en

DIGOXIN
Package insert instructions must be carefully followed. Reliability of
assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Read Highlighted Changes Revised May 2014

1E06-21

INTENDED USE

REAGENT HANDLING AND STORAGE

The MULTIGENT Digoxin assay is used for the quantitative in vitro

measurement of digoxin in human serum or plasma on the ARCHITECT
c Systems.

Reagent Handling

SUMMARY AND EXPLANATION OF TEST

Digoxin is a potent cardiac glycoside widely prescribed for the treatment

of patients suffering from congestive heart failure, as well as some types
of cardiac arrhythmias. Digoxin toxicity is a common and serious
problem in the clinical setting. This is, in part, a result of the fact that
cardiac glycosides have a low therapeutic ratio (a very small difference
between therapeutic and tissue toxic levels).1 Coupled with the narrow
therapeutic range is a marked patient variability in response to the
same dosage of drug, often resulting in unpredictable serum drug
levels.2 Symptoms of digoxin toxicity are often indistinguishable from
the original condition for which the drug was prescribed. It may not be
immediately apparent whether the patient has been under or overdosed.
Monitoring serum digoxin levels combined with other clinical data can
provide the physician with useful information to aid in adjusting patient
dosage, achieving optimal therapeutic effect while avoiding useless
subtherapeutic or harmful toxic dosage levels.3,4

Reagent Storage
Reagent stability is 60 days (1,440 hours) if the reagent is open and
onboard.
Unopened reagents are stable until the expiration date when stored
at 2 to 8C.
Do not freeze reagents or expose reagents to temperatures
above 32C.

PRINCIPLES OF PROCEDURE
The MULTIGENT Digoxin assay is a homogeneous particle-enhanced
turbidimetric inhibition immunoassay (PETINIA) used for the analysis
of digoxin in serum or plasma. The assay is based on competition
between drug in the sample and drug coated onto a microparticle for
antibody binding sites of the digoxin antibody reagent. The digoxincoated microparticle reagent is rapidly agglutinated in the presence of
the anti-digoxin antibody reagent and in the absence of any competing
drug in the sample. The rate of absorbance change is measured
photometrically, and is directly proportional to the rate of agglutination
of the particles. When a sample containing digoxin is added, the
agglutination reaction is partially inhibited, slowing down the rate of
absorbance change. A concentration-dependent classic agglutination
inhibition curve can be obtained, with maximum rate of agglutination at
the lowest digoxin concentration and the lowest agglutination rate at the
highest digoxin concentration.

Indications of Deterioration
Instability or deterioration should be suspected if there are visible
signs of leakage, extreme turbidity, microbial growth, if calibration does
not meet the appropriate package insert and/or ARCHITECT System
Operations Manual criteria, or if controls do not meet the appropriate
criteria.

WARNINGS AND PRECAUTIONS

Precautions for Users

Methodology: Particle-enhanced turbidimetric inhibition immunoassay

(PETINIA)

REAGENTS
Reagent Kit
1E06-21 MULTIGENT Digoxin is supplied as a liquid, ready-to-use,
two-reagent kit which contains:
3 x 22 mL
3 x 9 mL
Estimated tests per kit: 450
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients
Anti-digoxin monoclonal antibody (mouse)
Digoxin-coated microparticles

Ready for use. Before use invert several times, avoiding the
formation of bubbles.
Ready for use. Before use invert several times, avoiding the
formation of bubbles.
Remove air bubbles, if present in the reagent cartridge, with a
new applicator stick. Alternatively, allow the reagent to sit at the
appropriate storage temperature to allow the bubbles to dissipate.
To minimize volume depletion, do not use a transfer pipette to
remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
that could impact results.
Do not mix materials from different kit lot numbers.
When either the
or
reagent cartridge becomes empty, replace
both cartridges.

Concentration
< 0.1%
< 0.5%

For In Vitro Diagnostic Use.

