[Product Name]

Respiratory Pathogens Combined Detection Kit (Fluorescence PCR )

[Packaging Size]

48 tests/kit

[Intended Use]

This kit is used for qualitative detection of respiratory pathogens in nucleic acid extracted from human oropharyngeal swab samples. Pathogens detected include: influenza A virus (H1N1, H3N2, H5N1, H7N9), influenza B virus (Yamataga, Victoria), parainfluenza virus (PIV1, PIV2, PIV3), metapneumovirus (A, B), adenovirus (1, 2, 3, 4, 5, 7, 55), respiratory syncytial (A, B) and measles virus.

Diseases caused by pathogenic microorganisms invading the human nasal cavity, throat, trachea, bronchus, lungs and other respiratory tissues and organs and multiplying are called respiratory tract infections. Clinical manifestations include fever, cough, runny nose, sore throat, general fatigue and soreness . Respiratory pathogens include viruses, mycoplasma, chlamydia, bacteria, etc. Most of the infections are caused by viruses. Respiratory pathogens have the following characters such as many kinds of types, rapid evolution, complex subtypes, similar clinical symptoms. It has the clinical characters like the rapid onset, rapid spread, strong infectivity, and similar symptoms that are difficult to distinguish, which poses a serious threat to human health.

Influenza, commonly referred to as "flu", is an acute respiratory infectious disease caused by the Influenza virus (IFV), which is highly contagious and spreads mainly through coughing and sneezing. It usually breaks out in spring and winter. Influenza virus is divided into three types: type A, type B and type C, all of which belong to the family orthomyxoviridae and are single-stranded and negative-strand RNA viruses. Influenza A viruses include H1N1, H3N2, etc. Multiple subtypes are easy to mutate. So far, it has been found that HA has 18 subtypes and NA has 11 subtypes. There are outbreaks worldwide. "Antigenic shift" refers to the mutation of influenza A virus, resulting in a new virus "subtype" emerging. Influenza B virus is divided into two major lineages, Yamagata and Victoria. Influenza B virus only has antigenic drift, and evades the surveillance and clearance of the human immune system through its mutation. But influenza B viruses evolve slower than influenza A viruses, and influenza B viruses can also cause respiratory infections in humans and lead to epidemics.

Parainfluenza cirus (PIV) is a single-stranded RNA virus that can cause recurrent respiratory diseases, such as colds, sore throat, pneumonia, bronchitis and bronchiolitis. The incubation period is generally about 1-7 days. Serologically, human parainfluenza viruses can be divided into PIV1, PIV2, PIV3 and PIV4. Both PIV1 and PIV2 can cause a variety of respiratory infectious diseases, such as typical childhood laryngotracheobronchitis, etc. PIV3 often causes pneumonia and bronchiolitis. PIV4 is difficult to detect.

Human metapneumo virus (hMPV) is a single-stranded and negative-strand RNA virus belonging to the paramyxovirus family, subfamily pneumovirus, and genus metapneumovirus. The symptoms of hMPV infection are similar to those caused by respiratory syncytial virus and influenza virus, including cough, nasal congestion, runny nose, muscle aches, fever, etc., and can also lead to severe bronchitis, pneumonia and even chronic obstructive pulmonary disease (AE-COPD) acute exacerbation. hMPV infection can occur at any age. Young adults have mild or asymptomatic infection symptoms. hMPV infection in children, the elderly, and immunocompromised patients can cause severe illness. Winter is the peak period for hMPV.

Adenovirus (HAdV) is a double-stranded DNA virus without an envelope. At least 90 genotypes have been found, which are divided into 7 subgenus A-G. Respiratory tract infection related HAdV mainly includes B subgenus, C subgenus and E subgenus (HAdV-4 type). Adenovirus pneumonia accounts for about 4%-10% of community-acquired pneumonia. Severe pneumonia is mostly type 3 and type 7, which is one of the more serious types of community-acquired pneumonia in children.

Respiratory syncytial virus (RSV) is an RNA virus belonging to the family paramyxoviridae. The disease is transmitted by air droplets and close contact, and is the main pathogen causing lower respiratory tract infection in infants and young children. Severe bronchiolitis and pneumonia are associated with childhood asthma. Infants and young children have severe symptoms, including high fever, rhinitis, pharyngitis and laryngitis, and later bronchiolitis and pneumonia. A small number of sick children may be complicated by otitis media, pleurisy and myocarditis. After infection in adults and older children, the main manifestation is upper respiratory tract infection.

Measles virus (MV) is a negative-strand RNA virus belonging to the genus Measles virus of the family paramyxoviridae. It can cause an acute respiratory infectious disease characterized by fever, respiratory catarrhal symptoms and generalized maculopapular rash and it is one of the common acute infectious diseases. Measles virus is highly contagious and has a high morbidity rate. In addition to causing common cough, high fever, fear of light and rashes all over the face, trunk and upper limbs, it is also easy to be complicated by bronchopneumonia or meningitis, resulting in a high mortality rate.

[Main Components]

Specification 1: Influenza A/B nucleic acid detection kit (fluorescent PCR)

Specification 2: Influenza A virus universal/H1/H3 nucleic acid multiplex detection kit (fluorescent PCR)

Strength 3: Influenza B virus Yamagata/Victoria detection kit (fluorescent PCR)

Specification 4: Parainfluenza virus type 1/2/3 nucleic acid detection kit (fluorescent PCR)

Specification 5: Human metapneumovirus type 1/2 nucleic acid detection kit (fluorescence PCR)

Specification 6: Adenovirus universal nucleic acid detection kit (fluorescent PCR)

Specification 7: Respiratory syncytial virus (RSV)  type A and B  nucleic acid detection kit (fluorescent PCR)

Specification 8: Measles virus nucleic acid detection kit (fluorescent PCR)

Specification 9:Respiratory pathogens combined detection kit (fluorescent PCR )

Note: Components of different batches cannot be mixed or interchanged. Products of different specifications can be purchased in combination with each other.

[Storage Conditions and Shelf-life]

The kit should stored below -18℃ protected from light, the shelf-life is 9 months(please use in the shelf life).

After the kit is opened, the number of repeated freezing and thawing should not be more than 4 cycles and it can be stored stably for 7 days when transported on dry ice and protected from light.

See label for production and expiry dates.

[Applicable Instruments]

QuantStudio™ 5 Real-Time PCR Systems, SLAN ® -96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler® 480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection System（FQD-96A，Bioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.) , BioRad CFX96 Real-Time PCR System, BioRad CFX Opus 96 Real-Time PCR System.