Sansure Bio: Bordetella pertussis nucleic acid test kit obtained NMPA mark

On Dec. 1st, Sansure announced that its bordetella pertussis nucleic acid test kit (PCR-fluorescent probe method) obtained the certificate approved by NMPA.

The announcement shows that the nucleic acid detection kit for Bordetella pertussis (PCR fluorescent probe method) uses fluorescent PCR technology, which can be used for the auxiliary diagnosis of patients with respiratory tract infection suspected of Bordetella pertussis infection, and provides a technical basis for the precise prevention and control of Bordetella pertussis. The application covers pediatrics, respiratory department, infectious department, etc. The launch of this product will provide more comprehensive and accessible systematic service solution for respiratory infection, improve the "accuracy" and "accessibility" of respiratory pathogen detection, and promote the construction of an accurate diagnosis and treatment system for early diagnosis and treatment.

Pertussis is highly infectious and can be spread by droplets. It often causes epidemics. The symptoms of infected patients are atypical and similar to the clinical symptoms of other respiratory tract infections. The younger the patients with high incidence are, the worse their condition is, and they may die of pneumonia and encephalopathy. In the pre vaccine era, it was generally believed that pertussis was a childhood disease. However, clinical data in recent years showed that the infection rate of pertussis among adolescents and adults had rebounded, and its symptoms were relatively mild and difficult to detect, thus causing serious adverse effects such as community infection.

Although the reported incidence of whooping cough in China has increased year by year in recent years, the actual incidence may still be seriously underestimated. It is worth noting that for the diagnosis of whooping cough cases, except for laboratory diagnosis carried out by some medical institutions in some provinces in China, other institutions are basically based on clinical diagnosis, while the United States and Japan are mainly based on laboratory diagnosis. In fact, the reported incidence rate of whooping cough is lower than the actual incidence at home and abroad to varying degrees. The reasons include that the symptoms of adolescents and adults are not typical, and they often do not seek medical advice; The laboratory diagnosis rate of pertussis cases is low; The clinical diagnostic criteria are not uniform; Limitations of laboratory testing conditions, etc. At present, most hospitals in China do not carry out relevant testing work. The objective impact of epidemic reporting and management is that pertussis is a legal infectious disease in China. Clinicians sometimes diagnose suspected cases as upper respiratory tract infections and other diseases due to the cumbersome epidemic reporting, thus reducing the number of case reports in hospitals.

Sansure said that the medical device registration certificate of this product would help to enrich the company's product categories, expand the company's product layout in the molecular diagnosis field, constantly meet diversified market demands, and further enhance the company's core competitiveness.