Alpha Fetoprotein AFP Test Cassette

Alpha Fetoprotein AFP Test Cassette

  • Format: Cassette
  • Specimen: Serum or Whole Blood
  • Size: 3.0mm, 4.0mm
  • Accuracy over 99.2%
  • Results read in 15 minutes
  • Methodology: Colloidal gold
  • Shelf time: 2 years
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  • Description
  • Instruction for Use
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The One Step AFP Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Alpha Fetoprotein (AFP) in human serum specimen. AFP tests are based on the principle of sandwich immunossay for determination of AFP in human serum specimen. Two monoclonal antibodies are employed to identify AFP specifically. There are two antibody bands in reaction region on the test paper: test band (T) and control band. When AFP rise beyond the normal range, a distinct pink colored band will appear in the test (T) region.

 

Features

  • High accuracy  99.2%
  • Relative Sensitivity 99.5%
  • Relative Specificity 99.1%
  • Result read in 15 minutes

 

Packaging

Box of 25T, Ctn of 1000T

One Step AFP Rapid Screen Test Cassette

Alpha Fetoprotein (AFP) is one kind of main protein in embryo blood serum which blong to tumor associated antigen. The concentration range would drop to normal leval (20ng/ml) in several months postnatal in newborn serum.AFP is a single peptide chain, molecular weight is about 65000~70000. The concentration range of AFP could reach to 90~500 ng/ml in mid trimester of pregnancy.

The One Step AFP Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Alpha Fetoprotein (AFP) in human serum specimen.AFP tests are based on the principle of sandwich immunossay for determination of AFP in human serum specimen.Two monoclonal antibodies are employed to identify AFP specifically. There are two antibody bands in reaction region on the test paper : test band (T) and control band.When AFP rise beyond the normal range, a distinct pink colored band will appear in the test (T) region.

SPECIMEN COLLECTION

For serum, collect blood into a container without anticoagulant.  Allow the blood to clot and separate the serum from the clot.  Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer.  Bring the specimens to room temperature before testing.  Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

  1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
  2. Draw about 2-3drops sample into the pipette, and dispense it into the sample well on the cassette.
  3. Wait 10-15 minutes and read result. Do not read results after 15 minutes.

 

INTERPRETATION OF RESULTS

Negative:  Only one colored band appears on the control (C) region.  No apparent band on the test (T) region.

Positive:  In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.  Please consult your physician to perform a much more detailed exam.

Invalid:  A total absence of color in both regions is an indication of procedure error and/or the test reagent has been deteriorated.

STORAGE AND STABILITY

The test kit should be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION:

  1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
  2. Use it before expiry date.
  3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
  4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

  • The test is for in-vitro diagnostic use only.

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