Professional Manufacturer of Rapid Test Devices

About Us
Factory Tour
Quality Control
Contact Us
Home ProductsHepatitis Rapid Test Kit

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit

  • In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit
  • In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit
  • In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit
  • In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit
In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit
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
Contact Now
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:

In Vitro Diagnostic Hepatitis Test Kit

,

100% Hepatitis Rapid Test Cassette

,

FDA Hepatitis Rapid Test kit

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


1. High Sensitivity: > 96%


2. Specificity: 100%


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


4. Simple: No Instrument Required


5. Convenient: Room Temperature Storage Built-In Control


6. Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes


7. Certified by Authoritative Certification System and Standards


8. Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"


In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 0


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.

 
Reagents and Materials Provided


1. One sealed pouched cassette with desiccant and a disposable pipette..
2. Blood diluent in a dropper bottle. Store at 2-8℃
3. One piece of operating instruction with 40 test pouches.
 
Sample Collection and Preparation


Whole Blood ( Fingerstick Specimens)


Clean the area to be lanced with an alcohol swab.


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;  Use micropipette to obtain about 100ul fresh blood.

 

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 1


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
In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 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.

 

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 3

 
Warning and Precautions


FOR IN VITRO DIAGNOSTIC USES ONLY; All patient samples should be treated as if capable of transmitting diseases; Do not interchange reagents from different lots or use test kit beyond expiration date;  Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
 
Storage


The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 4

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit 5

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)