Do not use components beyond the expiration date.
Do not mix materials from different kit lot numbers.
Contains nonsterile mouse monoclonal antibodies.
CAUTION: This product contains human sourced and/or
potentially infectious components. Refer to the REAGENTS
section of this package insert. No known test method can
offer complete assurance that products derived from human
sources or inactivated microorganisms will not transmit
infection. Therefore, all human sourced materials should be
considered potentially infectious. It is recommended that these
reagents and human specimens be handled in accordance
with the OSHA Standard on Bloodborne Pathogens.5 Biosafety
Level 26 or other appropriate biosafety practices7,8 should be
used for materials that contain or are suspected of containing
infectious agents.
The human sourced material used in the reagents has been
tested and found to be non-reactive for HBsAg, HIV-1 RNA or
HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2.

The following warning and precaution apply to

and
:
Contains sodium azide.
EUH032 Contact with acids liberates very toxic gas.
These materials and their containers must be disposed of in a safe
way.
NOTE: Refer to Section 8 of the ARCHITECT System Operations
Manual for proper handling and disposal of reagents containing
sodium azide.
Safety Data Sheets are available at www.abbottdiagnostics.com or
contact your local representative.

Inactive Ingredients:
and
contain human-sourced material and
sodium azide (< 0.1%).
contains BIS-TRIS buffer.

SPECIMEN COLLECTION AND HANDLING

CALIBRATION

Samples should be drawn 12 hours after oral administration of digoxin or

6 hours after IV administration.9
Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
Centrifuge according to tube manufacturers instructions to ensure
proper separation of serum from blood cells.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may exhibit increased clotting
time. If the specimen is centrifuged before a complete clot forms, the
presence of fibrin may cause erroneous results.
Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin, sodium heparin, potassium EDTA, and heparin gel plasma
separator. Ensure centrifugation is adequate to remove platelets.
Centrifuge according to tube manufacturers instructions to ensure
proper separation of plasma from blood cells.
NOTE: Some gel separation tubes may not be suitable for use with
therapeutic drug monitoring assays; refer to information provided by the
tube manufacturer.10
It is the responsibility of the operator to verify the correct sample type is
used with the MULTIGENT Digoxin assay.
Specimens containing particulate matter or red blood cells may
give inconsistent results and should be centrifuged before testing
(recommended 8,000 to 10,000 RCF* x 10 minutes).
*RCF = Relative Centrifugal Force
Analyze fresh specimens, if possible. If not, separated samples may
be stored for up to 48 hours at 2 to 8C prior to being tested. If testing
will be delayed more than 48 hours, separated samples may be stored
frozen at -20C or colder for up to 7 days (168 hours).
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
For total sample volume requirements, refer to the ASSAY PARAMETERS
section of this package insert and Section 5 of the ARCHITECT System
Operations Manual.

The MULTIGENT Digoxin assay must be calibrated using a full

calibration (6-point) procedure. To perform a full calibration, test the
TDM MCC
or MULTIGENT Digoxin
in duplicate.
Calibration is stable for approximately 60 days (1,440 hours) and is
required with each change in reagent lot number. Verify calibration
curve with at least two levels of controls according to the established
quality control requirements for your laboratory. If control results fall
outside acceptable ranges, recalibration may be necessary.
NOTE: TDM MCC
or MULTIGENT Digoxin
is the
calibration blank for this assay.
For information on calibrator standardization, refer to the TDM MCC or
MULTIGENT Digoxin Calibrators package insert.
For a detailed description of how to calibrate an assay, refer to Section 6
of the ARCHITECT System Operations Manual.

QUALITY CONTROL
As appropriate, refer to your laboratory standard operating procedure(s)
and/or quality assurance plan for additional quality control requirements
and potential corrective actions. Verify the recommended control
requirement for the MULTIGENT Digoxin assay.
A minimum of two levels of controls spanning the medical decision
range are to be run every 24 hours.
If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
Review quality control results and acceptance criteria following a
change of reagent cartridge, reagent lot, or calibrator lot.

RESULTS
Results for the MULTIGENT Digoxin assay can be reported as ng/mL
or nmol/L. To convert results from ng/mL to nmol/L, multiply ng/mL
by 1.28.11
IMPORTANT: In very rare cases, patient samples may contain
heterophile antibodies, which may produce low results with the
MULTIGENT Digoxin assay. Refer to the LIMITATIONS OF THE
PROCEDURE section of this package insert.
As with all analyte determinations, the digoxin value should be used in
conjunction with information available from clinical evaluation and other
diagnostic procedures.
Refer to Appendix C of the ARCHITECT System Operations Manual for
information on results calculations.
For additional information, refer to the EXPECTED VALUES section of
this package insert.

