Tumor Marker CA50 Carbohydrate Antigen 50 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 50 (CA50) in human serum.

The method can be used for samples over the range of 1.0~140.0 U/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

Test the CA50 zero standard 20 times Calculate the mean value (M)and standard deviation(SD) of the RLU and get the value of M+2SD. Then correspond it into the simple equation got by regression fitting from Calibrator A and Calibrator B.The sensitivity is typically less than 1.0 U/mL.

3) Specificity

The specificity of the CA50 assay system was assessed by measuring the apparent response of the assay to various potentially cross reactive analytes.

4) Accuracy (Fortified Recovery)

Use 10 μL CA50 sample A in concentration of 100U/mL(permitted deviation ±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 CA50 calibrator F by the ratio of 1/8, 1/16, 1/32, 1/64, 1/128. 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.