Tumor Marker CA125 Carbohydrate Antigen 125 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box

Tumor Marker CA125 Carbohydrate Antigen 125 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box

INTENDED USE

The kit has been designed for the quantitative determination of Cancer Antigen 125 in human serum.

The method can be used for samples over the range of 1.0-600.0U/mL.

The test has to be performed on the CIA fully auto analyzer (Including CIA 600, CIA 1200, CIA 1800, CIA2800)

PERFORMANCE CHARACTERISTICS

1) Precision

Intra-assay coefficient of variation was evaluated on testing Control 1 and Control 2 10 times each of 3 different batches in the same assay, then calculate the average and get the coefficient of variation.

Inter-assay coefficient of variation was evaluated on three batches of kit. Repeatedly measured same level of control serum 10 times for each batch, calculating the coefficient of variation.

2) Analytical Sensitivity

The sensitivity is defined as the concentration of CA125 equivalent to the mean RLU of 20 replicates of the zero standard plus two standard deviations corresponding to the concentration from the standard curve. The sensitivity is typically less than 1.0 U/mL.

3) Specificity

The specificity of the CA125 assay system was assessed by measuring the apparent response of the assay to various potentially cross reactive analytes.

4) Recovery

Use 10 μL CA125 sample A in concentration of 100U/mL(allowing its concentration deviation of ±20%) add to 90 μL sample B which could be serum or other appropriate substrate.Test the diluted sample 3 times. Calculate the average concentration. The accuracy should be within 85%-115%.

5) Linearity

Dilute CA125 calibrator F by the ratio of 1/8, 1/16, 1/32, 1/64, 1/512. measuring all points’ RLU 3 times and calculate the mean value, and then do linear fitting by least square method. The absolute linear correlation coefficient(r) should be bigger than 0.9900

Physical Examination Package:

Zecen Biotech CO., LTD., founded in 2011, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents. Zecen focus on the Chemiluminescent immunoassay (CLIA) field. With all products CE marked, our market presence currently spreads from across China to other countries including India, Switzerland, Russia etc., Zecen is expanding its footprint to become a global brand.

Zecen is the only enterprise with independent intellectual property rights in the entire chemiluminescence industry chain in China, including reagent, instrument, magnetic microbead, and reagent raw material. Our current products include more than 100 assays, from thyroid, inflammation, diabetes, tumer markers, immune disorders, hormones to cardiac markers. Our ever-expanding test menu helps our customers and collaborators keep up with the demands of healthcare sector. Zecen is striving for innovation and perfection to deliver the best products to the customers.

As a manufacturer, Zecen provide the OEM, ODM and other customized service of all products. We have the core R&D centers and innovative ability to lay a solid foundation for developing the broadest range of CLIA analyzers and test menu. High-quality sales and after-sales links provide the more intimate service. The patent and CE certification give us the confident sending all over the world, and more than 50 companys in the requiement of customized and have a long term coorperation with Zecen.