en

Total T3
system
7K64
G2-7947/R05
B7K640
Read Highlighted Changes
Revised July 2012

Total T3
Customer Service: Contact your local representative or find country specific contact information
on www.abbottdiagnostics.com
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 Reaction Vessels
In Vitro Diagnostic Medical
Device Sample Cups

Lot Number Replacement Caps

Serial Number
Reagent Lot
Septum
Control Number
Expiration Date
Warning: May cause an
allergic reaction
Store at 2-8°C Global Trade Item
Number
Consult instructions for use Product of Ireland

Information needed for

Manufacturer United States of
America only

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

component naming.

1
NAME REAGENTS
ARCHITECT Total T3 Reagent Kit, 100 Tests/500 Tests
INTENDED USE NOTE: Some kit sizes are not available in all countries or for use on all
ARCHITECT i Systems. Please contact your local distributor.
The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle
immunoassay (CMIA) for the quantitative determination of total ARCHITECT Total T3 Reagent Kit (7K64)
triiodothyronine (Total T3) in human serum and plasma. • 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep)
coated microparticles in MES buffer with sheep IgG stabilizers.
SUMMARY AND EXPLANATION OF TEST Preservative: ProClin 300.
3,5,3’ Triiodothyronine (T3) is a thyroid hormone with a molecular weight • 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled
of 651 daltons1 and a half-life in serum of 1.5 days.2 T3 circulates in the conjugate in citrate buffer with NaCl and Triton X-100 stabilizers.
blood as an equilibrium mixture of free and protein bound hormone.3 T3 is Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300.
bound to thyroxine binding globulin (TBG), prealbumin, and albumin. The
actual distribution of T3 among these binding proteins is controversial as Other Reagents
estimates range from 38-80% for TBG, 9-27% for prealbumin, and 11-35% ARCHITECT i Pre-Trigger Solution
for albumin.4 The binding of these proteins is such that only 0.2-0.4% of • Pre-Trigger Solution containing 1.32% (w/v)
the total T3 is present in solution as unbound or free T3.5 This free fraction hydrogen peroxide.
represents the physiologically active thyroid hormone.3 ARCHITECT i Trigger Solution
It has become apparent in recent years that T3 plays an important role • Trigger Solution containing 0.35 N sodium
in the maintenance of the euthyroid state. Serum T3 measurements can hydroxide.
be a valuable component of a thyroid screening panel in diagnosing
ARCHITECT i Wash Buffer
certain disorders of thyroid function as well as conditions caused by
iodine deficiency. Clinically, measurements of serum T3 concentration NOTE: Bottle and volume vary based on order.
are especially valuable in diagnosing hyperthyroidism and in following the • Wash Buffer containing phosphate buffered saline
course of therapy for this disorder.2,6,7 Under conditions of strong thyroid solution. Preservatives: antimicrobial agents.
stimulation, the T3 measurement provides a good estimation of thyroid WARNINGS AND PRECAUTIONS
reserve.2 Recognition of a thyroid dysfunction called T3-thyrotoxicosis, •
associated with an increased serum T3 level but normal thyroxine (T4),
• For In Vitro Diagnostic Use
free T4, and in vitro Uptake results have further highlighted the importance of
serum T3 measurements.2,8-11 Dietary iodine deficiency results in inadequate • Package insert instructions must be carefully followed. Reliability of
production of thyroid hormones despite the presence of normal thyroid assay results cannot be guaranteed if there are any deviations from
tissue. In these cases, the serum T4 concentration is often low while the the instructions in this package insert.
thyroid stimulating hormone (TSH) concentration is elevated. Elevated TSH Safety Precautions
associated with low T4 is normally indicative of hypothyroidism. However,
in iodine deficiency, these results together with normal or slightly elevated • CAUTION: This product requires the handling of human specimens.
serum T3 are indicative of euthyroid status in most individuals.12 It is recommended that all human sourced materials be considered
potentially infectious and handled in accordance with the OSHA
T3 levels are also affected by conditions which affect TBG concentration.13‑15
Standard on Bloodborne Pathogens18. Biosafety Level 219 or other
Slightly elevated T3 levels may occur in pregnancy or during estrogen
appropriate biosafety practices20,21 should be used for materials that
therapy, while depressed levels may occur during severe illness, malnutrition,
contain or are suspected of containing infectious agents.
in renal failure and during therapy with anti-thyroid drugs, propranolol
and propylthiouracil and salicylates. 2,16,17 In patients with severe or The following warnings and precautions apply to these components:
chronic illnesses, many abnormalities of thyroid hormone balance occur. • Microparticles
T4 production and the extent of serum thyroid hormone binding may be • Conjugate
independently abnormal, resulting in a low, normal or high free T4 estimate.
Serum T3 concentrations are often low; TSH levels may be normal or slightly WARNING: Contains methylisothiazolones.
elevated. Total T3 measurements may be valuable when hyperthyroidism H317 May cause an allergic skin reaction.
is suspected and the free T4 estimate is normal.13 Prevention
The ARCHITECT Total T3 assay is to be used as an aid in the assessment P261 Avoid breathing mist / vapours / spray.
of thyroid status. P272 Contaminated work clothing should not
be allowed out of the workplace.
BIOLOGICAL PRINCIPLES OF THE PROCEDURE P280 Wear protective gloves / protective
The ARCHITECT Total T3 assay is a two-step immunoassay to determine the clothing / eye protection.
presence of Total T3 in human serum and plasma using CMIA technology
with flexible assay protocols, referred to as Chemiflex. Response
In the first step, sample and anti-T3 coated paramagnetic microparticles P302+P352 IF ON SKIN: Wash with plenty of water.
are combined. T3 present in the sample binds to the anti-T3 coated P333+P313 If skin irritation or rash occurs: Get
microparticles. After washing, T3 acridinium-labeled conjugate is added medical advice / attention.
in the second step. Pre-Trigger and Trigger Solutions are then added to P363 Wash contaminated clothing before
the reaction mixture; the resulting chemiluminescent reaction is measured reuse.
as relative light units (RLUs). An inverse relationship exists between the This material and its container must be disposed of in
amount of Total T3 in the sample and the RLUs detected by the ARCHITECT a safe way.
i optical system. • Safety Data Sheets are available at www.abbottdiagnostics.com or
For additional information on system and assay technology, refer to the contact your local representative.
ARCHITECT System Operations Manual, Section 3. • For a detailed discussion of safety precautions during system operation,
refer to the ARCHITECT System Operations Manual, Section 8.