PROCEDURE
Materials Provided
1E06-21 MULTIGENT Digoxin Reagent Kit

Materials Required but not Provided

5P04-01 TDM Multiconstituent Calibrator (TDM MCC)

Control Material
Saline (0.85% to 0.90% NaCl) for specimens that require dilution
5P04-01 TDM Multiconstituent Calibrator (TDM MCC) is
NOTE: If
not available, use
1E06-02 MULTIGENT Digoxin Calibrators.

Assay Procedure

LIMITATIONS OF THE PROCEDURE

For a detailed description of how to run an assay on the ARCHITECT

c Systems, refer to Section 5 of the ARCHITECT System Operations
Manual.

Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC

PERFORMANCE CHARACTERISTICS sections of this package insert.
In very rare cases, patient samples may contain heterophile antibodies,
which may produce low results with the MULTIGENT Digoxin assay.
Interfering heterophile antibodies occur at a low frequency in the
general population. These antibodies can cause autoagglutination of the
microparticle reagent leading to undetected erroneously low results.
For diagnostic purposes, the test findings should always be assessed in
conjunction with the patients medical history, clinical examinations, and
other findings.

Specimen Dilution Procedure

Specimens with digoxin values exceeding 5.0 ng/mL (6.40 nmol/L) or
the highest calibrator may be diluted by following either the Automated
Dilution Protocol or the Manual Dilution Procedure.
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a
1:4 or 1:8 dilution of the specimen and automatically corrects the
concentration by multiplying the result by the appropriate dilution factor.
Manual Dilution Procedure
A manual dilution can be performed on patient samples with digoxin
concentrations reported as greater than 5.0 ng/mL (6.40 nmol/L) or the
highest calibrator. Make a dilution of the specimen with
5P04-01
TDM MCC
(0 ng/mL),
1E06-02 MULTIGENT Digoxin
(0 ng/mL), or saline before pipetting the sample into the sample cup.
The dilution must be performed so the diluted test results are greater
than the assay sensitivity of 0.15 ng/mL (0.19 nmol/L).
(Volume of Sample + Volume of Dilution Reagent)
Volume of Sample
The operator must enter the manual dilution factor in the patient
or control order screen. The system uses this dilution factor to
automatically correct the concentration by multiplying the result by the
entered factor. The printed result is the reportable result if no errors are
present.
NOTE: If the operator does not enter the manual dilution factor, the
printed result must be multiplied by the manual dilution factor before
reporting the result.
Manual Dilution Factor =

EXPECTED VALUES

SPECIFIC PERFORMANCE CHARACTERISTICS

(Continued)

The MULTIGENT Digoxin assay accurately quantitates digoxin

concentrations in human serum or plasma containing up to 5.00 ng/mL
(6.40 nmol/L). Numerous studies have shown a relationship between
serum levels of digoxin and its concentration in myocardial and other
tissues. Optimum therapeutic effects usually are observed when serum
levels are in the range from 0.8 to 2.0 ng/mL (1.02 to 2.56 nmol/L).
Below 0.8 ng/mL, the patient generally receives little relief from
symptoms, and above 2.0 ng/mL the patient may begin to experience
discomforting toxic symptoms.3 These symptoms may include
gastrointestinal disturbances such as nausea, vomiting and diarrhea,
nervous system disturbances manifested by blurred vision, headache
and general weakness, and cardiac arrhythmia and slowing of the
pulse.12
Mean serum concentrations of 2.0 to 2.7 ng/mL (2.56 to 3.46 nmol/L)
[range up to 4.3 ng/mL (5.50 nmol/L)], which may be associated with
toxicity in adults, exhibit no signs of cardiac rhythm disturbances in
young children.13 After two years of age, serum values for children more
closely approximate those of adults. It is important to note that the
distinction between adequate digitalization and toxicity in patients cannot
be made on the basis of digoxin concentrations alone. Most studies
show a significant overlap between the toxic and nontoxic groups.
Additional factors to consider when evaluating the correct therapeutic
dosage for each patient are age, thyroid condition, acid-base balance,
hypoxia, hypokalemia, renal function, and other clinical factors.14 Refer
to the drug manufacturers package insert or the Physicians Desk
Reference (PDR) for proper drug dosage and digoxin measurement
sample times.12
For diagnostic purposes, the test findings should always be assessed in
conjunction with the patients medical history, clinical examinations, and
other findings.

