Getein fPSA Fast Test Kit is used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect.
Intended Use
The fPSA Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of free PSA in human serum and plasma samples. It is primarily used for dynamic monitoring of patients with malignant tumors to assist in evaluating disease progression or treatment effects. It is not suitable for early diagnosis of malignant tumors or tumor screening in the general population.
This assay is intended to be used alongside the Getein total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men aged 50 years or older. This applies to patients with a digital rectal examination (DRE) that is not suspicious for prostate cancer and a Getein total PSA value between 4 ng/mL and 10 ng/mL.
About fPSA
Prostate-specific antigen (PSA) is a single-chain glycoprotein with a molecular weight of 34 kilodaltons. As a serine protease with chymotrypsin-like activity, PSA belongs to the kallikrein family. PSA exists in blood either as a free form or in a complex with protease inhibitors, such as α-1-antichymotrypsin (ACT). It is produced mainly by the glandular epithelium of the prostate and is secreted into seminal fluid at high concentrations.
Low levels of PSA are present in the blood due to leakage from the prostate gland. PSA’s function is to break down gel-forming proteins in the seminal fluid, which liquefies the seminal gel and increases sperm mobility.
PSA tests lack sufficient sensitivity and specificity to be ideal or completely diagnostic for screening or early detection because PSA is not specific to prostate cancer. Although organ-specific, PSA can be elevated in non-malignant conditions such as benign prostatic hyperplasia (BPH). Studies have shown that the percentage of free PSA (fPSA) is significantly lower in prostate cancer patients compared to those with benign conditions. The ratio of fPSA to total PSA (tPSA) improves the sensitivity and specificity of the test for patients with tPSA levels in the "gray zone" of 4-10 ng/mL.
An equimolar determination of tPSA is crucial for reliable fPSA/tPSA ratios. In patients undergoing therapy, especially hormone withdrawal therapy, the fPSA/tPSA ratio cannot be used to differentiate prostate hyperplasia from prostate cancer. Mixing tPSA and fPSA tests from different manufacturers may produce erroneous results due to differences in standardization or detection methods.
Contents
A kit for Getein 1100 contains:
Package specifications: 25 tests/box, 10 tests/box
Getein fPSA test card in a sealed pouch with desiccant
Disposable pipette
Sample diluent
User manual: 1 piece/box
SD card: 1 piece/box
A kit for Getein 1600 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 Getein 1600:
- Sample diluent: 1 bottle/box
- Box with pipette tips: 96 tips/box
- Mixing plate: 1 piece/box
Note: Do not mix or interchange different batches of kits.
Specifications
Test Item:
fPSA
Sample:
Serum, Plasma
Detection Range:
0.05-30.00 ng/mL
Storage Condition:
4-30℃
Method:
Immunofluorescence Assay
Test Time:
10 min
Cut-off Value:
1.00 ng/mL
Shelf Life:
24 months
Applicable Devices
- Getein 1100 Immunofluorescence Quantitative Analyzer
- Getein 1600 Immunofluorescence Quantitative Analyzer
Clinical Application
This test is used for dynamic monitoring of patients with malignant tumors to assist in evaluating disease progression or treatment effects.
