DIAGNOSTICS

Performance Evaluation of Alinity c Assays

from the Therapeutic Drug Monitoring
.

and Specific Protein Assay Panels

.

Authors*: L. Ruvuna, A. Reeves, M. Berman, G. Sumerdon, C. Rudolph, R. El Kouhen, D. Daghfal & P. Ravalico

*Abbott Diagnostics, Abbott Park, Illinois 60014.

DIAGNOSTICS
ABSTRACT
Specific proteins are valuable markers for a variety of
diseases including microbial infections, inflammatory
response, cardiac risk, and even cancer. Abbott provides
a broad spectrum of specific protein assays which enable
diagnosis and management of many immune system
related diseases. These assays include testing levels of the
complement system to monitor inflammatory response and
to help diagnose and monitor autoimmune diseases, such as
rheumatoid arthritis.
The Abbott Therapeutic Drug Monitoring Panel, or TDMs,
determines drug concentration measurements in body fluids
as an aid to the management of drug therapy for the cure,
alleviation, or prevention of disease. Routine monitoring
ensures that therapeutic drug concentrations are in the
right therapeutic range for optimal patient care. By testing
levels of medications, doctors can monitor and adjust the
prescribed dosage to ensure a drug’s safety and efficacy.
Abbott TDM assays are carefully designed to measure drug
concentrations of analytes that require strict dosage control
under STAT or routine testing conditions.
Abbott recently led studies to demonstrate the analytical
performance of representative assays from the Specific
Proteins and Therapeutic Drug Monitoring Panels of the
Alinity c system. The assays utilize photometric technology
for the quantitative determination of analytes in human
serum or plasma. The Alinity c system is part of a unified
family of systems that are engineered for flexibility and
efficiency. The design is based on insights from customers,
resulting in a number of benefits including a smaller
footprint, improved workflow, and greater throughput
with up to 1350 tests per hour. The Alinity ci system has an
increased reagent load capacity, holding up to 70 Clinical
Chemistry reagents, onboard QC and calibrators, clot and
bubble detection ability, and smartwash technology to
provide consistent and reliable results.
Key performance testing including precision, limit of
quantitation (LoQ), linearity and method comparison were
assessed per Clinical and Laboratory Standards Institute
(CLSI) protocols. The assay measuring interval was defined
by the range for which acceptable performance for bias,
imprecision, and linearity was met.
The observed results for precision, LoQ, method comparison,
and defined measuring intervals for the Specific Protein
assays and TDM assays utilizing photometric technology on
the Alinity c system demonstrated acceptable performance
for precision, sensitivity, and linearity. Method comparison
data showed excellent agreement with on-market
ARCHITECT clinical chemistry assays.1,2
INTRODUCTION
The Alinity Systems Series is designed to simplify
diagnostics and help deliver results that drive better
patient outcomes. The Alinity ci system, Abbott’s next
generation immunoassay and clinical chemistry system,
utilizes Chemiluminescence Microparticle Immunoassay
(CMIA) technology or photometric/potentiometric (CC)
technology for the quantitative determination of analytes
in human serum, plasma, urine and/or CSF. The analytical
performance, including precision, limit of quantitation,
and linearity of the following clinical chemistry assays
is presented for Alinity c Immunoglobulin A, Immuno-
globulin G, Immunoglobulin M, Prealbumin, Complement
C3, Complement C4, Haptoglobin, Apolipoprotein A1 and
Apolipoprotein B (Specific Proteins) assays as well as Alinity
c Amikacin, Theophylline, Tobramycin, Valproic Acid, and
Phenobarbital (TDM) assays.
MATERIALS AND METHODS
Instrumentation
Assay performance studies were conducted using the
Abbott ARCHITECT c8000 and the Alinity c systems.
Assays
The Alinity c Amikacin assay (LN 09P44) is used for the
quantitative determination of amikacin in human serum
or plasma on the Alinity c analyzer. The results obtained
are used in the diagnosis and treatment of amikacin
overdose and in monitoring levels of amikacin to help
ensure appropriate therapy. Amikacin is a semi-synthetic
aminoglycoside that exhibits bactericidal activity against
a wide range of pathogens, including many organisms
resistant to other aminoglycosides. Amikacin is active in
vitro against gram-negative organisms, penicillinase, and
non-penicillinase producing staphylococci. The strength of
this drug is due primarily to its high degree of resistance
to aminoglycoside-inactivating enzymes. Determination of
serum or plasma drug levels is required to achieve optimum
therapeutic efficacy and minimize toxicity.3
2
DIAGNOSTICS
The Alinity c Theophylline assay (LN 09P89) is for in vitro
diagnostic use for the quantitative measurement of theoph-
ylline in human serum or plasma on the Alinity c analyzer.
The measurements obtained are used in the diagnosis and
