Getein tPSA Fast Test Kit is used as an aid in the diagnosis and management of patients with prostate cancer.
Intended Use
The tPSA (total Prostate Specific Antigen) Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of total PSA (tPSA) in human serum and plasma.
About tPSA
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 two forms in the blood: free PSA and PSA complexed with protease inhibitors such as α-1-antichymotrypsin (ACT). Total PSA (tPSA) represents the sum of both forms.
Elevated PSA levels in serum or plasma can be found in patients with prostate cancer, benign prostatic hyperplasia (BPH), or inflamed prostatic tissue. PSA is uniquely associated with prostate tissues at different stages: normal, inflamed, or cancerous. PSA has been found in various prostate conditions including benign hyperplastic tissue, malignant prostate tissue, and metastatic prostate carcinoma, as well as in prostatic fluid and seminal fluid. However, PSA is not found in other tissues of the male body and is not produced by cancers originating in organs such as the lung, colon, rectum, stomach, pancreas, or thyroid.
PSA measurement is a key tool for assessing disease status in prostate cancer patients, particularly when serial samples are monitored over time. Monitoring tPSA concentrations in prostate cancer patients, regardless of the treatment regimen, provides clinical value for disease management.
Contents
1. For Getein1100
Package specifications: 10 tests/box, 25 tests/box
- Getein tPSA test card in a sealed pouch with desiccant
- Disposable pipette
- User Manual: 1 piece/box
- SD card/RFID card: 1 piece/box
2. For Getein1600
Package specifications: 2×24 tests/box, 2×48 tests/box
- Sealed cartridge with 24/48 Getein tPSA test cards
- User manual: 1 piece/box
Materials required for Getein1600:
- 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:
tPSA
Sample:
Serum, Plasma
Detection Range:
0.50~100.00 ng/mL
Storage Condition:
4-30℃
Method:
Immunofluorescence Assay
Test Time:
15 min
Cut-off Value:
4.0 ng/mL
Shelf Life:
24 months
Applicable Device
- Getein1100 Immunofluorescence Quantitative Analyzer
- Getein1600 Immunofluorescence Quantitative Analyzer
Clinical Application
- As an aid in the diagnosis and management of patients with prostate cancer.
- As an essential tool in assessing disease status in prostate cancer patients through serial monitoring over time.
