Intended use
This device is intended to be used for the in vitro quantitative determination of fragments of cytokeratin 19 (CYFRA21-1) in human serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.
Summary
Cytokeratins are structural proteins forming the subunits of epithelial intermediary filaments. Twenty different cytokeratins have so far been identified, CYFRA 21‑1 which is a fragment of cytokeratin 19, being the most prominent one. Intact cytokeratin polypeptides are poorly soluble, but soluble fragments like CYFRA 21‑1, are frequently released into the blood of cancer patients and can be detected in serum. Although being expressed in different organs, its major occurrence is in the lung. CYFRA 21‑1 can be considered as the biomarker of choice for non-small cell lung cancer (primarily for squamous cell and large cell carcinoma
subtypes). In adenocarcinoma of the lung, a combination of CYFRA 21‑1 and Carcinoembryonic antigen (CEA) has been found to be the most useful. The main indication for CYFRA 21‑1 is monitoring the course of NSCLC. Successful therapy is accompanied by a rapid decrease of serum levels to the normal range.
Increased CYFRA 21‑1 levels have also been described in non-malignant diseases (i.e. pneumonia, sepsis) and renal dysfunction. 14 Therefore evaluation of renal function (i.e. by measuring serum creatinine levels) should be considered in cases of high CYFRA 21‑1 levels that are not consistent with the diagnostic and clinical characteristics of the patient.
With the use of two specific monoclonal antibodies (KS 19.1 and
BM 19.21), the Elecsys CYFRA 21‑1 assay measures a fragment of cytokeratin 19 having a molecular weight of approximately 30000 Da.
The current clinical methods for detecting CYFRA21-1 include chemiluminescence, immunochromatography and so on.
PRODUCT PARAMETER
TEST INFORMATION | |||
Method | Microfluidic Fluorescent Immunoassay | Test | LYOFIA® CYFRA21-1 |
Format | Cassette | Reaction Time | 10min |
Linearity | [0.5,400] pg/mL | Reference Interval | ＜2.37ng/mL |
Sample | S / P | Certificate | CE |
ORDERING | |||||
Cat. No. | LMTMCY25 | Applicable analyzer | LYOFIA-I, LYOFIA 8, | Kit Size | 25T |
Cat. No. | LATMCY25 | Applicable analyzer | LYOFIA 100 (Full-Automatic) | Kit Size | 25T |
APPLICATION SCENARIOS
Hospitals
Laboratory
Clinics
Ambulance
Cardiology
Pediatrics
Emergency
CSC
FAQ
Q: Is it possible to add emergency testing to our instrument in the middle of the testing process?
A: LYOFIA 100, DISKFLU 1000, these two instruments can achieve.
This question is placed under LYOFIA 100, DISKFLU 1000, these two products.
Q: Does whole blood sample hemolysis, lipidemia, or fibrin, etc., have any effect on the product?
A: There will be an impact, so be careful.
Q: What is our product testing time?
A: There are 5-15 minutes, CRP is 5 minutes, and most others are 10 minutes.
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