Test Overview
Clinical Utility
Prognostication and monitoring in NSCLC. The level of CYFRA 21-1 cannot be used as absolute evidence for the presence or absence of disease.
Method
Enzyme-linked immunosorbent assay (ELISA)
Analytical Platform
Fujirebio Diagnostics
Result Included
CYFRA 21-1 (Cytokeratin 19 Fragment)
Specimen
Specimen Type
SerumVolume
Sample Volume
1 mL
Minimum Volume
0.5 mL
Specimen Comment
Gel-separator tubes are acceptable.
Collection & Handling
Handling Information
Separate serum from cells ASAP or within 2 hours of collection. Store and send frozen.
Stability
| Ambient | Refrigerated | Frozen |
|---|---|---|
| 48 hours | 14 days | 2 months |
Avoid repeated freeze/thaw cycles.
Rejection Criteria
| Criteria | Specification |
|---|---|
| Specimen | Plasma |
| Hemolysis | Present |
| Lipemia | Present |
| Other | Icteric |
Performance & Interpretation
Turnaround Time
13 days
Results
Name
Units
Reference Range
Conversion
-
CYFRA 21-1 (Cytokeratin 19 Fragment)ng/mL0.0 - 2.3
Comment
This assay is performed using the Fujirebio Diagnostics CYFRA 21-1 Enzyme Immunoassay. Results obtained with different assay methods or kits cannot be used interchangeably. Results cannot be interpreted as absolute evidence of the presence or absence of malignant disease.
Referral Location
Out-of-Country
Interface & Setup
HL7 Interface Codes
| Order Code | Result Name | Result Codes | Units |
|---|---|---|---|
| CYFR T | CYFRA21-1, Serum | 63095 | ng/mL |
Test Version
Last Updated
2019-11-20