8K26-27

en
SHBG
ARCHITECT 8K26-21 8K26
SHBG G95323R02
B8K2T0
Revised April 2018.

Package insert instructions must be carefully followed. Reliability The concentration of SHBG in the sample is determined by
of assay results cannot be guaranteed if there are any deviations comparing the chemiluminescent signal in the reaction to the
from the instructions in this package insert. ARCHITECT SHBG calibration.
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NAME For additional information on system and assay technology, refer
to the ARCHITECT System Operations Manual, Section 3.
ARCHITECT SHBG
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REAGENTS
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INTENDED USE
Kit Contents
The ARCHITECT SHBG assay is a chemiluminescent
microparticle immunoassay (CMIA) for the quantitative ARCHITECT SHBG 8K26
determination of sex hormone binding globulin (SHBG) in human NOTE: Some kit sizes are not available in all countries or for use
serum and plasma on the ARCHITECT iSystem. on all ARCHITECT iSystems. Please contact your local distributor.
The ARCHITECT SHBG assay is used as an aid in the diagnosis 8K26-27 8K26-21
of androgen disorders.
100 400
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SUMMARY AND EXPLANATION OF THE TEST
1 x 6.6 mL 4 x 6.6 mL
Sex hormone binding globulin (SHBG) is a glycoprotein of about
80-100 kDa; it has a high affinity for 17 beta-hydroxysteroid 1 x 5.9 mL 4 x 5.9 mL
hormones such as testosterone and estradiol. SHBG 1 x 8.0 mL 4 x 8.0 mL
concentration in plasma is regulated by, amongst other things,
androgen/estrogen balance, thyroid hormones, insulin and dietary Anti-SHBG (mouse, monoclonal) coated
factors. It is the most important transport protein for estrogens microparticles in TRIS buffer. Minimum concentration: 0.05%
and androgens in peripheral blood. SHBG concentration is a solids. Preservative: sodium azide.
major factor regulating their distribution between the protein- Anti-SHBG (mouse, monoclonal) acridinium-labeled
bound and free states. Plasma SHBG concentrations are conjugate in phosphate buffer with protein (mouse, bovine)
affected by a number of different diseases, high values being stabilizers. Preservative: sodium azide.
found in hyperthyroidism, hypogonadism, androgen insensitivity SHBG Assay Diluent containing phosphate buffer
and hepatic cirrhosis in men. Low concentrations are found in with protein (mouse, bovine) stabilizers. Preservative: sodium
myxoedema, hyperprolactinaemia and syndromes of excessive azide.
androgen activity. Measurement of SHBG is useful in the
evaluation of mild disorders of androgen metabolism and enables Other Reagents
identification of those women with hirsutism who are more likely 1 x 100 mL ARCHITECT Multi-Assay
to respond to estrogen therapy. Manual Diluent, 7D82-50, containing phosphate buffered
The ratio of testosterone to SHBG is also known as the Free saline solution. Preservative: antimicrobial agent.
Androgen Index (FAI) or the Free Testosterone Index (FTI). This
ratio correlates well with both measured and calculated values ARCHITECT Pre-Trigger Solution containing
of free testosterone and helps to discriminate subjects with 1.32% (w/v) hydrogen peroxide.
excessive androgen activity from normal individuals.1-3 ARCHITECT Trigger Solution containing 0.35 N
sodium hydroxide.
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BIOLOGICAL PRINCIPLES OF THE PROCEDURE
ARCHITECT Wash Buffer containing phosphate
The ARCHITECT SHBG assay is a two-step immunoassay to buffered saline solution. Preservatives: antimicrobial agents.
determine the presence of SHBG in human serum and plasma
using CMIA technology with flexible assay protocols, referred to Warnings and Precautions
as Chemiflex. •
1. Sample, assay diluent, and anti-SHBG coated paramagnetic • For In Vitro Diagnostic Use
microparticles are combined. The SHBG present in the
Safety Precautions
sample binds to the anti-SHBG coated microparticles.
2. After washing, SHBG binds to the anti-SHBG acridinium- CAUTION: This product requires the handling of human
labeled conjugate that is added to create a reaction mixture. specimens. It is recommended that all human-sourced materials
be considered potentially infectious and handled in accordance
3. Following another wash cycle, Pre-Trigger and Trigger
with the OSHA Standard on Bloodborne Pathogens. Biosafety
Solutions are added to the reaction mixture.
Level 2 or other appropriate biosafety practices should be
4. The resulting chemiluminescent reaction is measured as used for materials that contain or are suspected of containing
relative light units (RLUs). There is a direct relationship infectious agents.4-7
between the amount of SHBG in the sample and the RLUs
detected by the ARCHITECT iSystem optics.

