IVD Department Qualitative Antibody Test for HTLV-I and HTLV-II - Vietnam Registration 2403239ĐKLH/BYT-HTTB

The ARCHITECT rHTLV-I/II calibrator is used to calibrate the ARCHITECT iSystem when performing qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma. Refer to the ARCHITECT rHTLV-I/II Assay User Manual and the ARCHITECT System Operations Manual for more information. The ARCHITECT rHTLV-I/II control material is used to assess the accuracy of the test and to detect systematic analytical deviation of the ARCHITECT iSystem when performing qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma. Refer to the ARCHITECT rHTLV-I/II Assay User Manual and the ARCHITECT System Operations Manual for more information. The ARCHITECT rHTLV-I/II is a fluorescent bead-based immunoassay (CMIA) for qualitative detection of HTLV-I and HTLV-II antibodies in human serum and plasma, including samples collected from patients who have no pulse (cardiac arrest). The ARCHITECT rHTLV-I/II test is used to support the diagnosis of HTLV-I and HTLV-II infections, and is used as a screening test to prevent the transmission of HTLV-I and HTLV-II infected blood, blood components, cells, tissues, and organs.