Prostate Specific Antigen (PSA) Rapid Test
For professional use only.
For in vitro diagnostic use only.
【INTENDED USE】
The Prostate Specific Antigen (PSA) is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasmaspecimens. This kit is intended for use as an aid in the diagnosis of prostate cancer.
【INTRODUCTION】
Prostate cancer is the most frequent type of cancer found in the man and the second cause of death due to the cancer in man. Prostate cancer incidences increase dramatically in males with an age over 40 years, occurring in 50% of those over 70 years. Compared to other cancers, prostate cancer is more successfully treated if diagnosed early. Recently, another prostate enzyme has been identified and purified, which specific for prostate tissue, normal or malignant, and also found in periurethral glands. This enzyme is called prostate specific antigen (PSA). Looking at PSA from the biological side, it is a 33 kDa protein that is synthesized in the prostatic gland. It functions as a serine protease and serves to liquefy the seminal fluid. As demonstrated by immunohistological studies, PSA is localized in the cytoplasm of prostate acinar cells, ductal epithelium and in the secretion on the ductal lumina, present in normal, benign hyperplastic and malignant prostate tissues as well as in metastatic prostate cancer and in seminal fluid. An elevation of the serum concentration is reported in patients with both benign prostatic hypertrophy prostate carcinoma, but rarely in healthy men and is absent in normal women. PSA is not present in any other normal tissue obtained from men, nor is it produced by cancers of the breast, lung, colon, rectum, stomach, pancreas and thyroid. The PSA level in serum or plasma of normal health men should be lower than 4 ng/ml, so the reference line is designed to be approximately the intensity of 4 ng/ml.
【PRINCIPLE】
The PSA Rapid Test detects prostate specific antigens through visual interpretation of color development on the internal strip. PSA antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with PSA antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【MAIN CONTENTS】
• Rapid test cassette with desiccant.
• Buffer
• Pipette
• Package insert
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
【SAMPLE COLLECTION】
• The PSA Rapid Test is intended for use with human whole blood, serum, or plasma specimens only.
• Intake of Finasteride (5-reductaseinhibitor) will reduce the PSA concentration by max. 50%. This should be considered by the interpretation of the results.
• Different factors could increase the PSA level in blood serum and should be avoided before collection of the blood sample and/or should be desisted from by the patient before sample taking.
• Ride on a bicycle: 24 hours before taking of blood sample
• Activities (Ejaculation): 24-48 hours before taking of blood sample
• Every manipulation of the prostate by medical examinations. The following intervals are recommended until taking of blood sample:
|
Examination
|
Interval
|
|
Prostatic biopsy
|
> 6 weeks
|
|
Transurethal resection of the prostate
|
> 6 weeks
|
|
Transrectal prostatic ultrasound
|
> 1 week
|
|
Rigid Cytoscopy
|
> 1 week
|
|
Digital rectal examination
|
3 days – 1 week
|
|
Prostatic massage
|
> 1 week
|
• Only clear, non-hemolyzed specimens are recommended for use with thistest. Serum or plasma should be separated assoon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
【DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test cassette from the sealed pouch and use it within one hour.
2. Using the provided disposable pipette, transfer 1 drop of Whole Blood, Serum or Plasma specimen into the center of the specimen well(s) of the test cassette, then add 1 drop of buffer, and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
For further operation or performance details, please refer to final instruction manual.
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