IVD Department, quantitative DNA testing of EBV - Vietnam Registration 2403252ĐKLH/BYT-HTTB

Alinity m EBV AMP Kit: Alinity m EBV is an in vitro PCR test used with the Alinity m automated system to quantify the DNA of the Epstein-Barr virus (EBV) in human EDTA blood. Alinity m EBV is indicated for use as a diagnostic and management tool for EBV in transplant patients and other immunocompromised patients. In patients being monitored for EBV, the concentrations of DNA in the sample series can indicate the need for a change in therapy and the evaluation of viral response. The results of the Alinity m EBV test must be interpreted in conjunction with all clinical findings and relevant test data. The Alinity m EBV test is not indicated for use in screening for EBV in blood, blood products, or tissues or organs from human donors. Alinity m EBV CTRL Kit: The Alinity m EBV control samples are used to determine the validity of the Alinity m EBV test on the Alinity m automated system. These control samples are intended for use with the Alinity m EBV test; refer to the test's user manual for additional information. Alinity m EBV CAL Kit: The Alinity m EBV calibration samples are used to calibrate the Alinity m EBV test on the Alinity m automated system when quantifying the DNA of EBV. These calibration samples are intended for use with the Alinity m EBV test; refer to the test's user manual for additional information.