HIL Transa 303525r5

Sample Interference Indices, ALT/AST Protocol
Hemolysis (H), Icterus (I), and Lipemia (L)

30-3525/R5
Sample Interference Indices,

ALT/AST Protocol
Hemolysis (H), Icterus (I), and Lipemia (L)
This application sheet contains information to run the H, I, and L sample interference indices on the ARCHITECT
cSystems™.
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: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative
Symbols in Product Labeling

Authorized Representative in the
European Community
Catalog number/List number
Manufacturer
ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
©2002, 2006 Abbott Laboratories
30-3525/R5/December 2006
ARCHITECT® cSystems™ Sample Interference Indices, ALT/AST Protocol: H, I, and L
NAME SPECIMEN COLLECTION AND HANDLING
SAMPLE INTERFERENCE INDICES, ALT/AST PROTOCOL: Suitable Specimens
HEMOLYSIS (H), ICTERUS (I), AND LIPEMIA (L) Any serum or plasma specimen suitable for analysis on the ARCHITECT
cSystems is also suitable for determination of the H, I, and L index
INTENDED USE values. Hemoglobin and bilirubin concentrations may be altered in aged
The sample interference indices are used to generate semi-quantitative or improperly stored specimens. Since the index value is determined by
index values and qualitative estimates for the presence of hemolysis, reading specific multiple wavelengths for each component, fresh
icterus, or lipemia (turbidity) in serum or plasma samples. specimens will provide the most reliable index values. Index values for
aged specimens or those exposed to light may still indicate the presence
of interferent, but the estimate may not reflect the condition of the fresh
SUMMARY AND EXPLANATION OF TEST specimen.
Clinical specimens of serum or plasma may contain some amount of For total sample volume requirements, refer to the ASSAY PARAMETERS
hemoglobin derived from hemolysis, elevated bilirubin due to hepatic or section of this application sheet and Section 5 of the ARCHITECT
hemolytic disease, or turbidity (lipemia) due primarily to elevated System Operations Manual.
triglycerides. These three constituents may act as interferents in some
clinical chemistry tests, and all Abbott Clinical Chemistry package inserts
contain quantitative data that indicate the extent to which this
PROCEDURE
interference occurs. Materials Required but not Provided
The purpose of the sample interference index determinations is to obtain 7D56 ALT Reagent Kit, or
a semi-quantitative or qualitative value for one or any combination of 7D81 AST Reagent Kit
these interferents. This is achieved by selecting the desired index or
Use of the non-activated ALT or AST reagent for determination of
combination of index values on the Patient order screen, designated as
H, I, and L sample interference indices provides an alternative to the
H, I, and L. Alternatively, a panel may be defined to simplify ordering of
Saline Protocol that may also be used for this purpose. Laboratories
any combination of two or more index values. The ARCHITECT cSystems
that perform ALT or AST analysis on a high percentage of their samples
software contains formulae that use multiple wavelengths to derive the
may wish to consider use of ALT or AST reagent rather than saline.
requested index values. Index values are printed on the sample report
Use of ALT or AST reagent avoids loss of sample throughput since the
and reflect the approximate concentration of the specified interferent.
H, I, and L index absorbance readings are taken at the same time as
For more information on the topic of interference due to these
the analytical absorbance readings used for determination of enzyme
components, refer to the review article by Kroll and Elin.1
activity.
NOTE: Either ALT or AST may be selected as the H, I, and L index
PRINCIPLES OF PROCEDURE reagent, but not both. If the reagent selection is changed at any time, it
Visual inspection of specimens has been shown to be an unreliable is necessary to review the H, I, and L test file parameters and ensure
method for estimation of interferent concentrations.2 More consistent that they match the appropriate values supplied in the ASSAY
determination of sample interference index values on the ARCHITECT PARAMETERS section of this application sheet.
cSystems involves measurement of the sample at multiple wavelengths, Assay Configuration
following dilution with ALT (Alanine Aminotransferase, non-activated) or
AST (Aspartate Aminotransferase, non-activated) reagent. When one or NOTE: These procedures must be completed before initial use of the
more sample interference index values are requested, sample and sample interference indices.
reagent are pipetted into a cuvette and read spectrophotometrically at up Loading the assay files:
to seven wavelengths. Pre-programmed formulae for each index value Five files must be installed initially from the ARCHITECT cSystems Assay
use these absorbance readings to calculate the index value in the Disk before configuring H, I, and L assays to use the ALT or AST
appropriate units for that interferent. protocol.
The procedure described in this application sheet uses ALT or AST • ALT or AST assay
reagent, placed on the ARCHITECT cSystems. Saline may be used in
• HILref assay (must be installed before installing the H, I, and L
place of ALT or AST reagent by modifying the parameter file. Refer to
assays)
the ARCHITECT cSystems Sample Interference Indices, Saline Protocol
application sheet for information regarding this alternate procedure. • H, I, and L assays
Refer to Section 3 of the ARCHITECT System Operations Manual for Refer to Install or delete an assay file in Section 2 of the ARCHITECT
additional information. System Operations Manual.
Edit the reference assay:
WARNINGS AND PRECAUTIONS 1. Access the Configuration screen - Assay settings - Assay parameters
Precautions for Users view.
1. Not for in vitro diagnostic use. 2. Select the H, I, and L assays from the Assays list, and then select
2. The index values for hemolysis, icterus, and lipemia are F6 - Configure.
spectrophotometric estimates of potential sample interference. The Configure assay parameters window - General view displays.
These indices can not be used for determining actual concentrations 3. Select the Reference photometric assay list button, and then select
of hemoglobin, bilirubin, and triglycerides. the ALT (or AST) assay.
3. Refer to your laboratory standard operating procedure(s) for 4. Use the previous/next buttons to display each assay, and then select
determining the criteria for which the specific index values can be the same reference photometric assay for each.
used for reporting the presence of potential interferents. 5. Select Done to save your changes.
4. CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and handled in accordance with the OSHA
Standard on Bloodborne Pathogens.3 Biosafety Level 24 or other
appropriate biosafety practices5,6 should be used for materials that
contain or are suspected of containing infectious agents.
ABBOTT LABORATORIES, Diagnostics Division 2 30-3525/R5/December 2006

