ACE Alera® Performance Characteristics1

ACE Alera® Performance Characteristics1

ACE Alera® Performance Characteristics
1
Within-Run
Total
Precision%CV2 Precision%CV2
Reportable
Range3
Reportable Range
Tolerance Limits4
Accuracy5:
y = mx + b
≤2.5
0.3-7.0 g/dL
± 5% or 0.5 g/dL
1.005x - 0.03
≤1.7
≤1.7
0.3-7.0 g/dL
± 5% or 0.5 g/dL
1.002x - 0.01
≤2.2
≤4.5
9-1400 U/L
± 10% or 10 U/L
0.991x + 0.5
U/L
≤1.1
≤4.6
9-1400 U/L
± 10% or 10 U/L
0.983x - 6.4
serum
U/L
≤3.3
≤4.9
4-480 U/L
± 7% or 10 U/L
0.988x + 1.3
ALT
plasma
U/L
≤2.6
≤4.7
4-480 U/L
± 7% or 10 U/L
1.000x - 3.6
Amylase
serum
U/L
≤2.1
≤3.3
9-1900 U/L
± 10% or 10 U/L
0.995x + 2.9
Amylase
plasma
U/L
≤2.1
≤3.5
9-1900 U/L
± 10% or 10 U/L
0.979x + 0.9
AST
serum
U/L
≤3.3
≤4.4
4-450 U/L
± 7% or 10 U/L
1.006x + 1.5
SA1047
AST
plasma
U/L
≤2.5
≤3.7
4-450 U/L
± 7% or 10 U/L
0.999x - 0.6
SA1007
Bilirubin, Direct
serum
mg/dL
≤5.3
≤6.6
0.1-14.0 mg/dL
± 10% or 0.2 mg/dL
0.998x + 0.00
SA1007
Bilirubin, Direct
plasma
mg/dL
≤1.7
≤2.8
0.1-14.0 mg/dL
± 10% or 0.2 mg/dL
1.005x + 0.01
SA1008
Bilirubin, Total
serum
mg/dL
≤5.7
≤8.5
0.2-40.0 mg/dL
± 9% or 0.3 mg/dL
1.001x + 0.00
SA1008
Bilirubin, Total
plasma
mg/dL
≤1.0
≤1.1
0.2-40.0 mg/dL
± 9% or 0.3 mg/dL
1.020x + 0.00
SA2024
BUN
serum
mg/dL
≤2.1
≤3.2
3-100 mg/dL
± 5% or 3 mg/dL
1.000x + 0.1
SA2024
BUN
plasma
mg/dL
≤1.6
≤2.1
3-100 mg/dL
± 5% or 3 mg/dL
1.009x - 0.1
SA2024
Urea Nitrogen
urine
mg/dL
≤2.0
≤3.0
40-2115 mg/dL
± 2.5 mg/dL or 12.50%
0.919x + 22.5
Catalog #
Assay
Sample Type
Units
SA2001
Albumin
serum
g/dL
≤1.9
SA2001
Albumin
plasma
g/dL
SA2002
Alkaline Phosphatase
serum
U/L
SA2002
Alkaline Phosphatase
plasma
SA1046
ALT
SA1046
SA1004
SA1004
SA1047
SA1009
Calcium
serum
mg/dL
≤1.8
≤2.3
0.4-15.0 mg/dL
± 5% or 0.4 mg/dL
0.991x - 0.02
SA1009
Calcium
plasma
mg/dL
≤1.2
≤2.0
0.4-15.0 mg/dL
± 5% or 0.4 mg/dL
1.008x - 0.06
SA1009
Calcium
urine
mg/dL
≤5.3
≤5.7
1.0-29.1 mg/dL
± 1.0 mg/dL or 15%
1.034x - 0.03
SA1010
Cholesterol
serum
mg/dL
≤1.6
≤2.4
6-600 mg/dL
± 4% or 6 mg/dL
0.987x + 8.7
SA1010
Cholesterol
plasma
mg/dL
≤1.4
≤1.9
6-600 mg/dL
± 4% or 6 mg/dL
0.994x - 2.5
SA2011
CK
serum
U/L
≤1.8
≤3.0
11-1350 U/L
± 10% or 10 U/L
0.991x - 1.3
SA2011
CK
plasma
U/L
≤2.8
≤5.4
11-1350 U/L
± 10% or 10 U/L
0.978x + 0.1
SA2039
CO2-LC
serum
mEq/L
≤4.3
≤11.9
4-50 mEq/L
± 10% or 4 mEq/L
0.981x - 0.60
SA2039
CO2-LC
plasma
mEq/L
≤3.0
≤6.1
4-50 mEq/L
± 10% or 4 mEq/L
1.000x - 0.09
SA1012
Creatinine
serum
mg/dL
≤3.9
≤9.8
0.23-25.00 mg/dL
± 5% or 0.1 mg/dL
1.016x - 0.002
SA1012
Creatinine