treatment of theophylline overdose and in monitoring levels
of theophylline to help ensure appropriate therapy. The
physiological effects of the anti-asthmatic drug theophylline
correlate better with the drug concentration in serum than
with dosage. Since serious toxic effects of theophylline
are related to the serum concentration and are not always
preceded by minor adverse symptoms, serum theophylline
monitoring helps to avoid adverse effects.4
The Alinity c Tobramycin assay (LN 9P90) is used for the
quantitative determination of tobramycin in human serum
or plasma on the Alinity c analyzer. Tobramycin sulfate is an
aminoglycoside derived from Streptomyces tenebrarius. This
aminoglycoside antibiotic is used to treat serious bacterial
infections by inhibiting the growth of the bacterium by
intervening in the protein synthesis thereby killing the
bacterium. Tobramycin is absorbed minimally from the
gastrointestinal tract. In the first 24 hours after intravenous
dosing, the usual route of administration, about 99% of
the tobramycin is excreted unchanged by the kidneys. The
average half-life in patients with normal renal function is
about 2 to 3 hours. Therapeutic serum levels vary depending
on the microorganism involved and the patient’s tolerance
to the drug. Tobramycin serum or plasma concentrations
are monitored to help guide therapy, since individual patient
differences require dose changes that are difficult to predict.
Monitoring serum or plasma levels of tobramycin decreases
the frequency of serious toxic effects.5
The Alinity c Valproic Acid assay (LN 9P92) is used for the
quantitative in vitro measurement of valproic acid in human
serum or plasma on the Alinity c analyzer. Valproic acid
(2-propylpentanoic acid; Depakene) is a broad-spectrum
anticonvulsant drug used solely or in combination with other
anticonvulsant drugs for the treatment of absence seizures.
It also has demonstrated effectiveness in the management
of generalized tonic-clonic and myoclonic seizures, as well
as atypical absence, simple and complex partial, and mixed
grand mal and petit mal seizures. The capability of treating
many types of seizures with a single anticonvulsant has
resulted in the widespread use of valproic acid, particularly
in children in whom tonic-clonic and myoclonic seizures
are most prevalent. Valproic acid has proven effective in the
treatment of many patients otherwise refractory to other
anticonvulsant treatments. Most patients receiving valproic
acid do not develop a tolerance to its anticonvulsant effects.6
The Alinity c Phenobarbital assay (LN 9P85) is for in vitro
diagnostic use for the quantitative measurement of pheno-
barbital in human serum or plasma on the Alinity c analyzer.
The measurements obtained are used in the diagnosis and
treatment of phenobarbital overdose and in monitoring
levels of phenobarbital to help ensure appropriate therapy.
Phenobarbital was introduced in 1912 for the treatment
of epilepsy, particularly for controlling focal motor or
sensory seizures and grand mal seizures. Phenobarbital
is bound to both plasma and tissue proteins. Monitoring
serum concentrations of phenobarbital has been shown
to improve patient therapy by providing physicians with a
tool for adjusting dosage. In addition, because of the narrow
therapeutic index and wide inter-individual variability in
the rate of phenobarbital metabolism and clearance, the
determination of blood levels of phenobarbital for patients
receiving therapy is important.7
The Alinity c Immunoglobulin A (IgA) assay (LN 09P61) is
used for the quantitation of IgA in human serum or plasma.
IgA comprises approximately 10 – 15% of total serum
immunoglobulins. IgA provides protection against infection
in mucosal areas of the body such as the respiratory and
gastrointestinal tract.8,17
The Alinity c Immunoglobulin G (IgG) assay (LN 09P62) is
used for the quantitation of IgG in human serum or plasma.
IgG comprises approximately 70 – 80% of immunoglobulins
in the blood. IgG antibodies form the basis of long term
protection against microorganisms.9,17
The Alinity c Immunoglobulin M (IgM) assay (LN 09P63) is
used for the quantitation of IgM in human serum or plasma.
IgM comprises approximately 7 – 10% of normal serum
immunoglobulins and is produced as a body’s first response
to a new infection, providing short term protection.10,17
The Alinity c Prealbumin assay (LN 09P86) is used for the
quantitation of prealbumin in human serum. Prealbumin
(transthyretin or thyroxin-binding prealbumin) is
synthesized in the liver and is involved in triiodothyronine
(T3), thyroxine (T4) and vitamin A transport.11
The Alinity c Complement C3 (LN 09P56) and Complement
C4 (LN 09P57) assays are used for the quantitation of C3 and
C4 respectively, in human serum or plasma. All complement
proteins are acute phase reactants and rise rapidly in
concentrations during inflammatory episodes to promote
immune and inflammatory responses. Their principal role
is to destroy foreign substances like bacteria and viruses.12,13
3
DIAGNOSTICS

