CL0816R

Free Prostate-Specific Antigen CLIA Kit

Description

This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of human Free Prostate specific antigen levels in serum using the ECL100 or ECL25 Immunoassay analyzer. This immunoassay is indicated for measurement of free PSA in conjunction with the CL0815R EDI™ Total Prostate-specific antigen CLIA kit to develop a ratio of Free PSA to Total PSA. This ratio is used as an aid in the detection of prostate cancer in men.
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For Research Use Only. Not for use in diagnostics procedures.

Background


This CLIA is designed, developed, and produced for the quantitative measurement of human free PSA in serum samples. The assay utilizes a two-site “sandwich” technique with one antigen and one antibody that bind to different epitope and paratope of free PSA.

Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Simultaneously, an acridinium ester antibody and a biotin antibody are added. The magnetic particles capture the biotin antibody as well as an immunocomplex in the form of “magnetic particles – biotin free PSA antibody –free PSA– acridinium ester free PSA antibody”.

​​​​​​​The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel and light generated by the reaction is measured with the ECL100 or ECL25 analyzer. The relative light units (RLU) are proportional to the concentration of free PSA in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum free PSA concentration

Product Summary 


Several forms of prostate-specific antigen (PSA) are found in serum. Free PSA is one of these, and unlike other forms, is unbound to protease inhibitors. The measurement of the different complexed and uncomplexed forms helps distinguish between prostate cancer and other non-cancerous diseases. The determination of PSA levels present is serum can be used for screening and determination if a more invasive biopsy is required, and additionally, can be used for monitoring patients with prostate cancer.

Specifications

Catalog no. CL0816R
Target Free Prostate-specific antigen
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 0.09 ng/mL
Dynamic Range 1 - 1.5 ng/mL
Total Incubation Time < 30 minutes
Sample Type Serum
Sample Volume 10 µL
Storage Temperature 2-8 °C
For research use only. 
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