Download LACTIC ACID

LACTIC ACID
9D89-20
30-4266/R6
LACTIC ACID
This package insert contains information to run the Lactic Acid assay on the ARCHITECT c Systems and the
AEROSET System.
NOTE: Changes Highlighted
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
Call your local Abbott representative
Symbols in Product Labeling
Concentration
Catalog number/List number
Authorized Representative in the
European Community
Serial number
Ingredients
Consult instructions for use
In vitro diagnostic medical device
Manufacturer
Batch code/Lot number
Temperature limitation
Reagent 1
Use by/Expiration date
ABBOTT LABORATORIES
Abbott Park, IL 60064, USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
March 2009
©2002, 2009 Abbott Laboratories
1
NAME
REAGENT HANDLING AND STORAGE (Continued)
LACTIC ACID
Instructions for Use
INTENDED USE
1. Remove the reagent caps from two bottles of
.
2. Prepare the Working Reagent by adding 10 mL of sterile water to
each of the two
bottles.
The Lactic Acid assay is used for the quantitation of lactic acid in
human plasma.
SUMMARY AND EXPLANATION OF TEST
Lactic acid, an intermediary in carbohydrate metabolism, is derived
predominantly from skeletal muscle, brain, and erythrocytes. The blood
lactate concentration is dependent on the rate of production and the
rate of metabolism in the liver and kidneys. Approximately 30% of total
lactate production is used by the liver. Moderate increase in lactate
production results in increased hepatic lactate clearance, but uptake
by the liver is saturable when concentrations exceed 2 mmol/L. For
example, during strenuous exercise, lactate concentrations may increase
significantly, from an average concentration of about 0.9 mmol/L to more
than 20 mmol/L within 10 seconds.1
The review by Stacpoole2 describes the biochemistry and pathobiology
of lactate metabolism. A pivotal characteristic of this metabolism is
that lactate can only arise from reduction of pyruvate. Elevated lactate
associated with reduced arterial pH is called lactic acidosis. Tissue
hypoxia is the most common cause of lactic acidosis and is classified
as Type A, while lactic acidosis that is nonhypoxic is classified as
Type B. Under normal conditions, the concentration of lactate is about
10-fold higher than that of pyruvate.
Shock is perhaps the most widely recognized cause of lactic acidosis;
however, in some cases, excess lactate production may precede
shock. Such conditions as myocardial infarction, severe congestive
heart failure, pulmonary edema, and blood loss are common causes
of shock associated with lactic acidosis. Other causes of lactic
acidosis include intravenous infusion of substances such as fructose,
sorbitol, or epinephrine, and large doses of drugs such as ethanol or
acetaminophen. Hepatic necrosis, neoplasms, lymphomas, and various
forms of leukemia have been reported to cause lactic acidosis. In
diabetic coma, lactic acidosis is common.3
10 mL
H2 O
+
R1
=
Working
Reagent 1
1.
2.
3.
4.
For in vitro diagnostic use.
Do not use components beyond the expiration date.
Do not mix materials from different kit lot numbers.
CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.4 Biosafey Level 25 or other
appropriate biosafety practices6,7 should be used for materials that
contain or are suspected of containing infectious agents.
is classified per applicable European Community (EC) Directives
5.
as: Irritant (Xi). The following are the appropriate Risk (R) and Safety
(S) phrases:
R36/37/38 Irritating to eyes, respiratory system and skin.
S26
In case of contact with eyes, rinse
immediately with plenty of water and seek
medical advice.
S35
This material and its container must be
disposed of in a safe way.
S46
If swallowed, seek medical advice
immediately and show this container or label.
Reagent Kit
9D89 Lactic Acid is supplied as a lyophilized, single reagent kit
which contains:
10 x 10 mL
Funnels (5)
Bar code labeled cartridges (5)
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Plasma is the acceptable specimen.
Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes without gel barriers. The acceptable
anticoagulant is sodium fluoride/potassium oxalate. Venous specimens
should be obtained without the use of a tourniquet or immediately
after the tourniquet has been applied. If there is any delay in obtaining
the specimen, the tourniquet should be removed after the puncture
has been performed, and the blood should be allowed to circulate
for at least two minutes before sample is withdrawn. Patients should
avoid exercise of the hand or arm immediately before and during the
procedure. Centrifuge the specimen as soon after collection as possible
and immediately remove the plasma from the red blood cells.1 Ensure
centrifugation is adequate to remove platelets.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
Estimated tests per kit: 393
Calculation is based on the minimum reagent fill volume per kit.
