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Influenza A / B influenza virus antigen detection kit (fluorescence immunochroma
Influenza A / B influenza virus antigen detection kit (fluorescence immunochromatography)

Influenza A / B influenza virus antigen detection kit (fluorescence immunochromatography)

Clinical background

   The epidemic of influenza (flu) is seasonal and highly contagious, which can easily cause widespread epidemics. In the 20th century, three influenza pandemics occurred in the world, namely the "Spanish flu" caused by H1N1 virus in 1918, the "Asian flu" caused by H2N2 virus in 1957, and the "Hong Kong flu" caused by H3N2 virus in 1968. In recent years, the flu situation is still very serious. The infection rate in the severe influenza season from 2017 to 2018 reached 7.1%. This data reached a new high since 2009. During this period, most hospitals were overcrowded and the situation was grim.
 
  In response to the seriousness of influenza's threat to humans, based on the fluorescent nanomicrosphere technology platform, our company has broken through the limitations of the low sensitivity of the colloidal gold method and the slow detection of PCR nucleic acid methods commonly used in the market, becoming a new generation of detection technology.


First in China

★ National High-tech Research and Development Plan (863 Plan)
★ Shenzhen's major strategic technology research products
★ With Tsinghua University as the leader, comprehensively develop products for production, study, research and application
★ Sensitivity is 10-100 times higher than traditional colloidal gold method
★ Compared with PCR detection method, the coincidence rate is up to 80%
★ On-site inspection, results in 15 minutes


Technical principle (fluorescence immunochromatography)


  The samples were added dropwise to the two wells of the test cards A and B. After the influenza A and (or) influenza B virus antigens were combined with the fluorescent microsphere-labeled influenza A and (or) influenza B virus nucleoprotein monoclonal antibodies After the chromatography to the test line is captured by the coated antibody, under the 365nm wavelength ultraviolet radiation, a fluorescent band appears, and the influenza A and / or B viruses can be determined by naked eyes.


Product advantages
The first in China : the first influenza virus detection product developed based on fluorescent nanotechnology, the technology is nationally leading and
Convenient : it can be used for on-site testing, which is convenient for emergency, outpatient, community hospitals and basic hospitals to develop
Quickly : a single sample can be completed in 15 minutes
High  sensitivity : 10-100 times higher sensitivity than colloidal gold detection technology,
Strong specificity : no cross-reaction with other respiratory pathogens and other subtypes,
Good stability : intra-batch difference and inter-batch difference <5%

Comparison of clinical methodologies

Detection method

Advantage

limitation

application

PCR detection

High sensitivity and accuracy

Need special laboratory and 

equipment to carry out, 

an experiment process takes 

3-4 hours, high testing cost

Specific patients and 

specific departments

Colloidal gold

Fast, results in 15 minutes

Sensitivity accuracy is limited 

by the technology platform, 

low sensitivity, low accuracy, 

high false negative

Preliminary clinical screening, 

as well as the development of 

basic hospitals

Virus culture

High accuracy

Long time required, up to 

6-7 days

Specialized laboratory diagnosis

This product
(Fluorescent 

Nanotechnology)

Fast, easy to operate, the results 

are produced within 15 minutes, 

high sensitivity and accuracy, and up to 

80% consistency with PCR control

Low limitations, no special 

laboratories and equipment 

required

Preliminary clinical screening, 

and the development of 

grassroots hospitals

The need for rapid testing

01. Flu symptoms are generally only fever, body pain, significant fatigue, and mild respiratory symptoms, requiring timely treatment, otherwise it is easy to induce other chronic diseases;
02. Most of them can heal without treatment, but for infants and young children with poor resistance, the elderly and patients with cardiopulmonary diseases, they are prone to death due to serious complications such as pneumonia
03. Sudden onset and extremely infectious. If the patient does not pay attention to isolation, it is easy to infect people around them;
04. According to the mechanism of influenza disease, patients use drugs within 24 hours for best results;
05. Accurate diagnosis to avoid the abuse of antibiotics.

Application field
 Clinical, hot clinic, emergency test
 Infection sentinel surveillance of disease control system, rapid screening of epidemic scene
 Influenza A / B screening
 Risk assessment of influenza A / B
 High-risk groups, newborn influenza screening
product information
Test specimen: throat swab
Technical principle: fluorescence immunochromatography
Packing specification: 20 tests/ kit
Validity: 18 months
Applicable instrument: Fluorescence chromatography test paper interpreter