plasma
mg/dL
≤5.5
≤7.8
0.23-25.00 mg/dL
± 5% or 0.1 mg/dL
1.050x - 0.077
SA1012
Creatinine
urine
mg/dL
≤2.0
≤3.2
6.8-333.2 mg/dL
± 2.5 mg/dL or 12.50%
1.029x + 1.10
ACI-32
Direct TIBC
serum
µg/dL
≤1.9
≤3.1
52-700 µg/dL
± 8% or 11 µg/dL
0.987x + 3.6
ACI-35
Ferritin
serum
ng/mL
≤6.4
≤7.6
11-889 ng/mL
± 15% or 2.25 ng/mL
0.975x + 12.06
SA2013
Gamma-GT
serum
U/L
≤3.4
≤4.7
7-950 U/L
± 7% or 5 U/L
0.975x + 4.3
SA2013
Gamma-GT
plasma
U/L
≤1.9
≤1.9
7-950 U/L
± 7% or 5 U/L
0.960x + 2.8
SA1014
Glucose
serum
mg/dL
≤1.8
≤1.9
4-750 mg/dL
± 5% or 6 mg/dL
1.011x + 4.3
SA1014
Glucose
plasma
mg/dL
≤2.0
≤2.1
4-750 mg/dL
± 5% or 6 mg/dL
0.997x + 0.8
SA2038
HDL-C
serum
mg/dL
≤2.7
≤5.7
8-125 mg/dL
±10% or 3 mg/dL
1.030x - 1.3
SA2038
HDL-C
plasma
mg/dL
≤1.8
≤2.4
8-125 mg/dL
±10% or 3 mg/dL
0.989x + 0.4
SA1044
Hemoglobin A1c
whole blood
%
≤2.1
≤3.2
4.2-13.0%
± 5% or 1% HbA1c
0.910x + 0.65
SA2016
Inorganic Phosphorus
serum
mg/dL
≤3.2
≤5.7
0.4-20.0 mg/dL
± 10% or 0.4 mg/dL
1.006x - 0.01
SA2016
Inorganic Phosphorus
plasma
mg/dL
≤3.7
≤5.0
0.4-20.0 mg/dL
± 10% or 0.4 mg/dL
1.049x - 0.28
SA2016
Inorganic Phosphorus
urine
mg/dL
≤2.2
≤2.3
4.5-210.0 mg/dL
± 4 mg/dL or 11.50%
0.968x + 3.99
SA1017
Total Iron
serum
µg/dL
≤5.2
≤7.3
12-600 µg/dL
± 7% or 30 µg/dL
0.993x + 0.9
SA3018
LDH
serum
U/L
≤4.9
≤5.5
18-850 U/L
± 10% or 10 U/L
0.997x - 3.6
SA1040
LDL-C
serum
mg/dL
≤2.2
≤2.4
4-430 mg/dL
± 10% or 3 mg/dL
1.004x + 2.1
SA1040
LDL-C
plasma
mg/dL
≤2.1
≤2.8
4-430 mg/dL
± 10% or 3 mg/dL
0.995x - 1.3
4 Henderson Drive, West Caldwell, NJ 07006
Phone: 800-220-4488
Fax: 973-276-0383
Website: www.AlfaWassermannUS.com
Email: [email protected]
ACE Alera® Performance Characteristics
1
Within-Run
Total
Precision%CV2 Precision%CV2
Reportable
Range3
Reportable Range
Tolerance Limits4
Accuracy5:
y = mx + b
40-205 mmol/L
± 3% or 4 mmol/L
0.990x + 1.1
≤0.8
40-205 mmol/L
± 3% or 4 mmol/L
0.980x + 3.46
≤2.4
1.5-15.0 mmol/L
± 0.5 mmol/L
1.046x - 0.16
≤1.3
≤1.8
1.5-15.0 mmol/L
± 0.5 mmol/L
0.969x + 0.187
mmol/L
≤1.1
≤2.0
50-200 mmol/L
± 4% or 4 mmol/L
1.000x - 0.3
Catalog #
Assay
Sample Type
Units
ISE
Sodium
serum
mmol/L
≤0.6
≤0.8
ISE
Sodium
plasma
mmol/L
≤0.7
ISE
Potassium
serum
mmol/L
≤1.8
ISE
Potassium
plasma
mmol/L
ISE
Chloride
serum
ISE
Chloride
plasma
mmol/L
≤0.6
≤1.6
50-200 mmol/L
± 4% or 4 mmol/L
1.000x + 0.89
SA1045
Lipase
serum
U/L
≤9.8
≤9.9
15-700 U/L
± 10% or 15 U/L
1.038x - 4.8
SA1045
Lipase
plasma
U/L
≤3.2
≤7.4
15-700 U/L
± 10% or 15 U/L
1.022x - 0.9
SA2019
Magnesium
serum
mg/dL
