Controls

Assayed control material to monitor the precision of laboratory testing procedures for the analysis of procalcitonin on the LUMIPULSE G Systems.

For in vitro diagnostic (IVD) use as quality controls, to monitor the precision and accuracy of the Lumipulse G SARS-CoV-2 S-IgG assay on the automated LUMIPULSE G System. The assay using this control is performed to quantitatively measure IgG antibodies to SARS-CoV-2 Spike (S) Receptor Binding Domain (RBD) in human serum or plasma and is intended to be used in the assessment of the immune response to the SARS-CoV-2 S protein.

Assayed control to monitor the precision of laboratory testing procedures for the analysis of Pepsinogen I and Pepsinogen II on the LUMIPULSE G Systems.

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of pTau using LUMIPULSE G Systems.

These controls are intended for use as an assayed quality control to monitor the precision and accuracy of laboratory testing procedures for the analysis of renin on the LUMIPULSE G System. 

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of total Tau using LUMIPULSE G Systems.

Lung Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analysis of CYFRA and ProGRP with the LUMIPULSE G system.

Assayed control to monitor the performance of laboratory testing procedures for the analysis of Anti-HIV 1, IgG Anti-HBc, Anti-HTLV Ig, Anti-HCV IgG HBsAg, Anti-Treponema pallidum IgG analytes in human serum and plasma.

Assayed quality control serum to monitor the precision of laboratory measurement procedures.

Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.