Chromogen precursors
=
Precautions for Users
REAGENTS
Peroxidase (Horseradish)
R1
WARNINGS AND PRECAUTIONS
Lactic acid is converted to pyruvate and hydrogen peroxide (H2O2)
by lactate oxidase. Peroxidase catalyzes the oxidation of chromogen
precursor by H2O2 to produce a colored dye. The increase in
absorbance at 548 nm is directly proportional to the lactic acid
concentration in the sample.
Methodology: Lactic Acid to Pyruvate
Lactate Oxidase
+
3. Replace the
reagent caps and mix each bottle by gentle
inversion until completely dissolved. Do Not Shake.
bottles into one of the empty bar code
4. Pour contents of both
labeled cartridges provided with the reagent kit. Remove air bubbles,
if present in the cartridge, with a new applicator stick.
5. Place the cartridge in Reagent Supply Center 1.
PRINCIPLES OF PROCEDURE
Reactive Ingredients
10 mL
H2 O
Concentration
400 U/L
2,400 U/L
As required
Inactive Ingredients: Contains buffer, fillers, and stabilizers.
REAGENT HANDLING AND STORAGE
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
Specimen Storage
Plasma: Separated plasma may be analyzed immediately, stored at
2 to 8°C, or frozen. Samples are stable for 14 days at 2 to 8°C or up to
4 weeks at -20°C.
Specimen stability was verified in an in-house study of 20 sodium
fluoride/potassium oxalate plasma samples.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
Reagent Storage
Unopened reagents are stable until the expiration date when stored
at 2 to 8°C. Do not pool reagents.
Reagent stability is 7 days if the reagent is uncapped and onboard.
2
PROCEDURE
RESULTS
Materials Provided
Refer to the instrument-specific operations manual for information on
results calculations.
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
9D89 Lactic Acid Reagent Kit
Materials Required but not Provided
•
1E75 Lactic Acid Calibrator 1 x 10 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure
LIMITATIONS OF THE PROCEDURE
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
The performance characteristics of Lactic Acid on an analyzer other
than an ARCHITECT c Systems or the AEROSET System must be
validated and verified.
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Plasma: Specimens with lactic acid values exceeding 120.0 mg/dL
(13.32 mmol/L) are flagged and may be diluted using the Automated
Dilution Protocol or the Manual Dilution Procedure.
EXPECTED VALUES
Reference Range
Plasma8
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a dilution
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information.
Venous
Range (mg/dL)
Range (mmol/L)
4.5 to 19.8
0.5 to 2.2
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.111.
A study was conducted using 204 plasma samples from 99 female and
105 male volunteers. Data were analyzed as described by Solberg9
and Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS
C28-A.10 From this study, 95% of male specimens fell within 5.0 to
19.4 mg/dL, with male samples ranging from 3.9 to 20.6 mg/dL. For
female specimens, 95% fell within 4.7 to 16.8 mg/dL, with female
samples ranging from 4.5 to 18.6 mg/dL.
It is recommended that each laboratory determine its own reference
range based upon its particular locale and population characteristics.
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must
be multiplied by the appropriate dilution factor before reporting the
result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
Lactic Acid is linear up to 120.0 mg/dL (13.32 mmol/L). Linearity was
verified using CLSI protocol NCCLS EP6-A.11
Limit of Detection (LOD)
The LOD for Lactic Acid is 0.05 mg/dL (0.006 mmol/L). The LOD is the
mean concentration of an analyte-free sample + 2 SD, where SD = the
pooled, within-run standard deviation of the analyte-free sample.
CALIBRATION
Calibration is stable for approximately 7 days (168 hours).
Calibration is required whenever a new reagent is reconstituted.
Verify calibration curve with at least two levels of controls according
to the established quality control requirements for your laboratory. If
control results fall outside acceptable ranges, recalibration may be
necessary.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Lactic Acid
Calibrator package insert.
Limit of Quantitation (LOQ)
The LOQ for Lactic Acid is 0.18 mg/dL (0.020 mmol/L). The LOQ is the
analyte concentration at which the CV = 20%.
Interfering Substances
Interference studies were conducted on the AEROSET System using
CLSI protocol NCCLS EP7-P.12 Interference effects were assessed by
Dose Response and Paired Difference methods, at the medical decision
level of the analyte.