≤4.3
≤5.1
0.4-6.1 mg/dL
± 8% or 0.5 mg/dL
0.960x + 0.12
SA2019
Magnesium
plasma
mg/dL
≤3.5
≤4.1
0.4-6.1 mg/dL
± 8% or 0.5 mg/dL
0.986x + 0.02
SA1022
Total Protein
serum
g/dL
≤2.3
≤3.1
0.4-14.0 g/dL
± 7% or 0.2 g/dL
1.009x - 0.01
SA1023
Total Protein
plasma
g/dL
≤1.1
≤1.3
0.4-14.0 g/dL
± 7% or 0.2 g/dL
0.999x + 0.14
SA3007
Total Thyroxine T4
serum
µg/dL
≤3.3
≤5.6
1.3-19.6 µg/dL
± 20% or 1.0 µg/dL
1.004x - 0.08
SA3007
Total Thyroxine T4
plasma
µg/dL
≤2.4
≤5.2
1.3-19.6 µg/dL
± 20% or 1.0 µg/dL
0.976x + 0.17
SA1023
Triglycerides
serum
mg/dL
≤2.0
≤3.2
16-1000 mg/dL
± 8% or 7 mg/dL
1.018x - 0.2
SA1023
Triglycerides
plasma
mg/dL
≤1.7
≤4.2
16-1000 mg/dL
± 8% or 7 mg/dL
1.007x - 7.4
SA1025
Uric Acid
serum
mg/dL
≤3.0
≤5.2
1.5-16.0 mg/dL
± 8% or 0.9 mg/dL
0.992x + 0.05
SA1025
Uric Acid
plasma
mg/dL
≤3.3
≤5.5
1.5-16.0 mg/dL
± 8% or 0.9 mg/dL
1.028x - 0.29
Alfa Wassermann
Open Channel Application Kits
Within-Run
Total
Precision%CV2 Precision%CV2
Reportable
Range3
Reportable Range
Tolerance Limits4
Accuracy5:
y = mx + b
≤2.6
4-320 mg/dL*
± 6% or 7 mg/dL
1.001x + 2.68
≤8.0
12-271 mg/dL*
± 7% or 4 mg/dL
1.034x - 1.61
≤5.14
≤4.00
2-158 mg/dL*
± 10% or 3 mg/dL
0.980x + 3.79
mg/dL
≤6.11
≤5.34
0.86-30 mg/dL*
± 10% or 4 mg/dL
1.058x + 0.23
mg/dL
≤3.0
≤1.8
23-568 mg/dL*
± 6% or 6 mg/dL
0.991x - 1.85
Catalog #
Assay
Sample Type
Units
ACI-25
Apolipoprotein A1
serum
mg/dL
≤2.1
ACI-26
Apolipoprotein B
serum
mg/dL
≤4.9
ACI-27
Lipoprotein(a)
serum
mg/dL
ACI-29
Microalbumin
urine
ACI-28
Transferrin
serum
* Typical range; actual range is the value of the low and high calibrators.
1 Representative expected performance. See method specific package insert for details.
2 Reference: CLSI. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline- Second Edition.
CLSI document EP5-A2 (ISBN 1-56238-542-9). CLSI, 940 West Valley Road, Suite 100, Wayne, PA 19087-1898, USA, 2004.
3 Represents the undiluted sample reportable range.
NOTE: for expected values refer to method specific package insert.
IT IS RECOMMENDED THAT EACH LABORATORY DETERMINE THE EXPECTED VALUES FOR ITS PARTICULAR POPULATION.
4 Reportable range tolerance limits represent the value expected ± the greater of the two criteria (% or units).
These limits may be used when verifying the reportable range.
5 Expressed as correlation with ACE® Clinical Chemistry System
610-1430 Rev 20 1014
4 Henderson Drive, West Caldwell, NJ 07006
Phone: 800-220-4488
Fax: 973-276-0383
Website: www.AlfaWassermannUS.com
Email: [email protected]