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      Industry News

      In the post epidemic era, multiple detection of respiratory syndrome pathogens has shown a trend

      Attribute:Industry News Date:2019-09-03 14:46:55

      With the extensive vaccination of New Coronavirus vaccine and the continuous strengthening of epidemic prevention and control work, the normalization of epidemic prevention and control work, the pathogen detection (multi joint inspection) of common respiratory syndrome will cause more and more attention of medical and health institutions.

      In the post epidemic period, the detection of respiratory virus syndrome will play an important role in the prevention and control of community transmission of respiratory diseases and nosocomial infection.

      On the surface, the detection of respiratory syndrome seems to increase the burden of medical expenses, but from the perspective of comprehensive factors, because the detection method can not only effectively prevent the community transmission and nosocomial infection of respiratory infectious diseases, but also prompt medical intervention measures in advance, which will greatly reduce the possibility of community and nosocomial infection, thus saving the cost of medical treatment Therefore, the detection of respiratory syndrome should be included in the scope of diagnosis and treatment norms and medical insurance payment.

      1、 Respiratory infection syndrome

      Respiratory tract infection is a kind of pathogen that infects the respiratory system of human body, such as nose, throat, trachea, bronchus and lung tissue, and causes corresponding symptoms. The main manifestations were fever, cough, expectoration and dyspnea. Respiratory tract infection is usually caused by viruses, bacteria and atypical pathogens. In addition to influenza A and influenza B, other pathogens can also cause respiratory tract infection, such as rhinovirus, enterovirus, coronavirus, adenovirus, parainfluenza virus, metapneumovirus, respiratory syncytial virus, Pneumocystis, Staphylococcus aureus, etc. Respiratory tract infection is a common clinical disease. The pathogens of different infection places (such as community infection, hospital infection), different seasons, different ages, different basic diseases (such as organ transplantation, diabetes, AIDS) are different. For example, the main pathogens of community-acquired respiratory tract infection are virus, mycoplasma, Chlamydia, Streptococcus pneumoniae, influenza The main pathogens of hospital acquired respiratory tract infection are bacteria, especially drug-resistant bacteria, such as Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, etc. [17].

      In recent years, with the use of molecular diagnosis technology, especially multiplex PCR technology (which can detect several targets in a sample) and integrated detection (microfluidic) technology, the detection of respiratory infection syndrome (SIAS) has developed rapidly. This diagnosis method is different from the previous single target detection mode for possible pathogens. It starts from the symptoms and characteristics of patients and covers the common pathogen combinations related to syndrome infection. One sample and one test can diagnose or exclude multiple pathogens, which significantly improves the diagnosis efficiency.

      In 1991, the World Health Organization (who) put forward the concept of syndrome detection "comprehensive case management" [19]. In 2004, who summarized the key characteristics of syndrome case management

      (1) Problem oriented (it reflects the patient's symptoms);

      (2) It has high sensitivity, covers more pathogens at one time, and will not miss mixed infection of multiple pathogens;

      (3) Accurate detection was carried out at the first visit of patients, and effective intervention was carried out for accurate treatment;

      (4) Make the diagnosis and treatment of STI have higher accessibility, which can be carried out in primary medical institutions;

      (5) According to the flow chart of epidemic season, health workers are guided by logical steps.

      2、 Epidemiology and clinical status

      According to who data, lower respiratory tract infection is the fourth leading cause of death in the world and the third leading cause of death in children under 5 years old in China. In the respiratory tract infection of children under 5 years old, virus is more common than bacteria. According to statistics, the median number of children with viral respiratory tract infection is 5 times a year, and more than 10% of children have respiratory tract virus infection more than 10 times a year [2-3]. The incidence of respiratory tract virus infection in children is much higher than that in adults, and the younger the age, the higher the incidence of respiratory tract infection. In the hospitalized cases of children with acute lower respiratory tract infection and community-acquired pneumonia, the detection rate of respiratory virus in children under 1 year old was 76.1% - 83%, and that in children 2-5 years old was 63.1% - 73.8% [4-5]. The main pathogens of cap in children were respiratory syncytial virus, rhinovirus, metapneumovirus, adenovirus, Mycoplasma pneumoniae, parainfluenza virus and influenza virus [6]. Rhinovirus was more often detected in lower respiratory tract specimens [7].

      Among all patients with clear etiological evidence, the proportion of viral pneumonia has exceeded that of bacteria, and has risen to the first place. The detection rate of virus in CAP patients with adult community-acquired pneumonia in China is 15% ~ 34.9%, influenza virus is the first, and other viruses include parainfluenza virus, rhinovirus, adenovirus, human metapneumovirus and respiratory syncytial virus [8-9]. The severity of non influenza pneumonia is similar to that of influenza pneumonia [10].

      3、 Guidelines for respiratory diseases

      The guidelines for the management of community-acquired pneumonia in children (revised in 2013) points out that the detection of virus specific gene fragments in respiratory secretions by molecular biological means, especially polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR), has high sensitivity, strong specificity and early diagnostic value. Multiplex PCR can detect multiple viruses at the same time and improve the detection efficiency.

      "Suggestions on collection, transportation and detection of microbiological specimens in children's respiratory tract infection (virus)" points out that nucleic acid detection is highly sensitive, and pharyngeal swabs, aspirates, bronchoalveolar lavage fluid or sputum collected in clinic can be used for detection. Coupled with its advantages of fast, simple and high throughput, it has become the main method for the diagnosis of respiratory tract virus infection.

      "Influenza diagnosis and treatment plan (2018 Edition)" pointed out: the specificity and sensitivity of viral nucleic acid detection is the best, and it can distinguish the type and subtype of virus.

      The guidelines for the diagnosis and treatment of community-acquired pneumonia for adults in China (2016 Edition) pointed out that the positive nucleic acid detection of influenza virus, parainfluenza virus type 1-4, respiratory syncytial virus, adenovirus, coronavirus and human metapneumovirus in oropharyngeal / nasopharyngeal swabs, qualified lower respiratory tract specimens or lung tissue specimens can be used as the basis for etiological diagnosis The nucleic acid detection of Mycoplasma pneumoniae and Chlamydia pneumoniae in qualified lower respiratory tract specimens, pleural effusion, bronchial mucosa biopsy or lung biopsy specimens is positive, which has important reference significance for etiological diagnosis.

      "New Coronavirus pneumonia diagnosis and treatment plan (trial version 8)" [2020]680 of the medical office of the State Health Office pointed out that New Coronavirus pneumonia is mainly differentiated from other known viral pneumonia and Mycoplasma pneumoniae infection such as influenza virus, adenovirus, respiratory syncytial virus and so on. In particular, suspected cases should be taken as fast as possible, including rapid antigen detection and multiplex PCR nucleic acid detection. Common respiratory pathogens were detected.

      The guiding principles for the registration of respiratory virus multiple nucleic acid detection reagents (No. 80, 2019) issued by the State Food and Drug Administration in 2019 clearly points out that respiratory virus multiple nucleic acid detection reagents should detect eight viruses: influenza A virus, influenza B virus, respiratory syncytial virus, parainfluenza virus, enterovirus / rhinovirus, adenovirus, metapneumovirus and coronavirus Viruses.

      Combined with the guideline recommendation and clinical demand, the market needs multiple nucleic acid detection products with wider spectrum (including at least eight viruses listed in the guidelines of National Drug Administration), more accurate (nucleic acid detection), more convenient (simple process and short reporting time).


      Next:Development status of IVD in China

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