IVD Department for Quantitative sTfR Testing - Vietnam Registration 240000944/PCBB-HCM

1/ The Quantitative sTfR Assay (Type: ACCESS sTfR/ Product Code: A32493): It is a fluorescent chemiluminescence immunoassay, based on the detection of the concentration of the circulating transferrin receptors (sTfR) in human serum and heparinized plasma by the Access Immunoassay System. This test is used to support the diagnosis of Iron Deficiency Anemia (IDA) and to differentiate IDA from Chronic Disease Anemia (CDA) with or without IDA. The test can also be used in combination with the ferritin measurement to calculate the sTfR/log ferritin index. This index is used to support the diagnosis of IDA and to differentiate CDA from IDA with or without CDA. 2/ The Quantitative sTfR Assay Calibration Standards (Type: ACCESS sTfR CALIBRATORS/ Product Code: A32494): Used to calibrate the Access sTfR Assay to determine the concentration of the circulating transferrin receptors in human serum and heparinized plasma by the Access Immunoassay System. 3/ The Level 1 Quality Control Material for the Quantitative sTfR Assay (Type: ACCESS sTfR QC1/ Product Code: B11056): Used to monitor the performance of the Access sTfR Assay of the system. 4/ The Level 2 and 3 Quality Control Materials for the Quantitative sTfR Assay (Type: ACCESS sTfR QC2 and QC3/ Product Code: B11057): Used to monitor the performance of the Access sTfR Assay of the system.