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 aciλ™← d test kit (PCR-fluorescent π§♦εprobe method)

Clinical background

    Res§↑₽piratory tract infection is one of the most c'¶∑ommon infectious diseases in humans in the worldλ‍‍ , and the incidence rate ranks first in ✘♦↑various infectious diseases. 20% of the dea‍φ​ ths of preschool children worldwide↓Ω π are respiratory infe←$≠ctions, causing 400 million people to be infec≈≠↕ted with respiratory patho☆×gens every year. The←±← World Health Organization (WHO) published an ±¥♠article in the "Lancet" magazine in 2005: in 2¶↑©‍000-2003, 1060 per year Of the 10,0β✘γε00 children under the age of 5, deaths d ≤∑≈ue to infectious disease÷®s accounted for 54%, has become the main cause  "  of death of children under ±↑¶the age of 5, and is also one of the pu↕βαblic health problems of the elde¶≈rly.

Technical principles

Based on PCR-fluorescent probe method, δαqualitative detection of R$✔NA and DNA of pathogens in p≠εharyngeal swabs of subjects.

Testing process
Product advantages
Innovation : PCR-flu$÷orescent probe method combined ©→>with molecular beacon melting curλΩ've analysis method, simultaneously detecting 18 ♣↓Ω'respiratory pathogens, the first domestic &≈♥nbsp;
comprehensive : cover¥✘•ing 18 common respiratory viruses, bacte₹‍₹™ria, chlamydia and mycoplasma
High efficiency : the∏→ entire detection can be completed wit α$×hin 1.5 hours; PCR The product is directly ¥≥analyzed by melting cur​≠ve without opening the cover.
Sensitivity : the minimum detection l$€imit can reach 10 copies / μL.
Specificity : the application of molecularΩεβ₽ beacon technology, the specificity oφ"★∑f the detection is high and
Economy: the cost of a single det←​ection is much lower than th∏ε<≥at of liquid chip products, and no specε®λial equipment is required
Comparison of clinical methodologiesγδ↕

Project indicators

7 immunofluorescence tests

Single fluorescent PCR

16 inspections of liquid chip✘✔©≠s

(U.S. luminex)

Capillary electrophoresis π¶™$

Method of this pδ™βroject 

Detection of pathogen♣$s

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 operat↑‍<∏ion

Extremely compleδ×x and slow

Relatively complex β₹

Relatively complex

Relatively complex

Simple and fast ¶♣ 

Product contamination

no

Not easy to pollute>"✘

Easily contaminγ®≈ated

Relatively easy to pollut→¥÷e

Not easy to pollute '☆¶β

Clinical charges

low

high

high

high

low

Product performance

Respiratory patho♠∞¶gen multiple typing detection kit (multi♣¶πple fluorescent probe melting curve method) <≠

Pathogen type φσ≠

New coronavirus 2019-nCoV, corona©☆ €virus (HCoV-229E, HCoV-OC43, ™σ☆HCoV-NL63, HKU1), influenza A vi↔₩•εrus, 

influenza B virusε&, respiratory syncytial virus‍☆★↕, adenovirus, parainfluenza∞​• virus Type II, Type III), •♦↔αrhinovirus,

 human metapneumovirus, Bocavirus, ±™ B. pertussis, Chlamydia pneumon←→‌£iae, 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 tδΩhe test results is 100% ®♥

Precision

Coefficients of variation w ±✘ithin and between batches CV are less than 4.5% "♣and 3.5%, respectively ≈≥≥ 

Specificity

100% specificitπ  y, no cross-reactivity with other clinically co∏§ δmmon pathogenic microorganisms  δ

Anti-interference

Commonly used drugs for₩♦ the treatment of respiratory diseases do ™∏§not interfere with this pro§β duct

Application field

Diagnosis of pathogen classification o∑<f respiratory tract pati↓¥ents

Respiratory tract risk assessment

High-risk groups, newborn screening


Product information
Test specimen: pharyngeal swab
Technical principle:∏  PCR-fluorescent probe metho•∑d
Packaging specificati→©↕₹ons: 24 tests/ kit, 48 tests/ kit, 96®δ tests/ kit
Category : In vitro diagnostic reage•®₹>nts
Applicable instrumen∏★‌ ts : fluorescent quantitative PCR instrume♣×≠nt