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.
| Intra-assay precision |
| Control | Mean(U/mL) | SD(U/mL) | CV% |
| Level 1 | 20.40 | 0.44 | 2.17% |
| Level 2 | 73.51 | 1.67 | 2.28% |
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.
| Inter-assay precision |
Control Level 1 | Mean(U/mL) 19.99 | SD(U/mL) 1.05 | CV% 5.24% |
| Level 2 | 78.86 | 5.12 | 6.49% |
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.
| Compound | Concentration | Cross reactivity |
CEA CA19-9 | 150 ng/mL 400 U/mL | 0.12 U/mL 0.41 U/mL |
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%.
| Sample | Mean Measuring | Fortified Recovery |
| 10A+90B | 21.74 U/mL | 91.0% |
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.
| Calibrator Point | Concentration U/mL | Absolute linear correlation coefficient (r) |
| F | 139.62 | |
| 1/8F | 16.49 |
R= 0.9999
|
| 1/16F | 9.80 |
| 1/32F | 5.33 |
| 1/64F | 2.93 |
| 1/128F | 1.12 |