Method Comparison
Correlation studies were performed based on guidance from CLSI
protocol NCCLS EP9-A.16
Sodium heparinized plasma and serum results from the MULTIGENT
Digoxin assay on the AEROSET System were compared with a
commercially available particle-enhanced turbidimetric immunoassay
(PETIA) and a commercially available microparticle enzyme
immunoassay (MEIA).
Serum results from the MULTIGENT Digoxin assay on an ARCHITECT
c System were compared with results from the same assay on the
AEROSET System.

N
Slope
Y-Intercept
Correlation Coefficient
Range (ng/mL)

Samples
N
Mean (ng/mL)

Limit of Quantitation (LOQ)

The LOQ for the MULTIGENT Digoxin assay was calculated to be
< 0.15 ng/mL (0.19 nmol/L). LOQ is defined as the concentration at
which the CV is 20% and the recovery is within 10% or 0.10 ng/mL.

Within Run

Assay Range
The linear range of the assay is 0.15 to 5.00 ng/mL (0.19 to 6.40 nmol/L).

Between Day

Linearity
1E06-02 Digoxin Calibrator was diluted to span the
The highest
entire assay range. Ten replicates of each dilution were assayed and
the mean concentration was compared with the expected concentration
based on the Clinical and Laboratory Standards Institute (CLSI) protocol
NCCLS EP6-P.15
Acceptance criteria: 10% for concentrations over 1.00 ng/mL or
0.10 ng/mL at concentrations less than 1.00 ng/mL.

Total

0.25
0.32
0.225
0.288
0.75
0.96
0.735
0.941
1.50
1.92
1.535
1.965
2.50
3.20
2.520
3.226
4.00
5.12
3.945
5.050
* Calculation based on conventional units (ng/mL).

Level 2
80
1.52
0.024
1.58
0.017
1.12
0.029
1.91

Level 3
80
3.15
0.037
1.17
0.032
1.02
0.053
1.68

Potential interference in the MULTIGENT Digoxin assay from bilirubin,

hemoglobin, and Intralipid is 10% at the levels indicated below. A study
based on guidance from CLSI protocol NCCLS EP7-P18 was performed
using the MULTIGENT Digoxin assay. Specimens with approximately
0.80 ng/mL digoxin were supplemented with the potentially interfering
compounds. No clinically significant differences in MULTIGENT Digoxin
assay performance were observed.
Interfering Substance
Bilirubin
Hemoglobin
Intralipid

x 100

Acceptance criteria: 10% of the expected value

Mean Recovered
Concentration
(ng/mL)
(nmol/L)

SD
%CV
SD
%CV
SD
%CV

Level 1
80
0.54
0.026
4.81
0.018
3.33
0.035
6.48

Interfering Substances

Accuracy by Recovery
A study was conducted in which each level of
1E06-02 calibrator
was diluted with an equal volume of the next lower calibrator to create
samples with midpoints between the calibrator levels. Samples were
assayed in duplicate, and the percent recovery was calculated according
to the following equation.

Expected
Concentration
(ng/mL)
(nmol/L)

ARCHITECT
vs. AEROSET
57
1.00
0.03
0.9971
0.25 to 4.81

Precision was determined as described in CLSI protocol NCCLS

EP5-T2.17 A tri-level human serum based commercial control containing
digoxin was used in the study. Each level of control was assayed
in duplicate twice a day for 20 days. Each of the runs per day was
separated by at least two hours. The means were calculated, and the
within run, between day, total SD, and percent CVs were calculated.
Data from this study are summarized below.
Acceptance criteria: 8% total CV below 1.00 ng/mL and 5% total CV
above 1.00 ng/mL.

Representative performance data are given in this section. Results

obtained in individual laboratories may vary.