2
Handling Precautions • The ARCHITECT i System does not provide the capability to verify
• Do not use reagent kits beyond the expiration date. specimen type. It is the responsibility of the operator to verify the
• Do not mix reagents from different reagent kits. correct specimen types are used in the ARCHITECT Total T3 assay.
• Prior to loading the ARCHITECT Total T3 Reagent Kit on the system • Use caution when handling patient specimens to prevent cross
for the first time, the microparticle bottle requires mixing to resuspend contamination. Use of disposable pipettes or pipette tips is
microparticles that have settled during shipment. For microparticle recommended.
mixing instructions, refer to the PROCEDURE, Assay Procedure section • Do not use heat-inactivated specimens.
of this package insert. • For optimal results, inspect all samples for bubbles. Remove bubbles
• Septa MUST be used to prevent reagent evaporation and with an applicator stick prior to analysis. Use a new applicator stick
contamination and to ensure reagent integrity. Reliability of assay for each sample to prevent cross contamination.
results cannot be guaranteed if septa are not used according to the • For optimal results, serum and plasma specimens should be free of
instructions in this package insert. fibrin, red blood cells or other particulate matter.
• To avoid contamination, wear clean gloves when placing a septum on • Ensure that complete clot formation in serum specimens has taken
an uncapped reagent bottle. place prior to centrifugation. Some specimens, especially those
• Once a septum has been placed on an open reagent bottle, do from patients receiving anticoagulant or thrombolytic therapy, may
not invert the bottle as this will result in reagent leakage and may exhibit increased clotting time. If the specimen is centrifuged before
compromise assay results. a complete clot forms, the presence of fibrin may cause erroneous
• Over time, residual liquids may dry on the septum surface. These are results.
typically dried salts which have no effect on assay efficacy. • If testing will be delayed more than 24 hours, remove serum or plasma
• For a detailed discussion of handling precautions during system from the clot, serum separator or red blood cells. Specimens may be
operation, refer to the ARCHITECT System Operations Manual, stored for up to 6 days at 2-8°C prior to being tested. If testing will be
Section 7. delayed more than 6 days, specimens should be frozen at -10°C or
colder. Specimens stored frozen at -10°C or colder for 6 days showed
Storage Instructions no performance difference.
• Multiple freeze-thaw cycles of specimens should be avoided.
Specimens must be mixed THOROUGHLY after thawing, by LOW speed
• The ARCHITECT Total T3 Reagent Kit must be stored at 2-8°C
vortexing or by gently inverting, and centrifuged prior to use to remove
and may be used immediately after removal from 2-8°C storage.
red blood cells or particulate matter to ensure consistency in the results.
• When stored and handled as directed, reagents are stable until the • When shipped, specimens must be packaged and labeled in
expiration date. compliance with applicable state, federal and international regulations
• The ARCHITECT Total T3 Reagent Kit may be stored on board the covering the transport of clinical specimens and infectious substances.
ARCHITECT i System for a maximum of 30 days. After 30 days, the Prior to shipment, it is recommended that specimens be removed from
reagent kit must be discarded. For information on tracking onboard the clot, serum separator or red blood cells.
time, refer to the ARCHITECT System Operations Manual, Section 5.
PROCEDURE
• Reagents may be stored on or off the ARCHITECT i System. If reagents
are removed from the system, store them at 2-8°C (with septa and Materials Provided
replacement caps) in an upright position. For reagents stored off the • 7K64 ARCHITECT Total T3 Reagent Kit
system, it is recommended that they be stored in their original trays and Materials Required but not Provided
boxes to ensure they remain upright. If the microparticle bottle does • ARCHITECT i System
not remain upright (with a septum installed) while in refrigerated • ARCHITECT Total T3 Assay file, may be obtained from:
storage off the system, the reagent kit must be discarded. After
reagents are removed from the system, you must initiate a scan to • ARCHITECT i System e-Assay CD-ROM found on
update the onboard stability timer. www.abbottdiagnostics.com
• ARCHITECT i Assay CD-ROM
Indications of Reagent Deterioration • 7K64-01 ARCHITECT Total T3 Calibrators
When a control value is out of the specified range, it may indicate
• 7K64-50 ARCHITECT Total T3
deterioration of the reagents or errors in technique. Associated test results
are invalid and samples must be retested. Assay recalibration may be • ARCHITECT i
necessary. For troubleshooting information, refer to the ARCHITECT System • ARCHITECT i
Operations Manual, Section 10. • ARCHITECT i
INSTRUMENT PROCEDURE • ARCHITECT i
• The ARCHITECT Total T3 assay file must be installed on the ARCHITECT • ARCHITECT i
i System from the ARCHITECT i Assay CD-ROM prior to performing • ARCHITECT i
the assay. For detailed instructions on assay file installation and on • ARCHITECT i
viewing and editing assay parameters, refer to the ARCHITECT System • Any commercially available controls
Operations Manual, Section 2. • Pipettes or pipette tips (optional)
• For information on printing assay parameters, refer to the ARCHITECT • For information on materials required for maintenance procedures, refer
System Operations Manual, Section 5. to the ARCHITECT System Operations Manual, Section 9.
• For a detailed description of system procedures, refer to the
ARCHITECT System Operations Manual. Assay Procedure
• Before loading the ARCHITECT Total T3 Reagent Kit on the system
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS for the first time, the microparticle bottle requires mixing to resuspend
• Human serum (including serum collected in serum separator tubes) microparticles that have settled during shipment:
or plasma collected in sodium heparin, lithium heparin, or potassium • Invert the microparticle bottle 30 times.
EDTA anticoagulant tubes may be used in the ARCHITECT Total T3
• Visually inspect the bottle to ensure microparticles are
assay. Other anticoagulants have not been validated for use with the
resuspended. If microparticles are still adhered to the bottle,
ARCHITECT Total T3 assay. Follow the manufacturer’s processing
continue to invert the bottle until the microparticles have been
instructions for serum or plasma collection tubes.
completely resuspended.
• When serial specimens are being evaluated, the same type of specimen
• Once the microparticles have been resuspended, remove and
should be used throughout the study.
discard the cap. Wearing clean gloves, remove a septum from
the bag. Carefully snap the septum onto the top of the bottle.
• If the microparticles do not resuspend, Do Not Use. Contact
your local Abbott representative.

