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 t ←↕<est kit (PCR-fluores‌∏≤≥cent probe method)

Clinical background

    Respiratory↕✘γ> tract infection is one o★↑f the most common infectious diseases​∏≤ in humans in the world, and the incidenc♣ ∞<e rate ranks first in various infectious d× γiseases. 20% of the deaths of♥&♠ preschool children worldwide are respirato φλry infections, causing 400 million people to ✘♦¶be infected with respiratory pathog∏<¥εens every year. The World Health ∑✔Organization (WHO) published an arti≠×cle in the "Lancet" magazine in 2005: i α♦n 2000-2003, 1060 per year Of the 10,000 ¶✘αchildren under the age of 5, deaths due to 'δγ✔infectious diseases accounted ​₹for 54%, has become the main cause ♠₽Ω♥of death of children under the age of 5, and i₩§s also one of the public health'γ• problems of the elderly.

Technical principles

Based on PCR-fluorescent probe method,‍∏¥> qualitative detection of RNA and DNA of patho∞↕gens in pharyngeal swabs of subjects. α≤≈

Testing process
Product advantages
Innovation : PCR-fluorescent probe method combin±φφ<ed with molecular beacon melting curve analyδδsis method, simultaneously deβ€tecting 18 respiratory pathogens, the​↔ first domestic &nbsπ¶ε>p;
comprehensive : covering 18 c εommon respiratory viruses, bacteria, chl✔≠♦amydia and mycoplasma
High efficiency : the entire dεφΩ÷etection can be completed with‍∑♦in 1.5 hours; PCR The product is directly ana™ ×lyzed by melting curve without opening the co"‌ver.
Sensitivity : the min↔≤δimum detection limit can reach 10 copi"§×es / μL.
Specificity : the application of molecula €≠r beacon technology, the specificity of the d≤÷etection is high and
Economy: the cost of a single dete¶≠★ction is much lower th ε∞an that of liquid chip products, <‌←®and no special equipment is rφΩequired
Comparison of clinical m ®ethodologies

Project indicators

7 immunofluorescence tests

Single fluorescent PCR

16 inspections ∞φof liquid chips

(U.S. luminex)

Capillary electrophoresis

Method of this project 

Detection of pat∞♠π₹hogens

7 inspections

1 ~ 2 inspection☆γ₹

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 operatio'€♦ n

Extremely complex and slow ✔ • 

Relatively complex

Relatively complex

Relatively complex

Simple and fast

Product contamination ↑£×

no

Not easy to pollute ε 

Easily contaminated

Relatively easy to pollute

Not easy to pollute ®'‍

Clinical charges α​α

low

high

high

high

low

Product performance

Respiratory pathogen multiple∏ §Ω typing detection kit (multiple ↓λ§πfluorescent probe melting c÷∞✔↑urve method)

Pathogen type

New coronavirus 2019-nCoV, ★ coronavirus (HCoV-229E, HCoV-OC43, HCoV-NL6↓±∑3, HKU1), influenza A♠γ↔÷ virus, 

influenza B virus,×  respiratory syncytial virus, adenoviru©₩‍s, parainfluenza virus Type II, Type III), rhiφ∞novirus,

 human metapneumovirus, Bocaviru↓∞ ×s, B. pertussis, Chlamydia pneumoniae, M£ε ycoplasma pneumoniae←® .

Sensitivity

10 copies / μL  ×ε  

Linear range π→♠¥

10-1.0x109 copies / μL

Accuracy

Use national reference ‌•≠<products as the control, the coincidence ratγ↔>e of the test results is 100%

Precision

Coefficients of variation wit©πhin and between batches CV are le∏→♦ss than 4.5% and 3.5%, respectively β•≈

Specificity ₽₩™

100% specificity, no cr✘★oss-reactivity with ot¶♦<her clinically common pathogenic mi ♣croorganisms

Anti-interference

Commonly used drugs for the tr✘£eatment of respiratory disea‌¶Ω÷ses do not interfere with thi☆₩$s product

Application field

Diagnosis of pathogen classificatio &n of respiratory tract pa£©±→tients

Respiratory tract risk ≤ assessment

High-risk groups, newborn scree‌≥>ning


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 PCRαγ  instrument