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Methods Introduction
V 2.00.00
This document contains general information for all methods performed on
ADVIA® Chemistry systems and explanations of important sections contained in the
method sheets (IFUs).
Bayer HealthCare provides the procedures necessary for the preparation, use, and
storage of the ADVIA Chemistry reagents in the specific method sheet. Calibrator
information is provided in their respective package inserts.
IMPORTANT NOTICE
Any modification of computer disks and/or the programs contained on such disks can
adversely affect the control of the instrument’s performance and thereby invalidate the
results obtained and the claims that have been made regarding system performance.
Bayer HealthCare cannot be responsible for errors that are introduced by, or results
from, any modifications or alteration of the computer disks and/or programs contained
on such disks by the user, or for any direct or indirect consequences resulting from such
modification or alteration.
During sample collection and preparation, avoid hemolysis of erythrocytes. When the
effect of hemolysis on a method is significant, this effect is described in the Limitations
of the Procedure and Interferences sections of the specific clinical method. Process
samples in a manner that prevents the introduction of clots, fibrin strands, or other solid
materials into the system.
Unless otherwise specified in the clinical method IFU, collect plasma samples using
lithium heparin as an anticoagulant. The individual laboratory should qualify the use of
other anticoagulants.
The use of urine preservatives is beyond the scope of this document.1,2 Special analyte-
specific storage conditions such as freezing or protection from direct exposure to light
are noted in the specific clinical method. For example, timely separation of serum from
cells is especially important to prevent elevated results for aspartate aminotransferase,
lactate dehydrogenase, magnesium, potassium, and total bilirubin. Erythrocytes
normally contain high concentrations of these analytes, which may increase the serum
Calculation of Results
The system automatically performs all calculations necessary for obtaining final
results. The system reports the results for each sample qualitatively or as
concentration/activity (quantitatively).
The system questions questionable results. One of the following automatic system
responses is assigned for each flag: no action, rerun with no dilution, or rerun with
dilution. Samples designated for rerun can be repeated automatically from the sample
tray or the dilution tray.
Review results using the Review/Edit window or at the host computer. You can screen
sample results transmitted to the host computer using the Data Clean feature.
Interpretation of Results
System operators and laboratory supervisors are responsible for operating and
maintaining Bayer HealthCare products in accordance with the procedures described in
the applicable product labeling (such as Instructions for Use, package inserts, bulletins,
product labels, and online documentation) and for determining that product
performance conforms to the applicable claims.
All in vitro assays can generate erroneous results. There are many possible causes for
discordant results. Erroneous results may occur due to interferences from identifiable
serum constituents or patient-specific serum constituents.
If, under these prescribed conditions of operation and maintenance, an aberrant or
abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel
should first make certain that the system is performing and is being operated in
accordance with the product labeling. Laboratory personnel should then follow a
protocol consistent with applicable legal requirements for advising the clinician of a
result that appears to deviate from the norms established by the laboratory.
Test results alone are not diagnoses of medical conditions. A physician’s diagnosis
involves evaluation of the test result in conjunction with, and in the context of, the
Bibliography
1. Kaplan LA, Pesce AG. Clinical Chemistry – Theory, Analysis, and Correlation. St.
Louis: CV Mosby Company; 4th Edition, 1996: 69–81.
2. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed.
Philadelphia, PA: WB Saunders Company; 2006: 41–57.
3. CLSI Standard Procedure for the Collection of Diagnostic Blood Specimens by
Venipuncture. CLSI Standard H3-A3. 1991. Available from CLSI, 940 West Valley
Road, Suite 1400, Wayne, PA, 19087-1898.
4. CLSI Standard Procedures for the Collection of Diagnostic Blood Specimens by
Skin Puncture, CLSI Standard H4-A3. 1991. Available from CLSI, 940 West
Valley Road, Suite 1400, Wayne, PA, 19087-1898.
5. Refer to the Information Bulletin titled Sample Handling Guidelines (Publication
No. TN9-5729-31).