ACCU-TELL PSA WHOLE BLOOD TEST
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name
ABT-TM-A86 PSA Whole Blood Strip
ABT-TM-B86 PSA Whole Blood Cassette
Accu-Tell ® Rapid PSA Whole Blood 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 human whole blood, serum or plasma.
Accu-Tell ® Rapid PSA Test is a colloidal gold enhanced immunoassay for the determination of Prostate Specific Antigen in human serum, plasma and whole blood. The nitrocellulose membrane was treated with mouse anti-human PSA McAb in the test region. During the assay, the serum, plasma and whole blood specimen is allowed to react with the colored conjugate (antibody-colloidal gold conjugate); the mixture then migrates on the membrane chromatographically by the capillary action. If PSA is present in the specimen, the specific antibody-PSA-colored conjugate complex will form in test region on the membrane. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at control region should always appear in the test area.
Accu-Tell ® Rapid PSA Test should be stored at room temperature 2-30oC. 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. All serum, plasma and whole blood specimens should be treated as infectious material. Do not contact the test strip without wearing safety gloves.
3. Devices used for the assay should be sterilized before being disposed.
4. Do not use the test beyond expiration date.
1. Collect serum, plasma and whole blood specimens following regular clinical laboratory procedures.
2. Only those serum, plasma and whole blood specimens that are clean, clear and with good fluidity can be used for the assay.
3. Those serum, plasma and whole blood specimens that are apparently hemolyzed, extremely thickened or with very high fat level are NOT suitable for the assay.
4. Storage: A specimen should be refrigerated if not used in the same day of collection; a specimen should be kept frozen if not used within 3 days after being collected. Do not thaw-and-freeze the specimens many times before using. Up to 0.1% of sodium azide can be added to specimen as preservative without affecting the results of assay.
For Test Cassette:
1. Remove the test cassette from the foil pouch, and place it on a flat, dry surface.
2. Dispense 100μl(3 drops) serum, plasma or whole blood to the sample well.
3. Read the test result between 5 to 10 minutes. Do not interpret the result after 15 minutes.
For Test Strip:
1. Remove test strip from the sealed foil pouch.
2. Dip the test strip into serum, plasma or whole blood sample with the arrows pointing toward the specimen.
Note: The serum, plasma and whole blood level should reach the maximum line marked on the strip, but must not exceed the maximum line.
3. Hold the strip in the sample until a reddish color appears at the lower edge of the test membrane (approximately 10 seconds).
4. Withdraw the strip and place it face-up on a clean, dry surface.
5. Read the test result between 5 to 10 minutes. Do not interpret the result after 15 minutes.
Positive: Two pink bands form, and the color of the test band is equal to or more intense than that of the control band. This result indicates the presence of PSA in the specimen at a level equal to or greater than 4 ng/ml,
Negative: Only one pink band forms in the control region (C); no band is found in the test region (T) , or the color of the test band is less intense than that of the control band. This result indicates the presence of PSA in the specimen at a level lower than 4 ng/ml.
Invalid: A total absence of color in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.
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 Whole Blood Test 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.
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