The Alinity c Haptoglobin assay (LN 09P59) is used for the Measuring Interval
quantitation of haptogen in human serum or plasma. Hapto-
Measuring Interval is defined as the range of values, which
globin is a protein produced by the liver that binds with the
meets the limits of acceptable performance for linearity,
globin alpha-chains of hemoglobin in the blood. This hapto-
imprecision and bias.
globin/free hemoglobin complex is rapidly cleared from the
circulation for destruction and iron recycling.14
Correlation
The Alinity c Apolipoprotein A1 (LN 09P46) and B (LN Correlation between the Alinity c analyzer and the
09P47) assays are used for the quantitation of apolipo- on-market comparator ARCHITECT c8000 was evaluated
protein A-1 or B respectively in human serum or plasma. with three lots of reagents over a minimum of 3 days in
Apolipoproteins are the protein component of lipoproteins, accordance with CLSI EP09-A3.
complexes that transport lipids throughout the blood-
stream. Apolipoprotein A1 activates enzymes that load
cholesterol from the tissues into high density lipoprotein RESULTS
(HDL) and allows HDL to be recognized and bound by Correlation
liver receptors at the end of transport. Apolipoprotein B is a
Method Comparison
Alinity c Immunoglobulin A and Alinity c Immunoglobulin G a
the Alinity c analyzer and the ARCHITECT c8000 was evaluate
component of the low-density lipoprotein (LDL) and is vital Correlation
regression method.
for cell membrane integrity, sex hormone production and
steroid production.15,16 Figure 1a.

Total Precision
Immunoglobulin A Immunoglob
Scatterplot with Passing- Bablok regression Scatterplot w
Slope = 0.98 Slope = 0.99
For the Alinity c assays, controls and panels in serum Intercept = 0.13 Intercept = -
Correlation Coefficient (r) = 1.00 Correlation C
were assayed on the Alinity c analyzer using one lot of
reagent across the measuring interval. A minimum of two
replicates were tested twice a day over 20 days. The % CV’s
for within-run and within laboratory (total) imprecision
were calculated. Total imprecision includes within-run,
between-run, and between-day variance components.
The study was performed based on guidance from CLSI
document EP05-A2. Correlation
Alinity c Immunoglobulin A and Alinity c Immunoglobulin G assays Correlation between
the Alinity c analyzer and the ARCHITECT c8000 was evaluated with Passing-Bablok
Sensitivity regression method.
Limit of Blank, Limit of Detection and Limit of quantitation Figure 1b.
(LOB/D/Q) were determined using one zero-level sample
and two sets of at least four low-level
Immunoglobulin samples
A on two Alinity Immunoglobulin G
c analyzers using three lotsScatterplot
of with Passing-
reagent
Slope = 0.98
over Bablok regression
three days in Scatterplot with Passing- Bablok regression
Slope = 0.99
accordance with CLSI document Intercept EP17-A2.
= 0.13 Intercept = -0.12
Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

Linearity
A sample set spanning the measuring range of the TDM
assays was tested in replicates of four on the Alinity c
analyzer using one lot of reagent. The study was performed
based on guidance from CLSI document EP06-A.

4
 DIAGNOSTICS

Correlation Correlation
Correlation Alinity
Alinity c Immunoglobulin c Complement
M and C3 and Complement
Alinity c Prealbumin C4 assay
assays Correlation Correlation
between the between the Alinity c
analyzer
Alinity c analyzer and the and the
ARCHITECT ARCHITECT
c8000 c8000 was
was evaluated withevaluated with Passing-Bablok
Passing-Bablok regression regression method.
method.
Figure 1c. Figure 1f.