1
 Indications of Reagent Deterioration
The following warnings and precautions apply to:
/ / When a control value is out of the specified range, it may
Contains sodium azide. indicate deterioration of the reagents or errors in technique.
Associated test results are invalid, and samples must be retested.
EUH032 Contact with acids liberates very toxic
Assay recalibration may be necessary. For troubleshooting
gas.
information, refer to the ARCHITECT System Operations Manual,
P501 Dispose of contents / container in
Section 10.
accordance with local regulations.
Safety Data Sheets are available at [Link]
ll
INSTRUMENT PROCEDURE
or contact your local representative. The ARCHITECT SHBG assay file must be installed on the
For a detailed discussion of safety precautions during system ARCHITECT iSystem from an ARCHITECT iSystem Assay CD-
operation, refer to the ARCHITECT System Operations Manual, ROM prior to performing the assay.
Section 8. For detailed information on assay file installation and viewing
and editing assay parameters, refer to the ARCHITECT System
Reagent Handling
Operations Manual, Section 2.
• Do not use reagent kits beyond the expiration date. For information on printing assay parameters, refer to the
• Do not pool reagents within a kit or between kits. ARCHITECT System Operations Manual, Section 5.
• Before loading the reagent kit on the system for the first For a detailed description of system procedures, refer to the
time, the microparticle bottle requires mixing to resuspend ARCHITECT System Operations Manual.
microparticles that may have settled during shipment. For
Alternate Result Units
microparticle mixing instructions, refer to the PROCEDURE,
Assay Procedure section of this package insert. Edit assay parameter "Result concentration units" to select an
alternate unit.
• Septums MUST be used to prevent reagent evaporation
and contamination and to ensure reagent integrity. Conversion formula:
Reliability of assay results cannot be guaranteed if (Concentration in Default result unit) x (Conversion factor) =
septums are not used according to the instructions in this (Concentration in Alternate result unit)
package insert. Default result unit Conversion factor Alternate result unit
• To avoid contamination, wear clean gloves when placing nmol/L 0.095 μg/mL
a septum on an uncapped reagent bottle. 0.095 mg/L
• Once a septum has been placed on an open reagent
bottle, do not invert the bottle as this will result in ll
SPECIMEN COLLECTION AND PREPARATION
reagent leakage and may compromise assay results. FOR ANALYSIS
• Over time, residual liquids may dry on the septum Specimen Types
surface. These are typically dried salts and have no Verified specimen types to be used with this assay:
effect on assay efficacy.
Specimen Types Collection Tubes
For a detailed discussion of handling precautions during system Serum
operation, refer to the ARCHITECT System Operations Manual, Human serum
Serum separator tubes
Section 7.
Lithium Heparin
Reagent Storage Human plasma Sodium Heparin
When stored and handled as directed, reagents are stable until Ammonium Heparin
the expiration date.
Storage Maximum Additional Storage • Performance has not been established for the use of
Temperature Storage Time Instructions cadaveric specimens or the use of body fluids other than
Unopened/ 2-8°C Until May be used human serum or plasma.
Opened* expiration immediately after • Liquid anticoagulants may have a dilution effect resulting in
date removal from 2-8°C lower concentrations for individual patient specimens.
storage. • The instrument does not provide the capability to verify
Store in upright position. specimen type. It is the responsibility of the operator to verify
On board System 30 days Discard after 30 days. that the correct specimen types are used in the assay.
temperature For information on • Potassium EDTA plasma can not be used with the
tracking onboard time, ARCHITECT SHBG assay. SHBG dimer destabilization
refer to the ARCHITECT in EDTA could result in low SHBG measurements by
System Operations immunoassay.8 Use of Potassium EDTA tubes may result in a
Manual, Section 5. decrease in concentration values of greater than 20% when
compared with serum collected in serum tubes.
* Reagents may be stored on or off the ARCHITECT iSystem.
• Na-Fluoride/K-Oxalate and Na-Citrate plasma separator tubes
If reagents are removed from the system, store them at 2-8°C
can not be used with the ARCHITECT SHBG assay.
(with septums and replacement caps) in an upright position. For
reagents stored off the system, it is recommended that they be
stored in their original trays and boxes to ensure they remain
upright. If the microparticle bottle does not remain upright
(with a septum installed) while in refrigerated storage off the
system, the reagent kit must be discarded. For information on
unloading reagents, refer to the ARCHITECT System Operations
Manual, Section 5.

