Getein Fpsa Fast Test Kit/Tumor Markers Test Reagent

• Type: IVD Reagent
• Test Item: Fpsa Fast Test Kit
• Sample: Serum/Plasma
• Certificate: CE, Nmpa
• Method: Immunofluorescence Assay
• Manufacturer: Independent R&D
• Model NO.: fPSA Fast Test Kit
• Storage Condition: 4-30 ºC
• Delivery Detail: Depend on Quantity
• Place of Origin: Nanjing,Jiangsu,China
• Nanjing,Jiangsu,China: Carton Box
• Transport Package: Carton Box
• Specification: 25 Tests/Kit
• Trademark: Getein
• Origin: China
• Production Capacity: 5000000

Product Description

 

Product Description

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.
specifications

Product Name	Sample	Test Time	Storage Condition	Shelf Life
fPSA Fast Test Kit	Serum/Plasma	10 min	4-30ºC (test cards)	24 months
Test Item	Detection Range	Method	Cut-off Value	Certificate
fPSA	0.05-30.00 ng/mL	Immunofluorescence Assay	1.00 ng/mL	CE

contents
Clinical Application:
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.
Applicable Device
Operation

Company Profile

Getein Biotech, Inc(stockcode:603387), established in 2002, is a fully integrated into vitro diagnostic company that researches and develops manufactures, markets, and distributes a broad range of innovative diagnostic test kits in point-of-care testing(POCT).In July 2017Getein Biotech got listed on the main board of the Shanghai Stock Exchange.
With the great contribution of our advanced R&D center and 19-year continuous developmentGetein Biotech has developed 8 technology platforms including Point-of-Care Testing(POCT), clinical chemistry, and chemicals
luminescence. hematology coagulation urinalysis. molecular diagnostics and raw materials for diagnostic reagents, covering fields of cardiovascular disease kidney injury diabetes mellitus gestation infectious disease cancer, etc.
 

Certifications

 

 

EXHIBITIONS

 

 

FAQ

 

1. Q: Are you a trading company or manufacturer?
A: We are a manufacturer established in 2002.

2. Q: what can you buy from us?
A: IVD products, POCT equipment and reagents, Hematology equipment and reagents, chemiluminescence equipment and reagents, biochemistry equipment, etc.

3. Q: Do you provide samples? Is it free or extra?
A: Yes, if you buy equipment we could offer a sample test for free charge but do not pay the cost of freight.

4. Q: What are your terms of payment?
A: 100% T/T in advance

5. Q: What is your warranty?
A: For most products the warranty is for 12 months, for some products we provide 18 months warranty.

6. How to ship the product?
A: The shipping way normally depends on your quantity, total CBM, and weight.
We have our own shipping company to provide the best shipping cost and the most efficient way.