Mean recovered concentration

Expected concentration

AEROSET
vs. MEIA
55
0.96
-0.04
0.9828
0.42 to 3.07

Precision

SPECIFIC PERFORMANCE CHARACTERISTICS

% Recovery =

AEROSET
vs. PETIA
55
1.06
-0.13
0.9935
0.22 to 3.00

Interferent Concentration
Conventional Units
SI Units
20 mg/dL
342 mol/L
1,000 mg/dL
10 g/L
2,000 mg/dL
22.6 mmol/L

A case report by Steimer et al.19 has shown that a negative bias in the
determination of digoxin results may be observed when the aldosterone
inhibitors spironolactone or canrenone are present in serum. A sample
containing 2.00 ng/mL of digoxin was spiked separately with 800 g/L
spironolactone and 3,000 g/L canrenone and analyzed with the
MULTIGENT Digoxin assay. The results below show no significant
interference.

Recovery*
(%)
90.0
98.0
102.3
100.8
98.6

Compound
Spironolactone
Canrenone

Sample Control
Digoxin (ng/mL)
1.98
2.07

Concentration Recovered
Digoxin (ng/mL)
1.98
2.12

SPECIFIC PERFORMANCE CHARACTERISTICS

(Continued)

BIBLIOGRAPHY

Interfering Substances (Continued)

2.

1.

The sera from patients in specific patient populations (i.e., patients with
renal and/or hepatic failure, newborn infants, and pregnant women)
have been reported to contain an unidentified component that gives
positive results for digoxin with a number of immunoassays.2026 This
component has been called digoxin-like immunoreactive factor (DLIF)
or substance (DLIS). The presence of DLIF in a sample can result in
falsely elevated digoxin assay results. The amount of DLIF in these
patient samples is extremely variable, but in some cases these levels
have been shown to approach concentrations that are in the therapeutic
range of digoxin.21,22,24
As with any assay employing mouse antibodies, the possibility exists for
interference by human anti-mouse antibodies (HAMA) in the sample,
which could cause falsely elevated results.
The manufacturer of Digoxin Immune F Ab has stated that no
immunoassay technique is suitable for quantitating digoxin in serum
from patients on antibody fragment therapy. According to the
manufacturers insert, Digibind will interfere with digitalis immunoassay
measurements.27,28

3.
4.
5.
6.
7.
8.

9.
10.

Specificity
Cross-reactivity was tested for the major digoxin active metabolites
(digoxigenin bis-digitoxoside, digoxigenin mono-digitoxoside, digoxigenin),
digitoxin, and its common analogue digitoxigenin to determine whether
these compounds affect the quantitation of digoxin concentrations using
the Digoxin assay. High concentrations of these compounds were spiked
into a serum pool (control) containing a therapeutic level of digoxin. The
samples were assayed and the digoxin concentrations of the spiked
samples were compared to the control serum. Percent cross-reactivity
was calculated:

11.
12.
13.
14.

Equivalent digoxin conc. of spiked sample digoxin conc. of control

x 100
Conc. of cross-reactant

15.

Conc. of Cross-Reactant Cross-Reactivity

Spiked (ng/mL)
(%)

16.

Compound
Digitoxigenin
Digitoxin
Digoxigenin
Digoxigenin bis-digitoxoside
Digoxigenin mono-digitoxoside

500
50
50
5
5

0.5
3.1
4.0
112.0
78.2

17.

18.
19.
20.
21.
22.
23.

24.
25.
26.
27.
28.