2
Specimen Conditions ll
PROCEDURE
• Do not use specimens with the following conditions:
Materials Provided
• heat-inactivated
8K26 ARCHITECT SHBG Reagent Kit
• pooled
Materials Required but not Provided
• grossly hemolyzed (> 500 mg/dL hemoglobin)
• ARCHITECT SHBG Assay file obtained from the
• obvious microbial contamination
ARCHITECT iSystem e-Assay CD-ROM found on
• For accurate results, serum and plasma specimens should [Link].
be free of fibrin, red blood cells, and other particulate matter.
• 8K26-02 ARCHITECT SHBG Calibrators
Serum specimens from patients receiving anticoagulant or
thrombolytic therapy may contain fibrin due to incomplete clot • 8K26-11 ARCHITECT SHBG Controls
formation. • 7D82-50 ARCHITECT Multi-Assay Manual Diluent
• To prevent cross contamination, use of disposable pipettes or • ARCHITECT Pre-Trigger Solution
pipette tips is recommended. • ARCHITECT Trigger Solution
Preparation for Analysis • ARCHITECT Wash Buffer
• Follow the tube manufacturer’s processing instructions • ARCHITECT Reaction Vessels
for collection tubes. Gravity separation is not sufficient for • ARCHITECT Sample Cups
specimen preparation. • ARCHITECT Septum
• Mix thawed specimens thoroughly by low speed vortexing • ARCHITECT Replacement Caps
or by inverting 10 times. Visually inspect the specimens. If • Pipettes or pipette tips (optional) to deliver the volumes
layering or stratification is observed, continue mixing until specified on the patient or control order screen.
specimens are visibly homogeneous. For information on materials required for maintenance
• To ensure consistency in results, specimens must be procedures, refer to the ARCHITECT System Operations Manual,
transferred to a centrifuge tube and centrifuged at ≥ 10,000 Section 9.
RCF (Relative Centrifugal Force) for 10 minutes before testing
Assay Procedure
if
• Before loading the reagent kit on the system for the first
• they contain fibrin, red blood cells, or other particulate
time, the microparticle bottle requires mixing to resuspend
matter, or
microparticles that may have settled during shipment. After
• they require repeat testing. the first time the microparticles have been loaded, no further
• Transfer clarified specimen to a sample cup or secondary mixing is required.
tube for testing. For centrifuged specimens with a lipid layer, • Invert the microparticle bottle 30 times.
transfer only the clarified specimen and not the lipemic
• Visually inspect the bottle to ensure microparticles are
material.
resuspended. If microparticles are still adhered to the
• Inspect all specimens for bubbles. Remove bubbles with an bottle, continue to invert the bottle until the microparticles
applicator stick before analysis. Use a new applicator stick have been completely resuspended.
for each specimen to prevent cross contamination.
• If the microparticles do not resuspend, DO NOT USE.
Specimen Storage Contact your local Abbott representative.
Specimen Type Storage Temperature Maximum Storage Time • Once the microparticles have been resuspended, place
Serum 2-8°C ≤ 8 days a septum on the bottle. For instructions about placing
septums on bottles, refer to the Reagent Handling
Serum specimens may be stored at 2-8°C on or off the clot, red section of this package insert.
blood cells, or separator gel for ≤ 8 days.
• Load the reagent kit on the ARCHITECT iSystem.
Plasma specimens may be stored at 2-8°C on the clot, red blood
• Verify that all necessary reagents are present.
cells, or separator gel for ≤ 8 days. Plasma specimens may be
• Ensure that septums are present on all reagent bottles.
stored at 2-8°C off the clot, red blood cells, or separator gel for
≤ 5 days. • Order calibration, if necessary.
If testing will be delayed more than 8 days, remove serum or • For information on ordering calibrations, refer to the
plasma from the clot, red blood cells, or separator gel and store ARCHITECT System Operations Manual, Section 6.
frozen. • Order tests.
Serum and plasma specimens stored frozen for 3 months • For information on ordering patient specimens and
showed no performance differences. controls and for general operating procedures, refer to
Avoid more than 1 freeze/thaw cycle. the ARCHITECT System Operations Manual, Section 5.
Plasma specimens may increase in concentration after one
freeze/thaw cycle.
Specimen Shipping
• Package and label specimens in compliance with applicable
state, federal, and international regulations covering the
transport of clinical specimens and infectious substances.
• Do not exceed the storage limitations listed above.

