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WWHS Biotech INC CYFRA21-1 Colloidal Gold POCT FIA Rapid Test Kits For Human

Categories POCT Test Kit
Brand Name: WWHS
Model Number: CYFRA21--1
Certification: CE
Place of Origin: CN
MOQ: 1000
Price: Negotiable
Payment Terms: T/T
Supply Ability: 50000 Kits per Week
Delivery Time: 7 Days
Packaging Details: Colorful Paper Box
Product Name: CYFRA21-1 Rapid Test Kit
Pack Size: 25 Tests
Storage: 4-30℃
Reactivity: Human
Manufacturer: WWHS Biotech INC
Features: High Accuracy, High Sensitivity
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WWHS Biotech INC CYFRA21-1 Colloidal Gold POCT FIA Rapid Test Kits For Human

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%.

  1. Precision

The within and between assay coefficient of variations are within 10%.

  1. 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 ItemSpecimenReaction TimeMeasure RangeClinical RangeIntended Use
20AFPSerum/Plasma15min.2.5-200ng/ml<20ng/mlpregnancy cancer
21CEASerum/Plasma15min.1-200ng/ml<5ng/mlcolon cancer, colorectal cancer,etc.
22NSESerum/Plasma15min.1-400ng/ml<16ng/mlnon-small cell lung cancer
23FOBfecal specimens10min.50-1000ng/ml<100ng/mlAbnormal recessive gastrointestinal bleeding
24PG IISerum/Plasma15min.1-100ug/LPGI/PGII>3.0gastric abnormalities
25PG ISerum/Plasma15min.2.5-200ug/L>70ng/mlgastric abnormalities
26TPSASerum/Plasma15min.0.5-40ng/ml<4ng/mlprostate cancer
27FPSASerum/Plasma15min.0.1-10ng/ml<1ng/mlprostate cancer
28CA12-5Serum/Plasma15min.20-500U/ml<35U/mlovarian cancer
29CA15-3Serum/Plasma15min.10-400U/ml< 25 U/mLbreast cancer
30HE4Serum/Plasma15min.50-2000pmol/L<140 pmol/Lovarian cancer
31CA19-9Serum/Plasma15min.10-400U/ml< 27 U/mLpancreatic cancer
32β-HCGSerum/Plasma15min.5-400mIU/ml<10 mIU/mLEarly pregrancy, ectopic HCG cancer,incomplete abortion
33CK19(Cyfra21-1)Serum/Plasma15min.0.5-50ng/ml<2.5ng/mlnon-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


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