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.
| Intra-assay precision |
| Control | Mean(U/mL) | SD(U/mL) | CV% |
| Level 1 | 49.64 | 1.64 | 3.30 |
| Level 2 | 368.83 | 7.15 | 4.50 |
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 | Mean(U/mL) | SD(U/mL) | CV% |
| Level 1 | 50.62 | 1.03 | 2.04 |
| Level 3 | 362.75 | 10.50 | 2.89 |
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.
| Compound | Concentration | Cross reactivity |
| CA15-3 | 600 U/mL. | 0.42 U/mL. |
| CEA | 150 ng/mL | 0.22 U/mL. |
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%.
| Expected | Mean Measuring | Recovery |
| 71.27 U/mL | 68.28 U/mL | 95.8% |
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
| Calibrator Point | Concentration U/mL | Absolute linear correlation coefficient (r) |
| F | 596.18 | |
| 1/8F | 77.82 | R=0.9984 |
| 1/16F | 37.81 |
| 1/32F | 18.87 |
| 1/64F | 9.11 |
| 1/512F | 1.41 |
Physical Examination Package:
