Cytokeratin 19 Fragment Antigen 21-1
CLINICAL SIGNIFICANCE
The determination of cytokeratin 19 fragment is mainly used clinically for non-small cell lung cancer (non-small cell lung cancer, NSCLC) auxiliary diagnosis, disease monitoring and prognostic evaluation. Under normal circumstances, cytokeratin 19 is undetectable or low in peripheral blood, bone marrow, and lymph nodes. However, in malignant epithelial tumors, activated proteases will accelerate the degradation of cells, causing a large amount of soluble cytokeratin 19 fragment to be released, resulting in an increase in the concentration of soluble cytokeratin 19 fragments in tissue fluid and body fluid.Therefore, cytokeratin 19 fragment (cyfra21-1) is a tumor marker of epithelial origin. The clinical application of cyfra21-1 is mostly the auxiliary diagnosis of NSCLC. It also has certain detection value in other malignant epithelial tumors such as nasopharyngeal cancer, esophageal cancer, laryngeal cancer, bladder cancer, and breast cancer.
SENSITIVITY
SENSITIVITY
When the sample concentration is 10.0ng/mL, the absorbance change should ≥ 0.0150.
PRECISION
PRECISION
a)Repeatability(N=20)
|
|
Mean(ng/mL) |
CV（%） |
|
Level1 |
8.80 |
1.66 |
|
Level 2 |
20.81 |
0.69 |
b)Intermediate precision(N=80)
|
|
Mean(ng/mL) |
CV（%） |
|
Level1 |
7.76 |
3.34 |
|
Level 2 |
23.43 |
1.44 |
LINEARITY
The linearity is [2.5, 150.0]ng/mL.
INTERFERENCES
INTERFERENCES
|
bilirubin |
up to 65 mg/dL |
|
hemoglobin |
up to 1 g/dL |
|
RF |
up to 200IU/mL |
|
Fat emulsion |
up to 0.3% |