IVD Quantitative HBeAg Test Kit - Vietnam Registration 2403602ĐKLH/BYT-HTTB

ARCHITECT HBeAg Quantitative Calibrators are used to calibrate the ARCHITECT iSystem and are intended for use only with the ARCHITECT HBeAg Test Kit. The ARCHITECT HBeAg test, combined with the ARCHITECT HBeAg Quantitative Calibrators, is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma and for the monitoring of patients infected with the hepatitis B virus. ARCHITECT HBeAg Quantitative Controls are used to assess the accuracy of the test and to detect systematic analytical errors in the ARCHITECT iSystem when performing quantitative determinations of hepatitis B e antigen (HBeAg) in human serum and plasma. Refer to the ARCHITECT HBeAg Quantitative Calibrators User Guide (7P24-01) and the ARCHITECT System Operations Manual for additional information. ARCHITECT HBeAg is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum and plasma. The test is used to support the diagnosis and monitoring of hepatitis B infection. The ARCHITECT HBeAg test can also be used to quantify HBeAg. Refer to the ARCHITECT HBeAg Quantitative Calibrators User Guide (7P24-01) for instructions and additional information.