Recently, the Chinese Academy of Metrology (hereinafter referred to as”the Chinese Academy of Metrology”) successfully developed two pseudovirus reference materials, monkeypox virus wild-type b6r gene and mutant f3L gene. These two reference materials can be used for the development of monkeypox virus detection kit, performance confirmation, method validation and laboratory quality control.
Monkeypox is a zoonotic viral disease caused by monkeypox virus infection. Clinically, it is mainly characterized by fever, rash, and swollen lymph nodes. The main source of infection is rodents infected with monkeypox virus.
The guidelines for the diagnosis and treatment of monkeypox (2022 Edition) issued by the National Health Commission specifies that nucleic acid amplification detection method can be used to detect monkeypox virus nucleic acid in skin rash, blister fluid, scab skin, oropharyngeal or nasopharyngeal secretions and other samples.
It is understood that there is no monkeypox virus pseudovirus reference material at home and abroad. The reference materials introduced by the Chinese Academy of Metrology this time ensure the accuracy and traceability of their quantities by using preparation methods, measurement methods and measuring instruments that meet the requirements of metrological characteristics. These two reference materials provide a”biological scale” for the diagnosis of monkeypox virus, thus providing technical support for effectively reducing”false negative”.
The copy number concentration of b6r and f3L genes of monkeypox virus was determined by digital PCR method in China Metrology Institute. The characteristic quantity is the copy number concentration of monkeypox virus b6r gene or f3L gene contained in each tube of solution. See Table 1 for specific quantity values.
At present, many domestic enterprises are developing or have developed monkeypox virus nucleic acid detection kits. China Metrology InstitutethisThe reference materials introduced can be used as measurement standards for the development and performance evaluation of monkeypox virus detection kits, and also provide traceability support for the export of domestic kits.