Prostate Specific Antigen (PSA) Rapid Test

Prostate Specific Antigen (PSA) 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).

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.

Our mission:

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.