Helicobacter Pylori antibdy Hp-Ab uncut sheet

Short Description:

Helicobacter Pylori antibody Hp-Ab uncut sheet

Methodology: Colloidal Gold

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

Send email to us

Product Detail

Product Tags

1. INTEDED USE

The H. pylori Antibody Rapid Test Device (the “uncut sheet” format for manufacturing use) is intended for the qualitative detection of antibodies (IgG) to Helicobacter pylori in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of H. pylori infection in patients presenting with clinical signs and symptoms suggestive of gastroduodenal disorders such as active chronic gastritis, gastric ulcer, or duodenal ulcer.

The device provides presumptive (preliminary) screening test results ,results obtained shall be used in combination with other clinical information for analysis.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.

2. PRODUCT SPECIFICATION

Model No.	HP-AB Uncut sheet
Methodology	Colloidal Gold
Sample Type	Serum,plasma,whole blood
Time to Result	10-15mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485, CE Certificate, UCKA MHRA Certificate

Feature

• High sensitive

• result reading in 15-20 minutes

• Easy operation

• High Accuracy

PACKING

* 20 bags /CTN

* Aluminum foil bag labeling

* shrink wrap

3.TEST METHOD

1	Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in sample marking.
2	In case of serum and plasma sample, add 2 drops to the well, and then add 2 drops of sample diluent dropwise. In case of whole blood sample, add 3 drops to the well, and then add 2 drops of sample diluent dropwise.
3	Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation).