18 respiratory pathogens nucleic acid test kit (PCR-fluorescent probe method)
18 respiratory pathogens nucleic acid test kit (PCR-fluorescent probe method)

18 respiratory pathogens nucleic acid test kit (PCR-fluorescent probe method)

Clinical background

    Respiratory tract infection is one of the most common infectious diseases in humans in the world, and the incidence rate ranks first in various infectious diseases. 20% of the deaths of preschool children worldwide are respiratory infections, causing 400 million people to be infected with respiratory pathogens every year. The World Health Organization (WHO) published an article in the "Lancet" magazine in 2005: in 2000-2003, 1060 per year Of the 10,000 children under the age of 5, deaths due to infectious diseases accounted for 54%, has become the main cause of death of children under the age of 5, and is also one of the public health problems of the elderly.

Technical principles

Based on PCR-fluorescent probe method, qualitative detection of RNA and DNA of pathogens in pharyngeal swabs of subjects.

Testing process
Product advantages
Innovation : PCR-fluorescent probe method combined with molecular beacon melting curve analysis method, simultaneously detecting 18 respiratory pathogens, the first domestic  
comprehensive : covering 18 common respiratory viruses, bacteria, chlamydia and mycoplasma
High efficiency : the entire detection can be completed within 1.5 hours; PCR The product is directly analyzed by melting curve without opening the cover.
Sensitivity : the minimum detection limit can reach 10 copies / μL.
Specificity : the application of molecular beacon technology, the specificity of the detection is high and
Economy: the cost of a single detection is much lower than that of liquid chip products, and no special equipment is required
Comparison of clinical methodologies

Project indicators

7 immunofluorescence tests

Single fluorescent PCR

16 inspections of liquid chips

(U.S. luminex)

Capillary electrophoresis

Method of this project 

Detection of pathogens

7 inspections

1 ~ 2 inspection

16 inspections

16 inspections

18 inspections

Detection cycle

2 hours

3 hours

6 hours

4 hours

1.5 hours

Sensitivity

low

high

high

high

high

Sample flux

1

6 ~ 12

96

48

48

Experimental operation

Extremely complex and slow

Relatively complex

Relatively complex

Relatively complex

Simple and fast

Product contamination

no

Not easy to pollute

Easily contaminated

Relatively easy to pollute

Not easy to pollute

Clinical charges

low

high

high

high

low

Product performance

Respiratory pathogen multiple typing detection kit (multiple fluorescent probe melting curve method)

Pathogen type

New coronavirus 2019-nCoV, coronavirus (HCoV-229E, HCoV-OC43, HCoV-NL63, HKU1), influenza A virus, 

influenza B virus, respiratory syncytial virus, adenovirus, parainfluenza virus Type II, Type III), rhinovirus,

 human metapneumovirus, Bocavirus, B. pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae.

Sensitivity

10 copies / μL  

Linear range

10-1.0x109 copies / μL

Accuracy

Use national reference products as the control, the coincidence rate of the test results is 100%

Precision

Coefficients of variation within and between batches CV are less than 4.5% and 3.5%, respectively

Specificity

100% specificity, no cross-reactivity with other clinically common pathogenic microorganisms

Anti-interference

Commonly used drugs for the treatment of respiratory diseases do not interfere with this product

Application field

Diagnosis of pathogen classification of respiratory tract patients

Respiratory tract risk assessment

High-risk groups, newborn screening


Product information
Test specimen: pharyngeal swab
Technical principle: PCR-fluorescent probe method
Packaging specifications: 24 tests/ kit, 48 tests/ kit, 96 tests/ kit
Category : In vitro diagnostic reagents
Applicable instruments : fluorescent quantitative PCR instrument