ACCU-TELL PSA SERUM TEST

Accu-Tell ^®  Rapid PSA Serum Test is a rapid direct binding test for the visual detection of Prostrate Specific Antigen (PSA) in serum as an aid in the diagnosis of prostrate cancer. The test is based on the principle of sandwich immunoassay for determination of PSA in serum. Monoclonal and polyclonal antibodies are employed to identify PSA specifically. This Rapid test is very sensitive and only takes about 10-20 minutes. The sensitivity of the test can reach to 4ng/ml.

Prostate-specific antigen (PSA) is found exclusively in the tissues of normal, benign prostatic hyperplasia (BPH) and cancerous prostate glands. It is produced by the epithelial lining cells of the acini and the ducts of the prostate gland. It is not detected in any other human tissues including heart, pancreas, colon, stomach, liver, testes, kidneys or saliva glands. Many studies confirm that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer, prostate infection or BPH.

Accu-Tell ^®  Rapid PSA Test should be stored at room temperature 2-30^oC. The test is sensitive to humidity as well as to heat. Perform the test immediately after removing the test device from the foil pouch. Do not use it beyond the expiration date.

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.

1.  Remove the test cassette from the foil pouch, and place it on a flat, dry surface.

2.  Draw 0.2ml (about 5 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.

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

2.  Dip the test strip with arrow downwards into the specimen for about 10 seconds. Do not exceed the maximum line.

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

Positive: If two color bands are visible and the test band is equal to or darker than the control band, it indicates that the PSA concentration of specimen has reached to or greater than 4ng/ml. Please consult your physician to perform a much more detailed exam.

Negative: Only one colored band appears on the control region(C) or the test band is lighter than the control band.

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

Note: A positive result will not change once it has been established at 10 minutes. However, in order to prevent any incorrect results, the test result should not be interpreted after 30 minutes. Interpreting test results after 30 minutes, the sensitivity of the test will be higher than 4 ng/ml. Some serum specimens with a high rheumatoid factor concentration may yield a nonspecific positive result.

A procedural control is included in the test. A red line appearing in the control region (C) is considered as internal positive procedural control. A clear background in the result window is considered as internal negative procedural control.

Although the Accu-Tell ^®  Rapid PSA Test Cassette is very accurate in detecting PSA, other clinically available tests are required if questionable results are obtained. 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.