Pertussis bacteria nucleic acid detection kit (PCR-fluorescent probe method)
Clinical background
Pertussis is a bacterial respiratory infection caused by Bordetella pertussis infection. People of all ages are susceptible to it, but infants and children are more seriously ill than adults after infection. According to the World Health Organization (WHO) statistical report, in 2013, whooping cough caused the death of nearly 63,000 infants and children under 5 years of age. In recent years, the infection of whooping cough in China has been on the rise, and even broke out in some areas. According to the clinical big data analysis carried out by our company, the high incidence season of whooping cough is generally from March to September, and the incidence rate can reach more than 30%.
Whooping cough reappears globally, and small babies are critical, and accurate diagnosis has been put on higher demands in the new era!
Clinical manifestations
Pertussis is clinically divided into three stages: the incubation period, the spasm period, and the recovery period; the
epidemic season has paroxysmal spasm cough or vomiting after cough, and the severe cases have subconjunctival hemorrhage or tongue ulcer.
Neonate or infant There are unexplained episodes of bruising or suffocation, which are mostly typical spasms.
Persistent cough, accompanied by chicken cries, and increased lymphocytes in the peripheral blood.
Complications of B. pertussis infection
Respiratory diseases: bronchial pneumonia; bronchiectasis; pneumothorax; diaphragmatic hernia, etc.
Central diseases: Pertussis encephalopathy
Others: otitis media; bleeding; hernia etc.....
Features
Based on real-time fluorescent PCR technology, the first CFDA registered product in China.
The reaction system of this kit contains a dU-UNG enzyme anti-pollution system to avoid false positive results; the system contains internal standards to avoid false negative results.
Using highly conserved regions of the B. pertussis genome as the target area, specific primers and fluorescent probes are designed to perform PCR amplification to ensure the accuracy of the product.
Carry out big data clinical verification covering national representative clinical units, with outstanding product performance.
Product performance
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Pertussis bacteria nucleic acid detection kit (PCR-fluorescent probe method)
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Sensitivity
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1.0x104copies / mL
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Linear range
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1.0x104copies / mL ~ 1.0x 109copies / mL
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Accuracy
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The detection result coincidence rate is 100%
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Precision
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Coefficient of variation within and between batches CV≤5%
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Specificity
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100% specificity, no cross reaction with Streptococcus pneumoniae, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Epstein-Barr virus, adenovirus, respiratory syncytial virus, etc.
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Anti-interference
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Mucin, pus, erythromycin, chloramphenicol did not interfere with the test results
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Application field
Applicable people: dry cough or paroxysmal spasm, accompanied by chicken-like roar or vomiting after cough without other causes for laboratory diagnosis of B. pertussis
Applicable departments: pediatrics, infections, otolaryngology, etc.
Product information
Test specimen: pharyngeal swab
Technical principle: PCR-fluorescent probe method
Packaging specifications: 24 tests/ kit, 48 tests/ kit, 96 tests/ kit
Applicable instruments: two-color fluorescence channel PCR instrument, including ABI 7500, ABI 7300 , Roche480, Roche96, etc.
