In vitro diagnostic reagents drug class specific what?

"In vitro diagnostic reagents registration management approach" said in vitro diagnostic reagents, refers to the management of in vitro diagnostic reagents according to the medical device, including in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and evaluation of the state of health, used for in vitro testing of human samples reagents, reagent kits, calibration products, quality control products. They can be used alone or in combination with instruments, apparatus, equipment or systems. In vitro diagnostic reagents for blood screening and in vitro diagnostic reagents labeled with radionuclides, which are managed in accordance with pharmaceuticals, do not fall under the management of this approach.

So, what kinds of in vitro diagnostic reagents for screening and in vitro diagnostic reagents labeled with radionuclides are included?

1, in vitro diagnostic reagents used for blood screening

According to the blood donor health examination requirements GB 18467-2011, the content of blood testing after blood donation includes: blood type testing (ABO and RhD blood type correct stereotyping); alanine aminotransferase (ALT), hepatitis B virus (HBV) testing, hepatitis C virus (HCV) testing, AIDS virus (HIV) test, syphilis (Syphilis) test, etc. meet the relevant requirements. The in vitro diagnostic reagents for blood screening are designed to ensure the safety of patient blood transfusion and to avoid the blood-borne transmission of HIV and hepatitis viruses. Therefore, the national statutory screening kits used for blood source screening are the above five blood virus antigen and antibody screening kits except alanine aminotransferase.

2, radionuclide-labeled in vitro diagnostic reagents

As for radionuclide-labeled in vitro diagnostic reagents, the CFDA approved the most radioimmunoassay kits. Radioimmunoassay is the use of isotopically labeled and unlabeled antigens, with the antibody method of competitive inhibition to determine the body's immune substances. For example, hepatitis B virus surface antigen diagnostic kit (radioimmunoassay).