ACCU-TELL AFP SERUM TEST (CE)

Accu-Tell ^®  Rapid AFP Serum Test is a rapid direct binding test for the visual detection of Alpha Fetoprotein (AFP) in serum as an aid in the diagnosis of primary hepatocellular carcinomas, testicular teratocarcinomas and neural tube defects. The sensitivity of the test is 25ng/ml. It also has an internal control of 400ng/ml.

Accu-Tell ^®  AFP is a protein with molecular mass ranging from 67,000 to 74,000 D. Its normal concentration in serum is below 9 ng/ml; higher concentrations are associated with hepatoma and ovarian, testicular and presacral teratocarcinomas, and other cancers. Detection of elevated AFP levels can also be used in the detection of fetal open neural tube defects.

Accu-Tell ^®  Rapid AFP Test Cassette is based on the principle of sandwich immunoassay for determination of AFP in serum. Monoclonal and polyclonal antibodies were employed to specifically identify AFP with high sensitivity.

1.  For in vitro diagnostic use only.

2.  Do not eat or smoke while handling specimens.

3.  Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.

4.  Avoid splashing or aerosol formation.

5.  Clean up spills thoroughly using an appropriate disinfectant.

6.  Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.

7.  Do not use the test kit if the pouch is damaged or the seal is broken.

Store as packaged in the sealed pouch at room temperature (2-30°C) for duration of shelf life. The test cassette should be kept away from direct sunlight, moisture and heat.

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

Read the entire procedure carefully prior to performing any tests. Allow test and serum samples to equilibrate to room temperature (18-30°C) prior to testing.

1.  Remove the test cassette from the foil pouch when ready to perform the test.

2.  Draw 0.2ml (about 6 drops) sample into the pipette, and dispense it into the sample well on the cassette.

3.  Wait 10-20 minutes and read results. Do not read results after 30 minutes.

 For Test Strip:

1.  Remove the test strip from the foil pouch when ready to perform the test.

2.  Dip the test strip with arrow downwards the specimen for 5 seconds. Do not exceed the maximum line.

3.  Wait 10-20 minutes and read results. Do not read results after 30 minutes.

Positive: Two distinct red lines will appear, one in the test region (T) and another in the control region (C). And if the test band is equal to or darker than the control band, it indicates that the AFP concentration of specimen has reached to or more than 400ng/ml. Please consult with your physician to perform much more detailed exam or test.

Negative: Only a single red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

Invalid: A total absence of colored lines in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.

Although the Accu-Tell ^®  Rapid AFP Test Cassette is very accurate in detecting AFP, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.