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ADVIA 1650/ADVIA 1800 Updates: Method Summary; Materials Required but Not
Provided; Calibration; Calibration Frequency; Reagent Blank
(RBL) Frequency
Note To run the concentrated Alanine Aminotransferase reagents, you must use a
special parameter set. Refer to the system- and software-specific ALT_c parameter
sheets.
Method Summary
Item Description
Method Principle Modified IFCC
Intended Use
For in vitro diagnostic use in the quantitative determination of alanine aminotransferase
activity in human serum and plasma on ADVIA Chemistry systems. Such
measurements are used mainly in the diagnosis and treatment of liver disease and to
monitor the course of treatment for hepatitis and active post necrotic cirrhosis.
Reaction Equations
Reagents
The reagents are provided in the package as listed below. Components of the package
are available as a kit only.
40-mL Reagent 1 6 x 38 mL
40-mL Reagent 2 6 x 27 mL
CAUTION! This device contains material of animal origin and should be handled as a
potential carrier and transmitter of disease.
Note Sodium azide can react with copper and lead plumbing to form explosive metal
azides. If disposal into a drain is in compliance with federal, state, and local
requirements, flush reagents with a large amount of water to prevent the buildup of
azides.
For all systems, unopened reagents are stable until the expiration date printed on the
product label when stored at 2° to 8°C. Do not freeze reagents.
Sample Handling
Siemens Healthcare Diagnostics recommends using serum or plasma (lithium heparin)
for this method.
Calibration
To calibrate the ADVIA Chemistry ALT_c assay, use the ADVIA Chemistry Enzyme 2
Calibrator (REF 10916058).
Enter the lot-specific calibrator values that are provided with each lot of calibrator.
Perform the calibration as described in the calibrator instructions for use.
For setup and use instructions, refer to the Calibration Overview section of the
system-specific operator’s guide.
Calibration Frequency
Calibrate the assay every 45 days.
Individual laboratory quality control programs and procedures may require more
frequent calibration.
Run an additional RBL when a reagent pack is replaced by a new reagent pack with the
same lot number and an additional reagent blank was run during use.
Note Use deionized water as the sample for the RBL in the ADVIA Chemistry ALT_c
assay.
Quality Control
Follow government regulations or accreditation requirements for quality control
frequency.
Siemens recommends the use of commercially available quality control materials with
at least 2 levels (low and high). A satisfactory level of performance is achieved when
the analyte values obtained are within the Acceptable Control Range for the system or
within your range, as determined by an appropriate internal laboratory quality control
scheme.
The actual frequency of control in a laboratory is based on many factors, such as
workflow, system experience, and government regulation. Each laboratory should
evaluate the controls based on the frequency established by their laboratory guidelines.
When the method is performed, analyze at least 2 levels of controls daily.
Also, assay controls under the following conditions:
• whenever you use a new reagent lot
• following the performance of any system maintenance, cleaning, or troubleshooting
procedure
• after performing a new calibration
For more information, refer to the Quality Control Overview section of the
system-specific operator’s guide.
As with any chemical reaction, you must be alert to the possible effect on results of
unknown interferences from medications or endogenous substances. The laboratory
and physician must evaluate all patient results in light of the total clinical status of the
patient.
Interferences
At the Analytical Parameters (Serum) window, you can set up the ADVIA Chemistry
system to flag different levels of lipemia (turbidity), hemolysis, and icterus for samples
run on the system.
Note Turbidity resulting from equivalent levels of Intralipid and naturally occurring
triglycerides in actual patient samples may not correlate.
Siemens tested the following potential interferents and found the results shown below:
ADVIA 1200
ALT Sample
Interferent Interferent Level Concentration Interference*
ADVIA 2400
Interferent ALT Sample
Interferent Level Concentration Interference*
Performance Characteristics
Precision
Each sample was assayed 2 times per run, 2 runs per day, for at least 10 days.
Precision estimates were computed according to CLSI document EP5-A2, Evaluation
of Precision Performance of Quantitative Measurement Methods; Approved Guideline.3
ADVIA 1200
Within-Run Total
ADVIA 2400
Within-Run Total
Analytical Range
This method is linear from 8 to 1100 U/L for serum and plasma (lithium heparin).
Siemens has validated an automatic rerun condition for this method that extends the
reportable range for serum and plasma up to 3300 U/L on the ADVIA 1200 Chemistry
system, and up to 6600 U/L on the ADVIA 1650, 1800 and 2400 Chemistry systems.
Expected Values
The expected values for adults are 10 to 49 U/L.4 Siemens provides this information for
reference. Each laboratory should establish its own normal range. At the Analytical
Parameters (Chemistry) window, enter expected range values and abnormal range
values.
System Correlation
The performance of the ADVIA Chemistry ALT_c assay (y) was compared with the
performance of the comparison assay on the indicated system (x).
ADVIA 1200
Regression Sample
Specimen Type Comparison System (x) N Equation Sy.x r Range
Serum ADVIA 1200 (Serum) 70 y = 1.028x - 1.25 4.38 1.000 3–928 U/L
non-concentrated
reagent
Plasma* ADVIA 1200 (Serum) 30 y = 0.952x + 0.26 0.66 0.998 11–61 U/L
concentrated reagent
Serum** IFCC Reference Method 48 y = 0.990x - 3.00 37.00 0.980 9–646 U/L
* lithium heparin plasma (matrix comparison)
** Refer to Standardization
ADVIA 2400
Regression Sample
Specimen Type Comparison System (x) N Equation Sy.x r Range
Serum ADVIA 2400 (Serum) 68 y = 1.012x - 1.04 3.78 1.000 3–1073 U/L
non-concentrated
reagent
Plasma* ADVIA 2400 (Serum) 45 y = 0.992x - 1.70 0.66 0.998 12–57 U/L
concentrated reagent
Serum** IFCC Reference Method 49 y = 1.010x - 5.40 14.70 0.997 12–829 U/L
Standardization
The ADVIA Chemistry ALT_c method is traceable to the IFCC reference method via
patient sample correlation using the non-concentrated version of the assay which
provides identical levels of all reaction components. See the correlation data in the
System Correlation section for the relationship.
References
1. International Federation of Clinical Chemistry, Committee on Reference Systems
for Enzymes, Chem Clin Lab Med 2002; 40 (7):718–724.
2. Young DS, Effects of Drugs on Clinical Laboratory Tests. 5th ed. Washington,
AACC Press; 2000.
3. Clinical and Laboratory Standards Institute (formerly NCCLS). Evaluation of
Precision Performance of Quantitative Measurement Methods; Approved Guideline
- Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
NCCLS Document EP5-A2.
4. Data on file. Siemens Healthcare Diagnostics.
Technical Assistance
For customer support, contact your local technical support provider or distributor.
siemens.com/healthcare
Trademarks
ADVIA is a trademark of Siemens Healthcare Diagnostics.
Intralipid is a trademark of Fresenius Kabi AB.
Made in: UK
Definition of Symbols
The following symbols may appear on the product labeling:
Batch code