Serum Indices: Reduction of clinical errors in

Transcription

xxxxxxxx001햲 - 0907 - X. Xx
CEDIA, COBAS, COBAS C,
COBAS INTEGRA, ELECSYS,
MODULAR, LIFE NEEDS ANSWERS
and TINA-QUANT
are trademarks of Roche.
Intralipid is a trademark
of KabiPharmacia, Inc.
©2007 Roche
Roche Diagnostics GmbH
D-68298 Mannheim
Germany
www.roche.com
Serum Indices:
Reduction of clinical errors
in laboratory medicine
Going straight for the answer
Clinical errors
in laboratory medicine
Going straight for the answer
Medical laboratory tests can be affected by endogenous and exogenous constituents in the sample matrix. The automated objective
determination of the interfering substances provides benefits compared with the subjective visual interpretation. These benefits include
the traceability, efficiency and effectiveness of the work process.
Content
cobas® brand
Roche introduces the cobas® brand
as the umbrella for products used to
complete or expand the screening,
diagnostic and monitoring applications
of the professional laboratory.
2
cobas brand includes:
serum work area with clinical
chemistry and immunochemistry
data management and pre-analytical
solutions
products for coagulation analysis and
urinalysis
instruments for rapid blood and
cardiovascular testing
PCR-based applications for virology
and women’s health testing
Serum Indices: Reduction of clinical errors in laboratory medicine
Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Endogenous interferences in
laboratory assays . . . . . . . . . . . . . . . . . . . . . . . 7
Interference by Hemolysis . . . . . . . . . . . . 8
Mechanisms of Interference by
hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Interference by Icterus . . . . . . . . . . . . . . . 10
Mechanisms of bilirubin
interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Interference by Lipemia . . . . . . . . . . . . . 12
Mechanisms of Lipemic
interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Endogenous interferences in
immunoassays . . . . . . . . . . . . . . . . . . . . . . . . 14
Identifying Clinical Errors . . . . . . . . . . 14
Serum Indices . . . . . . . . . . . . . . . . . . . . . . . . . 16
How accurate are the
Serum-Indices? . . . . . . . . . . . . . . . . . . . . . . . 17
Serum Indices - How are they
done on cobas c 501 analyzer? . . . . . . 17
Advantages of Automated
Serum Indices . . . . . . . . . . . . . . . . . . . . . . . . . 20
Improved Result Quality and
Patient Care . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
What does that really mean? . . . . . . . . 23
Reagents on the various Roche
systems - interference lists:
– Roche/Hitachi Systems . . . . . . . . . . . . 24
– COBAS INTEGRA® Systems . . . . . . 26
– cobas c 501 analyzer . . . . . . . . . . . . . . . . 29
Consolidated Workstations . . . . . . . . . . . 31
We want to thank the following people for their contribution and their support:
Prof. L. Thomas, E. Gainska, C.A. Mitchell, Q. May
3
Preamble
The aim of the clinical laboratory is to report the true value of a concentration or activity. But the results are often influenced by interfering factors related to the presence of hemoglobin, bilirubin and lipemia, which
may be recognized by a colored or turbid appearance of the sample. It is
difficult to predict the effect of hemolysis, turbidity (lipemia) and hyperbilirubinemia because each sample must be visually examined immediately after centrifugation and the potential interfering property recorded
in the laboratory journal.
At hemoglobin concentrations exceeding 300 mg/l (18.8 mmol/l), hemolysis
is visible to the eye by the red color of the plasma. Hemolyzed samples
are a rather frequent occurence in laboratory practice, with a prevalence
as high as 3.3% and accounting for nearly 60% of rejected samples.
Lipemia is defined as turbidity in serum samples which is visible to the
naked eye. This is usually observed at trigyceride concentrations above
300 mg/dl (3.4 mmol/l).
4
“With the cobas® 6000 analyzer series, the handling of serum indices has
been improved further, thereby simplifying the cross check of data and
the identification of affected requests. The work process is thus shorter
and safer.”
Prof. Lothar Thomas, Frankfurt, Germany
Introduction
A laboratory error may be defined as “any real or potentially negative
effect on patient management.”
Laboratory reporting has a great influence on clinical decision making.
Laboratory medicine has high performance quality control which are
ensured by regulatory authorities and certification procedures.
All laboratories make use of statistical quality control procedures to
enhance their analytical quality. But, clinical laboratory quality standards
and error detection rates still fall below industrial quality standards.
The visual recognition of hyperbilirubinemia is often not sufficiently
sensitive. Because of the high absorbance of bilirubin within the range
340 to 500 nm and the high background, the linearity range of the
method can become a limiting factor for spectrophotometric analyzes at
these wavelengths.
Many studies (1, 2, 3) have shown that the majority of clinical laboratory
errors occur in the pre- and post-analytical phases but within the analytical phase, where the minority of errors occur (13-32 %), there may be
undetected errors due to the way in which these errors were identified.
Of the visible interferences, hemolysis most often affects the major 20
clinical chemistry tests, closely followed by total bilirubin and turbidity.
Enzyme tests are hardly affected at all. Certain major tests like creatinine,
triglycerides, glucose, cholesterol, phosphorus, uric acid, iron, total protein
and bilirubin may be sensitive to the interference of hemoglobin, bilirubin
and turbidity.
Lapworth and Teal (4) reported finding in the literature an overall error
rate of approx. 0.3 % but the authors acknowledged that some errors
may have gone unnoticed due to the design of the study. Kalra (5) quotes
reported error rates of between 0.1–9.3 %. Many studies of error detection
rates do not include erroneous results that were unreported due to the
result fitting other clinical data.
With the so-called serum indices, the automated determination of potential
interferences of hemolysis, hyperbilirubinemia and turbidity (lipemia),
Roche has created a tool which (i) makes laboratory professionals aware
of interferences, (ii) helps to increase the quality of the sample, and (iii)
minimizes aberrant test results.
Bonini (6) et al found error rates of 0.60 % in inpatients and 0.039 % in
outpatients
Chambers (7) reported an error rate of 0.3 % in a large laboratory and earlier studies by McSwiney and Woodrow (8) found an occurrence of 2.3 %.
5
Goldschmidt and Lent (9) found that 12.5 % of laboratory errors lead to
an erroneous medical decision, 75 % of erroneous results were within
the reference range and 12.5 % of the erroneous results were so wrong as
to be implausible. Plebani and Carraro (1) found that 74 % of laboratory
errors did not influence patient outcome and 19 % resulted in increased
costs and/or further investigations. The authors also commented that
6.4 % of laboratory errors caused inappropriate care or inappropriate
changes to therapy.
No influence
Further investigations
Endogenous interferences in laboratory assays
Plebani and Carraro also found that only 13.3 % of total clinical laboratory errors were attributed to the analytical phase, but the most common
errors here were due to interference or lack of sensitivity of the analytical
method.
Some aspects of the testing procedure are often outside the laboratory’s
control and are outside the bounds of typical analytical process control.
These may be differences in biological variation, systematic errors and
interfering substances.
Inappropriate care
Kroll and Elin (10) defined interference as “the effect of a substance
present in the sample that alters the correct value of the result”.
Medical laboratory tests can be affected by endogenous constituents in
the sample. Some of these may be recognized by a colored appearance of
the sample (hemolysis, icterus and turbidity) but others (drugs) require
more detailed information or direct analysis. Interference in an analytical
method can produce a false result, which does not reflect the in vivo
situation.
Impact on patient outcome (Plebani and Carraro)
Delays
NADH
Potential damage
Lipemia
None
Icterus
Medical intervention
Absorbance
Hemolysis
480 505
340
Wavelength
Range 1
546
570 600
Range 2
660
700 (nm)
Range 3
Impact on patient outcome (Goldschmidt)
6
7
Interference by Hemolysis
7
8
700 800
9
10
900 1000
Plasma samples with increasing degrees of hemolysis
Differences in the individual appearance is hard to distinguish from level to level (Increase of interference level in steps of 100, starting from “zero”)
Hemolysis is defined as the release of intracellular components from
erythrocytes and other blood cells into the extra cellular fluid and can be
caused by many mechanisms.
Hemolysis may be in vivo as the result of biochemical, immunological,
physical or chemical mechanisms. More commonly hemolysis is in vitro
and is usually caused by inappropriate or incorrect sample processing.
Even if hemolysis is not visible there may still be discharge of cellular
contents into the serum/plasma.
A study by Carraro and Plebani found that up to 3.3 % of all specimens
received by the laboratory were hemolyzed. It is widely accepted that
hemolysis can be a source of error in many chemical analyses.
Mechanisms of Interference by hemolysis (11, 12, 13)
Rise of intracellular constituents in the extra-cellular space
Some cell constituents have an intra-cellular concentration 10 times higher
than the extra-cellular concentration. Hemolysis in the plasma/serum
will cause an increase in concentration of these analytes (for example,
potassium, lactate dehydrogenase, aspartate aminotransferase).
