CYFRA 21-1 ELISA Kit

Sample

serum or plasma (heparin- or citrate plasma)

Species Reactivity

Human

Detection Method

sELISA

Intended Use

The CYFRA 21-1 ELISA is an enzyme immunoassay for the quantitative measurement of CYFRA 21-1 in serum or plasma (heparin- or citrate plasma).

Contents of Kit

1. MTP Microtiter Plate ,
12 x 8 (break apart) strips, 96 wells; Wells coated with anti-CYFRA 21-1 antibody (monoclonal).
2. CAL 0-4 LYO Standard (Standard 0 - 4),
5 vials, 1 mL each, lyophilized;
Concentrations: 0 - 3 - 10 - 25 - 50 ng/mL
See "Reagent Preparation". Contain non-mercury preservative.
3. CONTROL LOW LYO & CONTROL HIGH LYO Control Low & High,
2 vials, 1 mL each, lyophilized;
For control values and ranges please refer to vial label or QC-Datasheet.
See "Reagent Preparation". Contain non-mercury preservative.
4. SAMPLEDIL Sample Diluent,
1 vial, 3 mL, ready to use; Contains non-mercury preservative.
5. ASSAYBUF Assay Buffer,
1 vial, 7 mL, ready to use; Contains non-mercury preservative.
6. ENZCONJ Enzyme Conjugate,
1 vial, 1.2 mL, ready to use, Anti-CYFRA 21-1 antibody conjugated with horseradish peroxidase;
Contains non-mercury preservative.
7. TMB SUBS TMB Substrate Solution,
1 vial, 14 mL, ready to use; Tetramethylbenzidine (TMB).
8. STOP Stop Solution,
1 vial, 14 mL, ready to use; Contains 0.5 M H₂SO₄,
Avoid contact with the stop solution. It may cause skin irritations and burns.
9. WASH CONC Wash Solution,
1 vial, 30 mL (40X concentrated); See "Reagent Preparation".
Note: Additional Sample Diluent for sample dilution is available upon request.

Storage

When stored at 2°C to 8°C unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
Opened reagents must be stored at 2°C to 8°C. Microtiter wells must be stored at 2°C to 8°C. Once the foil bag has been opened, care should be taken to close it tightly again. Opened kits retain activity for 8 weeks if stored as described above.

Detection Range

The range of the assay is between 0.079 ng/mL - 50 ng/mL.

Sensitivity

The Limit of Blank (LoB) is 0.079 ng/mL.
The Limit of Detection (LoD) is 0.185 ng/mL.
The Limit of Quantification (LoQ) is 0.343 ng/mL.

General Description

Cytokeratins are epithelial markers whose expression is not lost during malignant transformation. CYFRA 21-1 is a cytokeratin-19 fragment that is soluble in serum and can be used as circulating tumor marker. Although expressed in all body tissues, its major occurrence is in the lung, particularly in lung cancer tissues. CYFRA 21-1 is a sensitive and specific tumor marker of non-small-cell lung cancer (NSCLC), especially of squamous cell subtype (1,2,3). It also reflects the extent of the disease and has an independent prognostic role along with performance status and disease stage in NSCLC (4,5,6). In addition, detection of serum CYFRA 21-1 allows for identification of high risk patients that may benefit from adjuvant chemotherapy (7), and enables the early detection of progressive disease in recurrent NSCLC (8). Additionally, CYFRA 21-1 has been described as a useful marker for esophageal squamous cell carcinoma (9) and for therapy monitoring of bladder cancer (10). The CYFRA 21-1 ELISA uses the two mouse monoclonal antibodies KS19.1 and BM19.21 to determine cytokeratin-19 fragments.

Standard Curve

The following data is for demonstration only and cannot be used in place of data generations at the time of assay.