Hbsag strip test
has been widely used in pre-operative testing, on-site blood donor screening, and other emergency tests, as well as routine clinical testing in primary medical institutions, including five hepatitis B markers: HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc, etc. Hbsag strip test is faster and simpler than the traditional methods and has certain clinical application significance.
Hbsag strip test mostly uses the colloidal gold method, and other methods include colloidal selenium method, latex method, etc. The principle is the same as the traditional method of enzyme-linked immunosorbent assay. Due to the different judgment methods, the operation process is fast and simple, and there are differences in reagent quality standards such as enzyme-linked immunosorbent assay and chemiluminescence assay. It mainly shows in the aspect of sensitivity. The minimum detectable amount of HBsAg, which the enzyme-linked immunoassay reagent can reach 0.05~0.1 IU/ml, while the rapid detection reagent is only 4~5 IU/ml. The minimum detectable amount of Anti-HBs, which enzyme-linked immunosorbent reagent 10IU/ml, rapid detection reagent 30 IU/ml, and the other three hepatitis B markers minimum detection limit enzyme-linked immunoassay reagents are higher than the rapid detection reagent 2~3 times Dilution. Therefore, the hbsag strip test is also limited in clinical application.
The hbsag strip test belongs to the management of medical devices. There are no import registrations for rapid test reagents in the registration of many hepatitis B reagents. The declared registered product standards are not standardized. At present, the national reference products for the five reagents of hepatitis B have been established, providing a basis for developing medical device industry standards for this product.