Immunoglobulin M C3 Prealbumin C4
Scatterplot with Passing- Bablok regression Scatterplot with Passing- BablokScatterplot
Scatterplot with Passing- Bablok regression regressionwith Passing- Bablok regression
First Replicate on Alinity c (mg/dL)

Slope = 1.02 Slope = 1.03 Slope = 1.00 Slope = 0.98

Intercept = 1.07 Intercept = 0.58 Intercept = 1.00 Intercept = 0.35
First Replicate on Alinity c (mg/dL)

First Replicate on Alinity c (mg/dL)

Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

First Replicate on Alinity c (mg/dL)

Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

Correlation Correlation
d Alinity c Prealbumin assays Correlation between the Alinity c Haptoglobin assay Correlation between the Alinity c anal
Mean ARCHITECT c8000 (mg/dL) Mean ARCHITECT c8000 (mg/dL)
ITECT c8000 was evaluated with Passing-Bablok regression c8000 was evaluated with Passing-Bablok regression method.

Figure 1d. Figure 1g.

Prealbumin Haptoglobin
Scatterplot with Passing- Bablok regression Scatterplot with Passing- Bablok regression
First Replicate on Alinity c (mg/dL)

Slope = 1.00 Slope = 0.99

Intercept = 1.00 Intercept = -0.29
Correlation Coefficient (r) = 1.00
First Replicate on Alinity c (mg/dL)

Correlation Coefficient (r) = 1.00

Correlation Correlation
Alinity c Complement C3 and Complement C4 assay Correlation between the Alinity c Apolipoprotein
Alinity c A1 and Apolipoprotein B assay Correlatio
analyzer and
Meanthe ARCHITECT
ARCHITECT analyzer and
c8000 was evaluated with Passing-Bablok regression method.
c8000 (mg/dL) the ARCHITECT c8000 was evaluated with Passing-Ba

Figure 1e. Figure 1h.

C3 C4 Apolipoprotein A1 Apolipoprotein B
Scatterplot with Passing- Bablok regression Scatterplot with Passing- Bablok regression
Scatterplot with Passing- Bablok regression Scatterplot with Pas
First Replicate on Alinity c (mg/dL)

Slope = 1.03 Slope = 0.98 Slope = 1.02 Slope = 0.98

Intercept = 0.58 Intercept = 0.35 Intercept = -0.68 Intercept = -1.93
First Replicate on Alinity c (mg/dL)
First Replicate on Alinity c (mg/dL)

Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00 Correlation Coefficie

5
 DIAGNOSTICS

Correlation
Correlation
Apolipoprotein B assay Correlation between the Alinity c
00 was evaluated with Passing-Bablok regression method.

Figure 1i. Figure 1l.

Apolipoprotein B Tobramycin
n Scatterplot with Passing- Bablok regression Scatterplot with Passing- Bablok regression
Slope = 0.98 Slope = 1.01
Intercept = -1.93 Intercept = 0.09
First Replicate on Alinity c (mg/dL)

Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

Figure 1j. Figure 1m.

Alinity c Amikacin Valproic Acid

Scatterplot with Passing- Bablok regression Scatterplot with Passing- Bablok regression
Slope = 1.02 Slope = 1.00
Intercept = -0.21 Intercept = -0.78
Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

Figure 1k. Figure 1n.

Alinity c Theophylline Phenobarbital

Scatterplot with Passing- Bablok regression Scatterplot with Passing- Bablok regression
Slope = 0.94 Slope = 0.98
Intercept = 0.19 Intercept = 0.13
Correlation Coefficient (r) = 1.00 Correlation Coefficient (r) = 1.00

6
DIAGNOSTICS

Table 1. Method Comparison Summary Table 2. Sensitivity, Linearity and Measuring Interval