Spectral interference
Hemoglobin absorbs light very strongly at its characteristic wavelength
of 415 nm. The effect of hemolysis on various analytes measured in clinical chemistry has been thoroughly investigated. The observed increase or
decrease of a result by hemoglobin has been found to be dependent on
method and analyte concentration.
8
Free hemoglobin with its pseudo-peroxidase activity interferes in the
bilirubin procedure of Jendrassik and Grof by inhibiting the diazonium
color formation. Proteases released from blood cells reduce the activity
of coagulation factors and fibrin split product formation may increase.
Hemoglobin may also interfere by reacting with one or more constituents
of the reagent and the interference may differ with different reagent
sources.
Remote data
transfer to
cobas® 6000
analyzer series
5
6
500 600
Step in the cobas® 6000 analyzer series
1
2
3
4
100 200 300 400
Application data
via cobas® link
Serum Index
determination of the
individual sample
Individual sample
with Hemolysis
+ Haptoglobin normal
Pre-analytical
worksteps
0
0
Communication
to the ward
Dilution-level Tube # n
Index H
Chemical Interference
Blood cell constituents can interfere directly or indirectly in the measurement of analytes. Adenylate kinase released from erythrocytes may
cause an increase of creatine kinase and CK-MB activity.
S.I.
sample value:
H-index
Sample:
H-result: < ? > ? as
specified limit
Sample:
H-result < as
specified limit
Sample:
H-result > as
specified limit
All patient samples
with hemolysis
In vivo Hemolysis
(Haptoglobin:
low or 0)
Request
for new sample
“Results are disturbed in a
clinical relevant way; espc.
K, Phos, LDH, AST, NSE!
Result validated,
report of result
Hemolytic Interference?! - Sample operation with interference check on
cobas ® 6000 analyzer series; Prof. L. Thomas
9
1
6.6
2
3
4
5
6
7
8
9
10
13.2 19.8 26.4 33.0 39.6 46.2 52.8 59.4 66.0
Plasma samples with increasing degrees of icterus
Retrievable differentiation can be performed with automated process – to distinguish the individual
appearance can potentially classify the sample in another level (Increase of interference level in steps
of 6.6, starting from “zero”)
Elevated concentrations of bilirubin are another source of endogenous
interference. Such elevations can be found in a variety of conditions
including acute and chronic liver disease, biliary cirrhosis, alcoholism or
as a physiological response to many drugs.
Mechanisms of bilirubin interference (11, 12)
Bilirubin absorbs strongly between 340 nm and 500 nm wavelengths and
the high background absorbance can lead to absorbance readings in
excess of the linearity of spectrophotometric procedures.
In a strongly acidic solution the absorption of conjugated bilirubin shifts
to the UV wavelengths. Therefore bilirubin interferes in the determination
of some analytes that use these wavelengths. Under alkaline conditions
bilirubin is oxidized and loses some of its absorption properties.
Application data
via cobas® link
Serum Index
individual sample
S.I.
sample value:
I-index
Does bilirubin
interfere with
analyte?
I-index below
specified limit – no
interference occured
Pre-analytical
worksteps
0
0
Communication
to the ward
Index I
Remote data
transfer to
cobas® 6000
analyzer series
Interference by Icterus
Analyte has interference
limit for bilirubin:
Specified limit is indicated
No interference
with analyte
I-index above
specified limit
1+1 dilution of sample
with purified
serum albumin (40g/L)
Report result
Result to be
multiplied by 2
report result
Report of result
Icteric Interference?! - Sample operation with interference check on cobas ® 6000
analyzer series; Prof. L. Thomas
Chemical interference
Bilirubin may interfere by acting as a reducing substance as it is easily
oxidized to biliverdin and bilipurpurin with a reduction in absorbance.
Assays that utilize oxidase/peroxidase based reactions to produce hydrogen
peroxide, may produce lower results because bilirubin reacts with the
H2O2 formed in the test system. The reduction in H2O2 is relative to the
concentration of bilirubin present. This is true for enzymatic procedures
that are used for the measurement of glucose, cholesterol, triglycerides
and uric acid.
In albumin assays that employ dye binding, bilirubin can competitively
bind to the dye and produce lower albumin results.
10
11
Plasma samples with increasing degrees of turbidity
Any changes in the individual appearance from level to level might hardly be distinguished
(Increase of interference level in steps of 200, starting from “zero”)
Lipemia is defined as turbidity in samples which is visible to the naked
eye. The most common cause of turbidity is an increased concentration
of triglycerides. Lipemic samples cannot be avoided as increased concentration of lipids is often secondary to other disease states such as: diabetes
mellitus, ethanol use, chronic renal failure and pancreatitis etc.
Mechanisms of Lipemic interference (11, 12, 14, 15)
The interference caused by lipemia is fundamentally different from the
interference from hemolysis and icterus. Lipemia interferes by scattering
the light and disturbing (absorbing) the transmission of light through
the reaction mixture. In lipemia there is a number of lipid components
that can scatter light to produce a milky appearance or turbidity.
The degree of light scattering depends on the number, size and refractive
index of the suspended lipid particles. As patient serum samples are a
mixture of various particle sizes, the sample appears white because the
light is scattered at all angles.
Larger lipid entities such as chylomicrons and VLDL cause light to be
scattered to the greatest degree. Chylomicrons constitute a diverse group
of particles with varying sizes and vary from individual to individual.
VLDL particles are a heterogeneous mixture of sizes and lipid content and
the number of VLDL particles can be increased in various disease states.
The interference can be either positive or negative depending on the
blanking procedure of the assay. At high turbidity, no measurement may
be possible due to the limits of the linearity of the spectrophotometer.
12
Physico-chemical effects
An analyte that is soluble in lipids may not be accessible to the reagent
for reactivity. Similarly, electrophoretic and chromatographic procedures
may be affected by lipoproteins present in the matrix.
Remote data
transfer to
cobas® 6000
analyzer series
1
2
3
4
5
6
7
8
9
10
200 400 600 800 1000 1200 1400 1600 1800 2000
0
0
Application data
via cobas® link
Serum Index
individual sample
S.I.
sample value:
L-index
Does lipemia
interfere with
analyte?
Method 1 + 2 Failed high speed centrifugation: possible?!
Pre-analytical
worksteps
Index L
Volume depletion effect
Lipoproteins have a “solvent displacing effect” on sampling by reducing
the available water of the sample volume. Most analytes are dissolved in
the aqueous phase of the plasma/serum. Thus, the effect is to decrease
the apparent concentration of the analyte because the volume occupied
by lipoproteins in plasma or serum is included in the calculation of the
analyte concentration. For analytes that are lipid soluble, including certain
drugs that are taken up by lipoproteins, there is an apparent increase in
concentration.
Communication
to the ward
Interference by Lipemia
YES:
Centrifugation
> 40000g x 30min
YES (2): S/PI mix 1+1
with PEG 6000 incubate 30min at 4°C
- centrifuge 1000g x 10min
Determination
and report of
result
YES (1): centrifugation
(12000g x 10min)
S/PI lipid separation
Blood sampling: after
12h fasting + after 8h
infusion of lipids
NO:
Request of new
sample
Separate clear
supematant analyte
Start process
from beginning
Report result
Lipemic Interference?! - Sample operation with interference check on cobas ® 6000
analyzer series; Prof. L. Thomas
13
Endogenous interferences in immunoassays
Immunoassays may be susceptible to the same endogenous interferences
as mentioned above if the measuring system used is photometric such as
for enzyme linked immunoassay or fluorescence immunoassay.
Roche analyzers have a measuring system that employs heterogeneous
chemilluminscence, which is less prone to these interferences, although
some immunoassays may still have interference from unusual serum constituents.
Immunoassays employ antibodies to specific proteins and rely on the
binding of these antibodies to the antigen. Unusual proteins in the
patient sera, for example, endogenous heterophilic antibodies such as
rheumatoid factor, anti-animal antibodies or other non-specific antibodies may interfere in the binding process.
necessarily produce detectable abnormal results or raise questions for the
clinician. Errors caused by interfering substances cannot be detected or
prevented by the use of statistical QC procedures. Such procedures can
only control process (analytical) variations. Results released from “incontrol” runs may contain spurious results that are not detected.
In a study conducted by Glick (16) in an acute care hospital he determined the frequency with which turbidity, hemolysis or icterus was
encountered in serum samples. 32 % of all samples were found to have
more than trace concentrations of an interferent. Of these, approximately
63 % were icteric, 29 % hemolyzed and 8 % lipemic.
Ryder (17) studied serum from outpatients and found that 9.7 % of
specimens received contained at least one visible interferent. Of these,
76 % were lipemic (probably because of non-fasting state), 16.5 % were
hemolyzed and 5.5 % were icteric.
