en

Cortisol
system
8D15
840607/R4

Cortisol
Customer Service
United States: 1-877-4ABBOTT
International: Call your Abbott Representative

This package insert must be read carefully prior to product use. 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.

Key to symbols used

List Number Serial Number
In Vitro Diagnostic Medical
Device Reagent Lot
Lot Number
Calibrator (A-F)
Expiration Date
Control Number

Store at 2-8°C
Assay CD-ROM

Consult instructions for use Reaction Vessels

Sample Cups
Authorized Representative
Septum

Manufacturer Replacements Caps

See REAGENTS section for a full explanation of symbols used in reagent

component naming.

1
NAME Other Reagents
ARCHITECT Cortisol ARCHITECT i Pre-Trigger Solution
INTENDED USE • Pre-Trigger Solution containing 1.32% (w/v)
hydrogen peroxide.
ARCHITECT Cortisol is a chemiluminescent microparticle immunoassay
(CMIA) for the quantitative determination of cortisol in human serum, ARCHITECT i Trigger Solution
plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol • Trigger Solution containing 0.35 N sodium
assay is intended for use as an aid in the diagnosis and treatment of hydroxide.
adrenal disorders. ARCHITECT i Wash Buffer
SUMMARY AND EXPLANATION OF THE TEST • Wash Buffer containing phosphate buffered saline
solution. Preservative: antimicrobial agent.
Cortisol is the major glucocorticoid hormone secreted by the adrenal
cortex. Its physiological functions include regulation of carbohydrate WARNINGS AND PRECAUTIONS
metabolism and electrolyte and water distribution. Cortisol also has •
immunosuppressive and anti-inflammatory activity. In normal individuals, Safety Precautions
cortisol levels are regulated through a negative feedback loop in which
• CAUTION: This product requires the handling of human specimens.
the adrenal cortex responds to increased adrenocorticotropic hormone
It is recommended that all human sourced materials be considered
(ACTH) levels by increasing cortisol secretion, and the pituitary responds
potentially infectious and be handled in accordance with the OSHA
to elevated cortisol levels by down-regulation of ACTH production. Plasma
Standard on Bloodborne Pathogens 12. Biosafety Level 2 13 or other
cortisol levels are highest in the morning, and concentrations decrease by
appropriate biosafety practices 14,15 should be used for materials that
about half toward evening.1 Pregnancy or estrogen treatment markedly
contain or are suspected of containing infectious agents.
elevates cortisol levels. Other stimuli such as severe stress may also
lead to increased cortisol production. • The microparticles and conjugate contain methylisothiazolones,
which are components of ProClin, and are classified per applicable
Cortisol measurements are used as a direct monitor of adrenal status
European Community (EC) Directives as Irritant (Xi). The following
and an indirect measure of pituitary hyper or hypofunction. Elevated
are the appropriate Risk (R) and Safety (S) phrases.
cortisol levels are associated with adrenal tumors, pituitary tumors or
ectopic ACTH-producing tumors.2 Subnormal cortisol concentrations may R43 May cause sensitization by skin contact.
indicate generalized adrenal hypofunction or a defect in the metabolic S24 Avoid contact with skin.
pathway for cortisol biosynthesis.3 The majority of cortisol in plasma is S35 This material and its container must be disposed
bound to proteins and approximately 1% is excreted unchanged into the of in a safe way.
urine.4 Urinary cortisol is generally thought to reflect the level of unbound
(free) plasma cortisol, which is biologically active. In cases of cortisol S37 Wear suitable gloves.
overproduction, cortisol-binding globulin becomes saturated, such that S46 If swallowed, seek medical advice immediately
unbound plasma cortisol increases disproportionately, as does urinary and show this container or label.
excretion. The measurement of urinary cortisol is a sensitive means of • For product not classified as dangerous per European Directive
determining adrenocortical hyperfunction such as Cushing’s syndrome.5,6 1999/45/EC as amended - Safety data sheet available for
Urinary cortisol from 24-hour collections represent integration over a professional user on request.
full day and are not affected by the diurnal variation evident in plasma
cortisol levels. • For information on the safe disposal of sodium azide and a detailed
discussion of safety precautions during system operation, refer to
Cortisol measurements are often performed in conjunction with the ARCHITECT System Operations Manual, Section 8.
certain “challenge” tests designed to measure whether regulation
of the hypothalamic-pituitary-adrenal axis is intact. These include the Handling Precautions
dexamethasone suppression test (DST), ACTH stimulation test and insulin • Do not use reagent kits beyond the expiration date.
tolerance test.7-11 Such challenge tests aid in the differential diagnosis • Do not pool reagents between reagent kits.
of Cushing’s syndrome (cortisol overproduction) and the assessment of • Before loading the ARCHITECT Cortisol Reagent Kit on the system
Addison’s disease (cortisol underproduction). for the first time, the microparticle bottle requires mixing to resuspend
BIOLOGICAL PRINCIPLES OF THE PROCEDURE microparticles that have settled during shipment. For microparticle
The ARCHITECT Cortisol assay is a delayed one-step immunoassay mixing instructions, refer to the PROCEDURE, Assay Procedure
for the quantitative determination of cortisol in human serum, plasma section of this package insert.
or urine using CMIA technology with flexible assay protocols, referred • Septums MUST be used to prevent reagent evaporation and
to as Chemiflex. contamination and to ensure reagent integrity. Reliability of assay
Sample and anti-cortisol coated paramagnetic microparticles are results cannot be guaranteed if septums are not used according
combined to create a reaction mixture. Cortisol present in the sample to the instructions in this package insert.
binds to the anti-cortisol coated microparticles. After incubation, cortisol • To avoid contamination, wear clean gloves when placing a septum
acridinium-labeled conjugate is added to the reaction mixture. The cortisol on an uncapped reagent bottle.
acridinium-labeled conjugate competes for the available binding sites on • Once a septum has been placed on an open reagent bottle, do
the anti-cortisol coated microparticles. Following a second incubation, not invert the bottle as this will result in reagent leakage and
the microparticles are washed, and pre-trigger and trigger solutions are may compromise assay results.
added to the reaction mixture. The resulting chemiluminescent reaction • Over time, residual liquids may dry on the septum surface.
is measured as relative light units (RLUs). An inverse relationship exists These are typically dried salts, which have no effect on assay
between the amount of cortisol in the sample and the RLUs detected by efficacy.
the ARCHITECT i System optics. • For a detailed discussion of handling precautions during system
For additional information on system and assay technology, refer to the operation, refer to the ARCHITECT System Operations Manual,
ARCHITECT System Operations Manual, Section 3. Section 7.
REAGENTS
Reagent Kit, 100 Tests/500 Tests
NOTE: Some kit sizes are not available in all countries or for use on all
ARCHITECT i Systems. Please contact your local distributor.
ARCHITECT Cortisol Reagent Kit (8D15)
• 1 Bottle (6.6 mL /27.0 mL) Anti-cortisol (mouse,
monoclonal) coated microparticles in TRIS/BIS-TRIS buffer with
protein (bovine) stabilizer. Minimum concentration: 0.09% solids.
Preservatives: sodium azide and ProClin 300.
• 1 Bottle (5.9 mL/26.3 mL) Cortisol acridinium-labeled
conjugate in citrate buffer with surfactant stabilizer. Minimum
concentration: 0.7 ng/mL. Preservative: ProClin 300.