Method Comparison to
Total Measuring Linear Measuring
Assay LoQ ARCHITECT Assay LoB LoD LoQ
%CV Interval Range Interval
(Slope/Correlation)
3 5 to 3850 2 3 3 0 to 3850 5 to 3850
Immunoglobulin A ≤ 1.8 0.98/1.00 Immunoglobulin A
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
10 320 to 4675 4 8 10 0 to 4675 320 to 4675
Immunoglobulin G ≤ 1.5 0.99/1.00 Immunoglobulin G
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
3 5 to 1815 0 1 3 0 to 1815 5 to 1815
Immunoglobulin M ≤ 3.2 1.02/1.00 Immunoglobulin M
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
1.0 3 to 66 0.9 1 1 0 to 68 3 to 66
Prealbumin ≤ 2.2 1.00/1.00 Prealbumin
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
5 11 to 385 0 1 5 0 to 385 11 to 385
Complement C3 ≤ 1.8 1.03/1.00 Complement C3
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
0.7 2.9 to 72.0 0.1 0.2 0.7 0 to 72.0 2.9 to 72.0
Complement C4 ≤ 1.7 0.98/1.00 Complement C4
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
3 8 to 300 1 2 3 0 to 300 8 to 300
Haptoglobin ≤ 1.5 0.99/1.00 Haptoglobin
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
2 16 to 310 1 2 2 0 to 383 16 to 310
Apolipoprotein A1 ≤ 1.1 1.02/1.00 Apolipoprotein A1
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
3 11 to 240 1 2 3 0 to 263 11 to 240
Apolipoprotein B ≤ 3.7 0.98/1.00 Apolipoprotein B
mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
2.3 2.3 to 50.0 0.6 1.1 2.3 0 to 45.2 2.3 to 50.0
Amikacin ≤ 5.3 1.02/1.00 Amikacin
µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL
1.3 2.0 to 40.0 0.3 0.5 1.3 0.1 to 37.3 2.0 to 40.0
Theophylline ≤ 3.7 0.94/1.00 Theophylline
µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL
0.3 0.3 to 10.0 0.0 0.1 0.3 0.0 to 9.1 0.3 to 10.0
Tobramycin ≤ 3.1 1.01/1.00 Tobramycin
µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL
5.1 12.5 to 150.0 0.5 0.8 5.1 0.1 to 136.2 12.5 to 150.0
Valproic Acid ≤ 2.5 1.00/1.00 Valproic Acid
µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL
1.9 2.0 to 80.0 0.2 0.4 1.9 0 to 71.4 2.0 to 80.0
Phenobarbital ≤ 5.8 0.98/1.00 Phenobarbital
µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL

Correlation and bias plots for the TDM and Specific Protein Limit of Blank, Limit of Detection and Limit of quantitation
assays are shown in Figure 1 and summarized in Table 1. studies verified claims for the Alinity System assays. The
Method comparison results indicate a strong correlation data support acceptable low-end measurement capabilities
between the ARCHITECT and Alinity Systems supported of these assays and linearity across the range.
by correlation coefficients equal to 1.00 for the assays and
slopes and y intercepts approaching 1.00 and 0 respectively.
Note: Panels near the LoQ are not shown and were within
20% CV.

7
DIAGNOSTICS

PRECISION
In order to determine and support precision claims for
each assay, means, standard deviations and percent CV’s
were calculated for within run, between run and between
day to establish a total percent CV (Tables 3-16) The assays
achieved CV’s < or = 5.3% for concentrations within the
measuring interval and CV’s < or = 17% for panels at the
Upper and Lower limits of quantitation which are expected
to have higher imprecision.

Table 3. IgA Table 5. IgM

Within- Between- Between- Within- Within- Between- Between- Within-

IgA Run Run Day Laboratory IgM Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(mg/dL) (mg/dL)
Control Control
120 132.4 0.9 0.5 0.9 1.4 120 57 2.5 0.9 1.8 3.2
Level 1 Level 1
Control Control
120 213.5 0.6 0.4 0.6 0.9 120 101 1.6 1.2 0.9 2.2
Level 2 Level 2
Control Control
Serum 119 245.8 0.7 0.4 0.5 1.0 Serum 120 116 1.4 1.0 1.0 2.0
Level 3 Level 3

Panel 1 120 6.5 1.1 0.8 3.4 3.7 Panel 1 120 5 5.1 1.5 3.8 6.5

Panel 2 120 3173.4 1.8 0.0 0.2 1.8 Panel 2 120 1582 0.8 0.4 0.4 1.0

Table 4. IgG Table 6. Prealbumin

Within- Between- Between- Within- Within- Between- Between- Within-

IgG Run Run Day Laboratory Prealbumin Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(mg/dL) (mg/dL)
Control Control
120 628 0.6 0.4 0.5 0.8 120 17 1.7 0.3 1.3 2.2
Level 1 Level 1
Control Control
120 1100 0.6 0.2 0.4 0.7 120 23 1.7 0.7 0.9 2.1
Level 2 Level 2
Control Control
Serum 120 1264 0.7 0.5 0.5 1.0 Serum 120 33 1.5 0.4 0.0 1.6
Level 3 Level 3