3
• Order tests. Calibration
• Load the ARCHITECT Total T3 Reagent Kit on the ARCHITECT i System. • To perform an ARCHITECT Total T3 calibration, test Calibrators 1 and
Verify that all necessary reagents are present. Ensure that septa are 2 in duplicate. A single sample of all levels of controls must be tested
present on all reagent bottles. to evaluate the assay calibration. Ensure that assay control values
• The minimum sample cup volume is calculated by the system and are within the concentration ranges specified in the package insert.
is printed on the Orderlist report. No more than 10 replicates may Calibrators should be priority loaded.
be sampled from the same sample cup. To minimize the effects of • Calibrator Range: 0.0 - 8.0 ng/mL.
evaporation verify adequate sample cup volume is present prior to • Once an ARCHITECT Total T3 calibration is accepted and stored, all
running the test. subsequent samples may be tested without further calibration unless:
• Priority: 75 µL for the first Total T3 test plus 25 µL for each • A reagent kit with a new lot number is used.
additional Total T3 test from the same sample cup • Controls are out of range.
• ≤ 3 hours on board: 150 µL for the first Total T3 test plus 25 µL for • For detailed information on how to perform an assay calibration, refer
each additional Total T3 test from the same sample cup to the ARCHITECT System Operations Manual, Section 6.
• > 3 hours on board: additional sample volume is required. Refer
to the ARCHITECT System Operations Manual, Section 5 for QUALITY CONTROL PROCEDURES
information on sample evaporation and volumes. The recommended control requirement for the ARCHITECT Total T3 assay
is a single sample of all control levels tested once every 24 hours each
• If using primary or aliquot tubes, use the sample gauge to ensure
day of use. If the quality control procedures in your laboratory require more
sufficient patient specimen is present.
frequent use of controls to verify test results, follow your laboratory-specific
• ARCHITECT Total T3 Calibrators should be mixed by gentle inversion procedures. Ensure that assay control values are within the concentration
prior to use. ranges specified in the package insert.
• To obtain the recommended volume requirements for the ARCHITECT
Total T3 Calibrators, hold the bottles vertically and dispense 4 drops Verification of Assay Claims
of each calibrator into each respective sample cup. For protocols to verify package insert claims, refer to the ARCHITECT
• Load samples. System Operations Manual, Appendix B. The ARCHITECT Total T3 assay
belongs to method group 2.
• For information on loading samples, refer to the ARCHITECT System
Operations Manual, Section 5. RESULTS
• Press RUN. The ARCHITECT i System performs the following functions: The ARCHITECT Total T3 utilizes a 4 Parameter Logistic Curve Fit data
• Moves the sample to the aspiration point reduction method (4PLC, Y-weighted) to generate a calibration curve.
• Loads a reaction vessel (RV) into the process path Alternate Result Units
• Aspirates and transfers sample into the RV • The default result unit for the ARCHITECT Total T3 assay is ng/mL.
• Advances the RV one position and transfers microparticles into • Alternate result units available are as follows:
the RV • When the alternate result unit, nmol/L, is selected, the conversion
• Mixes, incubates and washes the reaction mixture factor used by the system is 1.536
• Adds conjugate to the RV Conversion Formula:
• Mixes, incubates and washes the reaction mixture (Concentration in ng/mL) x (1.536) = Concentration in nmol/L
• Adds Pre-Trigger and Trigger Solutions • When the alternate result unit, ng/dL*, is selected, the conversion
• Measures chemiluminescent emission to determine the quantity factor used by the system is 100.0
of Total T3 in the sample Conversion Formula:
• Aspirates contents of RV to liquid waste and unloads RV to solid (Concentration in ng/mL) x (100.0) = Concentration in ng/dL*
waste * i System Assay CD-ROM version 6.0 and higher will be required to install
• Calculates the result this alternate result unit (ng/dL).
• For information on ordering patient specimens, calibrators and controls, Flags
and general operating procedures, refer to the ARCHITECT System • Some results may contain information in the Flags field. For a
Operations Manual, Section 5. description of the flags that may appear in this field, refer to the
• For optimal performance, it is important to follow the routine maintenance ARCHITECT System Operations Manual, Section 5.
procedures defined in the ARCHITECT System Operations Manual,
Section 9. If your laboratory requires more frequent maintenance, LIMITATIONS OF THE PROCEDURE
follow those procedures. • For diagnostic purposes, results should be used in conjunction with
other data; e.g., symptoms, results of other thyroid tests, clinical
Specimen Dilution Procedures impressions, etc.
Specimens with a Total T3 value exceeding 8.00 ng/mL, are flagged with • If the Total T3 results are inconsistent with clinical evidence, additional
the code “>8.00” and may be diluted with the Manual Dilution Procedure. testing is suggested to confirm the result.
• Manual Dilutions should be performed as follows: • Performance of this test has not been established with neonatal
• The suggested dilution for Total T3 is 1:2. It is recommended specimens.
dilutions not exceed 1:2.
• For a 1:2 dilution, add a minimum of 75 µL of the patient specimen
EXPECTED VALUES
to 75 µL of ARCHITECT Total T3 Manual Diluent. A normal range of 0.58 ng/mL to 1.59 ng/mL (central 95% interval) was
obtained by testing serum specimens from 438 individuals determined as
• To avoid contamination of Manual Diluent, dispense several drops normal by AxSYM Ultrasensitive hTSH II and AxSYM Free T4 assays. It is
of Manual Diluent into a clean test tube prior to pipetting. recommended that each laboratory establish its own normal range, which
• The operator must enter the dilution factor (2) in the patient or control may be unique to the population it serves depending upon geographical,
order screen. The system will use this dilution factor to automatically patient, dietary, or environmental factors.
calculate the concentration of the sample before dilution. This will
be the reported result. The dilution should be performed so that the
reported result reads greater than 1.0 ng/mL.
• If the operator does not enter the dilution factor, the reported result
will be that of the diluted sample. This result (before dilution factor is
applied) should be greater than 0.5 ng/mL.
• For detailed information on ordering dilutions, refer to the ARCHITECT
System Operations Manual, Section 5.