Hemolysis interference in immunoassays may be caused by constituents of
red blood cells being released into the serum/plasma. These constituents
may influence antibody-antigen binding and produce lower or higher
results depending on where they interfere in the reaction.
80
Inpatient
Interference from Icterus in immunoassays is not common because the
wavelengths employed in chemilluminescent technology are separated
from the absorbance maxima of bilirubin.
Lipemia interference in immunoassays relates to the solubility of the
antigen to be measured in lipid and is therefore no longer available to
bind with the antibody.
%
60
Outpatient
40
20
0
Identifying Clinical Errors
Lipemia
Hemolysis
Icterus
Frequency of Endogenous Interferences
It is the responsibility of the laboratory to produce true and accurate
results and to decrease or avoid completely those with a real or potentially significant negative effect on patients’ health.
Because laboratory errors caused by interferences are rare, it is difficult
to detect and prevent them from being reported. Many errors may not
14
Therefore to prevent the reporting of erroneous results every sample
should be evaluated for the possibility of interference. The consequence
is the improvement of the quality of the service provided and improvements in patient care by reducing false results that can occur from interferences.
15
Within the manufacturing industry, Shingo (18) showed that because of
the rare nature of errors, they can only be controlled with 100 % inspection but this must be easy and inexpensive. He also reports that the
inspection must be upstream of the product before it results in an error,
which is before the result is released.
Hinkley (19) observed that human inspection methods failed to detect
most errors. Glick (16) found that the visual interpretation of hemolysis,
lipemia and icterus showed very little agreement to the actual concentration of interferent. Even when comparison samples are used, visual grading was still problematic. He noted that because of this inconsistency an
unbiased method is required to quantitate the level of interference.
Serum Indices
Serum indices are calculations of absorbance measurements that provide
a semi-quantitative representation of levels of icterus, hemolysis, or
lipemia that are present in unknown samples. Thus the quality of the
sample is assessed at the same time as the sample is processed.
How accurate are the Serum-Indices?
Lipemia and Intralipid®
The Lipemic Index L is measured in lipemia units and is based on the
optical behaviour of the lipid substitute Intralipid (L units are linear up
to 2000 mg/dL). The Lipemic Index provides an estimate of sample turbidity, not the concentration of triglycerides. This is because the lipemic
Index is a measure of light scatter, which is dependent on particle size.
Hemolysis and hemoglobin
Recovery of the Hemolysis Index correlates well with the hemoglobin
concentration in the patient’s sample depending on the method used to
measure Hb.
Icterus and bilirubin
Recovery of the Icteric Index correlates well with the bilirubin concentration in the patient’s sample.
Serum Indices - How are they done on cobas c 501 analyzer?
Roche analyzers have been capable of semi-quantitative measurement
and reporting of the Serum-Indices since the early 1980s using 9 % NaCl
as reagent.
The bichromatic wavelength pairs used for serum index measurement
are 480 nm and 505 nm (range 1), 570 nm and 600 nm (range 2), and
660 nm and 700 nm (range 3). Calculation formulas include corrections
to compensate for the spectral overlap.
16
Serum indexes are calculations of absorbance measurements that provide
a semiquantitative representation of levels of icterus, hemolysis or
lipemia (turbidity) present in patient samples.
A quantification of these interfering materials is possible with the Serum
Index Gen.2 (SI2) application which can be installed on all cobas c systems.
When measuring Serum Indices, the analyzer takes an aliquot of the
patient sample (cobas c 501 analyzer takes 6 µl), dilutes it with 0.9% NaCl,
and then measures the absorbances at three pairs of wavelengths:
1. For measurement of lipemia (L), wavelengths 700/660 nm are used
because this range is free from influence by hemolysis and icterus (see
figure page 7).
2. Hemolysis (H) is measured at 600/570 nm and correction is made for
absorption due to lipemia.
3. Icterus (I) is measured at 505/480 nm and correction is made for
absorption due to lipemia and hemolysis.
17
For performing Serum Index check on the cobas c 501 analyzer the
operator needs to apply some easy steps:
download Serum Index (SI2) application (via cobas® link)
cross-link SI application with pre-installed H, I and L applications
calibrate SI (only one blank calibration is required per reagent lot)
request SI together with other test requests for a serum sample
Serum indices can be programmed in either conventional or SI units.
If measured values are higher than specified limits of the individual test,
the analyzer issues alarms for the measured results: “Serum 1” - for one
index higher, “Serum 2” - when two or all three indices are higher than
their limits.
The benefit for the user: if the results are affected by endogenous sample
interference – there is no need to manually crosscheck the pack insert for
the index level nor is an additional LIS check needed.
Each report on laboratory findings should contain a notation characterizing the sample’s “appearance”. “If lipemia or a relevant color is found,
the cobas c 501 analyzer will indicate, in each case, the type of finding
(L)-index “lipemic”, (H)-index “hemolytic” and (I), index for “icteric”.”
Serum index limits are provided as a part of the application. Application
data is downloaded electronically via a remote access tool, called cobas®
link. Potential updates are provided on a daily basis. No manual interaction (such as typing in application data from an application sheet) is
required. The user initiates the download of the data from cobas® link to
the analyzer.
Lipemic serum
Bilirubin solution
Absorbance
Hemolytic solution
340
480
505
546
570
600
660
Serum index results are very useful for monitoring the degree of potential
interference due to lipemia (turbidity), hemolysis and icterus (bilirubin)
and therefore
improves the quality of reported results: 100% of samples are checked
in almost no time: One simple pipetting step in the analytical phase
replaces both the visual check in the pre-analytical phase and the
retrieval of suspicious samples in the post-analytical phase
with minimal cost: only the use of a simple NaCl solution compared to
manually intensive tasks in the pre and post-analytic phases
improved handling of pediatric samples: enabling efficient and reliable
handling of very small sample volumes
700 (nm)
Wavelength
The diagram shows an example absorption spectra of a turbid serum, a
hemolytic solution, and a bilirubin solution.
Once the serum indexes are determined, cobas c 501 analyzer compares
them with the H, I and L limits given in each individual test application.
The limits are indications below which potential interference is considered
clinically not relevent.
18
19
Advantages of Automated Serum Indices
Advances in technology allow Roche to incorporate an automated feature
into their analytical instruments to verify the quality of the specimen at
the same time as the result is produced.
Up to now, medical laboratories have taken a “judgment inspection”
approach to endogenous interferences; the operator decides whether the
sample is appropriate or not. If an abnormal result is obtained, the sample
is inspected for visible interferences. Thus judgment inspections can only
detect errors after they have been made and identified.
Decreased Turnaround Time (TAT)
Manual inspection may be performed on every specimen before analysis
(pre-analytical) or inspecting specimens that produce “suspect” results
(post-analytical). This is very time consuming and as previously reported,
this produces very inconsistent results. In addition a “normal” result does
not create suspicion.
When Serum Indices are produced by the instrument, consistent evaluations
are made and remove the potential for human error and save operator time.
Decreased Costs
With less operator time involved in examining suspicious samples not
only TAT is decreased but the costs involved in repeating “out of limit”
results due to interferences are reduced. The serum index result reported
simultaneously with the test result enables the operator to acknowledge
the presence of interfering substances as the potential cause of the “abnormal” result and removes the need to rerun the sample, thus reducing costs.
Improved Result Quality and Patient Care
Vermeer (20) in 2005 reported on improvements in patient results with
respect to endogenous interferences by the introduction of an automated
detection and reporting system. The laboratory information system (LIS)
used a rule-based algorithm to assess the effect of interference on each
analyte measured.
Test-specific serum index decision thresholds were used to:
Detect interference
Alert the operator
Add appropriate comments
Reject a result where necessary
Turn Around Time
Add
comment
(A) Manual Sample Inspection in Pre/Post-Analytical Phase
Result
Sample inspection
of dubious samples
Pre-analytical Phase
Sample inspection
of dubious results
Analytical Phase
Post-analytical Phase
Sample
LIS*
(B) Serum Index incorporated into Analytical Phase
H index
L index
I index
Automatic inspection
of ALL samples
Pre-analytical
Phase
Analytical Phase
Post-analytical
Phase
Alert
Operator
Release
result
* cobas® 6000 analyzer
series in software
* Roche/Hitachi Analyzer /
COBAS INTEGRA® = LIS
Thus: a slight increase in analytical time but a large decrease in preand/or post-analytical time – reduced TAT
20
21
They found that by introducing the rule-based system, the detection rate
of clinically significant hemolysis increased approximately 70 fold, icterus
10 fold and lipemia over 1000 fold.
Glick (22) interferographs are produced for all assays. This is an easily
understandable graphical display of the interference data showing the
deviation from the original result caused by the interferent.
The level of interference producing a clinically significant difference is
indicated in the Roche pack insert.