2
Storage Instructions • Use caution when handling patient specimens to prevent cross
contamination. Use of disposable pipettes or pipette tips is
recommended.
• The ARCHITECT Cortisol Reagent Kit must be stored
at 2-8°C in an upright position and may be used immediately after • Inspect all samples for bubbles. Remove bubbles with an applicator
removal from 2-8°C storage. stick prior to analysis. Use a new applicator stick for each sample to
prevent cross contamination.
• When stored and handled as directed, reagents are stable until the
expiration date. • Plasma and serum specimens should be free of fibrin, red blood
cells or other particulate matter.
• The ARCHITECT Cortisol Reagent Kit may be stored on board the
ARCHITECT i System for a maximum of 30 days. After 30 days, the • Ensure that complete clot formation in serum specimens has taken
reagent kit must be discarded. For information on tracking onboard place prior to centrifugation. Some specimens, especially those
time, refer to the ARCHITECT System Operations Manual, Section 5. from patients receiving anticoagulant or thrombolytic therapy, may
exhibit increased clotting time. If the specimen is centrifuged before
• Reagents may be stored on or off the ARCHITECT i System. If
a complete clot forms, the presence of fibrin may cause erroneous
reagents are removed from the system, store them at 2-8°C (with
results.
septums and replacement caps) in an upright position. For reagents
stored off the system, it is recommended that they be stored Preparation for Analysis
in their original trays and boxes to ensure they remain upright. If • Serum, plasma or urine specimens that appear cloudy or contain
the microparticle bottle does not remain upright (with a septum particulate matter should be centrifuged before testing.
installed) while in refrigerated storage off the system, the reagent • Following centrifugation, avoid the lipid layer (if present) when
kit must be discarded. For information on unloading reagents, refer pipetting the specimen into a sample cup or secondary tube.
to the ARCHITECT System Operations Manual, Section 5. • Specimens must be mixed THOROUGHLY after thawing by LOW
Indications of Reagent Deterioration speed vortexing or by gently inverting, and centrifuged prior to use to
• When a control value is out of the specified range, it may indicate remove red blood cells or particulate matter to ensure consistency
deterioration of the reagents or errors in technique. Associated test in the results. Multiple freeze/thaw cycles of specimens should be
results are invalid and must be retested. Assay recalibration may be avoided.
necessary. For troubleshooting information, refer to the ARCHITECT Storage
System Operations Manual, Section 10. • If testing will be delayed for more than eight hours, remove plasma
INSTRUMENT PROCEDURE or serum from the serum or plasma separator, red blood cells or
• The ARCHITECT Cortisol assay file must be installed on the clot. Specimens removed from the separator gel, cells or clot may
ARCHITECT i System from the ARCHITECT i Assay CD-ROM be stored up to 14 days at 2-8°C.
Addition B prior to performing the assay. For detailed information on • Urine samples may be stored up to 14 days at 2-8°C.
assay file installation and on viewing and editing assay parameters, • Serum, plasma or urine specimens can be stored up to 30 days at
refer to the ARCHITECT System Operations Manual, Section 2. -10°C or colder.
• For information on printing assay parameters, refer to the ARCHITECT Shipping
System Operations Manual, Section 5. • Before shipping specimens, it is recommended that specimens be
• For a detailed description of system procedures, refer to the removed from the serum or plasma separator, red blood cells or
ARCHITECT System Operations Manual. clot.
• The default result unit for the ARCHITECT Cortisol assay is μg/dL. • When shipped, specimens must be packaged and labeled in
When the alternate result unit, nmol/L, is selected, the conversion compliance with applicable state, federal and international
factor used by the system is 27.59.16 When the alternate result unit, regulations covering the transport of clinical specimens and
μmol/L, is selected, the conversion factor used by the system is infectious substances.
0.02759. • Specimens may be shipped ambient or on wet or dry ice. Do not
• Conversion Formula: (Concentration in μg/dL) x (27.59) = nmol/L exceed the storage limitations listed above.
• Conversion Formula: (Concentration in μg/dL) x (0.02759) = μmol/L
PROCEDURE
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS Materials Provided
Specimen Types • 8D15 ARCHITECT Cortisol Reagent Kit
The ARCHITECT i System does not provide the capability to verify Materials Required but not Provided
specimen type. It is the responsibility of the operator to verify the correct • ARCHITECT i System
specimen types are used in the ARCHITECT Cortisol assay.
• 3K51 ARCHITECT i -US- Addition B
Serum and Plasma
• 3K53 ARCHITECT i -WW (excluding US)- Addition B
• Human serum (including serum collected in serum separator tubes)
or plasma (collected in lithium heparin, plasma separator tubes with • 8D15-01 ARCHITECT Cortisol Calibrators
lithium heparin, sodium heparin or potassium EDTA) may be used • 6E20-10 Abbott Immunoassay Multi-Constituent Controls or other
in the ARCHITECT Cortisol assay. Other anticoagulants have not commercial controls
been tested for use with the ARCHITECT Cortisol assay. Follow the • ARCHITECT i
manufacturer’s processing instructions for collection tubes. • ARCHITECT i
Urine • ARCHITECT i
• Human urine may be used in the ARCHITECT Cortisol assay. The • ARCHITECT i
urine sample must be collected in a clean, previously unused • ARCHITECT i
container. Preservatives are not required; however, ten grams of • ARCHITECT i
boric acid per liter of urine may be used.
• ARCHITECT i
Specimen Conditions • Pipettes or pipette tips (optional)
• Do not use specimens with the following conditions: For information on materials required for maintenance procedures, refer
• heat-inactivated specimens to the ARCHITECT System Operations Manual, Section 9.
• cadaver specimens or body fluids other than human serum,
plasma or urine
• obvious microbial contamination

