ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit

Brand Name:Aichek
Certification:CE 13485
Model Number:HBS-A01
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location: Hangzhou Zhejiang China
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Supplier`s last login times: within 41 hours
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Product Details

Infection Disease Hepatitis B HbsAg Rapid uncut sheet

Product Name

Hepatitis B HbsAg Rapid Test uncut sheet

FormatsStrip(3mm)Device(4mm) uncut sheet
Place of OrigenChina
SpecimenBlood
Read Time15 minutes
Shelf life2 years
Packageuncut sheet
Storage2℃-30℃


For professional in vitro diagnostic use only

INTENDED USE

The HBsAg Rapid Test Strip (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.


PERFORMANCE CHARACTERISTICS

Table: HBsAg Rapid Test vs. EIA

Relative Sensitivity: 99.9% (99.3%-100.0%)*

Relative Specificity: >99.9% (99.7%-100.0%)*

Overall Agreement: 99.9% (99.8%-99.9%)*

*95% Confidence Interval

HBsAg Rapid Test
+-Total
EIA+8201821
-121342135
82121352956

PRINCIPLE

The HBsAg Rapid Test Strip (Serum/Plasma) has been designed to detect the HBsAg through visual interpretation of color development in the strip. The membrane was immobilized with anti-HBsAg antibodies on the test region. During the test, the specimen is allowed to react with colored anti-HBsAg antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HBsAg in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

China ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit supplier

ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit

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