Hemolysis
Icterus
Sample number
Of all the samples received by the laboratory as many as 22 % may be
influenced by endogenous interferences. The chance of identifying a possible
visible interferent is greatly decreased when primary tubes are covered with
several labels which prevent the clear inspection of the sample.
A serum index result generated simultaneously with the sample result
ensures that all samples are correctly identified.
Reporting results that acknowledge the effect of interferences, gives results
that are appropriate to the quality of the sample, thus avoiding inaccurate
results as a consequence of the interference.
The improved clinical usefulness of the result allows better clinical decisions
and better patient care.
Manufacturers of instruments and analytical methods by the FDA and
under the IVD directive are requested to provide details of the degree of
interference for each assay. Roche conducts the interference studies
according to the guidelines of the NCCLS (EP7-P).
10’000
1000
What does that really mean?
Lipemia
100
10
!
Manual inspection
Automated SI
LIS Processing
Effect of Serum Index and LIS
Recovery of known material
110 %
1
H > 700
Increasing
H index value
100 %
90 %
Glick interferograph
22
23
Reagents on Roche/Hitachi Systems
24
X
X
X
X
X
1
1
60
60
70
60
60
60
60
60
60
60
26
60
29
60
54
60
n/a
n/a
60
60
60
60
60
60
25
60
60
100
100
1000
1000
500
1000
60
50
500
500
1000
1000
1000
25
1000
1000
1000
1000
10
1000
1000
900
1000
1000
1000
850
700
100
20
17
17
1026
1026
1197
1026
1026
1026
1026
1026
1026
1026
445
1026
496
1026
923
1026
n/a
n/a
1026
1026
1026
1026
1026
1026
428
1026
1026
17
17
1026
1026
1197
1026
1026
1026
1026
1026
1026
1026
445
1026
496
1026
923
1026
n/a
n/a
1026
1026
1026
1026
1026
1026
171
1026
342
62
62
621
621
310
621
37
31
310
310
621
621
621
16
621
621
621
621
6
621
621
559
621
621
621
528
435
62
12
200
200
1000
1000
2000
1000
500
under
evaluation
1500
1500
1000
1000
1000
500
1250
890
750
2000
75
1000
1000
1000
1000
1000
750
1250
1250
1000
600
X
X
X
씯
씮 씯
씮 씯
씮 n/a
60
60
1000
1026
1026
621
Intralipid
not measured
X
X
X
X
X
X
X
X
X
X
X
X
앗
앗
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
10
4
25
60
10
4
25
60
750
750
1000
950
171
68
428
1026
171
68
428
1026
466
466
621
590
1000
1000
1000
1700
X
X
X
씯
씮 씯
씮 씯
씮 씯
씮
60
60
1000
1026
1026
621
500 (2mg/l)
X
X
X
씯
씮 씯
씮 씯
씮 씯
씮
60
60
1000
1026
1026
621
800 (4mg/l)
X
X
X
X
X
X
씯
씮
n/a
앗
앗
앖
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
60
n/a
20
60
60
60
60
60
60
60
60
60
5
60
n/a
20
60
60
60
60
60
60
60
60
60
5
1000
25
500
1000
1000
1000
601
200
100
1000
80
500
500
1026
n/a
342
1026
1026
1026
1026
1026
1026
1026
1026
1026
86
1026
n/a
342
1026
1026
1026
1026
1026
1026
1026
1026
1026
86
621
16
311
621
621
621
373
124
62
621
50
311
311
1000 (5mg/l)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
앗
앗
앗
씯
씮
앖
앖
씯
씮
씯
씮
씯
씮 씯
씮
n/a 앗
앖 앗
앗
앖 씯
씮
앖 앖
씯
씮 앗
씯
씮 앖
씯
씮 앗
씯
씮 앗
씯
씮 앗
씯
씮 앖
씯
씮 앖
앖 앗
씯
씮
앖
씯
씮
씯
씮
앖
씯
씮
앗
앗
앗
앗
씯
씮
씯
씮
씯
씮
140
1500
1000
850
1000
1768
500
500
500
1000
750
1000
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
씯
씮
앗
앗
앗
씯
씮
씯
씮 씯
씮
앗 앗
앗
씯
씮 씯
씮
씯
씮
Lipemic Index
as Intralipid®
Hemolytic Index
as Hb
Icteric Index
as unconj. Bilirubin
앗
씯
씮
씯
씮
n/a
씯
씮
앖
앖
앗
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
앖
씯
씮
앖
앗
씯
씮
앗
씯
씮
n/a
앖
앗
씯
씮
앖
씯
씮
앗
씯
씮
씯
씮
앗
앗
앖
씯
씮
씯
씮
앖
앗
n/a
앗
씯
씮
Icteric Index
as conj. Bilirubin
씯
씮
앗
앗
앖
씯
씮
앖
씯
씮
앖
앗
n/a
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
앖
씯
씮
앖
앗
앖
앗
씯
씮
앗
씯
씮
씯
씮
앖
씯
씮
앖
씯
씮
앗
씯
씮
앗
앗
앖
앖
씯
씮
씯
씮
Hemolytic Index as Hb
씯
씮
앗
앗
앗
씯
씮
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
앖
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
앗
앖
씯
씮
앖
Icteric Index
X
X
X
X
X
X
씯
씮
씯
씮
씯
씮
앗
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
Interference within Interference within
without
specification up to specification up to
units1
(conventional units):
(SI units):
Icteric Index
as conj. Bilirubin
X
X
X
X
X
X
X
Conj. Bili. Interference
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Others
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
EDTA-Plasma
Lipemic Index
as Intralipid®
Hemolytic Index
as Hb
Icteric Index
Icteric Index
as conj. Bilirubin
Icteric Index
1
1
60
60
70
60
60
60
60
60
60
60
26
60
29
60
54
60
n/a
n/a
60
60
60
60
60
60
10
60
20
X
X
X
X
X
X
X
X
Lipemia Interference
X
X
X
X
Icteric Index
as conj. Bilirubin
Others
X
X
앖
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
n/a
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
앖
앗
앗
씯
씮
씯
씮
앖
앖
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Hemolysis Interference
X
X
X
X
X
X
앗
앖
씯
씮
씯
씮
앗
앗
앖
앖
앗
앗
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
앖
씯
씮
앖
앖
앖
씯
씮
씯
씮
앖
앖
앖
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Unconj. Bili. Interference
X
X
X
X
X
X
X
X
X
앗
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
n/a
n/a
씯
씮
씯
씮
씯
씮
앖
씯
씮
앖
앗
씯
씮
앗
~mg/dl ~mg/dl ~mg/dl ~µmol/l ~µmol/l ~µmol/l Turbidity
Gentamycin OnLine
Gentamycin
GGT liquid
γ-Glutamyltransferase
GGT HiCo liquid
γ-Glutamyltransferase
GLDH
Glutamate Dehydrogenase
GLU HK
Glucose (Hexokinase)
GLU GOD PAP
Glucose (GOD PAP)
GPROT Tina-quant®
α1-Acid Glycoprotein
HBDH
Hydroxybutyrate Dehydrogenase
HDL-C plus 2nd gen. HDL-Cholesterol
HAPT Tina-quant®
Haptoglobin
IGA Tina-quant®
Immunoglobulin A
IGA Tina-quant®
Immunoglobulin E
IGA Tina-quant®
Immunoglobulin G
IGA Tina-quant®
Immunoglobulin M
Kappa Tina-quant®
Kappa Light Chains
Lactate
Lactate
Lambda Tina-quant® Lambda Light Chains
LDH opt
Lactate Dehydrogenase opt
LDH IFCC liquid
Lactate Dehydrogenase IFCC
LDL-C plus 2nd gen. LDL-Cholesterol
LIP colorimetric
Lipase
LP(a) Tina-quant®
Lipoprotein (a)
MG
Magnesium
Myoglobin Tina-quant® Myoglobin
NAPA CEDIA®
N-Acetyl Procainamide
Prealbumin Tina-quant® Prealbumin
PHENO CEDIA®
Phenobarbital
PHENY OnLine
Phenytoin
PHOS UV
Phosphate (inorganic)
PROC CEDIA®
Procainamide
QUIN OnLine
Quinidine
RF II Tina-quant®
Rheumatoid Factors
Salicylate
Salicylate
sTfR Tina-quant®
Soluble Transferrin Receptor
T Uptake CEDIA®
T Uptake
T4 CEDIA®
Total T4
TP
Total Protein
TG
Triglycerides
