|Specimen:||Whole Blood /Serum /Plasma||Storage:||2-30°C|
cancer diagnostic tests,
diagnostic blood tests
A rapid test for the qualitative detection of Prostate Specific Antigen (PSA) in whole blood, serum or plasma CE0123 certified
Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximate 34 kDa.1 PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1 – Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2
PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 4 to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer.3 Patients with PSA values between 4-10ng/ml should undergo further analysis of the prostate by biopsy.
The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH).4
The PSA Qualitative Rapid Test Dipstick (Whole blood /Serum /Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of 4ng/ml.
How to use?
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
For Serum, Plasma or Venipuncture Whole Blood specimens:
For Fingerstick Whole Blood specimen:
*Note: if migration is not observed in the result window after 30 seconds, add one or two extra drops of buffer.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of PSA present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test dipstick. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
|Cat. No.||Product Description||Specimen||Format||Kit Size||Cut-Off||Status|
|TPS-Q401||PSA Qualitative Rapid Test Dipstick||WB/S/P||Dipstick||25T||4ng/mL||