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

2.3 Pathogen Diagnosis of Gastroenteritis

Gastroenteritis is a common disease in infants and young children. The treatment of mild cases is based on the prevention and correction of dehydration, electrolyte disturbance, and acid-base imbalance, while anti-infective treatment should be considered for infants and young children with gastroenteritis that has obvious toxic symptoms and cannot be completely explained by dehydration. The common pathogens include viruses, bacteria, parasites, and fungi, and there are appropriate drugs for bacterial, parasitic, and fungal infections. Viruses are the most common pathogens, with Rotavirus and Adenovirus being the main types of viruses that cause gastroenteritis in infants and young children. Rotavirus causes up to 36% of all gastroenteritis deaths in infants and children. There is a lack of specific antiviral drugs, and antibacterial drugs should not be used. Since different pathogens are treated in different ways, pathogen testing is helpful to identify the causative agent and implement precise treatment.

The diagnostic criteria for Rotavirus and Adenovirus gastroenteritis recommended in the Infectious Diarrhea Diagnostic Guidelines include electron microscopy, polyacrylamide gel electrophoresis, agarose gel electrophoresis, enzyme-linked immunosorbent assay (ELISA), reverse transcription-polymerase chain reaction (RT-PCR)/polymerase chain reaction (PCR), and virus isolation. NMPA has approved 59 single test or multiplex test kits with immunochromatographic or ELISA methods. The detection targets are viral antigens. In 2020, Chongqing Wecan Bio-Tech Co., Ltd. launched Group A Rotavirus, Group F Enteric Adenovirus Type 40/41 Nucleic Acid Detection Kit (PCR-Fluorescence) (Registration No.: G.X.Z.Z 20203400618), which is the first Rotavirus and Adenovirus nucleic acid test kit. The sensitivity of fluorescence RT-PCR is better than that of immunochromatography and ELISA, so it will be better for the detection of low-concentration samples.

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