THEO OnLine
Theophylline
TOBR II CEDIA®
Tobramycin
Transferrin ver. 2
Tina-quant®
Transferrin
UA plus
Uric Acid
UIBC
Unsaturated Iron Binding Capacity
Urea liquid
Urea
VPA II CEDIA®
Valproic Acid
Heparin-Plasma
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
앗
앗
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
앖
앗
n/a
n/a
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
Direction
Interference within Interference within
without
specification up to specification up to
units1
(SI units):
Serum
Ceruloplasmin
Creatinine Jaffé
rate blanked + compensated
Crea
Creatinine Jaffé STAT compensated
Crea plus
Creatinine enzymatic
CRPLX Tina-quant®
C-Reactive Protein (latex)
CRPHS Tina-quant® C-Reactive Protein (latex)
high sensitive
high sensitive
high sensitive
D-Bil Jendrassik
Bilirubin Direct (Jendrassik)
D-Dimer Tina-quant® D-Dimer
Digoxin II CEDIA®
Digoxin
Digoxin Tina-quant® Digoxin
Digitoxin CEDIA®
Digitoxin
Digitoxin OnLine
Digitoxin
Ethyl Alcohol
Ethanol (904/911/912/917)
Ethyl Alcohol
Ethanol (902)
Ethyl Alcohol
Ethanol (Modular)
Fe
Iron
FERRI Tina-quant®
Ferritin
FRUCT
Fructosamine
X
X
X
X
X
X
X
Direction
Acid Phosphatase
Non-prostatic Acid Phosphatase
Albumin
Albumin (turbidimetric)
Alkaline phosphatase IFCC
Alkaline phosphatase opt
Alanine Aminotransferase IFCC
Ammonia
α-Amylase
α-Amylase Pancreatic
Apolipoprotein A-1
Apolipoprotein B
Antistreptolysin O
Aspartate Aminotransferase IFCC
Antithrombin III
α1-Antitrypsin
β2-Microglobulin
Bicarbonate
Bilirubin Total
Bilirubin Total liquid
Complement C3c
Complement C4
Calcium
Carbamazepine
Carbohydrate Deficient Transferrin
Cholinesterase
Cholesterol
Creatine Kinase
Creatine Kinase-MB
EDTA-Plasma
Serum
ACP
ACP-NPP
Albumin plus
Albumin Tina-quant®
ALP IFCC liquid
ALP opt
ALT/GPT IFCC
Ammonia
AMYL liquid
P-AMYL liquid
APOA1 Tina-quant®
APOB Tina-quant®
ASLO Tina-quant®
AST/GOT IFCC
ATIII
a1-Antitrypsin
b2-Microglobulin
BICARB liquid
BILI-Total DPD
TBILI liquid
C3c Tina-quant®
C4 Tina-quant®
Ca
CARB II CEDIA®
CDT Tina-quant®
CHE butyryl
CHOL
CK liquid
CK-MB liquid
Ceruloplasmin
Tina-quant®
Crea
Heparin-Plasma
Sample
Material
Analyte
Sample
Material
Analyte
List of interferences1 based on serum indices for serum and plasma
(not applicable for urine)
60
20
50
60
60
22
60
60
30
60
60
60
60
60
60
28
60
60
60
39
60
60
65
60
60
60
60
60
35
60
65
60
씯
씮 앖
앗 씯
씮
앗 앖
앖 씯
씮
씯
씮 씯
씮
60
40
60
60
60
60
60
21
10
45
60
20
20
60
60
20
60
60
70
60
60
60
60
60
60
60
60
60
60
70
60
60
37
60
60
60
60
60
62
60
65
60
60
60
60
60
21
27
60
60
1350
200
200
10
1000
850
1000
10
1200
n/a
1000
1000
1000
1000
500
1000
500
10
10
1500
500
500
400
500
1000
500
1000
1000
300
1000
1000
1000
100
1000
1000
550
650
500
1450
1000
60
40
60
60
60
1000
1000
200
1000
1000
1026
342
855
1026
1026
376
1026
1026
513
1026
1026
1026
1026
1026
1026
479
1026
1026
1026
667
1026
1026
1112
1026
1024
1026
1026
1026
599
1026
1111
1026
1026
1026
1026
359
171
770
1026
684
1026
1026
1026
342
342
1026
1026
342
1026
1026
1197
1026
1026
1026
1026
1026
1026
1026
1026
1026
1026
1197
1026
1026
633
1026
1024
1026
1026
1026
1060
1026
1111
1026
1026
1026
1026
1026
359
462
1026
1026
838
124
124
6
621
528
621
6
745
n/a
621
621
621
621
311
621
311
6
6
931
311
311
248
311
621
311
621
621
186
621
621
621
62
621
621
342
404
310
901
621
1026
684
1026
1026
1026
621
621
125
621
621
170
1000
1000
under
evaluation
1000
150
750
600
1000
1000
600
600
600
600
500
1000
500
900
1000
200
1000
Intralipid
not measured
400
450
1000
200
1000
800
1250
1000
2000
400
500
1000
1000
1000
1000
n/a
333
1000
500
1000
100
1000
1000
n/a
앖
앗
앖
앗
= not applicable
= over-recovery
= under-recovery
= variable recovery
씯
씮 = recovery within ±10 % of initial concentration
1 Interferences were tested with the following substances added to samples:
Hemoglobin up to 621 µmol/l (1000 mg/dL)
Bilirubin up to 1026 µmol/L (60 mg/dl)
Lipemia up to 20 g/l Intralipid® (2000 mg/dl). Lipemia has no units as it is a measure of turbidity.
Only significant interferences (> 10 %) are listed in the method sheets
Reference: Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470–474.
2 L index not measured with Intralipid®, interference measured as Triglycerides (see package insert)
3 Endogenous bilirubin samples were used, total bilirubin was measured
25
Reagents on COBAS INTEGRA® Systems
26
no
250
130
no
no
no
no
no
no
no
155
81
씯
씮
앖
씯
씮
앗
씯
씮
씯
씮
씯
씮
앖
앖
앗
앗
앗
씯
씮
씯
씮
씯
씮
n/a
씯
씮
씯
씮
씯
씮
앗
앗
no
18
52
17
no
no
no
no
18
no
17
no
no
no
130
1000
260
100
250
no
no
no
308
889
300
no
no
no
no
308
no
300
no
no
no
81
621
161
62
155
no
no
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
앖
앗
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
no
no
no
no
no
no
1500
X
X
X
씯
씮
씯
씮
앖
씯
씮
no
no
25
no
no
16
no
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
씯
씮
n/a
n/a
n/a
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
n/a
n/a
n/a
씯
씮
씯
씮
씯
씮
n/a
씯
씮
앖
씯
씮
앗
앖
앗
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
앗
앖
앖
씯
씮
씯
씮
씯
씮
n/a
앖
no
no
n/a
n/a
n/a
no
no
no
20
no
no
no
n/a
n/a
n/a
no
no
no
20
no
25
no
10
10
1000
no
no
no
750
no
no
no
n/a
n/a
n/a
no
no
no
342
no
no
no
n/a
n/a
n/a
no
no
no
342
no
16
no
6
6
621
no
no
no
466
no
no
no
270
9
1400
no
no
no
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
X
씯
씮
씯
씮
앖
no
no
no
no
no
no
no
no
no
no
Intralipid
not measured2
no
no
no
1000
1000
Intralipid
not measured2
50
50
씯
씮
씯
씮
씯
씮
앗
앖
앗
씯
씮
씯
씮
씯
씮
씯
씮
앗
앖
앗
씯
씮
씯
씮
씯
씮
씯
씮
앖
앖
앖
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
no
no
no
16
15
20
no
no
no
no
11
15
20
no
no
no
no
810
100
10
no
no
no
no
274
255
340
no
no
no
no
188
255
340
no
no
no
no
503
62
6
no
50
no
no
no
no
500
no
X
앗
앗
앖
앗
5
5
800
85
85
497
250
X
X
X
X
앗
앗
앗
앗
앖
앗
앗
앗
5
20
5
20
400
800
85
340
85
340
248
497
250
1000
X
X
X
씯
씮
씯
씮
씯
씮
앗
no
no
no
no
no
no
1500 (3mg/l)
X
X
X
씯
씮
씯
씮
씯
씮
앗
no
no
no
no
no
no
623 (80mg/l)
X
X
X
씯
씮
씯
씮
씯
씮
앗
no
no
no
no
no
no
1094 (3mg/l)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Lipemic Index
as Intralipid®
no
no
no
Hemolytic Index
as Hb
no
no
no
X
Icteric Index
씯
씮
씯
씮
씯
씮
X
Icteric Index
as conj. Bilirubin
씯
씮
앗
앖
X
X
X
씯
씮
씯
씮
씯
씮
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Icteric Index
