CYFRA21-1 Colloidal Gold POCT FIA Rapid Test Kit CE Approved IVD
Assay
Soluble forms of keratins in human sera seem to be useful analytes
for the monitoring of cancer patients. CYFRA 21-1 is a new test
measuring keratin 19 in human blood. The test was developed as
sandwich ELISA based on two monoclonal antibodies, both reacting
with keratin 19. The epitopes recognised
WWHS FIA Strip (not enzyme-linked immunosorbent assay) is a widely
used application for detecting and quantifying proteins and
antigens from various samples. Target-specific FIA POCT kits are
available from a variety of manufacturers and can help streamline
your immunodetection experiments.
【Test Method】
1. Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
2. Start NIR-1000 dry fluoroimmunoassay analyzer and correctly
select the corresponding sample type on the instrument.
3. Take out the ID card, make sure that the batch number of the ID
card is consistent with that of the test card, and insert the ID
card into the ID card port of the instrument.
4. Take out the test card from the aluminum foil bag and use it
within 15 minutes.
5. Place the test card on a clean horizontal table and mark it
horizontally.
6. Mix 100 µL of patient sample with 300µL of sample diluent. Apply
100 µL of diluted samples to the well of the test card.
7. At 10 minutes after addition of samples, insert the test card
into NIR-1000 dry fluoroimmunoassay analyzer and click the “Instant
test” button to read the results.
【Performance】
1. Limits of detection
No higher than 1ng/mL
2. Accuracy
The relative deviation to the target value is limited to ±15.0%.
- Precision
The within and between assay coefficient of variations are within
10%.
- Linear range
Within the linear range (1.00~ 100.00) ng/mL, the linear
correlation coefficient R≥0.990.
| Assay list | | | | | |
| Tumor Marker | | | | | |
| cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
| 20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
| 21 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
| 22 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
| 23 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
| 24 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
| 25 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
| 26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
| 27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
| 28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
| 29 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
| 30 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
| 31 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
| 32 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
| 33 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
About NIR-1000 Dry Fluoroimmunoassay Analyser
It is a fluorescence immunochromatographic analysing system with
internal temperature control,
which can help diagnose conditions such as infection, diabetes,
cardiovascular diseases, renal injury and cancers, etc.
Immunofluorescence technology
Testing time less than 15 minutes
Easy-to-use touch-screen platform,multi-language system
Reagents stored at room temperature for 12 months
Smarter Operation
1. High Quality: Imported Major Components with Advanced German
Technology
2.User-Friendly Design: 7 Inch touch screen, great touch feeling,
simple graphic interface
3. Built-In Lithium Battery: High Mobility for first
aid&amulance
4. Two Test Mode: Internal&External mode for different clinical
needs
5. Smart Report: Auto Printing
6. Visual Results: Able to connect with LIH/HIS