3
• Minimum sample cup volume is calculated by the system Calibration
and printed on the Orderlist report. To minimize the effects • Test Calibrators A-F in replicates of two. The calibrators
of evaporation, verify adequate sample cup volume is present should be priority loaded.
prior to running the test. A single sample of each control level must be tested to
Maximum number of replicates sampled from the same evaluate the assay calibration. Ensure that assay control
sample cup: 10 values are within the ranges specified in the respective
• Priority: control package insert.
Sample volume for first test: 70 μL • Calibration Range: 0.0 – 250.0 nmol/L.
Sample volume for each additional test from same • Once an ARCHITECT SHBG calibration is accepted and
sample cup: 20 μL stored, all subsequent samples may be tested without further
• ≤ 3 hours on board: calibration unless:
Sample volume for first test: 150 μL • A reagent kit with a new lot number is used or
Sample volume for each additional test from same • Controls are out of range.
sample cup: 20 μL • For detailed information on how to perform an assay
• > 3 hours on board: Additional sample volume required. calibration, refer to the ARCHITECT System Operations
For additional information on sample evaporation and Manual, Section 6.
volumes, refer to the ARCHITECT System Operations Quality Control Procedures
Manual, Section 5. The recommended control requirement for the ARCHITECT
• If using primary or aliquot tubes, use the sample gauge SHBG assay is that a single sample of each control level be
to ensure sufficient patient specimen is present. tested once every 24 hours each day of use. If the quality
• Prepare ARCHITECT SHBG Calibrators and Controls. control procedures in your laboratory require more frequent use
• Prior to use, thaw completely according to the respective of controls to verify test results, follow your laboratory-specific
calibrator and control package inserts. procedures.
• Mix calibrator(s) and controls thoroughly by inversion The ARCHITECT SHBG Control values must be within the
before use. acceptable ranges specified in the control package insert. If a
• Hold bottles vertically and dispense recommended control is out of its specified range, the associated test results
volumes into each respective sample cup. are invalid and samples must be retested. Recalibration may be
• Recommended volumes: indicated.
for each calibrator: 6 drops Verification of Assay Claims
for each control: 6 drops For protocols to verify package insert claims, refer to the
• Load samples. ARCHITECT System Operations Manual, Appendix B.
• For information on loading samples, refer to the The ARCHITECT SHBG assay belongs to method group 1.
ARCHITECT System Operations Manual, Section 5. ll
RESULTS
• Press RUN.
Calculation
• For additional information on principles of operation, refer to
The ARCHITECT SHBG assay utilizes a 4 Parameter Logistic
the ARCHITECT System Operations Manual, Section 3.
Curve fit data reduction method (4PLC, Y-weighted) to generate
• For optimal performance, it is important to perform routine a calibration curve.
maintenance as described in the ARCHITECT System
Operations Manual, Section 9. Perform maintenance more Flags
frequently when required by laboratory procedures. Some results may contain information in the Flags field. For a
description of the flags that may appear in this field, refer to the
Specimen Dilution Procedures
ARCHITECT System Operations Manual, Section 5.
Specimens with an SHBG concentration of > 250 nmol/L will
be flagged as “>250 nmol/L” and may be diluted with either the ll
LIMITATIONS OF THE PROCEDURE
Automated Dilution Protocol or the Manual Dilution Procedure. • Results should be used in conjunction with other data; e.g.,
Automated Dilution Protocol symptoms, results of other tests, and clinical impressions.
The system performs a 1:5 dilution of the specimen and • If the SHBG results are inconsistent with clinical evidence,
automatically calculates the concentration of the specimen additional testing is suggested to confirm the result.
before dilution and reports the result. • Specimens from patients who have received preparations of
Manual Dilution Procedure mouse monoclonal antibodies for diagnosis or therapy may
Suggested dilution: 1:5 contain human anti-mouse antibodies (HAMA). Specimens
containing HAMA may produce anomalous values when
1. Add 30 μL of the patient specimen to 120 μL of ARCHITECT
tested with assay kits (such as ARCHITECT SHBG) that
Multi-Assay Manual Diluent.
employ mouse monoclonal antibodies.9, 10
2. The operator must enter the dilution factor in the Patient or
• Heterophilic antibodies in human serum can react
Control order screen. The system will use this dilution factor
with reagent immunoglobulins, interfering with in vitro
to automatically calculate the concentration of the sample
immunoassays. Patients routinely exposed to animals or to
before dilution and report the result. The result should be
animal serum products can be prone to this interference, and
> 0.1 nmol/L before the dilution factor is applied.
anomalous values may be observed. Additional information
For detailed information on ordering dilutions, refer to the may be required for diagnosis.11
ARCHITECT System Operations Manual, Section 5.
• High protein concentration on plasma samples interferes with
the ARCHITECT SHBG assay.

