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Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit
Predicator of Gastric Cancer
This kit is intended for use in the qualitative detection of Helicobacter pylori (H. pylori) nucleic acid DNA and mutation sites related to Clarithromycin and Quinolones resistance from human gastric mucosal biopsy specimens.
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Introduction
Product Features
Specification
Q&A
Introduction

Helicobacter pylori infection is a common worldwide infection, and about 50% of the world's population were infected with H. pylori. H. pylori is an important cause of gastrointestinal digestive system-related diseases, such as chronic gastritis, stomach ulcers, duodenum ulcers and gastric cancer etc.

 

Currently, the treatment regimen for H. pylori in clinical is triple or quadruple therapy consisting of antibiotics and PPI. The overuse and misuse of antibiotics have led to H. pylori resistance to antibiotics; therefore, the detection of H. pylori and its resistance is important for guiding of clinical treatments of H. pylori Infection.


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Product Features
Specification
Product Name
Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit
Package Specification
10 Tests/Box | 50 Tests/Box
Storage Condition

The shelf life of this kit is 12 months when stored in freezer at -(20±5) °C. 

Performance

1. Limit of detection: When the sample concentration is too low (≤10copies/μL ),100% positive results cannot be reached in every test within 20 repeated amplification.

 

2. Precision: The within-run precision CV is ≤5%; The between-run precision CV is ≤5%.

 

3. Analytical Specificity

  • Cross-Reactivity: There are no cross-reactivities with the other pathogenic microorganisms in the gastrointestinal tract such as: Bacillus cereus, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus  pneumoniae, Plesiomonas shigelloides, Haemophilus influenzae, Vibrio parahaemolyticus, Salmonella, Pseudomonas aeruginosa, Meningococcus, Mycobacterium tuberculosis, Escherichia coli, etc.

  • Interference substances: When common interfering substances, such as the blood concentration reach to 3%, there is no effect on sample test results. 

  • Medication effects: When the test sample contains drugs at the following concentration, it will not affect the test results of the samples: Amoxicillin  0.75mg.L-1;  Clarithromycin  0.29mg.L-1;  Levofloxacin  1.62mg.L-1;  Omeprazole  0.4mg.L-1;  Bismuth  Potassium  Citrate 67.85mg.L-1


4. Limit of detection of mutation: When H. pylori DNA concentration is 1pg/μL, the mutant abundances is ≥0.1%, the resistant strain can be identified by using this kit; When H. pylori DNA concentration is 0.001pg/μL, the mutant abundances is ≥50%, the resistant strain can be identified by using this test.


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