3
Assay Procedure • Specimens with a cortisol value exceeding 119.6 μg/dL are flagged
• Before loading the ARCHITECT Cortisol Reagent Kit on the system with the code “>119.6” when run using the Automated Dilution
for the first time, the microparticle bottle requires mixing to resuspend Protocol. These specimens may be diluted by following the Manual
microparticles that have settled during shipment. After the first time Dilution Procedure.
the microparticles have been loaded, no further mixing is required. Manual Dilution Procedure
• Invert the microparticle bottle 30 times. • Manual dilutions should be performed as follows:
• Visually inspect the bottle to ensure microparticles are • The suggested dilution for a cortisol test is 1:4.
resuspended. If microparticles remain adhered to the bottle, • Prior to diluting the specimen, dispense approximately 7 drops
continue to invert the bottle until the microparticles have been of ARCHITECT Cortisol Calibrator A into a clean test tube for
completely resuspended. use in the next step.
• If the microparticles do not resuspend, DO NOT USE. Contact • Transfer 150 μL of ARCHITECT Cortisol Calibrator A from the
your local Abbott representative. test tube prepared in the prior step into another clean test tube
• Once the microparticles have been resuspended, place a septum and add 50 μL of the patient specimen.
on the bottle. For instructions on placing septums on bottles, • The operator must enter the dilution factor in the Patient or
refer to the Handling Precautions section of this package Control order screen. The system will use this dilution factor to
insert. automatically calculate the concentration of the sample before
• Load the ARCHITECT Cortisol Reagent Kit on the ARCHITECT dilution. This will be the reported result. The dilution should be
i System. performed so that the diluted result (before the dilution factor is
• Verify that all necessary assay reagents are present. Ensure that applied) reads greater than 3.0 μg/dL.
septums are present on all reagent bottles. • For detailed information on ordering dilutions, refer to the
• Order calibration, if necessary. ARCHITECT System Operations Manual, Section 5.
• For information on ordering calibrations, refer to the ARCHITECT Calibration
System Operations Manual, Section 6. • To perform an ARCHITECT Cortisol calibration, test Calibrators A, B,
• Order tests. C, D, E, and F in duplicate. A single sample of each cortisol control
• For information on ordering patient specimens and controls, level must be tested to evaluate the assay calibration. Ensure that
refer to the ARCHITECT System Operations Manual, Section 5. assay control values are within established ranges. Calibrators
• The minimum sample volume is calculated by the system and is should be priority loaded.
printed on the Orderlist report. No more than 10 replicates may be • Calibration Range: 0.0 - 59.8 μg/dL.
sampled from the same sample cup. Verify adequate sample cup • Once an ARCHITECT Cortisol calibration is accepted and stored,
volume is present prior to running the test. all subsequent samples may be tested without further calibration
• Priority: 70 μL for the first ARCHITECT Cortisol test plus 20 μL unless:
for each additional ARCHITECT Cortisol test from the same • A reagent kit with a new lot number is used.
sample cup. • Controls are out of range.
• ≤ 3 hours on board: 150 μL for the first ARCHITECT Cortisol test • For detailed information on how to perform an assay calibration,
plus 20 μL for each additional ARCHITECT Cortisol test from the refer to the ARCHITECT System Operations Manual, Section 6.
same sample cup.
• > 3 hours on board: additional sample volume is required. For QUALITY CONTROL PROCEDURES
information on sample evaporation and volumes, refer to the The recommended control requirement for the ARCHITECT Cortisol
ARCHITECT System Operations Manual, Section 5. assay is that a single sample of each control level be tested once every
24 hours each day of use. Commercial controls such as the Abbott
• If using primary or aliquot tubes, use the sample gauge to ensure
Immunoassay Multi-Constituent Controls are suitable for this purpose. If
sufficient patient specimen is present.
the quality control procedures in your laboratory require more frequent
• Prepare calibrators and controls. use of controls to verify test results, follow your laboratory-specific
• ARCHITECT Cortisol Calibrators and Abbott Immunoassay procedures.
Multi-Constituent Controls should be prepared according to their Each laboratory should establish control ranges to monitor the acceptable
respective package inserts. performance of the assay. If a control is out of its specified range, the
• To obtain the recommended volume requirements for the associated test results are invalid and must be retested. Recalibration
ARCHITECT Cortisol Calibrators, hold the bottles vertically and may be indicated.
dispense 5 drops of each calibrator into each respective sample
cup. Dispense 150 μL of each control into each respective Verification of Assay Claims
sample cup. For protocols to verify package insert claims, refer to the ARCHITECT
System Operations Manual, Appendix B. The ARCHITECT Cortisol assay
• Load samples.
belongs to method group 1.
• For information on loading samples, refer to the ARCHITECT
Use ARCHITECT Cortisol Calibrators in place of MasterCheck as
System Operations Manual, Section 5.
described in the ARCHITECT System Operations Manual, Appendix B.
• Press RUN.
• For additional information on principles of operation, refer to the RESULTS
ARCHITECT System Operations Manual, Section 3. Calculation
• For optimal performance, it is important to follow the routine The ARCHITECT Cortisol assay uses a 4 Parameter Logistic Curve Fit
maintenance procedures defined in the ARCHITECT System (4PLC, Y-weighted) data reduction method to generate a calibration
Operations Manual, Section 9. If your laboratory requires more curve.
frequent maintenance, follow those procedures. Flags
Specimen Dilution Procedures • Some results may contain information in the Flags field. For a
Specimens with a cortisol value exceeding 59.8 μg/dL are flagged with description of the flags that may appear in this field, refer to the
the code “>59.8” and may be diluted with the Automated Dilution Protocol ARCHITECT System Operations Manual, Section 5.
or the Manual Dilution Procedure.
Automated Dilution Protocol
• If using the Automated Dilution Protocol, the system performs
a 1:2 dilution of the specimen and automatically calculates the
concentration of the specimen before dilution and reports the
result.