4
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EXPECTED VALUES ll
SPECIFIC PERFORMANCE CHARACTERISTICS
It is recommended that each laboratory establish its own Precision
reference range, which may be unique to the population it serves The ARCHITECT SHBG assay is designed to have a precision
depending on the geographical, dietary, or environmental factors. of ≤ 10% total CV. A study was performed with the ARCHITECT
A reference range study was conducted with USA population, SHBG assay based on guidance from the Clinical and Laboratory
testing a total of 152 samples from female individuals and a total Standards Institute, document NCCLS Protocol EP5-A12. Multiple
of 167 samples from male individuals. These samples gave the ARCHITECT SHBG control lots and three serum samples were
values summarized in the following table.* assayed using one lot of reagents in replicates of two at two
SHBG (nmol/L) separate times per day for 20 days at one site and on one
2.5th 97.5th instrument. In addition, two lots of reagents were assayed for 10
n Median percentile percentile
days on three other instruments at different sites. A third reagent
Males 167 30.4 11.2 78.1
lot was tested in replicates of two at two separate times per day
Females 152 48.2 11.7 137.2
for 5 days on one instrument. Each reagent lot used a single
A second reference range study was conducted with European calibration curve throughout the study. Data from this study are
population, testing a total of 200 samples from female individuals summarized in the following table.*
and a total of 224 samples from male individuals. These samples Mean Conc. Within Run Totala
gave the values summarized in the following table.* Sample n (nmol/L) SD %CV SD %CV
SHBG (nmol/L) Low Control 1640 8.8 0.42 4.78 0.84 9.54
2.5th 97.5th Medium Control 1640 24.5 1.18 4.80 1.38 5.65
n Median percentile percentile High Control 1640 152.8 8.00 5.24 11.53 7.55
Males 224 34.8 13.5 71.4 Human Serum 760 16.8 0.86 5.11 1.11 6.63
Females 200 61.3 19.8 155.2 Low
Human Serum 760 47.3 2.26 4.78 3.77 7.97
A third study was conducted testing a total of 113 samples Medium
from female individuals and a total of 111 samples from male Human Serum 760 146.2 7.48 5.11 13.10 8.96
individuals at two sites. The free testosterone index (% FTI) or High
free androgen index (% FAI) correlates with the value of free a Total assay variability contains within run, run to run and day to
testosterone.2 Therefore, in addition to SHBG all samples were
