WWHS Biotech.Inc(exclusive marketed by Dawin)
Revolutionary NIR technology, Ultra-high Sensitivity and Higher Performance in POCT
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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%.
The within and between assay coefficient of variations are within 10%.
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