Bresnahan JF, Vlietstra RE. Digitalis glycosides. Mayo Clin Proc

1979;54:67584.
Surawicz B, Mortelmans S. Factors affecting individual tolerance to
digitalis. In: Fisch C, Surawiicz B, editors. Digitalis. New York: Grune
and Stratton; 1969:12747.
McNeely MDD. Making digitalis safer. Drug Ther 1975;5:2224.
Taggart AJ, McDevitt DG. Digitalis: its place in modern therapy. Drugs
1980;20:389404.
US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington, DC:
US Government Printing Office, December 2009.
World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
GuidelineThird Edition (M29-A3). Wayne, PA: Clinical and Laboratory
Standards Institute, 2005.
Bakerman S, Bakerman P, Strausbach P. Bakermans ABCs of
Interpretive Laboratory Data, 4th ed. Myrtle Beach, SC: Interpretive
Laboratory Data, Inc.; 2002:212.
Dasgupta A, Dean R, Saldana S, et al. Absorption of therapeutic
drugs by barrier gels in serum separator blood collection tubes. Am J
Clin Pathol 1994;101:45661.
Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical
and Molecular Diagnostics, 4th ed. Philadelphia, PA: Elsevier
Saunders; 2006:2306.
Physicians Desk Reference, 48th ed. Montvale, NJ: Medical
Economics; 1994:71720.
Butler VP Jr. Assays of digitalis in the blood. Prog Cardiovasc Dis
1972;14:571600.
Huffman DH, Crow JW, Pentikainen P, et al. Association between
clinical cardiac status, laboratory parameters, and digoxin usage.
Am Heart J 1976;91:2834.
Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards; 1986.
Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
and Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical Laboratory
Standards; 1995.
Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry DevicesSecond Edition; Tentative
Guideline (EP5-T2). Villanova, PA: The National Committee for Clinical
Laboratory Standards; 1992.
Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical
Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National
Committee for Clinical Laboratory Standards; 1986.
Steimer W, Muller C, Eber B, et al. Intoxication due to negative
canrenone interference in digoxin drug monitoring. Lancet
1999;354:11767.
Yatscoff RW, Desjardins PR, Dalton JG. Digoxin-like immunoreactivity
in the serum of neonates and uremic patients, as measured in the
Abbott TDx. Clin Chem 1984;30:588.
Greenway DC, Nanji AA. Falsely increased results for digoxin in sera
from patients with liver disease: ten immunoassay kits compared. Clin
Chem 1985;31:10789.
Rosenkranz B, Frolich JC. Falsely elevated digoxin concentrations in
patients with liver disease. Ther Drug Monit 1985;7:2026.
Pudek MR, Seccombe DW, Jacobson BE, et al. Seven different
digoxin immunoassay kits compared with respect to interference by a
digoxin-like immunoreactive substance in serum from premature and
full-term infants. Clin Chem 1983;29:19724.
Hicks JM, Brett EM. Falsely increased digoxin concentrations in
samples from neonates and infants. Ther Drug Monit 1984;6:4614.
Soldin SJ, Papanastasiou-Diamandi A, Heyes J, et al. Are
immunoassays for digoxin reliable? Clin Biochem 1984;17:31720.
Valdes R Jr. Endogenous digoxin-like immunoreactive factors: impact
on digoxin measurements and potential physiological implications. Clin
Chem 1985;31:152532.
Digibind Package Insert. Research Triangle Park, NC:
GlaxoSmithKline; 2003.
Rainey PM. Effects of digoxin immune Fab (ovine) on digoxin
immunoassays. Am J Clin Pathol 1989;92:77986.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, MULTIGENT,
SmartWash, and TDx are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are property of their respective owners.

c Systems Assay Parameters

Digoxin Serum/PlasmaConventional and SI Units
Configure assay parameters General

General

Configure assay parameters SmartWash

Calibration SmartWash Results

Interpretation

General Calibration SmartWash Results Interpretation

Assay:
Dig
COMPONENT
REAGENT / ASSAY
WASH
Volume Replicates
Cuvette
Trig**
10% Detergent B 345

Version:
Assay: Dig
Type: Photometric
Number: 2837
Assay availability: Enabled
Run controls for onboard reagents by: Lot
Reaction definition
Reagent / Sample
Validity checks
Reaction mode: Rate up
Primary
Secondary
Read times
Wavelength: 700 / None
Main: 19 33
Last required read: 33
Flex: ___ ___
Absorbance range: ___ ___
Color correction: ___ ___
Sample blank type: None

Reaction definition

Reagent / Sample

Reagent: DIG00
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STANDARD : 11.2
___
Dil 1 : 25.0
11.2
Dil 2 : 25.0
11.2

Reaction definition
Reaction check:

Digoxin Serum/PlasmaConventional Units

Configure assay parameters Results

General

SmartWash Results Interpretation

Assay: Dig
Assay number: 2837
Dilution default range:
Result units: ng/mL
0.15
Low-Linearity:
High-Linearity: 5.00
Gender and age specific ranges
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
2 130 (Y)
0.80 2.00

Validity checks

Reagent volume:
Water volume:
Dispense mode:

R1
112
___
Type 0

Diluent Water Dilution factor

___
___ =
1:1.00
75
___ =
1:4.00
175
___ =
1:8.00

Reagent / Sample

**Not required for ARCHITECT Software version 7.00 and above.

R2
37
___
Type 0
Default
dilution

Configure result units

Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:

Validity checks

None

Rate linearity %: ___

Assay:

Calibration SmartWash Results

Dig

Calibrators
Calibrator set:
TDMMCC*
Replicates: 2

[Range 1 3]

Intervals
Blank:
Cal 1:
Cal 2:
Cal 3:
Cal 4:
Cal 5:

Calibrators
Volumes
Calibrator: TDMMCC*
Calibrator level
Blank: TDMMCC1*
Cal 1: TDMMCC2*
Cal 2: TDMMCC3*
Cal 3: TDMMCC4*
Cal 4: TDMMCC5*
Cal 5: TDMMCC6*
Calibrators

Interpretation

Configure assay parameters Results

Calibration method: Spline

Volumes

Volumes
Calibration intervals:
Full interval: 1440
Calibration type:
Adjust type: None

Calibrator level:
TDMMCC1*
TDMMCC2*
TDMMCC3*
TDMMCC4*
TDMMCC5*
TDMMCC6*

Intervals
Sample
11.2
11.2
11.2
11.2
11.2
11.2

Dig

ng/mL
2
[Range 0 4]
1.0000
0.0000

Digoxin Serum/PlasmaSI Units

Configure assay parameters Calibration

General

Calibration

Diluted
sample
___
___
___
___
___
___

Intervals

General

SmartWash Results Interpretation

Assay: Dig
Assay number: 2837
Dilution default range:
Result units: nmol/L
0.19
Low-Linearity:
High-Linearity: 6.40
Gender and age specific ranges
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
2 130 (Y)
1.02 2.56

Validity checks
Concentration:
0

Configure result units

Validity checks
Diluent
___
___
___
___
___
___

Calibration

Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:

Water
___
___
___
___
___
___

Dig

nmol/L
2
[Range 0 4]
1.0000
0.0000

Validity checks

(hours)

Calibrators

Volumes
Intervals
Validity checks
Blank absorbance range: _____ _____
Span: Blank Blank
Span absorbance range: _____ _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0
Due to differences in instrument systems and unit configurations, version numbers may vary.
Parameter is available in ARCHITECT Software version 7.00 and above.
5P04-01 TDM MCC is not available, use
1E06-02 MULTIGENT Digoxin Calibrators. The corresponding Calibrator set name and
* If
Calibrator name are DigCal. Under Calibrator level, the Blank through Cal5 is DigCal1 thru DigCal6.
Displays the number of decimal places defined in the decimal places parameter field.
Refer to the concentration specified on calibrator labeling or value sheet. These values are defined on the Configure calibrator set screen.
The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
5

Key to Symbols
Calibrator 1
Calibrators 1 through 6
Contains sodium azide. Contact with acids
liberates very toxic gas.
Distributed in the USA by
Do not freeze
Authorized Representative in the European
Community
Identifies products to be used together

DIGOXIN
1E06-21

Information needed for United States

of America only
In Vitro Diagnostic Medical Device
Batch code/Lot number
Product of USA
Reagent 1

Customer Service: Contact your local representative or find

country-specific contact information on
www.abbottdiagnostics.com.

Reagent 2
Catalog number/List number
Serial number

Microgenics Corporation
46500 Kato Road
Fremont, CA 94538 USA

Caution
Consult instructions for use

Microgenics GmbH
Spitalhofstrasse 94
D-94032 Passau Germany
Tel: +49 (0) 851 886 89 0
Fax: +49 (0) 851 886 89 10

Manufacturer
Sufficient for
Temperature limitation

May 2014
306424/R03

Use by/Expiration date

Abbott Laboratories
Abbott Park, IL 60064 USA