day variability.
tested with ARCHITECT Testosterone. The free testosterone
index (% FTI) or free androgen index (% FAI) was calculated on * Representative performance data are shown. Results obtained
a molar/molar basis. These samples gave values for the different at individual laboratories may vary.
groups summarized in the following table.* Recovery
SHBG and Total Testosterone The ARCHITECT SHBG assay is designed to have a mean
SHBG (nmol/L) Testosterone (ng/mL)a recovery of 100 +/- 10%. A study was performed where known
95th 95th concentrations (12.5, 25, 50, 100, 200 nmol/L) of SHBG were
n Median 5th perc. perc. Median 5th perc. perc. added to 10 aliquots of human serum with endogenous levels
Normal Men 111 39.7 17.1 77.6 4.86 2.54 8.53 ranging from 9.4 to 46.6 nmol/L. The concentration of SHBG
Premenopausal 59 88.9 34.3 147.7 0.58 0.16 1.17 and the percent recovery were calculated for each sample. The
women
percent recovery of the ARCHITECT SHBG assay resulted in a
Postmenopausal 54 57.2 26.4 118.0 0.45 0.16 1.00
women mean of 99%. Data are representative performance data, but
results obtained at individual laboratories may vary.
Free Testosterone Index or Free Androgen Index
Dilution Linearity
FTI or FAI (%)b
n Median 5th percentile 95th percentile The ARCHITECT SHBG assay is designed to recover diluted
Normal Men 111 41.7 20.4 81.2 specimens within +/- 10% of the expected result. A dilution
Premenopausal women 59 2.5 0.5 7.3 linearity study was performed using specimens with undiluted
Postmenopausal women 54 2.5 0.6 8.0 values that ranged between 30.0 and 158.2 nmol/L. These
specimens were diluted manually using ARCHITECT Multi-Assay
aThe default unit for the ARCHITECT Testosterone assay is Manual Diluent at various dilution factors (0.2 to 0.9) to result in
ng/mL. 80 to 10% of the endogenous SHBG level. Data from this study
• When the alternate result unit, nmol/L, is selected, the are summarized in the following tables.*
conversion factor used by the system is 3.47. Observed Values
Conversion formula: [concentration in ng/mL] x 3.47= nmol/L Sample Dilution Factor (nmol/L) % Mean Recoverya
Testosterone Value (nmol/L) 1 undiluted 30.0 -
b FTI (%) = x 100 0.2 to 0.9 24.3 - 3.1 100
SHBG Value (nmol/L)
2 undiluted 78.0 -
* Representative performance data are shown. Results obtained 0.2 to 0.9 57.4 - 7.7 98
at individual laboratories may vary. 3 undiluted 158.2 -
0.2 to 0.9 124.2 - 15.1 97