씯
씮
씯
씮
씯
씮
270
no
X
Icteric Index
as conj. Bilirubin
X
Others
X
Intralipid
not measured2
CRPL2 C-Reactive Protein (Latex) INTEGRA 700/800
Application for C.f.a.s. Proteins
D-DI
D-Dimer
3
DIG
Digoxin
DIGIT3 Digitoxin
ETOH2 Ethanol Gen.2
FERR2 Ferritin Gen.2
FPHNY3 Free Phenytoin
FRA
Fructosamine
FVALP3 Free Valproic Acid
GENT3 Gentamicin
GGTI2 γ-Glutamyltransferase ver.2
Standardized against IFCC
GGTS2 γ-Glutamyltransferase ver.2
Standardized against Szasz
GLDH3 GLDH Gen.3 Utility Cassette Set
GLUC2 Glucose HK
GLUCL Glucose HK Liquid
HAPT2 Haptoglobin ver.2
HBDH2 HBDH Gen.2 Utility Cassette Set
HDL_C HDL-Cholesterol plus 2nd generation
IGA
Immunoglobulin A
IGGT Immunoglobulin G (Turbidimetric)
IGM
Immunoglobulin M
IRON Iron
LACT2 Lactate Gen.2
LDHI2 Lactate Dehydrogenase acc. IFCC ver.2
LDHL Lactate Dehydrogenase (P-L)
LDHPL Lactate Dehydrogenase (P-L)
Primary Tube
LDIP2 Lactate Dehydrogenase acc. IFCC ver.2
Primary Tube
LDL-C LDL-Cholesterol plus 2nd generation
3
LIDO Lidocaine
LIPC
Lipase colorimetric
LPALX Lipoprotein (a) (Latex)
MG
Magnesium
MYO Myoglobin
3
NAPA N-Acetyl-Procainamide
NH3L Ammonia
PHNO3 Phenobarbital
PHNY3 Phenytoin
PHOS2 Phosphate (Inorganic) ver.2
PREA3 Prealbumin INTEGRA 400
Application for C.f.a.s. PAC
PREA3 Prealbumin INTEGRA 700/800
PRIM3 Primidone
PROC3 Procainamide
QUIN3 Quinidine
RF-II
Rheumatoid Factors II
SALI3 Salicylate
SBARB3 Serum Barbiturates
SBENZ3 Serum Benzodiazepines
Lipemic Index
as Intralipid®
no
700
1200
Hemolytic Index
as Hb
Turbidity
no
621
no
248
6
261
~mg/dl
~mg/dl
~mg/dl
~µmol/l
~µmol/l
~µmol/l
Turbidity
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
앗
씯
씮
씯
씮
앗
앖
씯
씮
씯
씮
씯
씮
앖
씯
씮
앗
씯
씮
앗
앗
앖
씯
씮
씯
씮
앖
앖
씯
씮
앗
앗
앗
n/a
n/a
씯
씮
앗
n/a
씯
씮
n/a
n/a
no
no
25
19
no
no
26
5
27
15
no
no
25
19
no
no
26
5
27
15
no
300
2000
1000
no
960
1000
50
1000
1000
no
no
428
325
no
no
445
85
462
257
no
no
428
325
no
no
445
85
462
257
no
186
1242
621
no
596
621
31
621
621
797 (80mg/l)
no
X
X
X
씯
씮
앗
앖
씯
씮
no
48
550
no
821
342
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
앗
씯
씮
씯
씮
앗
앗
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
앖 씯
씮
앖 n/a
씯
씮 씯
씮
씯
씮 씯
씮
앖
n/a 앗
앖 앖
씯
씮 씯
씮
씯
씮 앖
씯
씮 씯
씮
씯
씮 앗
앖 앖
씯
씮 씯
씮
앖 씯
씮
앖 앗
no
22
no
no
no
no
24
no
no
no
40
18
no
no
48
54
no
no
no
no
24
no
no
no
40
no
no
no
550
10
no
no
n/a
25
1500
no
no
no
500
no
10
10
no
376
no
no
no
no
410
no
no
no
684
308
no
no
821
923
no
no
no
no
410
no
no
no
684
no
no
no
342
6
no
no
n/a
16
932
no
no
no
311
no
6
6
X
X
씯
씮
씯
씮
앖
앗
no
no
10
no
no
6
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
앖
씯
씮
앗
앗
씯
씮
앖
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
앖
씯
씮
씯
씮
씯
씮
앖
앗
앗
씯
씮
씯
씮
앖
씯
씮
앗
앖
앖
앖
앖
씯
씮
앗
n/a
씯
씮
씯
씮
씯
씮
앗
n/a
n/a
n/a
n/a
앖
no
40
18
no
no
no
no
28
11
38
29
51
no
40
18
no
no
no
no
28
11
38
29
no
10
1000
1000
no
no
550
no
1000
100
1000
1000
420
no
684
308
no
no
no
no
479
188
650
496
872
no
684
308
no
no
no
no
479
188
650
496
no
6
621
621
no
no
342
no
621
62
621
621
261
씯
씮
씯
씮
씯
씮
앖
no
no
no
no
no
no
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
앗
앗
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
n/a
n/a
n/a
씯
씮
n/a
n/a
n/a
no
18
19
24
no
23
24
23
no
18
19
24
no
23
24
23
no
1000
1000
1000
no
1000
1000
1000
no
308
325
410
no
393
410
393
no
308
325
410
no
393
410
393
no
621
621
621
no
621
621
621
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
without
units1
Icteric Index
~µmol/l
no
1026
no
222
12
no
Interference within
specification up to
(SI units):
Icteric Index
as conj. Bilirubin
~µmol/l
no
1026
no
222
12
no
Interference within
specification up to
Direction
Others
~µmol/l
no
1000
no
400
10
420
EDTA-Plasma
Icteric Index
~mg/dl
no
60
no
13
0.7
no
씯
씮
씯
씮
씯
씮
앖
앖
앗
Heparin-Plasma
Icteric Index
as conj. Bilirubin
~mg/dl
no
60
no
13
0.7
no
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
Sample
Material
Analyte
Serum
~mg/dl
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
X
X
without
units1
씯
씮
앗
앖
n/a
앖
씯
씮
X
Interference within
specification up to
(SI units):
X
X
X
X
Interference within
specification up to
Direction
X
X
X
X
X
X
EDTA-Plasma
Serum
α1-Acid Glycoprotein
α1-Acid Glycoprotein Gen.2
α1-Antitrypsin ver.2
Acetaminophen
Acid/Prostatic Phosphatase
Albumin Gen.2
Albumin (Turbidimetric)
Serum Application
ALP2 ALP IFCC Gen.2
ALTL Alanine Aminotransferase
ALTPL Alanine Aminotransferase
Pyridoxal Phosphate Activated
AMIKM3 Amikacin
AMYL2 α-Amylase EPS ver.2
AMY-P α-Amylase EPS Pancreatic
AP2P ALP IFCC Gen.2 Primary Tube
APOAT Apolipoprotein A-1 ver.2
APOBT Apolipoprotein B ver.2
ASO2 Antistreptolysin O
ASTL Aspartate Aminotransferase
ASTPL Aspartate Aminotransferase
AT
Antithrombin
BIL-D Bilirubin Direct
BIL-T Bilirubin Total
BILTS Total Bilirubin Special
C3C-2 Complement C3c ver.2
C4-2
Complement C4 ver.2
CA
Calcium
CARB3 Carbamazepine
CERU Ceruloplasmin
CERU2 Ceruloplasmin
CERU3 Ceruloplasmin
CHE
Cholinesterase
CHE-D Cholinesterase/Dibucaine
CHOL2 Cholesterol Gen.2
CKL
Creatinine Kinase
CKMBL Creatinine Kinase-MB
CO2-L Bicarbonate liquid
CREJC Creatinine Jaffé Integra 400
Comp. Method for Serum and Plasma
CREJC Creatinine Jaffé Integra 700/800
Comp. Method for Serum and Plasma
CREP2 Creatinine plus ver.2
CRPL2 C-Reactive Protein (Latex) Integra 400
CRPL2 C-Reactive Protein (Latex) Integra 400
CRPL2 C-Reactive Protein (Latex) Integra 700/800
AAGP
AAGP2
AAT2
ACETA3
ACPP
ALB2
ALBS
Heparin-Plasma
Sample
Material
Analyte
600
Intralipid
not measured2
Intralipid
not measured2
no
160
Intralipid
not measured2
no
Intralipid
not measured2
Intralipid
not measured2
no
under
evaluation
no
no
1600
700
no
750
no
150
120
no
no
120
120
no
400
Intralipid
not measured2
no
no
no
100
Intralipid
not measured2
under
evaluation
Intralipid
not measured2
Intralipid
not measured2
1000
120
169
Intralipid
not measured2
Intralipid
not measured2
Intralipid
not measured2
no
Intralipid
not measured2
Intralipid
not measured2
Intralipid
not measured2
27
Reagents on cobas c 501 analyzer
Turbidity
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
앖
씯
씮
씯
씮
씯
씮
앖
씯
씮
씯
씮
앖
씯
씮
n/a
n/a
n/a
씯
씮
n/a
앗
n/a
씯
씮
앗
씯
씮
n/a
n/a
no
15
29
13
no
5
no
33
39
no
no
38
17
no
15
29
