IVD Reagents

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

The Eclectica Free PSA assay for the Eclectica analyzers has been designed for the quantitative determination of free prostate-specific antigen in human serum and heparinized plasma. The method can be used to measure free prostate-specific antigen ( FPSA ) concentrations over the range of 0.05 to 35 ng/ml.

Prostate-specific antigen (PSA) is a single chain glycoprotein serine protease (contains 7% w/w carbohydrate) with a molecular weight of 33 k-Da (1). It is mainly found in the cytoplasm of prostate acinar cells and ductal epithelium (2). In addition to being present in normal tissue, PSA is also present in prostatic cancerous tissue, benign hyperplastic tissue, in prostatic fluid and seminal plasma, and is therefore a useful clinical marker for prostate cancer (3, 4, 5). Two immunoreactive forms of PSA are found in serum: free and complexed PSA. The complexed form is given by the binding of alpha-1-antichymotrypsin (ACT) to the active site of PSA (6, 7). The PSA molecule which is not bound to the serine protease inhibitor ACT, named Free PSA, is found in lower concentrations than the complexed form (6, 7). Free PSA/total PSA Ratio is used in distinguishing prostate cancer (CaP) from benign hyperplasia (BPH). A number of studies have indicated the clinical utility of Free PSA in diagnosing prostate cancer in patients with Total PSA values between 2.5 and 20.0 ng/ml (8, 9, 10, 11, 12).

The free PSA assay employs technology that allows the use of a conventional IEMA methodology, whilst minimising the disturbance to the free and bound PSA equilibrium. Two key factors allow a direct measurement of free PSA. They are: (1) a monoclonal antibody with high affinity for PSA bound to FITC; and (2) a monoclonal antibody with high affinity for PSA bound to Alkaline Phosphatase.

The Eclectica assays for the Eclectica analyzers consist of:

1. Eclectica Free PSA Reagent Kit: specific reagents of Eclectica Free PSA kit to execute the test and to verify the standardization.
2. Eclectica Free PSA Calibration Kit: for standardization.
3. Eclectica Immunoassay Common Reagents Kit: for general chemistry reaction.
4. Eclectica Immunoassay Wash Solution: Wash Solution specific for Immunological reaction.
5. Eclectica Systemic Wash Solution: Wash Solution of Eclectica system.

In the Eclectica Free PSA assay, two monoclonal antibodies are used in an immunoenzymetric assay system which incorporates magnetic solid phase separation. All incubation times and reagent volumes are determined by an assay specific software protocol. Fixed amounts of fluorescein-conjugated anti-PSA monoclonal antibody and anti-PSA monoclonal antibody conjugated to alkaline phosphatase are added to a sample, control, or standard. The reactants are incubated at 37°C. During the incubation Free PSA in the sample ,control or calibrators binds to both ant-PSA antibodies forming a “sandwich”.

At the end of the incubation period anti-fluorescein coupled to a magnetic solid phase is added in excess. This rapidly and specifically binds to the Free PSA monoclonal antibody complex and is sedimented in a magnetic field.

After aspirating the liquid phase and washing the solid phase, a solution of the enzyme substrate, phenolphthalein monophosphate is added to the incubation cell and the each cell incubated at 37°C. After incubation the enzyme reaction is stopped by the addition of a stop reagent and the intensity of the color developed is measured photometrically. The intensity of the color developed is directly proportional, within the working range of the assay, to the concentration of Free PSA in the sample. The concentration of Free PSA in a patient sample or control is then determined by interpolation from a stored standard curve.

Eclectica Free PSA Reagent Kit

Eclectica Free PSA Calibration Kit

Eclectica Immunoassay Common Reagents Kit

Eclectica Immunoassay Wash Solution

Eclectica Systemic Wash Solution

1700006 Eclectica Cleaning Kit