SKT-032

Human Cytokeratin fragment 19 (CYFRA21-1) CLIA Kit

Description

Human Cytokeratin fragment 19 (CYFRA21-1)  CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Cytokeratin fragment 19 (CYFRA21-1) concentration in serum.
​​​​​​​
For in-vitro diagnostics purposes only

Background


The Human Cytokeratin fragment 19 (CYFRA21-1) CLIA Kit is designed, developed, and produced for the quantitative measurement of human CYFRA21-1level in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of CYFRA21-1.
Assay calibrators, controls, or patient serum samples are added directly to a reaction vessel together with streptavidin coated magnetic particles and biotinylated anti-CYFRA21-1polyclonal antibody. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles–biotin CYFRA21-1antibody–PRL–acridinium ester CYFRA21-1antibody”. Materials bound to the solid beads are held in a magnetic field while unbound materials are washed away. Then, trigger solutions are added to the reaction vessel and light emission is measured with the ECL100 analyzer. The relative light units (RLU) are proportional to the concentration of a CYFRA21-1in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum CYFRA21-1.

Specifications

Catalog no. SKT-032
Target Human Cytokeratin fragment 19(CYFRA21-1)
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD ≤0.050 ng/mL
Dynamic Range 0.050 ng/mL to 500.0 ng/mL
Total Incubation Time
Sample Type Serum
Sample Volume 20 µL
Storage Temperature 2-8 °C

Selected Literature


​​​​​​​1.Chen Y M, Wang L, Zhong L H, et al. Application of tumor markers in the early diagnosis of ovarian cancer (J). Current Medicine,2012; 18 (20) : 12-3.
2.Hang ZQ, Zheng MF, Huang JH. Detection and diagnostic value of serum carcinoembryonic antigen and cytokeratin 19 fragment in lung cancer patients [J]. Zhonghua Zhong Liu Za Zhi,2011,33(11) :847-849.
3.Cedrés S, Muez I, Longo M, et al. Serum tumor markers CEA,CYFRA21-1 and CA-125 are associated with worse prognosis in advanced non-small-cell lung cancer ( NSCLC) [J]. Clin Lung Cancer,2011,12(3) :172-179.

For in-vitro diagnostic use.