CE ISO H. Pylori Antibody Serum Plasma Sample Rapid Test

• Type: IVD Reagent
• Certificate: ISO, CE
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Serum Plasma
• Result Time: Within 15 Mins
• Model NO.: HP-DP02
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 40test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

 

Intended Use

The H. pylori Antibody Rapid Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgM and IgG antibodies to Helicobacter pylori in human serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.

Introduction

Gastritis and peptic ulcers are among the most common human diseases. Since the discovery of H. pylori (Warren & Marshall, 1983), many reports have suggested that this organism is one of the major causes of ulcer diseases (Anderson & Nielsen, 1983; Hunt & Mohamed, 1995; Lambert et al, 1995). Although the exact role of H. pylori is not yet fully understood, eradication of H. pylori has been associated with the elimination of ulcer diseases. The human serological responses to infection with H. pylori have been demonstrated (Varia & Holton, 1989; Evans et al, 1989). The detection of IgG antibodies specific to H. pylori has been shown to be an accurate method for detecting H. pylori infection in symptomatic patients. H. pylori may colonize some asymptomatic people. A serological test may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.

Contents

• Rapid test cassette with desiccant    
• Pipette
• Package insert  

Storage & Statibility

•  Store at 2 ~ 30 º C in the sealed pouch for 24 months.
•  Keep away from direct sunlight, moisture and heat.
•  DO NOT FREEZE.

Sample Collection

• The H. pylori Antibody Rapid Test is intended for use with human serum, or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
 

Operation

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 2 drops of serum or plasma to the specimen well (S) with the provided disposable pipette, then start the timer.Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the result area in the center of the device.
3. Wait for the colored band(s) to appear. The result should be read within 10-15 minutes. Do not interpret the result after 10 minutes.

 

Detailed Photos

 

Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period of Corona, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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