Interfering
Substance
QUALITY CONTROL
The following process is the recommendation of Abbott Laboratories
for quality control. As appropriate, refer to your laboratory standard
operating procedure(s) and/or quality assurance plan for additional
quality control requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptable criteria following a
change of reagent or calibrator lot.
Bilirubin
Hemoglobin
Human
triglyceride
Intralipid
Interferent Concentration
N
Target Observed
(mg/dL) (% of Target)
15 mg/dL (257 μmol/L)
4
19.9
30 mg/dL (513 μmol/L)
4
19.9
80.2
500 mg/dL (5.0 g/L)
4
18.7
109.2
750 mg/dL (7.5 g/L)
4
18.7
114.5
750 mg/dL (8.5 mmol/L)
4
20.8
97.4
1,000 mg/dL (11.3 mmol/L)
4
20.8
97.1
125 mg/dL (1.25 g/L)
4
19.7
109.1
250 mg/dL (2.50 g/L)
4
19.7
117.9
90.9
Bilirubin solutions at the above concentrations were prepared by
addition of a bilirubin stock to human plasma pools. Hemoglobin
solutions at the above concentrations were prepared by addition of
hemolysate to human plasma pools. Human triglyceride solutions at the
above concentrations were prepared by mixing an elevated triglyceride
human plasma pool with a normal triglyceride human plasma pool.
Intralipid solutions at the above concentrations were prepared by
addition of Intralipid to human plasma pools.
Interferences from medications or endogenous substances may affect
results.13
3
SPECIFIC PERFORMANCE CHARACTERISTICS
(Continued)
BIBLIOGRAPHY
1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:975–6.
2. Stacpoole PW. Lactic acidosis. In: Ober PK, editor. Endocrinology
and Metabolism Clinics of North America. Philadelphia, PA: WB
Saunders; 1993:221–45.
3. Henry JB, editor. Clinical Diagnosis and Management by Laboratory
Methods, 19th ed. Philadelphia, PA: WB Saunders; 1996:206–7.
4. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Bloodborne Pathogens.
5. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
6. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
7. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
8. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
Philadelphia, PA: WB Saunders; 1995:382.
9. Solberg HE. Establishment and use of reference values. In: Burtis
CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
2nd ed. Philadelphia, PA: WB Saunders; 1994:454–84.
10. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
Reference Intervals in the Clinical Laboratory; Approved Guideline
(C28-A). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1995.
11. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity
of Quantitative Measurement Procedures: A Statistical Approach;
Approved Guideline (EP6-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2003.
12. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
National Committee for Clinical Laboratory Standards, 1986.
13. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-43–6.
14. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices—Second Edition;
Tentative Guideline (EP5-T2). Villanova, PA: The National
Committee for Clinical Laboratory Standards, 1992.
15. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1995.
Precision
The imprecision of the Lactic Acid assay is ≤ 6.3% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-T214
are summarized below.
Control
Level 1
Level 2
N
80
80
Mean (mg/dL)
46.2
15.6
Within Run
Between Run
SD
0.59
0.25
%CV
1.3
1.6
0.18
SD
0.81
%CV
1.7
1.1
SD
0.69
0.41
Between Day
Total
%CV
1.5
2.6
SD
1.21
0.51
%CV
2.6
3.3
Method Comparison
Correlation studies were performed using CLSI protocol NCCLS
EP9-A.15
Plasma results from the Lactic Acid assay on the AEROSET System
were compared with those from a commercially available lactate
oxidase methodology.
Plasma results from the Lactic Acid assay on an ARCHITECT c System
were compared with the Lactic Acid assay on the AEROSET System.
AEROSET vs.
Comparative Method
N
Y - Intercept
ARCHITECT
vs. AEROSET
78
52
0.774
0.021
Correlation Coefficient
0.999
0.999
Slope
1.018
0.993
6.2 to 92.3
7.00 to 116.30
Range (mg/dL)*
*AEROSET Range
TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, and c System are
trademarks of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are
property of their respective companies.