4
LIMITATIONS OF THE PROCEDURE SPECIFIC PERFORMANCE CHARACTERISTICS
• Due to the diurnal variation of cortisol levels in normal subjects, all Precision
serum/plasma cortisol measurements should be referenced to the The ARCHITECT Cortisol assay is designed to have an assay precision
time of day of sample collection. of ≤ 10% total CV for serum samples ≥ 3 to ≤ 35 μg/dL and ≤ 20% total
• Patients receiving fludrocortisone, prednisolone or prednisone (which CV for urine samples ≥ 3 to ≤ 35 μg/dL.
is converted to prednisolone in vivo) may show artificially elevated A study was performed with guidance from the Clinical and Laboratory
cortisol values due to cross-reactivity. Cross-reactivity to endogenous Standards Institute (CLSI, formerly NCCLS) Protocol EP5-A2.20 Abbott
and synthetic steroids is reported in the SPECIFIC PERFORMANCE Immunoassay Multi-Constituent Controls (Levels 1, 2 and 3) and seven
CHARACTERISTICS, Specificity section in this package insert. panels were assayed using two lots of reagents in replicates of two at two
• If the cortisol results are inconsistent with clinical evidence, additional separate times per day for 20 days on two instruments. Each reagent lot
testing is suggested to confirm the result. used a single calibration curve throughout the study. Data from this study
• For diagnostic purposes, results should be used in conjunction with are summarized in the following table.*
other data; e.g., symptoms, results of other tests, clinical impressions, Mean Within Run Total
etc. Conc.
Reagent
• Specimens from patients who have received preparations of mouse Sample Instr. Lot n (μg/dL) SD % CV SD % CV
monoclonal antibodies for diagnosis or therapy may contain human
anti-mouse antibodies (HAMA).17 Such specimens may show either 1 A 80 3.8 0.14 3.6 0.19 5.0
Level 1
falsely elevated or depressed values when tested with assay kits that 2 B 80 4.0 0.19 4.8 0.23 5.8
employ mouse monoclonal antibodies.17,18 Assay results that are not 1 A 80 16.6 0.43 2.6 0.62 3.7
consistent with other clinical observations may require additional Level 2
information for diagnosis. 2 B 80 17.3 0.40 2.3 1.32 7.7
• Heterophilic antibodies in human serum can react with reagent 1 A 80 30.3 0.87 2.9 1.17 3.9
Level 3
immunoglobulins, interfering with in vitro immunoassays.19 The 2 B 80 31.0 0.63 2.1 1.32 4.3
presence of heterophilic antibodies in a patient specimen may cause
Serum 1 A 80 2.9 0.08 2.9 0.11 4.0
anomalous values to be observed.19 Additional information may be
required for diagnosis. Panel 1 2 B 80 2.9 0.16 5.5 0.18 6.2
• The concentration of cortisol in a given specimen, determined with Serum 1 A 80 39.8 0.95 2.4 1.01 2.5
assays from different manufacturers, can vary due to differences in Panel 2 2 B 80 41.0 1.08 2.6 1.29 3.2
