Home Use PSA Rapid Test Cassette One Step Prostate Specific Antigen Rapid Test

【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 plasma specimens. 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

【DIRECTION OF USE】

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.

2. Transfer 1 drop of serum/plasma to the specimen well (S) of the cassette with the provided disposable pipette, then add 1 drop of buffer, and start the timer. OR Transfer 1 drop of whole blood to the specimen well (S) of the cassette with the provided disposable pipette, then add 1 drop of buffer, and start the timer. OR Allow 2 hanging drops of fingerstick whole blood to fall 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. As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.