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ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit

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Hangzhou Aichek Medical Technology Co.,Ltd

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ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit

Name: ISO13485 HbsAg Test Kit Uncut Sheet Hepatitis B Rapid Test Kit
Brand: Aichek
Price: 1 USD

Brand Name : Aichek

Model Number : HBS-A01

Certification : CE 13485

Place of Origin : China

MOQ : 5000 Test

Price : negotiable

Payment Terms : T/T

Supply Ability : negotiable

Packaging Details : 40box/carton

Storage : 2℃-30℃

Sample Type : b

User : Professional

Accuracy : 99.6% (97.7%-99.9%)

Certificate : CE ISO 13485

OEM : OEM customized packing avaliable

Formats : 25T/box 1T/box

After-sales Service : Available

Key words : HbsAg Rapid Test uncut sheet

For the crowd : Preliminary screening of infected people

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Infection Disease Hepatitis B HbsAg Rapid uncut sheet

Product Name	Hepatitis B HbsAg Rapid Test uncut sheet
Formats	Strip(3mm)Device(4mm) uncut sheet
Place of Origen	China
Specimen	Blood
Read Time	15 minutes
Shelf life	2 years
Package	uncut sheet
Storage	2℃-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	+	820	1	821
	EIA	-	1	2134	2135
			821	2135	2956

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.

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