Abbott Park, Illinois 60064
PROCEDURE (CONTINUED) LIMITATIONS OF THE PROCEDURE (CONTINUED)
Assay Configuration (Continued) Effect of Combined Interferents
Edit the correlation factor and intercept when using the ALT assay: NOTE: Table based on Sample Interference Index data obtained from
NOTE: These edits are only required if you select the ALT assay as the specimens diluted with saline. Similar effects are expected from
Reference photometric assay. specimens diluted with ALT or AST.
1. Access the Configuration screen - Assay settings - Assay parameters Conventional units are mg/dL; SI units, shown in parentheses, are g/L for
view. hemoglobin, µmol/L for bilirubin, and mmol/L for lipemia.
2. Select Result units from the Assay categories list on the Effects caused by a second interferent at the following
Configuration screen. concetrations are:
If the
3. Select the H and L assays from the Assays list, and then select Interferent Hemolysis
F6 - Configure. Icterus Lipemia
Level Is:
The Configure result units window displays. 250 1000 3.8 7.5 15 30 125 250 500 1000
(2.5) (10.0) (65.0) (128.3) (256.5) (513.0) (1.41) (2.83) (5.65) (11.30)
4. Edit the value in the Correlation factor and Intercept data entry
boxes to the appropriate values supplied in the ASSAY PARAMETERS 0* — —
section of this application sheet.
Hemolysis
5. Select Done to save your changes. 250
— — N/E N/E N/E N/E
(2.5)
Additions to existing ALT or AST assay parameters:
1000
You must configure the following additional SmartWash™ settings in the — — N/E N/E N/E N/E N/E
(10.0)
ALT or AST assay file. These washes are not listed in the ARCHITECT
cSystems ASSAY PARAMETERS section of the ALT or AST package 0* — — — —
insert, because they are only required when the ALT or AST assay is
used for the determination of H, I, and L. 3.8
— — — — N/E
(65.0)
Configure assay parameters – SmartWash
Icterus
7.5
N/E — — — — N/E N/E
General Calibration SmartWash Results Interpretation (128.3)
15
N/E — — — — N/E N/E N/E
COMPONENT REAGENT/ASSAY WASH Volume Replicates (256.5)
R1 ALBG0 Detergent A 345 1 30
N/E — — — — N/E N/E N/E N/E
(513.0)
R1 ALBP0 Detergent A 345 1
R1 CA000 Detergent A 345 1 0* N/E N/E N/E N/E — — — —
Refer to Configure the SmartWash settings in Section 2 of the
125
ARCHITECT System Operation Manual. N/E N/E N/E N/E — — — —
(1.41)
Lipemia
Assay Procedure 250

N/E N/E N/E N/E — — — —
For a detailed description of how to run an assay, refer to Section 5 of (2.83)
the ARCHITECT System Operation Manual. 500
N/E N/E N/E N/E N/E — — — —
(5.65)
CALIBRATION 1000
N/E N/E N/E N/E N/E N/E — — — —
Formulae for index values are contained within the ARCHITECT (11.30)
cSystems software. To ensure optimal reliability of the ARCHITECT * Where the initial interferent concentration is “0”, a percent change
cSystems Sample Interference Indices, ALT/AST Protocol, calibration of cannot be determined. The arrows indicate the direction and
the reagent is required at the interval specified in the Calibration section approximate magnitude of change.
of the ALT or AST package insert. N/E: Effect is less than 10%
or : Effect is between 10% and 25% in indicated direction
RESULTS
Results for H, I, and L index values as determined by this application are
printed as semi-quantitative values with an option to also print qualitative
interpretation text (1+, 2+, etc.). Recommended settings are provided in
the ASSAY PARAMETERS section of this application sheet. Index values
will approximate interferent concentrations in the units appropriate to the
installed assay file, i.e., conventional units or SI units.
LIMITATIONS OF THE PROCEDURE

The sample interference indices can not be used with urine or cerebral
spinal fluid (CSF) samples.
Some specimens may contain combinations of two or more interferents.
For example, specimens may be both icteric and hemolyzed. In these
situations, index values still indicate the presence of the interferent, but
not necessarily the approximate concentration of interferent.
Approximate interactions between each pair of index values are shown in
the table below. In the unusual circumstance that all three interferents
are present in a sample, use of the sample interference index option is
not recommended. Because of these interactions, sample interference
indices should not be used when combinations of interferents are
present that may result in altered index values, as shown in the following
table.
Note that a high degree of hemolysis can result in a positive L index
value even when lipemia is not present; icterus can result in a positive
H index value in an unhemolyzed sample.
30-3525/R5/December 2006 3 ABBOTT LABORATORIES, Diagnostics Division

BIBLIOGRAPHY
1. Kroll MH, Elin RJ. Interference with clinical laboratory analyses. Clin
Chem 1994;40:1996–2005.
2. Glick MR, Ryder KW, Glick SJ, et al. Unreliable visual estimation of
the incidence and amount of turbidity, hemolysis, and icterus in
serum from hospitalized patients. Clin Chem 1989;35:837–9.
3. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
4. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication (CDC),
4th ed. Washington, DC: US Government Printing Office, May 1999.
5. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
6. 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.
TRADEMARKS
ARCHITECT is a registered trademark of Abbott Laboratories.
cSystem and SmartWash are trademarks of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.

ARCHITECT cSYSTEMS ASSAY PARAMETERS
Hemolysis (H) Index Parameters—ALT Reagent Hemolysis (H) Index Parameters—ALT Reagent
Conventional Units SI Units
Configure assay parameters – General Configure assay parameters – General
General Calibration SmartWash Results Interpretation General Calibration SmartWash Results Interpretation
Assay: H Type: Hemolysis Version: 2 Assay: H Type: Hemolysis Version: 2
Number: 1071 Number: 1071
Reference photometric assay: ALT Reference photometric assay: ALT
Configure assay parameters – Results Configure assay parameters – Results

Assay: H Result units: Index Assay: H Result units: Index
Assay defaults: Assay defaults:
Low-Linearity: ___ Low-Linearity: ___
High-Linearity: ___ High-Linearity: ___
Gender and age specific ranges: Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME GENDER AGE (UNITS) NORMAL EXTREME
Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Assay: H Assay: H
Name: Range: Results review required: Name: Range: Results review required:
<Blank> < 30 <Blank> < 0.30
1+ >= 30 1+ >= 0.30
2+ >= 100 2+ >= 1.00
3+ >= 200 3+ >= 2.00
4+ >= 500 4+ >= 5.00
Configure result units Configure result units

Assay: H Assay: H
Version: 2 Version: 2
Result units: Index Result units: Index
Decimal places: 0 [Range 0 – 4] Decimal places: 2 [Range 0 – 4]
Correlation factor: 0.9800 Correlation factor: 0.0098
Intercept: 0.0000 Intercept: 0.0000

ARCHITECT cSYSTEMS ASSAY PARAMETERS (Continued)
Icterus (I) Index Parameters—ALT Reagent Icterus (I) Index Parameters—ALT Reagent
Assay: I Type: Icterus Version: 1 Assay: I Type: Icterus Version: 1

Assay: I Result units: Index Assay: I Result units: Index

Assay: I Assay: I
<Blank> < 2.0 <Blank> < 34.2
1+ >= 2.0 1+ >= 34.2
2+ >= 4.0 2+ >= 68.4
3+ >= 10.0 3+ >= 171.0
4+ >= 20.0 4+ >= 342.0

Assay: I Assay: I

Lipemia (L) Index Parameters†—ALT Reagent Lipemia (L) Index Parameters†—ALT Reagent
Assay: L Type: Lipemia Version: 2 Assay: L Type: Lipemia Version: 2

Assay: L Result units: Index Assay: L Result units: Index

Assay: L Assay: L
<Blank> < 50 <Blank> < 0.57
1+ >= 50 1+ >= 0.57
2+ >= 100 2+ >= 1.13
3+ >= 150 3+ >= 1.70
4+ >= 200 4+ >= 2.26
Configure results units Configure results units

Assay: L Assay: L
Intercept: -0.2582 Intercept: -0.0029
† Based on Intralipid.

Hemolysis (H) Index Parameters—AST Reagent Hemolysis (H) Index Parameters—AST Reagent
Assay: H Type: Hemolysis Version: 2 Assay: H Type: Hemolysis Version: 2
Reference photometric assay: AST Reference photometric assay: AST

Assay: H Result units: Index Assay: H Result units: Index

Assay: H Assay: H
<Blank> < 30 <Blank> < 0.30
1+ >= 30 1+ >= 0.30
2+ >= 100 2+ >= 1.00
3+ >= 200 3+ >= 2.00
4+ >= 500 4+ >= 5.00

Assay: H Assay: H

Icterus (I) Index Parameters—AST Reagent Icterus (I) Index Parameters—AST Reagent
Assay: I Type: Icterus Version: 1 Assay: I Type: Icterus Version: 1

Assay: I Result units: Index Assay: I Result units: Index

Assay: I Assay: I
<Blank> < 2.0 <Blank> < 34.2
1+ >= 2.0 1+ >= 34.2
2+ >= 4.0 2+ >= 68.4
3+ >= 10.0 3+ >= 171.0
4+ >= 20.0 4+ >= 342.0

Assay: I Assay: I

Lipemia (L) Index Parameters†—AST Reagent Lipemia (L) Index Parameters†—AST Reagent
Assay: L Type: Lipemia Version: 2 Assay: L Type: Lipemia Version: 2

Assay: L Result units: Index Assay: L Result units: Index

Assay: L Assay: L
<Blank> < 50 <Blank> < 0.57
1+ >= 50 1+ >= 0.57
2+ >= 100 2+ >= 1.13
3+ >= 150 3+ >= 1.70
4+ >= 200 4+ >= 2.26
Configure results units Configure results units

Assay: L Assay: L
Intercept: -0.2065 Intercept: -0.0023


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Sample Interference Indices, ALT/AST Protocol

Hemolysis (H), Icterus (I), and Lipemia (L)

Sample Interference Indices,

NOTE: Changes Highlighted

Symbols in Product Labeling

ABBOTT LABORATORIES ABBOTT

ABBOTT LABORATORIES, Diagnostics Division 2 30-3525/R5/December 2006

Assay Procedure 250

LIMITATIONS OF THE PROCEDURE

30-3525/R5/December 2006 3 ABBOTT LABORATORIES, Diagnostics Division

ABBOTT LABORATORIES, Diagnostics Division 4 30-3525/R5/December 2006

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure result units Configure result units

30-3525/R5/December 2006 5 ABBOTT LABORATORIES, Diagnostics Division

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure result units Configure result units

ABBOTT LABORATORIES, Diagnostics Division 6 30-3525/R5/December 2006

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure results units Configure results units

30-3525/R5/December 2006 7 ABBOTT LABORATORIES, Diagnostics Division

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure result units Configure result units

ABBOTT LABORATORIES, Diagnostics Division 8 30-3525/R5/December 2006

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure result units Configure result units

30-3525/R5/December 2006 9 ABBOTT LABORATORIES, Diagnostics Division

Configure assay parameters – Results Configure assay parameters – Results

Configure assay parameters – Interpretation Configure assay parameters – Interpretation

Configure results units Configure results units

ABBOTT LABORATORIES, Diagnostics Division 10 30-3525/R5/December 2006

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