tPSA Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

tPSA (total Prostate Specific Antigen) Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of tPSA in human serum and plasma.

About tPSA

Prostate-specific antigen (PSA) is a single-chain glycoprotein with molecular weight of 34 kilodaltons. As a serine prostate 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. Total PSA represents the sum of both free and complex forms.

Elevated PSA in serum or plasma is found in patients with prostate cancer, benign prostatic hypertrophy, or inflammatory tissues. PSA is uniquely associated with prostate tissues from normal, inflamed or cancerous stages. PSA has been found in normal, benign hyperplastic, malignant prostatic tissue, metastatic prostatic carcinoma and also in prostatic fluid as well as in seminal fluid. PSA is not found in any other tissues in men, and it is not produced by cancers

originating in the lung, colon, rectum, stomach, pancreas or thyroid. PSA measurement is an essential tool in assessing the status of disease in patients with prostate cancer when serial samples are measured over time. The clinical value realized by monitoring tPSA concentration in patients with prostate cancer regardless of the treatment regimen is well known.

Contents

1. For Getein1100

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

1) Getein tPSAtest card in a sealed pouch with desiccant.

2) Disposable pipet

3) User Manual:1 piece/box

4) 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:

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

1. As an aid in the diagnosis and management of patients with prostate cancer.

2. As an essential tool in assessing the status of disease in patients with prostate cancer when serial samples are measured over time.