Homocysteine Enzymatic Assay

Catalog Number: 05385415190

SYSTEM INFORMATION

Test HCYS, test ID 0-006

INTENDED USE

In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on COBAS INTEGRA systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.

STORAGE AND STABILITY

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1/R2-S-SR
Reaction direction Decrease
Wavelength A/B 340/659 nm
Calc. first/last 50/62
Unit µmol/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 175 µL
R2 27 µL
Sample 14 µL
SR 18 µL
Total volume 234 µL

Diluent (H2O)
R1 175 µL
R2 27 µL
Sample 14 µL
SR 18 µL
Total volume 234 µL

COBAS INTEGRA 800 test definition

Calibration

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction mode R1/R2-S-SR
Reaction direction Decrease
Wavelength A/B 340/659 nm
Calc. first/last 73/95
Unit µmol/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 175 µL
R2 27 µL
Sample 14 µL
SR 18 µL
Total volume 234 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against NIST SRM 1955 reference material.

Calibrators HCYS Calibrator KitCalibration dilution ratio:1:1, 1:2, 1:4, 1:8, 1:18 performed automatically by the instrument
Calibration mode Logit/log 5
Calibration replicate Duplicate recommended
Calibration frequency Full calibration• every 7 days• after reagent lot change• as required following quality control procedures

CALIBRATION DILUTION RATIO:

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3-50 µmol/L

THE LOWER AND THE UPPER LIMIT OF THE MEASURING RANGE DEPENDS ON THE ACTUAL CALIBRATOR VALUE.

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 accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS WITH REPEATABILITY AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Hcy values for human serum samples obtained on a COBAS INTEGRA 800 analyzer (y) were compared with those determined using the Diazyme reagent on a COBAS INTEGRA 400 analyzer (x).