In addition, a dilution study was performed using specimens

with different high and low SHBG concentration values ranging
between 24.7 to 214.0 nmol/L. The low level sample was used to
dilute the high level sample to different concentrations (dilution
factors of 0.25 to 0.75).

5
 Undiluted Potentially Interfering
Concentration Level Diluted Concentration Substance Concentration % Mean Recoverya
Sample Pair (nmol/L) Range (nmol/L) % Mean Recoverya Hemoglobin 500 mg/dL 99
1 Low 26.3 67.0 to 165.6 96 Bilirubin 20 mg/dL 99
High 214.0 Triglycerides 4000 mg/dL 103
2 Low 24.7 71.3 to 155.3 100 Protein low 4 g/dL 104
High 205.8
Protein high 12 g/dL 95b
3 Low 26.5 65.2 to 132.5 103
High 163.8 a % Recovery = Observed Value (nmol/L)
x 100
Expected Value (nmol/L)
a % Recovery = Observed Value (nmol/L)
x 100
Expected Value (nmol/L) % Mean Recovery = Mean of % Recovery of all tested serum
and plasma samples.
% Mean Recovery = Mean of % Recovery of all dilutions of a b Data provided for high protein are based on serum samples.
sample
High protein concentration on plasma samples interferes with the
* Representative performance data are shown. Results obtained
ARCHITECT SHBG assay.
at individual laboratories may vary.
* Representative performance data are shown. Results obtained
Sensitivity at individual laboratories may vary.
The ARCHITECT SHBG assay is designed to have an analytical
Method Comparison
sensitivity of ≤ 0.1 nmol/L. Analytical sensitivity is defined as the
concentration at two standard deviations above the calibrator A The ARCHITECT SHBG assay is designed to have a slope
(0.0 nmol/L). In a study (n = 6 runs, 20 replicates of calibrator difference of +/- 15% and a correlation coefficient of ≥ 0.90
A using three instruments and two reagent lots), the analytical when compared to a commercially available diagnostic kit. A
sensitivity was calculated to be 0.02 nmol/L* at a 95% level of study was performed with the ARCHITECT SHBG assay, where
confidence. regression analysis was performed using the Passing-Bablok
and Least Squares regression methods. Data from this study are
* Representative performance data are shown. Results obtained
summarized in the following table and graph.*
at individual laboratories may vary.
In this evaluation, specimen concentrations range from
Specificity 5.7 nmol/L to 1067.6 nmol/L with the ARCHITECT SHBG assay
The specificity of the ARCHITECT SHBG assay is designed to and from 6.5 nmol/L to 1072.0 nmol/L with the commercially
have no detectable cross-reactivity when tested with structurally available diagnostic kit. This evaluation also includes specimens
similar compounds listed in the table below. A study was diluted by the instrument.
performed with the ARCHITECT SHBG assay based on guidance ARCHITECT SHBG vs. Comparison Assay
from the Clinical and Laboratory Standards Institute, document Correlation
NCCLS Protocol EP7-A.13 Aliquots of calibrator A, containing Regression Method n Slope Intercept Coefficient
essentially no residual SHBG, were supplemented with potential Passing-Bablok a 626 1.09 0.35
0.98
cross-reactants at the concentrations listed and tested for SHBG. Least Squares 626 1.07 7.11
Data from this study are summarized in the following table.* a A linear regression method with no special assumptions
Concentration Cross-
Compound Reactant % Cross Reactivitya
regarding the distribution of samples and measurement errors.14
AFP 400 ng/mL 0.00
Cortisol 100,000 ng/mL 0.00
11-Deoxycortisol 4,000 ng/mL 0.00
Estradiol 3,600 pg/mL 0.00
Testosterone 20,000 ng/mL 0.00
5-dihydrotestosterone 20,000 ng/mL 0.00
TG 300 ng/mL 0.00
TBG 200 μg/mL 0.00
Transferrin 4 mg/mL 0.00
Mean Value spiked - Mean
a % Cross-Reactivity = Value non spiked (nmol/L)
x 100
Concentration of Cross-
Reactant (nmol/L)