assay methods, calibration, and reagent specificity. 1 A 80 53.3 1.71 3.2 1.73 3.3
Serum
EXPECTED VALUES Panel 3 2 B 80 55.8 1.50 2.7 1.87 3.4
Reference Range: Serum Urine 1 A 80 2.4 0.13 5.3 0.15 6.2
Serum cortisol levels were determined by assaying samples drawn from Panel 1 2 B 80 2.7 0.16 6.1 0.17 6.4
apparently healthy individuals collected before 10 a.m. and collected
Urine 1 A 80 14.5 0.39 2.7 0.59 4.1
after 5 p.m. The 95% reference interval of the a.m. and p.m. populations
was determined. Data from this study are summarized in the following Panel 2 2 B 80 15.9 0.60 3.8 0.72 4.5
table.* Urine 1 A 80 36.8 1.05 2.9 1.39 3.8
Panel 3 2 B 80 40.6 1.56 3.9 1.59 3.9
Specimen Specimen 95% Reference Interval
Type Collection n μg/dL nmol/L Urine 1 A 80 49.0 2.84 5.8 2.84 5.8
Before Panel 4 2 B 80 53.7 3.18 5.9 3.18 5.9
Serum 150 3.7 - 19.4 101.2 - 535.7
10 a.m. * Representative data; results in individual laboratories may vary from
After these data.
Serum 150 2.9 - 17.3 79.0 - 477.8
5 p.m.
Sensitivity
* Representative data; results in individual laboratories may vary from Functional Sensitivity
these data. It is recommended that each laboratory establish its own
The ARCHITECT Cortisol assay is designed to have a functional sensitivity
reference range.
of ≤ 1 μg/dL.
Reference Range: Urine In a study, serum and urine panels ranging in concentration from
Cortisol levels in urine were determined by assaying 24-hour urine 0.1 - 2.1 μg/dL were tested in replicates of two over 10 days on two
samples from apparently healthy individuals. The 95% reference interval instruments using two reagent lots and two calibrations for a total of
was determined. Data from this study are summarized in the following 40 replicates per panel. The total %CVs were calculated and plotted against
the mean concentration. A reciprocal curve was fitted through the data
table.*
and the functional sensitivity value was calculated as the concentration
95% Reference Interval corresponding to the 20% CV level of the fitted curve. At the upper 95%
Specimen Type n μg/24 houra nmol/24 hourb confidence limit, the lowest ARCHITECT Cortisol assay value exhibiting a
20% CV was calculated to be 0.8 μg/dL for serum samples and 1 μg/dL
Urine 128 4.3 - 176.0 11.8 - 485.6
for urine samples.*
a μg/24 hour = (Concentration in μg/dL) x (10) x (Volume of urine * Representative data; results in individual laboratories may vary from
excreted in liters per 24 hours) these data.
b nmol/24 hour = (Concentration in nmol/L) x (Volume of urine excreted
in liters per 24 hours)
* Representative data; results in individual laboratories may vary from
these data. It is recommended that each laboratory establish its own
reference range.

