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H Pylori Antibody Test Uncut Sheet Rapid Test For Infection Disease

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Hangzhou Aichek Medical Technology Co.,Ltd

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H Pylori Antibody Test Uncut Sheet Rapid Test For Infection Disease

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Brand Name :	Aichek
Model Number :	HP-A01
Certification :	CE
Price :	negotiable
Payment Terms :	T/T
Supply Ability :	negotiable

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H Pylori Antibody Test Uncut Sheet Rapid Test For Infection Disease

Infection Disease H.Pylori antibody uncut sheet

Product Name	Infection Disease H.Pylori antibody 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 H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.Pylori in whole blood, serum or plasma to aid in the diagnosis of H.Pylori infection.

PERFORMANCE CHARACTERISTICS

Table: H. pylori Rapid Test vs. Biopsy/Histology/RUT

Relative Sensitivity: >95.0% (90.0%-97.9%)* Relative Specificity: >95.7% (92.3%-97.9%)* Overall Agreement: >95.4% (92.8%-97.3%)* *95% Confidence Interval			H.Pylori Rapid Test
			+	-	Total
	Biopsy/ Histology/ RUT	+	131	7	138
	Biopsy/ Histology/ RUT	-	10	225	235
			141	232	373

The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a qualitative membrane device based immunoassay for the detection of H.Pylori antibodies in whole blood, serum, or plasma. In this test, specimen or specimen followed by buffer is added to the specimen well of the test device. The specimen migrates chromatographically along the length of the test strip contained within the device and interacts with the reagents on the strip. If the specimen contains H.Pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H.Pylori antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

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