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