13
no
5
no
33
35
no
no
38
17
no
1000
1000
1000
500
600
no
1000
no
100
no
1000
1000
no
257
496
222
no
86
no
564
667
no
no
650
291
no
257
496
222
no
86
no
564
599
no
no
650
291
no
621
621
621
311
373
no
621
no
62
no
621
621
n/a
no
앖
앗
앖
앗
= not applicable
= no significant interference up to the highest tested level
= over-recovery
= under-recovery
= variable recovery
씯
씮 = recovery within ±10 % of initial concentration
1 Interferences were tested with the following substances added to samples:
Hemoglobin up to 621 µmol/l (1000 mg/dL)
Bilirubin up to 1026 µmol/L (60 mg/dl)
Only significant interferences (>10%) are listed in the method sheets
2 L index not measured with Intralipid®, interference measured as Triglycerides (see Method Sheet)
3 Endogenous bilirubin samples were used, total bilirubin was measured
28
no
Intralipid
not measured2
Intralipid
not measured2
Intralipid
not measured2
no
n/a
1500
Intralipid
not measured2
no
200
no
Intralipid
not measured2
Intralipid
not measured2
60
60
25
60
60
60
60
25
60
60
60
60
25
60
60
1000
1000
150
1000
1000
1026
1026
428
1026
1026
1026
1026
428
1026
1026
621
621
93
621
no
650
900
1200
550
1500
ALP IFCC Gen.2
Alanine Aminotransferase
Alanine Aminotransferase
X
X
X
X
X4)
앗
앗
씯
씮
앗
앗
앖
앗
씯
씮 2000 200
앗 150 200
35
60
35
60
60
60
200
200
599
1026
1026
1026
124
124
2000
150
X
X
X4)
앗
앗
앖
앗
앗
150 700
60
60
60
700
1026
1026
435
150
a-Amylase EPS ver.2
a-Amylase EPS Pancreatic
Apolipoprotein A-1 ver.2
Apolipoprotein B ver.2
Antistreptolysin O
X
X
X
X
X
X
X
X
X
X8)
X
X
X8)
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
씯
씮
앖
1500 500
1500 200
1000 1000
1000 1000
1000 1000
60
60
60
60
60
60
60
60
60
60
60
60
60
60
60
500
200
1000
1000
1000
1026
1026
1026
1026
1026
1026
1026
1026
1026
1026
311
124
621
621
621
1500
1500
1000
1000
1000
Aspartate Aminotransferase
Aspartate Aminotransferase
Antithrombin
Bilirubin Direct
Bilirubin Direct (Multi)
X
X
X4)
씯
씮
씯
씮
앖2)
앗
150 40
60
60
60
40
1026
1026
25
150
X
X
X4)
씯
씮
씯
씮
n/a
n/a
씯
씮 앖2)
씯
씮 씯
씮
n/a
n/a
앗 150 20 60
씯
씮 1250 1000 60
앗
0 25 35
앗
0 10 100
60
60
n/a
n/a
60
60
n/a
n/a
20
1000
35
10
1026
1026
n/a
n/a
1026
1026
n/a
n/a
12
621
22
6
150
1250
35
100
AT
BIL-D
D-BIL
BILT2
SBIL2 Bilirubin Total
BILTS
SBILS Total Bilirubin Special
C3C-2 Complement C3c ver.2
C4-2
Complement C4 ver.2
CA
S-CA Calcium
CARB2 Carbamazepine
CERU Ceruloplasmin
CHE2 Cholinesterase Gen.2
CHED2 Cholinesterase/Dibucaine Gen.2
CHO2I
CHO2A Cholesterol Gen.2
CKL
Creatine Kinase
CKMBL Creatine Kinase-MB
CO2-L
SCO2L Bicarbonate liquid
CEEJ2 Creatinine Jaff‚ Gen.2
CREP2 Creatinine plus ver.2
CRPHS C-Reactive Protein High Sensitive
CRPLX C-Reactive Protein
D-DI
D-Dimer
DIG
Digoxin
DIGIT Digitoxin
ETOH2
SETH2 Ethanol Gen.2
FERR3 Ferritin Gen.3
FRA
Fructosamine
GENT2 Gentamicin
X
Lipemic Index
as Intralipid®
650 1000
900 1000
1200 150
550 1000
1500 1000
Hemolytic Index
as Hb
앖
앖
씯
씮
앗
씯
씮
Icteric Index
씯
씮
씯
씮
앖
씯
씮
씯
씮
Icteric Index
as conj. Bilirubin
씯
씮
씯
씮
앖
씯
씮
씯
씮
Icteric Index
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
Icteric Index
as conj. Bilirubin
X
X
X4)
X
X4)
Index I
X
X
X
X
X
Index H
X
X
X
X
X
Index L
a1-Acid Glycoprotein Gen.2
a1-Antitrypsin ver.2
Acetaminophen
Albumin BCG Gen.2
Albumin (Turbidimetric)
Others
Lipemic Index
as Intralipid®
~µmol/l
Hemolytic Index
as Hb
~µmol/l
Icteric Index
~µmol/l
Icteric Index
as conj. Bilirubin
~mg/dl
EDTA-Plasma
~mg/dl
Heparin-Plasma
Icteric Index
~mg/dl
AMYL2
SAMY2
AMY-P
APOAT
APOBT
ASLOT
ASTL
SASTL
ASTLP
Serum
Icteric Index
as conj. Bilirubin
X
X
X
X
without
units1
X
X
X
X
X
X
X
X
X
X
X
X
X
Interference within
specification up to
(SI units):
X
X
X
X
X
X
X
X
X
X
X
X
X
Interference within
specification up to
Direction
Others
Heparin-Plasma
Total T4 (Thyroxine)
Theophylline
Tobramycin
Total Protein
Triglycerides
Transferrin ver.2
T-Uptake
Uric Acid ver.2
Unsaturated Iron-Binding Capacity
Urea/BUN
Valproic Acid
Vancomycin
Serum
STFR
T43
THEO3
TOBR3
TP2
TRIGL
TRSF2
T-UP3
UA2
UIBC
UREAL
VALP3
VANC3
EDTA-Plasma
Sample
Material
Analyte
AAGP2
AAT2
ACETA
ALB2
ALBS2
ALP2S
ALP2L
ALTL
ALTLP
Instrument Interference within Interference within without
specification up to
specification up to
units1
settings (conventional units):
(SI units):
Direction
Sample
Material
Analyte
X
X
X
X
X
X4)
n/a n/a
0
n/a
n/a
50
n/a
n/a
31
300
X
X
X
X
X
X
X4)
n/a n/a
씯
씮앖 600 500 0
씯
씮 씯
씮 씯
씮 씯
씮 2000 1000 60
씯
씮 씯
씮 앖 씯
씮 1000 500 60
n/a
60
60
n/a
60
60
500
1000
500
n/a
1026
1026
n/a
1026
1026
311
621
311
600
2000
1000
X
X
X
X
X
X
X
X
X
X
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
앖
앖
씯
씮
씯
씮
앖
씯
씮
앖
2000 1000
2000 1000
200 1000
1000 700
500 200
60
50
60
60
40
60
50
60
60
60
60
50
60
60
40
1000
1000
1000
700
200
1026
855
1026
1026
1026
1026
855
1026
1026
684
621
621
621
435
124
2000
2000
200
1000
500
X
X
X
X
X
X
앗
씯
씮
앖
앗
씯
씮
앖
앖
앖
앖
씯
씮 2000 700
씯
씮 1000 200
앗 200 10
14
60
20
16
60
40
14
60
20
700
200
10
274
1026
684
239
1026
342
435
124
6
2000
1000
200
X
X
X
X
X
씯
씮
앗
앗
씯
씮
씯
씮
앖
앗
X
X
X
X
X
X
X
X
X
X
씯
씮
앖
앗
씯
씮
앗
앖
씯
씮
씯
씮
씯
씮
앖
앗
앗
앖
앖
앗
씯
씮
씯
씮
60
5
15
60
60
20
60
45
60
5
15
60
60
20
60
45
60
10
25
60
60
20
60
45
400
1000
800
1000
500
500
1000
1000
1026
86
257
1026
1026
342
1026
770
1026
171
428
1026
1026
342
1026
770
248
621
497
621
311
311
621
621
1800
800
2000
600
400
750
850
1000
X
X
X
X
X
X
X
X
앗
앖
앖
앗
씯
씮
앗 500 200 30
앗 500 400 60
앖 1800 100 5
앗 150 1000 50
30
60
5
50
60
60
5
50
200
400
100
1000
513
1026
86
855
1026
1026
86
855
124
248
62
621
500
500
1800
150
앗
앗
300 50
6) 7)
X
X
X4)
X4)
X4)
X4)
X4)
씯
씮
씯
씮
씯
씮
앖
앗
씯
씮
씯
씮
앖
씯
씮
씯
씮
X4)
X4)
X4)
X
앗
씯
씮
앖
씯
씮
씯
씮
씯
씮
앖
씯
씮
X
X
X4)
X4)
X
X
1800 400
800 1000
2000 800
600 1000
400 500
750 500
850 1000
1000 1000
29
n/a
no
앖
앗
앖
앗
씯
씮
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
X
X
X
X
X
X
X
X4)
X4)
X
X
X
X
X
X
X
X
X
X
X
X
X
X3)
50
20
200
855
342
124
1500
X
씯
씮
씯
씮
씯
씮
앖 1000 1000 60
60
60
1000
1026
1026
621
1000
X
씯
씮
앖
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗
앖
씯
씮
앖
앖
앗
씯
씮
1000 1000
250 50
600 10
1800 1200
60
60
60
30
60
60
60
30
60
60
60
60
1000
50
10
1200
1026
1026
1026
513
1026
1026
1026
1026
621
31
6
745
1000
250
600
1800
씯
씮
씯
씮
앖