5
Limit of Detection Interference
The ARCHITECT Cortisol assay is designed to have a limit of detection Potential interference in the ARCHITECT Cortisol assay from the following
(LoD) of ≤ 0.8 μg/dL. The limit of blank (LoB) and LoD of the compounds is designed to be ≤ 15% at the levels indicated.
ARCHITECT Cortisol assay were determined with guidance from CLSI A study based on guidance from the CLSI Protocol EP7-A223 was
Protocol EP17-A21 using proportions of false positives (α) less than performed for the ARCHITECT Cortisol assay. Serum specimens with
5% and false negatives (β) less than 5%. These determinations were cortisol levels between 5.1 and 34.2 μg/dL and urine specimens with
performed using 60 blank and 120 low level samples; LoB = 0.23 μg/dL cortisol levels between 4.6 and 37.9 μg/dL were supplemented with
and LoD = 0.40 μg/dL.* the following potentially interfering compounds. The average amount of
* Representative data; results in individual laboratories may vary from interference observed during the study ranged from -7.8% to 13.2%.*
these data.
Potentially Interfering Potentially Interfering
Linearity Specimen Type Substance Substance Concentration
The ARCHITECT Cortisol assay is linear between 1 and 59.8 μg/dL based Serum Bilirubin 20 mg/dL
on a study performed with guidance from CLSI Protocol EP6-A.22 Hemoglobin 500 mg/dL
Specificity Total Protein (Low) 3 g/dL
The specificity of the ARCHITECT Cortisol assay was determined by Total Protein (High) 10 g/dL
studying the cross-reactivity of compounds whose chemical structure
Triglycerides 2000 mg/dL
or concurrent usage may potentially interfere with the ARCHITECT
Cortisol assay. Specificity of the assay was determined by spiking each Urine Creatinine 5 mmol/L
compound into human serum specimens with cortisol levels spiked Urea 350 mmol/L
between 11.4 and 12.0 μg/dL.* Glucose 5 mmol/L
Concentration % Cross- Sodium Chloride 1000 mmol/L
Compound (μg/dL) Reactivity Total Protein (High) 1000 mg/dL
Aldosterone 1000 0.0 * Representative data; results in individual laboratories may vary from
Beclomethasone 1000 0.0 these data.
Budesonide 1000 0.0 Evaluation of Other Potential Interferents
Canrenone 1000 0.1 Potential interference in the ARCHITECT Cortisol assay from HAMA
Corticosterone 1000 0.9 and rheumatoid factor (RF) is designed to be ≤ 15%. In a study, the
Cortisol 21-glucuronide 1000 0.2 ARCHITECT Cortisol assay was evaluated by testing specimens with
Cortisone 1000 2.7 HAMA and RF to further assess the clinical specificity. Specimens
positive for HAMA and specimens positive for RF were evaluated
