fPSA Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

fPSA Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of free PSA in human serum and plasma samples. It is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect. It cannot be used as a basis for early diagnosis of malignant tumors, and is not suitable for tumor screening in the general population.

This assay is intended to be used in conjunction with the Getein total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and the Getein total PSA value between 4 ng/mL and 10 ng/mL.

About fPSA

Prostate-specific antigen (PSA) is a single-chain glycoprotein with molecular weight of 34 kilodaltons. As a serine protease with chymotrypsin-like activity, PSA belongs to the kallikrein family. PSA exists as a free or complex form with protease inhibitors such as α-1-antichymotrypsin (ACT) in blood. PSA is produced mainly by the glandular epithelium of the prostate and is secreted into the seminal fluid in high concentrations.

Low levels of PSA are found in the blood as a result of leakage of PSA from the prostate gland. The function of PSA is the proteolytic cleavage of gel forming proteins in the seminal fluid resulting in liquification of the seminal gel and increased sperm mobility. 

PSA tests lack sufficient sensitivity and specificity to be considered ideal or absolutely diagnostic for screening or early detection because PSA is not specific for prostate cancer. PSA is organ specific, but has long been known to be elevated in non-malignant conditions such as benign prostatic hyperplasia (BPH). A number of studies have found that the percent of free PSA was significantly lower in patients having prostate cancer than those with benign disease or normal controls. The ratio fPSA/tPSA has subsequently been demonstrated to improve the sensitivity and specificity in patients with tPSA values in the ‘’gray zone’’ of 4-10 ng/mL.

An equimolar tPSA determination is the prerequisite for reliable ratios. In patients receiving therapy, particularly hormone withdrawal therapy, the fPSA/tPSA ratio cannot be utilized to differentiate prostate hyperplasia from cancer of the prostate. Combining tests from different manufacturers to determine tPSA and fPSA can produce erroneous values, since total PSA tests may be standardized by differing methods or detect free PSA to differing degrees.

Contents

1. A kit for Getein1100 contains:

Package specifications: 25 tests/box, 10 tests/box

1) Getein fPSA test card in a sealed pouch with desiccant

2) Disposable pipet

3) Sample diluent

4) User manual: 1 piece/box

5) SD card: 1 piece/box

2. A kit for Getein1600 contains:

Package specifications: 2×24 tests/kit, 2×48 tests/kit

Sealed cartridge with 24/48 Getein fPSA test cards

User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

Note: Do not mix or interchange different batches of kits.

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Clinical Application

This test can be used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect.