Sample Interference Indices, Saline Protocol

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

30-3990/R7

Sample Interference Indices,

Saline 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.

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©2002, 2007 Abbott Laboratories
30-3990/R7/August 2007
 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
NAME
SAMPLE INTERFERENCE INDICES, SALINE PROTOCOL:
HEMOLYSIS (H), ICTERUS (I), AND LIPEMIA (L)
INTENDED USE
The sample interference indices are used to generate semi-quantitative
index values and qualitative estimates for the presence of hemolysis,
icterus, or lipemia (turbidity) in serum or plasma samples.
SUMMARY AND EXPLANATION OF TEST
Clinical specimens of serum or plasma may contain some amount of
hemoglobin derived from hemolysis, elevated bilirubin due to hepatic or
hemolytic disease, or turbidity (lipemia) due primarily to elevated
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
interference occurs.
The purpose of the sample interference index determinations is to obtain
a semi-quantitative or qualitative value for one or any combination of
these interferents. This is achieved by selecting the desired index or
combination of index values on the Patient order screen, designated as
H, I, and L. Alternatively, a panel may be defined to simplify ordering of
any combination of two or more index values. The ARCHITECT cSystems
software contains formulae that use multiple wavelengths to derive the
requested index values. Index values are printed on the sample report
and reflect the approximate concentration of the specified interferent.
For more information on the topic of interference due to these
components, refer to the review article by Kroll and Elin.1
PRINCIPLES OF PROCEDURE
Visual inspection of specimens has been shown to be an unreliable
method for estimation of interferent concentrations.2 More consistent
determination of sample interference index values on the ARCHITECT
cSystems involves measurement of the sample at multiple wavelengths,
following dilution with isotonic saline. When one or more sample
interference index values are requested, sample and saline are pipetted
into a cuvette and read spectrophotometrically at seven wavelengths.
Pre-programmed formulae for each index value use these absorbance
readings to calculate the index value in the appropriate units for that
interferent.
The procedure described in this application sheet uses isotonic saline,
placed on the ARCHITECT cSystems as an R1 reagent. ALT or AST
reagent may be used in place of saline by modifying the parameter file.
Refer to the ARCHITECT cSystems Sample Interference Indices,
ALT/AST Protocol application sheet for information regarding this
alternate procedure. Refer to Section 3 of the ARCHITECT System
Operations Manual for additional information.
WARNINGS AND PRECAUTIONS
Precautions for Users
1. Not for in vitro diagnostic use.
2. The index values for hemolysis, icterus, and lipemia are
spectrophotometric estimates of potential sample interference.
These indices cannot be used for determining actual concentrations
of hemoglobin, bilirubin, and triglycerides.
3. Refer to your laboratory standard operating procedure(s) for
determining the criteria for which the specific index values can be
used for reporting the presence of potential interferents.
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
Abbott Park, Illinois 60064
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Any serum or plasma specimen suitable for analysis on the ARCHITECT
cSystems is also suitable for determination of the H, I, and L index
values. Hemoglobin and bilirubin concentrations may be altered in aged
or improperly stored specimens. Since the index value is determined by
reading specific multiple wavelengths for each component, fresh
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
specimen.
For total sample volume requirements, refer to the ASSAY PARAMETERS
section of this application sheet and Section 5 of the ARCHITECT
System Operations Manual.
PROCEDURE
Materials Required but not Provided
• Saline (0.85% to 0.90% NaCl)
• Reagent Cartridge
The only required reagent is isotonic saline placed in an empty reagent
cartridge. Saline is not bar coded and must be manually assigned a
position in Reagent Supply Center 1.
Do not reuse cartridges.
Refer to Configure a user-defined reagent kit in Section 2 of the
ARCHITECT System Operations Manual and Load non-bar coded
reagents in Section 5 of the ARCHITECT System Operations Manual.
Assay Configuration
NOTE: These two procedures must be completed before initial use of the
assay.
Create a user-defined reagent:
1. Access the Configuration screen - Assay settings - Assay parameters
view.
2. Select CC reagent settings from the Assay categories list on the
Configuration screen.
3. Select NEW from the Reagents list, and then select F6 - Configure.
The Configure reagent (CC reagent settings) window displays.
4. Enter HILref in the Reagent name data entry box.
5. Select the Reagent type list button, and then select R1 only.
6. Enter a value in the Reagent low alert data entry box. (optional)
7. Enter a value in the Onboard stability data entry box. (optional)
8. Select Done to save your changes.
Refer to Configure a user-defined reagent in Section 2 of the
ARCHITECT System Operations Manual.
Edit the HILref assay to use the user-defined HILref reagent:
1. Access the Configuration screen - Assay settings - Assay parameters
view.
2. Select HILref from the Assays list, and then select F6 - Configure.
The Configure assay parameters window - General view displays.
3. Select the Reagent/Sample option.
The Configure assay parameters window - Reagent/Sample view
displays.
4. Select the Reagent list button, and then select the HILref reagent.
5. Enter 200 in the R1 Reagent volume data entry box.
6. Select Done to save your changes.
Refer to Configuration screen - Assay settings view in Section 2 of the
ARCHITECT System Operations Manual.
Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of
the ARCHITECT System Operations Manual.
2 30-3990/R7/August 2007
 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
CALIBRATION LIMITATIONS OF THE PROCEDURE (Continued)
Formulae for index values are contained within the ARCHITECT Effect of Combined Interferents
cSystems software. For the ARCHITECT cSystems Sample Interference Conventional units are mg/dL; SI units, shown in parentheses, are g/L for
Indices, Saline Protocol, calibration is not required for either the HIL hemoglobin, μmol/L for bilirubin, and mmol/L for lipemia.
reference file (HILref) or specific H, I, or L parameter files.
Effects caused by a second interferent at the following
RESULTS If the concetrations are:
Results for H, I, and L index values as determined by this application are Interferent Hemolysis Icterus Lipemia
printed as semi-quantitative values with an option to also print qualitative Level Is: 250 1000 3.8 7.5 15 30 125 250 500 1000
interpretation text (1+, 2+, etc.). Recommended settings are provided in (2.5) (10.0) (65.0) (128.3) (256.5) (513.0) (1.41) (2.83) (5.65) (11.30)
the ASSAY PARAMETERS section of this application sheet. Index values
will approximate interferent concentrations in the units appropriate to the 0* — —        
installed assay file, i.e., Conventional units or SI units.

Hemolysis
250
— — N/E N/E N/E N/E    
LIMITATIONS OF THE PROCEDURE (2.5)
1000
The sample interference indices cannot be used with urine or cerebral — — N/E N/E N/E N/E N/E   
spinal fluid (CSF) samples. (10.0)

Some specimens may contain combinations of two or more interferents. 0*   — — — —    

For example, specimens may be both icteric and hemolyzed. In these
situations, index values still indicate the presence of the interferent, but 3.8
not necessarily the approximate concentration of interferent.   — — — — N/E   
(65.0)
Approximate interactions between each pair of index values are shown in

Icterus
the table below. In the unusual circumstance that all three interferents 7.5
N/E  — — — — N/E N/E  
are present in a sample, use of the sample interference index option is (128.3)
not recommended. Because of these interactions, sample interference 15
indices should not be used when combinations of interferents are N/E  — — — — N/E N/E N/E 
(256.5)
present that may result in altered index values, as shown in the following
30
table. N/E  — — — — N/E N/E N/E N/E
(513.0)
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 0*   N/E N/E N/E N/E — — — —
H index value in an unhemolyzed sample.
125
  N/E N/E N/E N/E — — — —
(1.41)
Lipemia

250
  N/E N/E N/E N/E — — — —
(2.83)
500
N/E  N/E N/E N/E N/E — — — —
(5.65)
1000
N/E N/E N/E N/E N/E N/E — — — —
(11.30)

* Where the initial interferent concentration is “0”, a percent change

cannot be determined. The arrows indicate the direction and
approximate magnitude of change.
N/E: Effect is less than 10%
 or : Effect is between 10% and 25% in indicated direction
 or : Effect is between 26% and 50% in indicated direction
 or : Effect is between 51% and 100% in indicated direction

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Abbott Park, Illinois 60064
 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
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. 5th ed. Washington, DC:
US Government Printing Office; January 2007.
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 is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.

ABBOTT LABORATORIES, Diagnostics Division 4 30-3990/R7/August 2007

Abbott Park, Illinois 60064
 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
ARCHITECT cSYSTEMS ASSAY PARAMETERS

Sample Interference Indices, Saline Protocol Configure assay parameters – SmartWash

