In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XIII

2.4 Pertussis Diagnosis

Pertussis is a highly contagious acute respiratory disease that can last for several months and often causes epidemics. In recent years, the incidence of pertussis in children has increased yearly. For the diagnosis of pertussis, the Chinese Guidelines for the Diagnosis and Treatment of Pertussis in Children recommends using nucleic acid tests for laboratory confirmation of pertussis. In 2020, NMPA approved the Pertussis Bacteria Nucleic Acid Detection Kit (PCR-Fluorescence) (Registration No.: G.X.Z.Z 20203400152) of Shenzhen Yilifang Biotechnology Co., Ltd., which is the first pertussis bacteria molecular diagnostic kit. It is more sensitive than serological methods and allows an earlier diagnosis of pertussis.

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