Panel 1 120 14 1.7 0.8 2.2 2.9 Panel 1 120 4 8.6 2.1 5.5 10.4

Panel 2 120 4059 1.5 0.2 0.4 1.5 Panel 2 120 55 1.2 0.2 0.5 1.3

8
DIAGNOSTICS

PRECISION

Table 7. C3 Table 10. Apolipoprotein A1

Within- Between- Between- Within- Within- Between- Between- Within-

C3 Run Run Day Laboratory Apolipoprotein A1 Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(mg/dL) (mg/dL)
Control Control
119 106 1.2 0.2 0.3 1.3 120 105 0.7 0.7 0.4 1.1
Level 1 Level 1
Control Control
120 141 1.2 0.4 0.4 1.3 120 179 0.5 0.7 0.3 0.9
Level 2 Level 2
Control Control
Serum 120 208 1.2 0.3 0.0 1.3 Serum 120 232 0.5 0.5 0.0 0.7
Level 3 Level 3

Panel 1 120 12 1.5 1.6 0.0 2.2 Panel 1 120 2 11.3 10.2 5.2 16.1

Panel 2 120 332 1.8 0.2 0.2 1.8 Panel 2 120 299 0.8 0.7 0.5 1.1

Table 8. C4 Table 11. Apolipoprotein B

Within- Between- Between- Within- Within- Between- Between- Within-

C4 Run Run Day Laboratory Apolipoprotein B Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(mg/dL) (mg/dL)
Control Control
120 16.1 1.1 1.1 0.7 1.7 120 43 1.7 1.5 2.9 3.7
Level 1 Level 1
Control Control
120 23.2 1.1 0.7 0.5 1.5 120 88 1.0 1.3 2.3 2.8
Level 2 Level 2
Control Control
Serum 120 32.5 0.9 0.8 0.6 1.4 Serum 120 123 0.8 1.1 2.2 2.6
Level 3 Level 3

Panel 1 119 3.0 3.1 4.9 1.5 6.0 Panel 1 120 5 6.4 6.9 7.0 11.8

Panel 2 120 59.3 1.0 0.0 0.3 1.0 Panel 2 120 226 0.7 0.8 2.2 2.5

Table 9. Haptoglobin Table 12. Amikacin

Within- Between- Between- Within- Within- Between- Between- Within-

Haptoglobin Run Run Day Laboratory Amikacin Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(mg/dL) (ug/mL)
Control Control
120 84 0.6 0.7 1.1 1.5 120 4.6 3.2 3.7 2.2 5.3
Level 1 Level 1
Control Control
120 114 0.6 0.3 0.4 0.8 120 12.9 1.5 1.5 2.1 3.0
Level 2 Level 2
Control Control
Serum 120 145 0.7 0.3 0.0 0.7 Serum 120 29.8 1.3 0.7 1.7 2.2
Level 3 Level 3

Panel 1 120 9 4.3 1.1 2.9 5.3 Panel 1 120 2.3 6.7 7.3 6.8 12.1

Panel 2 120 264 1.1 0.2 0.0 1.1 Panel 2 121 46.3 1.7 0.4 0.5 1.8

9
DIAGNOSTICS

PRECISION

Table 13. Theophylline Table 15. Valproic Acid

Within- Between- Between- Within- Within- Between- Between- Within-

Theophylline Run Run Day Laboratory Valproic Acid Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(ug/mL) (ug/mL)
Control Control
120 6.0 1.6 0.8 1.1 2.1 120 36.1 1.5 0.7 0.8 1.8
Level 1 Level 1
Control Control
120 17 1.8 1.1 1.7 2.7 120 52.7 1.1 0.6 0.7 1.4
Level 2 Level 2
Control Control
Serum 120 21.2 1.5 1.5 2.0 2.9 Serum 120 84.9 1.5 0.0 0.5 1.6
Level 3 Level 3

