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Qualitative Hepatitis Rapid Test Kit

China Newscen Biopharm Co., Limited certification
China Newscen Biopharm Co., Limited certification
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Qualitative Hepatitis Rapid Test Kit

Qualitative Hepatitis Rapid Test Kit
Qualitative Hepatitis Rapid Test Kit Qualitative Hepatitis Rapid Test Kit Qualitative Hepatitis Rapid Test Kit Qualitative Hepatitis Rapid Test Kit

Large Image :  Qualitative 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
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:

Qualitative Hepatitis Rapid Test Kit

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Qualitative HCV 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

Simple: No Instrument Required

Reliable: high accurate, early detection of the presence of HCV

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"

 

Qualitative 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 Iine 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.

 

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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

 

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

 

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Assay Procedure

☀ Place the test cassette on flat surface. Before unseal the pouch, allow the test cassette to reach laboratory temperature(15-30°C) .Use it immediately once unsealed.

Open the pouch and add1dropor35pL of specimen into the sample well(S) .

After adding the specimen, add1dropor35pL of diluent buffer vertically into the sample well(s) immediately.

Avoid dropping specimen or diluent buffer in the observation window.

Do not allow the diluent buffer bottle touch the sample well when dropping the diluent buffer so as to prevent the cross contamination with the specimen.

Observe the result in 30 minutes once the diluent buffer added.

 

Interpretation of Results

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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.

 

Qualitative Hepatitis Rapid Test Kit 4

 

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.

 

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.

 

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Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

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