Currently, there are more than ten imported TORCH kits on the domestic market, with varying quality, and even fewer have registration certificates.
The eugenics TORCH kits (including IgM/IgG of toxoplasmosis, rubella virus, cytomegalovirus, herpes simplex virus type 1 and type 2) of DIESSE (Italy) have a high occupancy rate in the domestic tertiary hospitals and maternity and child health centers, and their quality stability and operational simplicity have been widely acclaimed by the users of all levels.
The IgM kits use the most advanced antibody capture method, which effectively excludes the use of the antibody capture method, and the IgM kit can be used for the detection of the antibody capture method. The IgM kit adopts the most advanced antibody capture method, which effectively excludes the interference of IgG and RF, and the specificity and sensitivity reach 98~100%; the IgG kit adopts the quantitative indirect method of 6-point calibration, which can directly measure the concentration of international standard unit of IgG antibody in serum.
In February 2009, all items of DIESSE's TORCH kit were awarded the Imported Medical Device Registration Certificate by the State Food and Drug Administration (SFDA). The product is exclusively distributed in mainland China by Shenzhen DIESSE Technology Development Co.