One-Step PSA Strip Rapid Test

One-Step PSA Strip Rapid Test

INTENDED USE

The PSA gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of prostate specific antigen (PSA) in human serum/plasma or whole blood.

PRINCIPLE

PSA is a normal secretion that secreted by normal prostatic epithelial cell and malignant cancer of prostate. PSA is normal product, but when its concentration exceed over 4ng/ml, it can be taken as an index to the risk probability of prostate cancer. The prostate cancer is the most frequent malignant tumor in male; PSA is considered as the most valuable tumor maker, so the detection of high level of PSA is a specific and effective way to diagnose the prostate cancer, also an index to examine the cancer relapse and therapy monitoring.

The PSA RST is a chromatographic immunoassay (CIA) for the detection of PSA in human serum/plasma or whole blood. Specific antibody against PSA is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If PSA present, a pink colored band will develop on the membrane in proportion to the amount of PSA presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of PSA.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. One piece of operating instruction.

3. One bottle of whole blood chasing buffer.

WARNING AND PRECAUTIONS

1.  FOR IN VITRO DIAGNOSTIC USES ONLY

2.  All patient samples should be treated as if capable of transmitting diseases.

3.  Do not interchange reagents from different lots or use test kit beyond expiration date.

4.  Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24months).

SAMPLE COLLECTION AND PREPARATION

Plasma

1.    Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2.    Separate the plasma by centrifugation.

3.    Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2. Allow the blood to clot.

3. Separate the serum by centrifugation.

4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE

Add 70-100ul or 2-3 drops of serum/plasma into the sample well. For whole blood tests, add 1~2 drops of whole blood into the sample well and then add 1~2 drops of chasing buffer into the sample well. Observe the result in 10 –20 minutes.