4
SPECIFIC PERFORMANCE CHARACTERISTICS Interference
Precision The ARCHITECT Total T3 assay is designed to have a mean potential
The ARCHITECT Total T3 assay is designed to have a precision of ≤ 10% interference from hemoglobin, bilirubin, triglycerides, and protein of ≤ 10%
(total CV). A study based on guidance from Clinical and Laboratory at the levels indicated below.
Standards Institute (CLSI, formerly NCCLS) document EP5‑A22 was • Hemoglobin - ≤ 500 mg/dL
performed for the ARCHITECT Total T3 assay. A three member processed • Bilirubin - ≤ 20 mg/dL
human serum based panel was assayed, using two lots of reagents, in • Triglycerides - ≤ 2000 mg/dL
replicates of two at two separate times per day for 20 testing days. Data • Protein - ≤ 12 g/dL
from this study are summarized in the following table.*
Accuracy by Correlation
Mean
The ARCHITECT Total T3 assay is designed to have a slope of 1.00 ± 0.20
Conc. Within Run Total and a correlation coefficient (r) of ≥ 0.90 when compared to the AxSYM
Panel Reagent Instru- Value
Total T3 assay.
Member Lot ment n (ng/mL) SD %CV SD %CV
A study was performed where specimens were tested using the ARCHITECT
1 1 1 80 0.75 0.021 2.7 0.027 3.6 Total T3 assay and AxSYM Total T3 assay. Data from this study were
1 1 2 80 0.73 0.023 3.1 0.030 4.1 analyzed using Least Squares and Passing-Bablok23 regression methods
1 2 1 80 0.79 0.036 4.6 0.043 5.4 and are summarized in the following table.*
1 2 2 80 0.81 0.047 5.8 0.057 7.0 Abbott ARCHITECT Total T3 vs. Abbott AxSYM Total T3
2 1 1 80 1.50 0.029 1.9 0.110 7.3 Number of Correlation
2 1 2 80 1.49 0.040 2.7 0.053 3.6 Method Specimens Intercept Slope Coefficient
2 2 1 80 1.53 0.031 2.0 0.035 2.3 Least Squares
2 2 2 80 1.54 0.040 2.6 0.049 3.2 Linear Regression 1440 0.02 1.04 0.964
3 1 1 80 3.27 0.062 1.9 0.128 3.9 Passing-Bablok
3 1 2 80 3.29 0.107 3.3 0.140 4.2 Linear Regression** 1440 -0.08 1.13 0.964
3 2 1 80 3.55 0.054 1.5 0.071 2.0 In this evaluation, serum specimens tested ranged from 0.25 ng/mL to
3 2 2 80 3.54 0.066 1.9 0.077 2.2 5.83 ng/mL with the ARCHITECT Total T3 assay and from 0.34 ng/mL to
5.19 ng/mL with the AxSYM Total T3 assay.
* Representative data; results in individual laboratories may vary from * Representative data; variables such as differences in sampling size and
these data. sample population may impact correlation of the assay; therefore, results
Recovery in individual laboratories may vary from these data.
The ARCHITECT Total T3 assay is designed to have a mean recovery of ** A linear regression method with no special assumptions regarding the
100 ± 10% when analyzing samples spiked with known amounts of T3. distribution of the samples and the measurement errors.23
T3 was added to nine normal human serum samples. The concentration of
BIBLIOGRAPHY
T3 was determined using the ARCHITECT Total T3 assay and the resulting
1. Budavari S, editor. Merck Index (11th Ed.). Rahway, NJ: Merck and
percent recovery was calculated.*
Co., Inc., 1989:868.
Observed 2. Larsen PR. Triiodothyronine: Review of Recent Studies of Its Physiology
