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

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

CYFRA21-1 Rapid Test Kit

Colloidal Gold Rapid Test Kit

POCT FIA Rapid Test Kits

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Product Details
High Accuracy, High Sensitivity
Product Name:
CYFRA21-1 Rapid Test Kit
Pack Size:
25 Tests
WWHS Biotech INC
Payment & Shipping Terms
Minimum Order Quantity
US 1.50 - 2.50 Kit
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
Supply Ability
50000 Kits per Week
Product Description

                                                 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.



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 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


WWHS Biotech INC CYFRA21-1 Colloidal Gold POCT FIA Rapid Test Kits For Human 0WWHS Biotech INC CYFRA21-1 Colloidal Gold POCT FIA Rapid Test Kits For Human 1


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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