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
앗
앖
씯
씮
앖
씯
씮
씯
씮
앖
씯
씮
씯
씮
앖
씯
씮
씯
씮
n/a
씯
씮
씯
씮
앗
2000 1000
2000 1000
0
0
2000 1000
1700 1000
1500 200
60
60
0
60
60
60
60
60
15
60
60
60
60
60
15
60
60
60
1000
1000
200
1000
1000
200
1026
1026
257
1026
1026
1026
1026
1026
257
1026
1026
1026
621
621
124
621
621
124
2000
2000
n/a
2000
1700
1500
앗
씯
씮
씯
씮
씯
씮 1500 1000 28
28
60
1000
479
1026
621
1500
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
앖
씯
씮
씯
씮
씯
씮
씯
씮
앗
앗
씯
씮
씯
씮
1500 15
900 15
200 1000
2000 1000
2000 1000
60
60
60
37
60
60
60
60
43
60
60
60
60
37
60
15
15
1000
1000
1000
1026
1026
1026
735
1026
1026
1026
1026
633
1026
9
9
621
621
621
1500
900
200
2000
2000
씯
씮
씯
씮
앖
앗
앖
앗
씯
씮
씯
씮
씯
씮
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
앗
씯
씮
앗
1700 1000
2000 400
50 200
1000 1000
800 1000
60
60
10
60
50
60
60
10
60
50
60
60
30
60
50
1000
400
200
1000
1000
1026
1026
171
1026
855
1026
1026
513
1026
855
621
248
124
621
621
1700
2000
505)
1000
800
앖
씯
씮
앗
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앖
씯
씮
앗
씯
씮
앗
씯
씮
앖
앖
씯
씮
앗
씯
씮
앗
1250 300
200 1000
2000 300
1000 1000
1000 800
300 1000
40
60
40
23
60
50
40
60
40
23
60
50
60
60
60
23
60
50
300
1000
300
1000
800
1000
684
1026
684
393
1026
855
1026
1026
1026
393
1026
855
186
621
186
621
497
621
1250
200
2000
1000
1000
300
앗
앗
씯
씮
앗
앗
앗
앖
씯
씮
앗
씯
씮
씯
씮
앖
씯
씮
씯
씮
앖
씯
씮
n/a
앖
씯
씮
앗
2000 1000
0 700
500 1000
1500 1000
300 40
20
10
60
40
60
20
10
60
40
60
20
35
60
40
60
1000
700
1000
1000
40
342
171
1026
684
1026
342
599
1026
684
1026
621
435
621
621
25
2000
n/a
500
1500
300
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
씯
씮
앗 1000 1000 60
앗 500 500 30
앗 500 650 30
60
30
30
60
30
30
1000
500
650
1026
513
513
1026
513
513
621
311
404
1000
500
500
X
Lactate Gen.2
X
Lactate Dehydrogenase acc. IFCC ver.2
Lactate Dehydrogenase (P-L)
LDL-Cholesterol plus 2nd generation
Lithium
Lipase colorimetric
X
X
X
X
X
X
X
X
X
X
Magnesium
Myoglobin Gen.2
Ammonia
CEDIA Phenobarbital
Phenytoin
X
X
X
X
X
X
X
X
X4)
X4)
X9)
X
Phosphate (Inorganic) ver.2
Prealbumin
Rheumatoid Factors II
Salicylate
Theophylline
X
X
X
X
X
X
X
X
X
X
X
X
X4)
X4)
X10)
X
Total Protein
Triglycerides
Transferrin ver.2
Uric Acid ver.2
Unsaturated Iron-Binding Capacity
X
X
X
X
X
X
X
X
X
X8)
X
X
Urea/BUN
Valproic Acid
Vancomycin
X
X
X
X
X
X
X4)
3)
X8)
X
X
X
= not applicable
= no significant interference up to the highest tested level
= over-recovery
= under-recovery
= variable recovery
= recovery within ±10 % of initial concentration
Interferences were tested with the following substances added to samples: Hemoglobin up to 621 µmol/l (1000 mg/dL), Bilirubin up to 1026 µmol/L (60 mg/dl),
Erythrocytes contain AST
Only K2-EDTA allowed, K3-EDTA is not allowed
Only K2-EDTA has been checked
Due to the fact that Intralipid contains NH3, the study performed with native lipemic samples
Neonates
Adults
Plasma values are lower than serum values - Please refer to the pack insert
Sodium EDTA
Only K3-EDTA allowed, K2-EDTA is not suitable
30
Consolidated Workstations
Clinical chemistry analyzers
Lipemic Index
as Intralipid®
Hemolytic Index
as Hb
20
Icteric Index
씯
씮 1500 200
Icteric Index
as conj. Bilirubin
앗
Icteric Index
앗
Icteric Index
as conj. Bilirubin
Immunoglobulin A
Immunoglobulin G
Immunoglobulin G
Immunoglobulin M
Immunoglobulin M
Iron Gen.2
X
Index I
X
X
X
X
Index H
X
Glucose HK Gen.3
Haptoglobin ver.2
HBDH Gen.2
HDL-Cholesterol plus 3rd generation
씯
씮
Index L
Glucose HK
4)
X4)
X
EDTA-Plasma
X
Others
Heparin-Plasma
γ-Glutamyltransferase ver.2
Serum
GGTI2
GGTS2
GLUC2
SGLU2
GLUC3
SGLU3
HAPT2
HBDH2
HDLC3
IGA-2
IGAP2
IGG-2
IGGC2
IGM-2
IGMP2
IRON2
LACT2
SLAC2
LDHI2
LDIP2
LDHL
LDL-C
LI
LIPC
MG
S-MG
MYO2
NH3L
PHNO3
PHNY2
PHOS2
SPHO2
PREA
RF-II
SALI
STFR
THEO2
TP2
S-TP2
TRIGL
TRSF2
UA2
UIBC
UREAL
SUREA
VALP2
VANC2
Instrument Interference within Interference within without
specification up to
specification up to
units1
settings (conventional units):
(SI units):
Direction
Sample
Material
Analyte
COBAS INTEGRA® Systems
Designed to consolidate testing and
increase efficiency while reducing total
running costs of the laboratory.
The broad reagent portfolio and the
innovative COBAS INTEGRA reagent
cassette are combined with four proven
measurement technologies and sophisticated, easy to use software.
COBAS INTEGRA systems are the right
choice for workflow consolidation in
the small to medium workload laboratory and special chemistry testing in
high volume sites. COBAS INTEGRA®
800 allows the use of Roche/Hitachi
5-position sample racks for improved
pre-analytical sample flow.
Roche/Hitachi Systems
Reliability, quality and convenience make
these analyzers the clinical chemistry
workhorse systems for routine test consolidation. The broad reagent portfolio
includes more than 100 applications.
The combination of throughput and
automation delivers high productivity
for the laboratory.
Immunochemistry analyzer
Elecsys® Systems
The Elecsys systems family includes a
range of immunochemistry analyzers,
meeting automation requirements of
nearly all sizes of clinical laboratories.
Dedicated STAT ports allow priority
handling of emergency samples.
The Elecsys systems family allows the use
of Roche/Hitachi 5-position sample racks
for improved pre-analytical sample flow.
Serum Work Area solutions
MODULAR® ANALYTICS SWA
cobas® 6000 analyzer series*
Roche serum work area solutions offer
one-touch sample processing with fully
automated rack transport between the
individual modules. Rack traffic and
sample throughput of the clinical
chemistry and immunoassay modules
are tailored to fulfil the turnaround
time (TAT) requirements for routine
and emergency samples.
Reflex testing capabilities enable the
laboratory to apply indication oriented
testing cascades efficiently.
* cobas 6000 analyzer series
is the first member of the
Roche 2nd generation of
serum work area solutions.
31
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Graphical Comparisons of
Interferences in Clinical Chemistry
Instrumentation. Clin Chem 1986;
32: 470-475
33
Notes
34
35

Serum Indices: Reduction of clinical errors in

Transcription

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