Bio-Rad 27126 Lyphochek Specialty Immunoassay Control Level 3

Intended use

Lyphochek Specialty Immunoassay Control, Level 3 is an assayed, lyophilized, human serum-based quality control material intended to monitor the precision of laboratory testing procedures for the specialty immunoassay analytes listed in the package insert: 25-Hydroxy Vitamin D, Erythropoietin (EPO), Intact PTH, Procalcitonin (PCT) and Sex Hormone Binding Globulin (SHBG). Level 3 provides a high control concentration and is typically run together with Level 1 (Part # 27124) for two-level QC. Assigned values are available for major automated immunoassay analyzers, including Beckman Coulter Access 2 systems. Results are intended for use by trained laboratory professionals as part of the laboratory’s quality control program.

Storage & shelf life

Supplied as 6 x 2 mL vials. Store unopened vials at 2-8 C. Stable until the expiration date printed on the label when stored unopened as directed. Reconstitute each vial with 2.0 mL of distilled or deionized water as directed in the package insert. Once reconstituted, most analytes are stable for 30 days at 2-8 C; Procalcitonin is stable for 3 days at 2-8 C. Aliquots stored frozen at -20 to -70 C are stable for 30 days. Refer to the package insert for analyte-specific stability claims, and to the lot-specific insert for instrument-specific target values and acceptable ranges. COLD CHAIN: YES - ships refrigerated (2-8 C) with gel packs.

Regulatory status

For In Vitro Diagnostic Use. For prescription / professional laboratory use only. Manufactured by Bio-Rad Laboratories, Inc. Refer to the current manufacturer’s package insert, lot-specific value assignment sheet and Safety Data Sheet (SDS) for the complete procedure, analyte stability exceptions, limitations, warnings and precautions.