* Representative performance data are shown. Results obtained

at individual laboratories may vary.
Interference
A bias analysis of the ARCHITECT SHBG vs. the comparison
Potential interference in the ARCHITECT SHBG assay from assay was performed on the same 626b serum specimens
hemoglobin, bilirubin, triglycerides, and protein at the levels in the range of 5.7 to 1072.0 nmol/L. The average % Bias of
indicated below is designed to be ≤ 10%. Interference was ARCHITECT SHBG vs. the comparison assay in this study was
demonstrated by a study based on guidance from the Clinical 13.26%. The 95% confidence interval of that average percent
and Laboratory Standards Institute, document NCCLS Protocol bias is -19.87% to 46.38%. The following graph demonstrates the
EP7-A.13 There was no significant interference observed since % Bias between the two assays.*
the % mean recovery is within +/- 10% of the expected value.
Data from this study are summarized in the following table.*

6
 ll
Key to Symbols
Consult instructions for use

Manufacturer

Sufficient for

Temperature limitation

Use by/Expiration date

Assay Diluent
Conjugate
Contains Sodium Azide.
Contact with acids liberates
very toxic gas.
b Control Number
One data point was removed for presentation purposes. The
% Bias between the two assays for this data point was 113.7%. Information needed for United
The concentration was 231.7 nmol/L on ARCHITECT SHBG and States of America only
108.4 nmol/L on the comparison assay. In Vitro Diagnostic Medical
* Representative performance data are shown. Variables such Device
as differences in sampling size and sample population may Lot Number
impact the correlation of the assay, therefore, results obtained at Microparticles
individual laboratories may vary from these data. Multi-Assay Manual Diluent
ll
BIBLIOGRAPHY Pre-Trigger Solution
1. Selby C. Sex hormone binding globulin: origin, function and clinical Produced for Abbott by
significance. Ann Clin Biochem 1990;27:532-541.
2. Pugeat M, Crave JC, Tourniare J, et al. Clinical utility of sex hormone Product of Spain
binding globulin measurement. Horm Res 1996;45(3-5):148-155.
3. Braunstein GD. Androgen insufficiency in women: summary of critical Reaction Vessels
issues. Fertil Steril 2002;77(4, suppl 4):S94-95. Reagent Lot
4. US Department of Labor, Occupational Safety and Health
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens. List Number
5. US Department of Health and Human Services. Biosafety in Replacement Caps
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
US Government Printing Office; December 2009. Sample Cups
6. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Septum
Geneva: World Health Organization; 2004.
7. Clinical and Laboratory Standards Institute (CLSI). Protection Serial number
of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne, Trigger Solution
PA: CLSI; 2014. Wash Buffer
8. Fillmore CM, Fear TR, Hoover RN, et al. Biomarkers: biochemical
indicators of exposure, response, and susceptibility to chemicals.
Biomarkers 2000;5(5):395–398. ARCHITECT and Chemiflex are trademarks of Abbott
9. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine Laboratories in various jurisdictions. All other trademarks are
immunoglobulin responses in patients receiving monoclonal antibody property of their respective owners.
therapy. Cancer Res 1985;45(2):879-885.
10. Primus FJ, Kelley EA, Hansen HJ, et al. “Sandwich”-type Abbott GmbH & Co. KG
immunoassay of carcinoembryonic antigen in patients receiving Max-Planck-Ring 2
murine monoclonal antibodies for diagnosis and therapy. Clin Chem 65205 Wiesbaden
1988;34(2):261-264. Germany
11. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all +49-6122-580
immunoassays. Clin Chem 1988;34(1):27-33.
12. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Clinical Chemistry Devices; Abbott Laboratories Biokit, S.A.
Approved Guideline. NCCLS Document EP5-A. Wayne, PA: NCCLS; Abbott Park, IL 60064 USA Av. Can Montcau 7
1999. 08186 Lliçà d’Amunt
13. National Committee for Clinical Laboratory Standards (NCCLS). Barcelona, Spain
Interference Testing in Clinical Chemistry; Approved Guideline. NCCLS
Document EP7-A. Wayne, PA: NCCLS; 2002.
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Application of linear regression procedures for method comparison
Revised April 2018.
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