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ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device

  • ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device
  • ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device
  • ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device
  • ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device
ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device
Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, FDA
Model Number: HBsAg (Hepatitis B Surface Antigen) Test Kit
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:

HBsAg Antigen Rapid Diagnostic Device

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ISO HBsAg Antigen Diagnostic Device

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96% HBsAg Antigen Diagnostic Device

HBsAg (Hepatitis B Surface Antigen) Diagnostic Kit (Colloidal Gold)

For The Qualitative Detection of Hepatitis B Surface Antigen In Serum/Plasma and Whole Blood

 

Main Features

 

* High Sensitivity: > 96%

* Specificity: 100%

* Reliable: Accuracy higher than 98%, early detection of the presence of HBsAg Antigen.

* Simple: No Instrument Required

* Convenient: Room Temperature Storage Built-In Control

* 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"

 

Intended Use


The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.

 

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device 0

 

Principle


The HBsAg RDT is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with anotherr specific antibody. If HBsAg is present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence or absence of HBsAg.

 

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device 1

 

Storage


Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

 

Assay Procedure


Serum/Plasma
Add 70-100ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5-20 minutes.


Whole blood
Add 1 drop of whole blood into sample well, after all blood is completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 5-20 minutes.

 

Interpretation of Results

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device 2

Negative:

 

No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HBsAg antibody has been detected.


Positive:

 

In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HBsAg.


Invalid:

 

If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

 

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device 3

ISO 96% Sensitivity HBsAg Antigen Rapid Diagnostic Device 4

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

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