Microprofit fluorecare® Cyfra21-1 test kit is based on immunofluorescence assay (FIA) for quantitative detection of cytokeratin 19 fragment. Fast, accurate and ideal for POCT and laboratory use.
The fluorecare® Cyfra21-1 Test Kit (Cytokeratin 19 Fragment) developed by Microprofit is a quantitative immunofluorescence assay (FIA) designed for the accurate detection of Cyfra21-1 levels in human serum and plasma. As part of the fluorecare® POCT diagnostic platform, this test kit enables rapid and reliable quantitative analysis, supporting efficient clinical decision-making in laboratories, hospitals, and point-of-care testing environments.
The fluorecare® Cyfra21-1 test kit utilizes fluorescence immunochromatographic assay technology based on a double-antibody sandwich method. Cyfra21-1 in the sample binds with fluorescent-labeled antibodies to form antigen-antibody complexes, which are captured on the test line. The fluorescence signal is positively correlated with the Cyfra21-1 concentration and is detected and analyzed by the fluorecare® immunofluorescence analyzer, enabling accurate and quantitative measurement.
• Monitoring of non-small cell lung cancer (NSCLC)
• Auxiliary assessment of squamous cell carcinoma
• Evaluation of treatment response and tumor recurrence
• Support for prognosis in lung and bladder cancers
• Clinical laboratory and decentralized POCT testing
Q: What is the fluorecare® Cyfra21-1 test kit used for?
A: The fluorecare® Cyfra21-1 test kit is used for quantitative detection of cytokeratin 19 fragment as a tumor marker, mainly for monitoring non-small cell lung cancer and squamous cell carcinoma.
Q: How fast is the fluorecare® Cyfra21-1 test?
A: The test provides accurate results within 15 minutes using the fluorecare® immunofluorescence analyzer.
Q: What samples can be used for this test?
A: Serum and plasma samples are suitable for testing with the fluorecare® Cyfra21-1 test kit.
Q: Is the fluorecare® Cyfra21-1 test suitable for POCT use?
A: Yes, it is specifically designed for point-of-care testing environments.
The fluorecare® Cyfra21-1 test kit is specifically designed to work with the fluorecare® immunofluorescence analyzer, providing fast, accurate, and quantitative results. This integrated POCT solution ensures efficient workflow and reliable performance for laboratories, clinics, and decentralized healthcare settings.
• Quantitative detection based on immunofluorescence assay (FIA)
• Rapid results within 15 minutes
• High sensitivity and specificity
• Seamless integration with fluorecare® POCT platform
• Stable performance with internal calibration
• User-friendly operation with minimal training required
• Suitable for laboratory and point-of-care testing scenarios

REF | MF-07 | |
Product Name | Cytokeratin 19 Fragment(Cyfra21-1)Diagnostic Kit | |
Method | Immunochromatographic assay | |
Qualification | CE | |
Testing content | Cytokeratin 19 Fragment(Cyfra21-1) | |
Sample Type | Serum、plasma | |
Sample Volume(uL) | 70μL | |
Working Range | 1-300ng/mL | |
Reaction Time (min) | 15 | |
Storage Temperature | 2-8℃ | |
Shelf Life | 24 months | |
Applied Instrument | fluorecare® MF-T1000 Dry-type Immunofluorescence Quantitative Analyzer | |
Specification | 20 tests/kit | 25 tests/kit |
Size(L*W*H)mm/Kit | 145*115*75 | 205*138*83 |
Weight(kg)/Kit | 0.280 | 0.337 |
Kit components | Test Card:20 Cassettes Diluent:20 tubes ID Chip:1 Piece Instruction:1 Copy | Test Card:25 Cassettes Diluent:25 tubes ID Chip:1 Piece Instruction:1 Copy |