【INTENDED USE】

The PSA Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for qualitative detection of Prostate Specific Antigen in whole blood,serum or plasma.

【SUMMARY】

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 0.1ng/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 3 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 3-10ng/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 Rapid Test Device (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 3ng/ml and a reference value of 10ng/ml.

【DIRECTIONS FOR USE 】

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it.Remove the test device from the sealed pouch and use it as soon as possible.Twist off the tab of the buffer vial without squeezing.

2. Place the device on a clean and level surface.

For Serum,Plasma specimens:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40uL) to the specimen well (S) of test device,then add 1 drop of buffer (approximately 40uL) and start the timer.

For Venipuncture Whole Blood specimen:

Fill the capillary tube and 2 drops of venipuncture whole blood (approximately 80uL) specimen to the specimen area of test device,then add 1 drop of buffer (approximately 40uL) and start the timer.

For Fingerstick Whole Blood specimen:

To use a capillary tube:Fill the capillary tube and transfer 2 drops of of fingerstick whole blood specimen(approximately 80uL) to the specimen area of test device,then add 1 drop of buffer (approximately 40uL) and start the timer.

3. Wait for the colored line(s) to appear*.Read results at 15 minutes.Do not interpret the result after 20 minutes.