Endogenous T3 Total T3 and Pathophysiology in Man. Metabolism 1972;21:1073-1092.
Concentration T3 Added Concentration % 3. Ekins RP, editor. Methods for the Measurement of Free Thyroid
Sample (ng/mL) (ng/mL) (ng/mL) Recovery** Hormones. Amsterdam: Excerpta Medica Foundation. 1979;72-92.
1 2.01 0.77 2.74 94.8 4. Robbins J, Rall JE. The Iodine-containing Hormones. In: Hormones in
2 0.97 0.78 1.64 85.9 Blood (3rd Ed.). London: Academic Press, 1979:1:632-667.
3 1.13 0.79 1.95 103.8 5. DeGroot LJ, Larsen PR, Refetoff S, Stanbury JB. Transport of Thyroid
4 0.99 1.54 2.43 93.5 Hormone and Cell Uptake. In: The Thyroid and Its Diseases. New York:
5 0.88 1.53 2.41 100.0 Wiley and Sons, 1984;62-66.
6 0.90 1.54 2.54 106.5 6. Wahner HW, Gorman CA. Interpretation of Serum Tri-Iodothyronine Levels
Measured by the Sterling Technic. N Engl J Med 1971;2824:225‑230.
7 1.07 3.03 4.28 105.9
7. Marsden P, McKerron CG. Serum Triiodothyronine Concentration in the
8 1.23 3.04 4.21 98.0 Diagnosis of Hyperthyroidism. Clin Endocrinol 1975;4:183-189.
9 0.90 3.03 3.89 98.7 8. Ivy HK, Washner HW, Gorman CA. Triiodothyronine (T3) Toxicosis: Its
Average Recovery: 98.6% Role in Graves’ Disease. Arch Intern Med 1971;128:529-534.
* Representative data; results in individual laboratories may vary from 9. Hollander CS, Mitsuma T, Nihei N, Shenkman L, Burday SZ, Blum M.
these data. Clinical and Laboratory Observations in Cases of Triiodothyronine
Toxicosis Confirmed by Radioimmunoassay. Lancet 1972;1:609-611.
Observed Total T3 Conc. (ng/mL) -
10. Sterling K, Refetoff S, Selenkow HA. T3 Thyrotoxicosis: Thyrotoxicosis
Endogenous Total T3 Conc. (ng/mL)
** % Recovery = x 100 Due to Elevated Serum Triiodothyronine Levels. JAMA 1970;213:571‑575.
T3 Added (ng/mL)
11. Hollander CS, Mitsuma T, Shenkman L, Stevenson C, Pineda G, Silva E.
T3 Toxicosis in an Iodine-Deficient Area. Lancet 1972;2:1276‑1278.
Analytical Sensitivity 12. Ermans AM. Disorders of Iodine Deficiency. In: Ingbar SH, Braverman
The ARCHITECT Total T3 assay is designed to have an analytical sensitivity LE, editors. The Thyroid (5th Ed.). Philadelphia: JB Lippincott Co.,
of ≤ 0.25 ng/mL. 1986:705-721.
Analytical sensitivity is defined as the concentration calculated as the 13. Kaplan MM, Larsen PR, Crantz FR, Deau VJ, Rossing TH. Prevalence of
mean plus two standard deviations of replicates of the ARCHITECT Total T3 Abnormal Thyroid Function Test Results in Patients with Acute Medical
MasterCheck Level 0 (0.0 ng/mL). The analytical sensitivity (low-linearity) Illnesses. Am J Med 1982;72:9-16.
is defined in the ARCHITECT Total T3 assay parameters as 0.25 ng/mL.
14. Bermudez F, Surks MI, Oppenheimer JH. High Incidence of Decreased
Analytical Specificity Serum Triiodothyronine Concentration in Patients with Nonthyroid
The ARCHITECT Total T3 assay is designed to have a mean analytical Disease. J Clin Endocrinol Metab 1975;41:27-40.
specificity of ≤ 0.1% cross reactivity with thyroxine (T4) at a concentration
of 1,100 ng/mL.