Panel 1 120 2.0 2.5 1.4 1.2 3.1 Panel 1 120 15.1 2.1 1.5 1.8 3.2

Panel 2 120 24.3 1.9 0.0 3.1 3.7 Panel 2 120 133.3 2.5 0.0 0.0 2.5

Table 14. Tobramycin Table 16. Phenobarbital

Within- Between- Between- Within- Within- Between- Between- Within-

Tobramycin Run Run Day Laboratory Phenobarbital Run Run Day Laboratory

Mean Mean
Matrix Sample N %CV %CV %CV %CV Matrix Sample N %CV %CV %CV %CV
(ug/mL) (ug/mL)
Control Control
120 1.6 1.8 2.6 0.4 3.1 120 13.7 1.2 1.1 0.7 1.8
Level 1 Level 1
Control Control
120 5.0 1.5 1.5 0.7 2.2 120 32.8 1.7 0.8 0.3 1.9
Level 2 Level 2
Control Control
Serum 120 7.4 1.3 0.7 1.2 1.9 Serum 120 49.7 1.9 0.7 2.1 2.9
Level 3 Level 3

Panel 1 120 0.6 4.4 5.1 3.5 7.6 Panel 1 120 3.4 2.1 1.6 0.0 2.7

Panel 2 120 9.0 1.7 0.6 1.0 2.1 Panel 2 111 67.6 5.2 1.3 2.0 5.8

10
DIAGNOSTICS
CONCLUSION
The Therapeutic Drug Monitoring assay Panel and the
Specific Protein Assay Panel on the Alinity c system are an
essential component of a complete menu on the system.
Maintaining a high level of analytical performance with
these assays while developing new instrumentation is a
hallmark of Abbott’s process.
These representative clinical chemistry assays utilizing
photometric technology on the Alinity c system demon-
strated acceptable performance for precision, sensitivity,
and linearity. Method comparison data showed good
agreement and commutability of results with the on-market
ARCHITECT clinical chemistry assays.
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Alinity, Alinity c, Alinity i, Alinity ci-series, ARCHITECT and ARCHITECT c8000
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REFERENCES
1. “Performance Evaluation of Representative Clinical Chemistry Assays from the Specific
Proteins Panel on the Alinity c System from Abbott Laboratories.” Presentation number
B- 409, 2018 AACC Annual Meeting, Chicago, Illinois • July 29 - August 2, 2018
2. “Performance Evaluation of Representative Clinical Chemistry Assays from the Therapeutic
Drug Monitoring Panel on the Alinity c System from Abbott Laboratories.” Presentation
number A- 340, 2018 AACC Annual Meeting, Chicago, Illinois • July 29 - August 2,
2018
3. Alinity c Amikacin reagent Kit Package Insert, IFU#G91732R01, Created October 2017.
Abbott Laboratories
4. Alinity c Theophylline reagent Kit Package Insert, IFU#G91786R01, Created October
2017. Abbott Laboratories
5. Alinity c Tobramycin reagent kit package insert, IFU#G91788R03, Revised July 2018.
© 2017, 2018 Abbott Laboratories
6. Alinity c Valproic Acid reagent Kit Package Insert, IFU#G91798R02, Revised July 2018.
© 2017, 2018 Abbott Laboratories.
7. Alinity c Phenobarbital Reagent Kit Package insert, IFU#G91784R02, Revised July 2018.
© 2017, 2018 Abbott Laboratories
8. Alinity c Immunoglobulin A reagent Kit package insert, IFU#G91780R01, Created
September 2017. © 2017 Abbott Laboratories
9. Alinity c Immunoglobulin G reagent Kit package insert, IFU#G91782R02, Revised
February 2018. © 2017, 2018 Abbott Laboratories
10. Alinity c Immunoglobulin M reagent Kit package insert, IFU#G90663R01, Created
June 2017 © 2017 Abbott Laboratories
11. Alinity c Prealbumin reagent Kit package insert, IFU#G90698R01, Created June 2017
© 2017 Abbott Laboratories
12. Alinity c Complement C3 reagent Kit Package Insert, IFU#G90600R01, Created June
2017. © 2017 Abbott Laboratories
13. Alinity c Complement C4 reagent Kit Package Insert, IFU#G90602R01, Created June
2017. © 2017 Abbott Laboratories
14. Alinity c Haptoglobin reagent Kit Package Insert, IFU#G90604R01, Created June 2017.
© 2017 Abbott Laboratories
15. Alinity c Apolipoprotein A1 reagent Kit Package Insert, IFU#G91734R01, Created
November 2017. © 2017 Abbott Laboratories
16. Alinity c Apolipoprotein B reagent Kit Package Insert, IFU#G91736R02, Revised
December 2017. © 2017 Abbott Laboratories.
17. “Quantitative serum immunoglobulin tests” Australian Family Physician Vol. 42, No. 4,
April 2013
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