Hemolysis Interference: Are Laboratories Getting the Information They Need?

[摘要] To the Editor:Laboratories frequently rely on information provided by assay manufacturers when establishing protocols for managing hemolyzed samples. One audit found that 95% of laboratories adopt the alert limits recommended by the manufacturer (1). Therefore, the information provided by manufacturers is critical for ensuring that laboratories appropriately manage hemolyzed samples.Regulatory bodies require that certain information is documented within an assay's instructions for use (IFU).1 For example, the US Food and Drug Administration requires that a reagent IFU contain a list of known interfering substances (2). Beyond such regulatory requirements, a 2012 CLSI guideline provides a resource available to assay manufacturers regarding what specific information regarding hemolysis might be published in an IFU (3).The CLSI guideline states that an IFU should document the concentrations of both hemoglobin and analyte tested, as well as the bias observed. It also recommends that interference testing be done at 2 medical decision levels of the analyte and performed up to 1000 mg/dL of hemoglobin. The CLSI has published recommendations for appropriate medical decision level concentrations for interference testing for common …

[学科分类] 过敏症与临床免疫学