5
15. Oppenheimer JH. Thyroid Function Tests in Nonthyroidal Disease.
J Chronic Dis 1982;35:697-701.
16. Abuid J, Larsen PR. Triiodothyronine and Thyroxine in Hyperthyroidism:
Comparison of the Acute Changes During Therapy with Antithyroid
Agents. J Clin Invest 1974;54:201-208.
17. Felig P, Baxter JD, Broadus AE, Frohman LA, editors. Endocrinology and
Metabolism (2nd Ed.). New York: McGraw-Hill Book Co., 1987:408‑416.
18. US Department of Labor, Occupational Safety and Health Administration,
29 CFR Part 1910.1030, Bloodborne pathogens.
19. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
US Government Printing Office; December 2009.
20. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Geneva: World Health Organization; 2004.
21. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections: Approved Guideline
– Third Edition. CLSI Document M29-A3. Wayne, PA: Clinical and
Laboratory Standards Institute; 2005.
22. National Committee for Clinical Laboratory Standards, Evaluation
of Precision Performance of Clinical Chemistry Devices - Approved
Guideline. NCCLS Document EP5-A. Wayne, PA: NCCLS, 1999.
23. Passing H, Bablok W. A New Biometrical Procedure for Testing the
Equality of Measurements from Two Different Analytical Methods. J Clin
Chem. Clin Biochem. 1983;21:709-20.

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Triton is property of its respective owner.

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+353-43-3331000

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July 2012
© 2005, 2012 Abbott Laboratories