the test cassette, add 3 drops of Sample buffer
to the "s" well after the specimen is added, and then begin timing. See the
illustration below.
3. Wait for colored lines to appear. Interpret the test results in 15 minutes. Do
not read results after 20 minutes.
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