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Recommendations when to order or not order the test. May include related or preferred tests.
Prognostication and monitoring in NSCLC.
New York DOH Approval Status
Indicates whether a test has been approved by the New York State Department of Health.
This test is New York state approved.
Specimen Required
Patient PreparationInstructions patient must follow before/during specimen collection.
CollectSpecimen type to collect. May include collection media, tubes, kits, etc.
Plain red or serum separator tube.
Specimen PreparationInstructions for specimen prep before/after collection and prior to transport.
Allow serum specimen to clot completely at room temperature. Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL)
Storage/Transport TemperaturePreferred temperatures for storage prior to and during shipping to ARUP. See Stability for additional info.
Refrigerated.
Unacceptable ConditionsCommon conditions under which a specimen will be rejected.
Plasma. Icteric, lipemic, or hemolyzed specimens.
RemarksAdditional specimen collection, transport, or test submission information.
StabilityAcceptable times/temperatures for specimens. Times include storage and transport time to ARUP.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 2 months (avoid repeated freeze/thaw cycles)
Methodology
Process(es) used to perform the test.
Quantitative Enzyme-Linked Immunosorbent Assay
Performed
Days of the week the test is performed.
Wed
Reported
Expected turnaround time for a result, beginning when ARUP has received the specimen.
1-8 days The level of CYFRA 21-1 cannot be used as absolute evidence for the presence or absence of disease.
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.
0.0-2.3 ng/mL
Interpretive Data
May include disease information, patient result explanation, recommendations, or details of testing.
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.
Compliance Category
FDA
Note
Additional information related to the test.
Hotline History
N/A
CPT Codes
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
Other names that describe the test. Synonyms.
CYFRA 21-1 (Cytokeratin 19 Fragment (CYFRA 21-1), Serum)
Soluble Cytokeratin 19 Fragment (Cytokeratin 19 Fragment (CYFRA 21-1), Serum)
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