Lithium

Catalog Number: 04679598190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

LI
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 1-Point
Reaction time / Assay points 10 / 7
Wavelength (sub/main) 480/505 nm
Reaction direction Decrease
Unit mmol/L (mg/dL)
Reagent pipetting Diluent
R1 100 µL -
R2 - -
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 4 µL 5 µL 100 µL
Decreased 2 µL 5 µL 100 µL
Increased 4 µL 5 µL 100 µL

 

CALIBRATION

Traceability: The lithium calibrator C.f.a.s. is traceable against AAS.

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2-point calibration• after 7 days on-board• after cobas c pack change• after reagent lot change• as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.05-3.00 mmol/L (0.03-2.08 mg/dL)

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB) and Limit of Detection (LoD)

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Lithium values for human serum samples obtained with the lithium reagent on a Roche/Hitachi cobas c 501 analyzer (y) were compared to those determined with the same reagent on a Roche/Hitachi 917 analyzer (x) and with the lithium ion-selective electrode on a COBAS INTEGRA 400 analyzer (x).

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY,