Glucose HK Gen.3

Catalog Number: 05168791190

SYSTEM INFORMATION

INTENDED USE

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

STORAGE AND STABILITY

GLUC3
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
On-board on the Reagent Manager: 24 hours
Diluent NaCl 9 %
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
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM, PLASMA, URINE AND CSF

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 18-38 (STAT 7 / 6-26)
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 28 µL 141 µL
R3 (STAT R2) 10 µL 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 10 µL 15 µL 135 µL
Increased 4 µL

CALIBRATION

Traceability: This method has been standardized against ID/MS.

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2-point calibration- after reagent lot change- as required following quality control procedures

LIMITS AND RANGES

Measuring range

Serum, plasma, urine and CSF

0.11-41.6 mmol/L (2-750 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test:

0.11 mmol/L (2 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard

1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.11 mmol/L) will not be flagged by the instrument.

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.

Serum/plasma: Repeatability (n = 21), intermediate precision (3 aliquots per run, 1 run per day, 21 days).

Urine/CSF: Repeatability (n = 21), intermediate precision (3 aliquots per run, 1 run per day, 10 days). The following results were obtained:

Serum/plasma

Urine

CSF

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

GLUC3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.17 (93.2) 0.04 (0.7) 0.8
Precipath U 13.4 (241) 0.1 (2) 0.7
Human serum A 3.27 (59.0) 0.02 (0.4) 0.5
Human serum B 19.1 (344) 0.1 (2) 0.7
Human serum C 36.1 (651) 0.3 (5) 0.7

SGLU3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.15 (92.8) 0.04 (0.7) 0.7
Precipath U 13.4 (241) 0.1 (2) 0.7
Human serum A 3.21 (57.8) 0.02 (0.4) 0.5
Human serum B 19.0 (342) 0.1 (2) 0.6
Human serum C 35.8 (645) 0.2 (4) 0.5

GLUC3 / SGLU3:
Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.38 (96.9) 0.07 (1.3) 1.3
Precipath U 13.4 (241) 0.2 (4) 1.1
Human serum 3 7.61 (137) 0.09 (2) 1.2
Human serum 4 5.28 (95.1) 0.06 (1.1) 1.1

GLUC3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Control level 1 1.62 (29.2) 0.03 (0.5) 1.7
Control level 2 15.8 (285) 0.1 (2) 0.7
Human urine A 0.833 (15.0) 0.015 (0.3) 1.8
Human urine B 32.6 (587) 0.2 (4) 0.5
Human urine C 3.71 (66.9) 0.04 (0.7) 1.1
SGLUC3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Control level 1 1.64 (29.6) 0.03 (0.5) 1.6
Control level 2 16.1 (290) 0.1 (2) 0.8
Human urine A 0.842 (15.2) 0.014 (0.3) 1.6
Human urine B 33.1 (596) 0.2 (4) 0.5
Human urine C 3.79 (68.3) 0.03 (0.5) 0.9
GLUC3/ SGLUC3:
Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Control level 1 1.51 (27.2) 0.01 (0.2) 1.0
Control level 2 15.4 (278) 0.1 (2) 0.8
Human urine 3 4.86 (87.6) 0.05 (0.9) 1.0
Human urine 4 10.3 (186) 0.1 (2) 0.8

GLUC3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.11 (92.1) 0.03 (0.5) 0.7
Precipath U 13.4 (241) 0.1 (2) 0.7
Human CSF A 1.57 (28.3) 0.01 (0.2) 0.6
Human CSF B 20.5 (369) 0.2 (4) 0.8
Human CSF C 35.7 (643) 0.1 (2) 0.4

SGLU3:
Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.09 (91.7) 0.04 (0.7) 0.7
Precipath U 13.4 (241) 0.1 (2) 0.5
Human CSF A 1.57 (28.3) 0.01 (0.2) 0.6
Human CSF B 20.4 (368) 0.1 (2) 0.7
Human CSF C 35.5 (640) 0.2 (4) 0.4

GLUC3 / SGLU3:
Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 5.37 (96.8) 0.07 (1.3) 1.3
Precipath U 13.4 (241) 0.2 (4) 1.1
Human CSF 3 3.00 (54.1) 0.04 (0.7) 1.5
Human CSF 4 8.30 (150) 0.10 (2) 1.2

METHOD COMPARISON

Glucose values for human serum, plasma, urine and CSF samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Serum/plasma

GLUC3:

Sample size (n) = 98

SGLU3:

Sample size (n) = 98

Urine

GLUC3:

Sample size (n) = 73

SGLU3:

Sample size (n) = 74

CSF

GLUC3:

Sample size (n) = 84

SGLU3:

Sample size (n) = 84

Passing/Bablok13 Linear regression
y = 1.003x + 0.000 mmol/L y = 1.003x - 0.006 mmol/L
τ = 0.981 r = 1.000
The sample concentrations were between 1.25 and 40.4 mmol/L (22.5 and 728 mg/dL).

Passing/Bablok13 Linear regression
y = 1.004x - 0.015 mmol/L y = 1.008x - 0.061 mmol/L
τ = 0.982 r = 1.000
The sample concentrations were between 1.25 and 40.4 mmol/L (22.5 and 728 mg/dL).

Passing/Bablok13 Linear regression
y = 0.005x + 0.017 mmol/L y = 1.009x - 0.000 mmol/L
τ = 0.991 r = 1.000
The sample concentrations were between 0.30 and 37.5 mmol/L (5.41 and 676 mg/dL).

Passing/Bablok13 Linear regression
y = 0.995x + 0.001 mmol/L y = 0.994x - 0.047 mmol/L
τ = 0.981 r = 1.000
The sample concentrations were between 0.303 and 41.6 mmol/L (5.46 and 750 mg/dL).

Passing/Bablok13 Linear regression
y = 1.000x + 0.030 mmol/L y = 0.990x + 0.100 mmol/L
τ = 0.982 r = 1.000
The sample concentrations were between 0.18 and 41.6 mmol/L (3.24 and 750 mg/dL).

Passing/Bablok13 Linear regression
y = 0.993x + 0.017 mmol/L y = 0.983x + 0.076 mmol/L
τ = 0.985 r = 1.000
The sample concentrations were between 0.18 and 41.6 mmol/L (3.24 and 750 mg/dL).