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FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit

FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit

  • FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit
  • FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit
  • FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit
  • FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit
Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, FDA
Model Number: HCV (Hepatitis C Virus)
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 400 Kits (40 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 100,000 Kits Per Day
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Detailed Product Description
Specimen: Serum, Plasma, Whole Blood Methodology: Colloidal Gold
Shelf Life: 2 Years Format: Cassette
OEM / ODM: Available Result Time: Read In 20 Minutes
High Light:

Colloidal Gold Hepatitis Rapid Test Kit

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FDA Hepatitis Rapid Test Kit

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40 Cassette Hepatitis Rapid Test Kit

HCV(Hepatitis C Virus) Antibody Rapid Test Kit
For the Qualitative Detection of HCV Antibodies in serum/plasma and whole Blood
 
Main Features
High Sensitivity
☀ High Specificity
Reliable: high accurate, early detection of the presence of HCV
Simple: No Instrument Required
Convenient: Room Temperature Storage, Built-In Control line
Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
Certified by Authoritative Certification System and Standards
Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
 
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 0


Intended Use
Newscen HCV Antibody Rapid Test is for the detection of antibodies to Hepatitis C type virus(HCV) in human serum, plasma or whole blood collected from vein or fingertip. It is intended for use in medical institutions by trained staff.
 
Principle
HCV(Core and NS 3) specific recombinant antigens are precoated on to the membrane as the capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles,which have been conjugated with HCV specific recombinant antigens. Antibodies to HCV, if present, will specifically bind to colloidal gold-antigen complex.
 
When the colloidal gold-antigen-antibody complexes move to the test zone, they will specifically bind to the precoated antigens. At the same time, a red colored I in e will develop in the test zone.
 
Absence of this red colored line in the test zone suggests a negative result. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of antibodies to HCV.
 
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 1
 
Reagents and Materials Provided
Each kit contains:
40 test cassettes(individually pouched)
Each pouch contains one cassette with one desiccant bag
One bottle of diluent buffer(5mL)
40 disposable plastic droppers
Instruction for use
 
Materials Required But Not Provided
Timer or stopwatch
Blood collection devices, for the testing of venipuncture whole blood, serum or plasma
Biohazard disposal container
Disposable gloves
 
For finger stick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 2
 
Sample Collection and Test Preparation
Finger stick Specimens(Whole Blood)
Clean the area to be lanced with an alcohol pad.
Squeeze the end of the fingertip and pierce it with a sterile lancet.
Wipe away the first drop of blood with sterile gauze or cotton;collect the sample from the second drop.
Use dropper to draw the fresh blood to 1/ 2 of the tube wall and dispense into the sample well.
 
Finger stick whole blood should be used immediately after collection.
Serum/Plasma specimens:fresh serum or plasma specimen can be used. No special patient preparation required.
 
Plasma
Collect whole blood into a collection tube(containing EDTA, Na-citrate or heparin) by venipuncture.
Separate the plasma by centrifugation.
 
Serum
Collect whole blood into a collection tube(containing no anticoagulants) by venipuncture.
Allow the blood to clot.
Separate the serum by centrifugation.
 
Avoid the use of hemolytic, turbid, microorganism contaminated specimens. Specimen should be stored at 2-8℃for 5 days or frozen at-20℃for maximum 3 months. Avoid specimen deterioration by multiple freeze-thaw cycles.
 
Venipuncture Whole Blood
Venipuncture whole blood can be used immediately after collection or store dupto4daysat 2-8℃.
 
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 3
 
Interpretation of Results
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 4
Note:'C'-Control line; T'-Test line
 
Negative: No redline appear in 30 minutes in the test zone(T), only a redline in the control zone(C) ,which indicates that the absence of HCV antibodies or the concentration of antibodies is too low(i.e., window period of infection) .
 
Positive: One redline in the control zone(C) and one redline in the test zone(T) .This indicates the specimen contains HCV antibodies.
 
Invalid: If no redlines appear, the test is invalid. Discard the test cassette and perform with new cassette.
 
Built-In Control
Newscen HCV Antibody Rapid Test has a built-in procedural control that demonstrates assay validity. A redline appeared on the control zone(C) indicates that the test runs correctly.
 
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 5
 
Warning
For invitro diagnostic use ONLY
 
Storage
Newscen HCV Antibody Rapid Test should be stored at 4-30°C(do not freeze) for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible(within 1hour) to avoid test cassette from becoming moist. Do not use the test beyond the indicated expiration date.
 
The diluent buffer should be stored at 4-30°C(do not freeze) for 24 months from the date of manufacture. After the diluent is opened, it will be stored for 24 months according to the validity period.
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 6
FDA 40 Cassette Colloidal Gold Hepatitis Rapid Test Kit 7

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)