Four files are required for determination of H, I, and L index values.
The first is the reference file that defines the major parameters.  General  Calibration  SmartWash  Results  Interpretation
A separate file is required for each index value that defines parameters Assay: HILref
specific to H, I, and L. COMPONENT REAGENT/ASSAY WASH Volume Replicates
HIL Reference Parameters—Conventional and SI Units R1 ALBG0 Detergent A 345 1
Configure assay parameters – General R1 ALBP0 Detergent A 345 1
 General  Calibration  SmartWash  Results  Interpretation R1 CA000 Detergent A 345 1
Assay: HILref Type: Photometric Version: † Cuvette Trig 10% Detergent B *** 345
Number: 1074 ***Select “Detergent B” for software prior to Version 2.2.
 Reaction definition  Reagent/Sample  Validity checks
Reaction mode: End up Configure assay parameters – Results
Primary Secondary Read times  General  Calibration  SmartWash  Results  Interpretation
Wavelength: 340 / None Main: 32 – 33 Assay: HILref Result units: ABS
Last required read: 33 Assay defaults:
Absorbance range: ___ – ___ Color correction: ___ – ___ Low-Linearity: ___
Sample blank type: None High-Linearity: ___
Gender and age specific ranges:
Configure assay parameters – General (For software versions 2.60 or 3.10 and higher)* GENDER AGE (UNITS) NORMAL EXTREME
 General  Calibration  SmartWash  Results  Interpretation
Assay: HILref Type: Photometric Version: †
Number: 1074
 Reaction definition  Reagent/Sample  Validity checks
Reaction mode: End up
Primary Secondary Read times Configure assay parameters – Interpretation
Wavelength: 340 / None Main: 4* – 5*  General  Calibration  SmartWash  Results  Interpretation
Last required read: 5* Assay: HILref
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None Name: Range: Results review required:
______ < 
______ >= 
 Reaction definition  Reagent/Sample  Validity checks
______ >= 
R1
______ >= 
Reagent: HILS0†† Reagent volume: 200
______ >= 
Diluent: None Water volume: ___
Diluent dispense mode: Type 0 Dispense mode: Type 0
Diluted Default Configure result units
Dilution name Sample sample Diluent Water Dilution factor dilution
Assay: HILref
STANDARD 5.3 ___ ___ ___ = 1:1.00  Version: †
_________ ___ ___ ___ ___ =  Result units: ABS
_________ ___ ___ ___ ___ =  Decimal places: 0 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000
 Reaction definition  Reagent/Sample  Validity checks
Reaction check: None

Maximum absorbance variation: ___

Configure assay parameters – Calibration

 General  Calibration  SmartWash  Results  Interpretation
Assay: HILref Calibration method: Abs

† Due to differences in instrument systems and unit configurations, version numbers may vary.
* Configure for software versions 2.60 or 3.10 and higher.
†† Reagent must be edited to HILref. Refer to the Assay Configuration section of this application sheet.

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Abbott Park, Illinois 60064
 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
ARCHITECT cSYSTEMS ASSAY PARAMETERS (Continued)

Hemolysis (H) Index Parameters Hemolysis (H) Index Parameters

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: † Assay: H Type: Hemolysis Version: †
Number: 1071 Number: 1071
Reference photometric assay: HILref Reference photometric assay: HILref

Configure assay parameters – Results Configure assay parameters – Results

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
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

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  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: † Version: †
Result units: Index Result units: Index
Decimal places: 0 [Range 0 – 4] Decimal places: 2 [Range 0 – 4]
Correlation factor: 0.9500 Correlation factor: 0.0095
Intercept: 0.0000 Intercept: 0.0000

† Due to differences in instrument systems and unit configurations, version numbers may vary.

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 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
ARCHITECT cSYSTEMS ASSAY PARAMETERS (Continued)

Icterus (I) Index Parameters Icterus (I) Index Parameters

Conventional Units SI Units
Configure assay parameters – General Configure assay parameters – General
 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: I Type: Icterus Version: † Assay: I Type: Icterus Version: †
Number: 1072 Number: 1072
Reference photometric assay: HILref Reference photometric assay: HILref

Configure assay parameters – Results Configure assay parameters – Results

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: I Result units: Index Assay: I 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

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: I Assay: I

Name: Range: Results review required: Name: Range: Results review required:
<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 

Configure result units Configure result units

Assay: I Assay: I
Version: † Version: †
Result units: Index Result units: Index
Decimal places: 1 [Range 0 – 4] Decimal places: 1 [Range 0 – 4]
Correlation factor: 1.1600 Correlation factor: 19.8360
Intercept: 0.0000 Intercept: 0.0000

† Due to differences in instrument systems and unit configurations, version numbers may vary.

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 ARCHITECT® cSystems™ Sample Interference Indices, Saline Protocol: H, I, and L
ARCHITECT cSYSTEMS ASSAY PARAMETERS (Continued)

Lipemia (L) Index Parameters‡ Lipemia (L) Index Parameters‡

Conventional Units SI Units
Configure assay parameters – General Configure assay parameters – General
 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: L Type: Lipemia Version: † Assay: L Type: Lipemia Version: †
Number: 1073 Number: 1073
Reference photometric assay: HILref Reference photometric assay: HILref

Configure assay parameters – Results Configure assay parameters – Results

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: L Result units: Index Assay: L 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

 General  Calibration  SmartWash  Results  Interpretation  General  Calibration  SmartWash  Results  Interpretation
Assay: L Assay: L

Name: Range: Results review required: Name: Range: Results review required:
<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
Version: † Version: †
Result units: Index Result units: Index
Decimal places: 0 [Range 0 – 4] Decimal places: 2 [Range 0 – 4]
Correlation factor: 20.2000 Correlation factor: 0.2283
Intercept: -0.2065 Intercept: -0.0023

‡ Based on Intralipid.
† Due to differences in instrument systems and unit configurations, version numbers may vary.

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Abbott Park, Illinois 60064