4
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Lactic Acid Plasma—Conventional and SI Units
Configure assay parameters — General
● General
Configure assay parameters — SmartWash
о Calibration о SmartWash о Results
о Interpretation
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Lact
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Assay: Lact
Type: Photometric
Version: †
Number: 1050
● Reaction definition
о Reagent / Sample
о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 548 / 700
Main: 16 – 25
Last required read: 25
Absorbance range: ___ – ___
Color correction: ___ – ___
Sample blank type: None
о Reaction definition
● Reagent / Sample
Reagent: LACT0
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STANDARD
2.0
___
_________ : ___
___
_________ : ___
___
Configure assay parameters — Results — Conventional Units
о General
о SmartWash ● Results о Interpretation
Assay: Lact
Assay number: 1050
Dilution default range:
Result units: mg/dL
Low-Linearity:
0.2‡‡
High-Linearity: 120.0
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
4.5 – 19.8
о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
___
___
___
Lactic Acid Plasma—Conventional Units
R1
200
___
Type 0
Water Dilution factor
___ =
1:1.00
___ =
___ =
Default
dilution
о Calibration
●
о
о
Configure result units — Conventional Units
о Reagent / Sample
о Reaction definition
Reaction check:
● Validity checks
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
None
Maximum absorbance variation: ___
Configure assay parameters — Calibration
о General
Assay:
Lactic Acid Plasma—SI Units
● Calibration о SmartWash о Results
Lact
Replicates: 3
о Volumes
о SmartWash ● Results о Interpretation
Assay: Lact
Assay number: 1050
Dilution default range:
Result units: mmol/L
Low-Linearity:
0.02‡‡
High-Linearity: 13.32
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.50 – 2.20
о Validity checks
Calibrator level: Concentration:
Blank: Water
0††
Cal 1: Lactic1
‡
● Volumes
Calibrator level
Water
Lactic1
о Volumes
Calibration intervals:
Full interval: 168
Calibration type:
Adjust type: None
о Calibrators
о General
о Intervals
о Intervals
Calibrator: Lactic
о Calibrators
Configure assay parameters — Results — SI Units
[Range 1 – 3]
о Calibrators
Blank:
Cal 1:
о Interpretation
Calibration method: Linear
● Calibrators
Calibrator set:
Lactic
о Volumes
Blank absorbance range:
Span:
Span absorbance range:
Expected cal factor:
Expected cal factor tolerance %:
Sample
2.0
2.0
Lact
†
mg/dL
1
[Range 0 – 4]
1.0000
0.0000
Diluted
sample
___
___
● Intervals
о Validity checks
Diluent Water
___ ___
___ ___
Configure result units — SI Units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Validity checks
(hours)
о Intervals
_____ – _____
Blank – Blank
_____ – _____
0.00
0
о Calibration
Lact
†
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
● Validity checks
† Due to differences in instrument systems and unit configurations, version numbers may vary.
†† Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to the concentration specified on calibrator labeling or value sheet. In ARCHITECT software version 5.00 and above, these values are
defined on the Configure calibrator set screen.
‡‡ The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
5
AEROSET SYSTEM ASSAY PARAMETERS
Lactic Acid Plasma—SI Units
Lactic Acid Plasma—Conventional Units
Assay Configuration: Outline Page
Assay Configuration: Outline Page
Assay Name
Assay #
Lact
50
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.2**
Reference Ranges*
Age
L-Reference-H
4.5
19.8
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Assay Name
Assay #
Lact
50
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.02**
Reference Ranges*
Age
Line
A-Line
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
120.0
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
A-Line
L-Reference-H
0.5
2.2
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
N/A
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
13.32
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Assay Configuration: Base Page
Assay Configuration: Base Page
Reaction Mode
Wavelength-Prim/Sec Read time-Main/Flex
AbsMaxVar
END UP
548 / 700
16 – 25 / 0 – 0
0.0
Sample Blank Test
Blank Read Time Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
2.0
0.0
0
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
LACT011 – ___*
200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
1
mg/dL
Reaction Mode
Wavelength-Prim/Sec Read time-Main/Flex
AbsMaxVar
END UP
548 / 700
16 – 25 / 0 – 0
0.0
Sample Blank Test
Blank Read Time Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.0
0.0
0
0
Rgt Name/Pos
Dil 1
2.0
0.0
0
0
Diluent: _____ _–__*
Dil 2
2.0
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
LACT011 – ___*
200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
___________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Assay Configuration: Calibration Page
Assay Configuration: Calibration Page
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.0
C1
Lactic
2.0
C2
2.0
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.0
C1
Lactic
2.0
C2
2.0
Interval (H)
168
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Interval (H)
168
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Assay Configuration: SmartWash Page
Assay Configuration: SmartWash Page
Rgt Probe
Rgt Probe
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
6
7
8