β-Cortol 1000 0.0 for % interference with cortisol levels spiked between 9.0 and 44.1 μg/dL.
β-Cortolone 1000 0.0 Mean absolute % interference is summarized in the following table.*
11-Deoxycorticosterone 100 0.0
Mean Absolute
11-Deoxycortisol 100 1.9 Other Potential Interferents n % Interference
Dexamethasone 1000 0.0 HAMA Positive 10 1.0
DHEA 1000 0.0 RF Positive 10 5.9
DHEA-S 1000 0.0 * Representative data; results in individual laboratories may vary from
β-Estradiol 1000 0.0 these data.
Estriol 1000 0.0
Correlation
Estrone 1000 0.0
The ARCHITECT Cortisol assay is designed to have a slope of
Fludrocortisone 100 36.6 1.0 ± 0.1 and a correlation coefficient (r) of ≥ 0.95 for serum samples
Fluticasone Propionate 1000 0.0 when compared to Liquid Chromatography Mass Spectrometry/Mass
6β-Hydroxycortisol 1000 0.2 Spectrometry (LC-MS/MS). The ARCHITECT Cortisol assay is also
17α-Hydroxypregnenolone 1000 0.1 designed to have a slope of 1.0 ± 0.2 and a correlation coefficient (r) of
11β-Hydroxyprogesterone 1000 0.2 ≥ 0.85 for urine samples when compared to LC-MS/MS. In a study the
ARCHITECT Cortisol assay was compared to LC-MS/MS. Data from this
17-Hydroxyprogesterone 1000 0.6 study were analyzed using the Passing-Babloka regression method and
Medroxyprogesterone Acetate 1000 0.0 are summarized in the following table.*
6-Methylprednisolone 1000 0.1
ARCHITECT Cortisol vs. LC-MS/MS
Mometasone 1000 0.0
Correlation
Prednisolone 100 12.3 Specimen Type n Slope Intercept Coefficient (r)
Prednisone 1000 0.6 Serum 125 1.08 -0.02 0.996
Pregnanediol 1000 0.0 Urine 81 1.06 0.84 0.997
Pregnanetriol 1000 0.0 Serum Sample Range (ARCHITECT): 1.5 – 52.5 μg/dL
Pregnenolone 1000 0.0 Serum Sample Range (LC-MS/MS): 1.4 – 49.4 μg/dL
Progesterone 1000 0.0 Urine Sample Range (ARCHITECT): 0.8 – 51.1 μg/dL
β-Sitosterol 1000 0.0 Urine Sample Range (LC-MS/MS): 0.1 – 49.5 μg/dL
Spironolactone 1000 0.0
Testosterone 1000 0.0
Tetracycline 1000 0.0
Tetrahydrocortisol 1000 0.5
Triamcinolone 1000 0.5
* Representative data; results in individual laboratories may vary from
these data.

6
The ARCHITECT Cortisol assay is designed to have a correlation 18. Primus FJ, Kelley EA, Hansen HJ, et al. “Sandwich”-type immunoassay
coefficient (r) of ≥ 0.90 for serum samples and ≥ 0.80 for urine samples of carcinoembryonic antigen in patients receiving murine monoclonal
when compared to the AxSYM Cortisol assay. In a study the ARCHITECT antibodies for diagnosis and therapy. Clin Chem 1988;34(2):261-4.
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