IVD Department, Quantitative S-100B Testing - Vietnam Registration 2402931ĐKLH/BYT-HTTB

1. LIAISON S100: LIAISON S100 is an in vitro fluorescent immunoassay (CLIA) used to quantify the concentration of S-100B protein in human serum and cerebrospinal fluid (CSF). LIAISON S100 is used to support the management of patients with melanoma. The test must be performed on the LIAISON automated immunoassay analyzer. 2. LIAISON S100 Cal (low/high): LIAISON S100 Cal (low/high) is used to calibrate the LIAISON S100 test. By measuring the calibration standards, the manufacturer's calibration curve is adjusted (re-calibrated) to a new, device-specific calibration curve after each calibration. Calibration standards are required to perform the LIAISON S100 test on the LIAISON automated immunoassay analyzer. 3. LIAISON Control S100: The LIAISON Control S100 (low and high) control materials are used in the fluorescent immunoassay (CLIA) LIAISON to assess the reliability of test runs. The performance characteristics of the LIAISON Control S100 control materials are not established for any other test or system other than the LIAISON and LIAISON XL automated immunoassay analyzers.