|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||1000|
|Price:||US 1.50-2.99 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||7 Days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||20000 Kits per Week|
|Features:||High Accuracy||Product Name:||PSA Rapid Test Kit|
|Storage:||Room Temperature||Sample Buffer:||20 Vials|
|Manufacturer:||WWHS BIOTECH INC||Type:||One Step Assay|
|Application:||Human||Usage:||Tumor Maker Detection|
|Application In:||WWHS NIR-1000 Dry Fluoroimmunoassay Analyser||Package:||20 Tests|
Prostate Specific Antigen (PSA) Rapid Quantitative Test(Fluorescence immunoassay)
This kit is used for quantitative determination of PSA in human whole blood, plasma and serum.
Human prostate-specific antigen (PSA) is a serine protease, a single chain glycoprotein with a molecular weight of approximately 34,000 daltons containing 7% carbohydrate by weight. In human serum, PSA exists in at least 3 different forms: free, alpha 1-antichymotrypsin (PSA-ACT) and alpha 2-macroglobulin (PSA-AMG). Only free PSA and PSA-ACT can be detected with available immunoassays. Elevated serum PSA concentrations have been reported in patients with prostate cancer, benign prostatic hypertrophy, prostatitis or inflammatory conditions of other adjacent genitourinary tissues. Also, increases in PSA to 4-10 ng/mL are not uncommon among men with benign prostatic hyperplasia (BPH) or prostatitis. The determination of PSA serum levels is not only important for the screening of patients for prostate cancer, but also for monitoring patients that have been treated for this disease.
The PSA Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of PSA. The PSA antigen in the sample was first bound with the conjugated compound of fluorescent labeled PSA monoclonal antibody, then moved and combined with another PSA monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescent labeled PSA monoclonal mouse antibody), nitrocellulose membrane (coated with PSA monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing|
|Sample diluent||25(300μL/tube)||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Healthy males are expected to have serum PSA values below 4ng/mL. However,as PSA levels increase with age, the use of age-specific reference ranges has been suggested in order to increase the sensitivity in younger men and increase the specificity in older men. Each laboratory must establish its own normal ranges based on the representative local population.
【Interpretation of results】
【Limitations of methods】
1. Limits of detection
No more than 0.5ng /ml.
The relative deviation from the target value is within ±15%.
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (2 ~ 100ng/ml), the linear correlation coefficient R≥0.990.
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
|WWHS Assay list|
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|21||CEA||Serum/Plasma||15min.||1-200ng/ml||<5ng/ml||colon cancer, colorectal cancer,etc.|
|22||NSE||Serum/Plasma||15min.||1-400ng/ml||<16ng/ml||non-small cell lung cancer|
|23||FOB||fecal specimens||10min.||50-1000ng/ml||<100ng/ml||Abnormal recessive gastrointestinal bleeding|
|24||PG II||Serum/Plasma||15min.||1-100ug/L||PGI/PGII>3.0||gastric abnormalities|
|25||PG I||Serum/Plasma||15min.||2.5-200ug/L||>70ng/ml||gastric abnormalities|
|29||CA15-3||Serum/Plasma||15min.||10-400U/ml||< 25 U/mL||breast cancer|
|30||HE4||Serum/Plasma||15min.||50-2000pmol/L||<140 pmol/L||ovarian cancer|
|31||CA19-9||Serum/Plasma||15min.||10-400U/ml||< 27 U/mL||pancreatic cancer|
|32||β-HCG||Serum/Plasma||15min.||5-400mIU/ml||<10 mIU/mL||Early pregrancy, ectopic HCG cancer,incomplete abortion|
|33||CK19(Cyfra21-1)||Serum/Plasma||15min.||0.5-50ng/ml||<2.5ng/ml||non-small cell lung cancer|
Contact Person: sales
Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen