BIOMÉRIEUX

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®
VIDAS T3 (T3)

Intended Use
VIDAS® T3 is an automated quantitative test for use on the VIDAS® family instruments for the quantitative measurement
of total triiodothyronine (T3) in human serum or plasma (lithium heparin) using the ELFA technique (Enzyme Linked
Fluorescent Assay).

Summary and Explanation

Triiodothyronine (T3) is a hormone produced by thyroidal secretion (20%) and from the peripheral deiodination
mechanism which converts T4 to T3 (80%). As T3 is physiologically much more active than T4, it plays an important part
in maintaining euthyroidism.1,2
T3 circulates as a free hormone (0.3%) or bound to carrier proteins (> 99.7%) such as TBG (thyroxine binding globulin),
albumin or prealbumin. The free form is the physiologically active fraction which appears to have the most effect on
metabolism control.3,4
T3 determination must be associated with other tests such as TSH and T4 assay, as well as with the clinical examination
of the patient.5

Principle
The assay principle combines an enzyme immunoassay competition method with a final fluorescent detection (ELFA).
The single-use Solid Phase Receptacle (SPR) serves as the solid phase as well as the pipetting device. Reagents for the
assay are ready-to-use and pre-dispensed in the sealed single-use reagent strips.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the
SPR device several times.
The sample is taken and transferred into the well containing the T3 antigen labeled with alkaline phosphatase
(conjugate).
Competition occurs between the antigen present in the sample and the labeled antigen for the specific anti-T3 antibodies
coated on the interior of the SPR device.
Unbound components are eliminated during washing steps.
During the final detection step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR device.
The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the
fluorescence of which is measured at 450 nm.
The intensity of the fluorescence is inversely proportional to the concentration of antigen in the sample.
At the end of the assay, the results are automatically calculated by the instrument according to the calibration curve
stored in memory. The results can then be printed out.

Content of the Kit (60 tests)

60 Strips (T3) STR Ready-to-use.

60 SPR devices (T3) SPR Ready-to-use.
2 x 30 Interior of SPR devices coated with anti-T3 recombinant antibodies.

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S1 Calibrator (T3) S1 Ready-to-use.

1 x 1.4 mL (liquid) Human serum* + L-triiodothyronine + 1 g/L sodium azide.
MLE data indicate the concentration in nmol/L (“Calibrator (S1) Dose Value”)
and the confidence interval in "Relative Fluorescence Value” (“Calibrator (S1)
RFV Range”).
C1 Control (T3) C1 Ready-to-use.
1 x 1.1 mL (liquid) Human serum* + L-triiodothyronine + 1 g/L sodium azide.
MLE data indicate the confidence interval in nmol/L (“Control C1 Dose Value
Range”).
Specifications for the factory master data required to calibrate the assay: MLE (Master Lot Entry) barcode printed on
the box label.
1 package insert downloadable from www.biomerieux.com

* This product has been tested and shown to be negative for HBs antigen, antibodies to HIV1, HIV2 and HCV. However,
since no existing test method can totally guarantee their absence, this product must be treated as potentially infectious.
Therefore, usual safety procedures should be observed when handling.

The SPR device

The interior of the SPR device is coated during production with anti-T3 recombinant antibodies. Each SPR device is
identified by the T3 code.
Only remove the required number of SPR devices from the pouch and carefully reseal the pouch after opening.

The Reagent Strip

The strip consists of 10 wells covered with a labeled foil seal. The label comprises a barcode which mainly indicates the
assay code, kit lot number, and expiration date. The foil of the first well is perforated to facilitate the introduction of the
sample. The last well of each strip is a cuvette in which the fluorometric reading is performed. The wells in the center
section of the strip contain the various reagents required for the assay.

Description of the T3 strip

Well Reagents
1 Sample well.
2-3-4-5 Empty wells.
Conjugate: alkaline phosphatase labeled T3 derivative + ANS (0.95 mmol/L) + sodium
6
salicylate (11.9 mmol/L) + 1 g/L sodium azide (400 µL).
7-8-9 Wash buffer: Tris-Polysorbate 20-NaCl (1 mmol/L) pH 7.4 + 1 g/L sodium azide (600 µL).
Reading cuvette with substrate: 4-Methyl-umbelliferyl phosphate (0.6 mmol/L) + diethanolamine
10
(DEA*) (0.62 mol/L or 6.6%, pH 9.2) + 1 g/L sodium azide (300 μL).

* Signal word: DANGER

Hazard statements
• H318: Causes serious eye damage.
Precautionary statements
• P280: Wear protective gloves/protective clothing/eye protection/face protection.
• P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
For further information, consult the Safety Data Sheet.

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Materials and Disposables Required but Not Provided

• Pipette with disposable tip to dispense 100 µL.
• Powderless disposable gloves.
• For other specific materials and disposables, please refer to the Instrument User Manual.
• Instruments of the VIDAS® family.

Warnings and Precautions

• For in vitro diagnostic use only.
• For professional use only.
• This kit contains products of human origin. No known analysis method can totally guarantee the absence of
transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially
infectious and handled observing the usual safety precautions (see Laboratory Biosafety Manual - WHO -
Geneva - latest edition).
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does
not totally guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest; do
not inhale).
• Do not use the SPR devices if the pouch is pierced or if the dot sealing a SPR device has come unstuck.
• Do not use visibly deteriorated strips (damaged foil or plastic).
• Do not use reagents after the expiration date indicated on the box label.
• Do not mix reagents (or disposables) from different lots.
• Use powderless gloves, as powder has been reported to cause false results for certain enzyme immunoassay tests.
• Kit reagents contain sodium azide which can react with lead or copper plumbing to form explosive metal azides. If
any liquid containing sodium azide is disposed of in the plumbing system, drains should be flushed with water to
avoid build-up.
• The substrate in well 10 contains an irritant agent (diethanolamine). Refer to the hazard statements “H” and
precautionary statements “P” indicated above.
• Spills should be wiped up thoroughly after treatment with liquid detergent or a solution of household bleach
containing at least 0.5% sodium hypochlorite. See the User Manual for cleaning spills on or in the instrument. Do not
autoclave solutions containing bleach.
• The instrument should be regularly cleaned and decontaminated (refer to the User Manual for user and preventive
maintenance operations).

Storage Conditions
• Store the kit at +2°C/+8°C.
• Do not freeze reagents.
• Store all unused reagents at +2°C/+8°C.
• After opening the kit, check that the SPR pouch is correctly sealed and undamaged. If not, do not use the SPR
devices.
• After use, carefully reseal the pouch with the desiccant inside to maintain stability of the SPR devices, and
return the complete kit to +2°C/+8°C.
• If stored according to the recommended conditions, all components are stable until the expiration date indicated on
the box label.

Samples

Specimen type and collection

Serum or plasma (lithium heparin). Do not use tubes with EDTA.
None of the following factors have been found to significantly influence this assay:
• hemolysis (after spiking samples with hemoglobin: from 0 to 300 µmol/L (monomer)),
• lipemia (after spiking samples with lipids: from 0 to 2 g/L equivalent in triglycerides),

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• bilirubinemia (after spiking samples with bilirubin: from 0 to 320 µmol/L).

However, it is recommended not to use samples that are clearly hemolyzed, lipemic or icteric and, if possible, to collect a
new sample.
Sample stability
Samples can be stored at +2°C/+8°C in stoppered tubes for up to 48 hours. If longer storage is required, freeze the
serum or plasma at -31°C/-19°C.
A study performed on frozen samples over a period of 2 months, showed that the quality of results is not affected.
Avoid successive freezing and thawing.

Instructions for Use

For complete instructions, see the Instrument User Manual.
Reading VIDAS® PTC (Protocol Test Change) data and MLE data

When using the assay for the first time

With the external instrument barcode reader, scan the barcodes (PTC and MLE) in the following order:
1. According to the instrument used, scan the PTC barcode(s) downloadable from www.biomerieux.com. This reading
allows VIDAS® PTC protocol data to be transferred to the instrument software for its update.
2. Scan the MLE data on the box label.

When opening a new lot of reagents

With the external instrument barcode reader, scan the MLE data on the box label before performing the test. If this
operation is not performed before initiating the tests, the instrument will not be able to print results.
Note: The master lot data need only be entered once for each lot.
It is possible to enter MLE data manually or automatically depending on the instrument (refer to the User Manual).
Calibration
Calibration, using the calibrator provided in the kit, must be performed each time a new lot of reagents is opened, after
the MLE data have been entered, and then every 56 days.
This operation provides instrument-specific calibration curves and compensates for possible minor variations in assay
signal throughout the shelf life of the kit.
The calibrator, identified by S1, must be tested in triplicate.
The calibrator value must be within the set RFV (Relative Fluorescence Value) range. If this is not the case, recalibrate.
Procedure
1. Only remove the required reagents from the refrigerator and allow them to come to room temperature for at
least 30 minutes.
2. Use one "T3" strip and one "T3" SPR device for each sample, control or calibrator to be tested. Make sure the SPR
pouch has been carefully resealed after the required SPR devices have been removed.
3. The test is identified by the "T3" code on the instrument. The calibrator, identified by S1, must be tested in triplicate. If
the control is to be tested, it should be identified by "C1".
4. If necessary, clarify samples by centrifugation.
5. Mix the calibrator, control and samples using a vortex type mixer (for serum or plasma separated from the pellet).
6. For this test, the calibrator, control and sample test portion is 100 µL.
7. Insert the "T3" SPR devices and "T3" strips into the instrument. Check to make sure the color labels with the assay
code on the SPR devices and the Reagent Strips match.
8. Initiate the assay as directed in the User Manual. All the assay steps are performed automatically by the instrument.
9. Close the vials and return them to +2°C/+8°C after pipetting.
10. The assay will be completed within approximately 40 minutes. After the assay is completed, remove the SPR
devices and strips from the instrument.
11. Dispose of the used SPR devices and strips into an appropriate recipient.

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Results and Interpretation

Once the assay is completed, results are analyzed automatically by the computer. Fluorescence is measured twice in the
Reagent Strip’s reading cuvette for each sample tested. The first reading is a background reading of the substrate
cuvette before the SPR device is introduced into the substrate.
The second reading is taken after incubating the substrate with the enzyme bound to the interior of the SPR device.
The RFV (Relative Fluorescence Value) is calculated by subtracting the background reading from the final result. This
calculation appears on the result sheet.
Results are calculated automatically by the instrument in relation to the calibration curve stored in memory (4-parameter
logistic model) and are expressed in nmol/L.
Samples with a concentration greater than 9 nmol/L, may be diluted by 1/2 in C1 control or normal serum. The result will
be calculated taking into account the dilution factor and the concentration of C1 or normal serum used.
The results of a VIDAS® T3 assay must be interpreted as part of a complete clinical profile and in association with thyroid
function tests, including at least a TSH assay.

Quality Control
One control is included in this kit.
This control must be performed immediately after opening a new kit to ensure that reagent performance has not been
altered. Each calibration must also be checked using this control.
The instrument will only be able to check the control value if it is identified by C1.
Results cannot be validated if the control value deviates from the expected values.
Note: It is the responsibility of the user to perform Quality Control in accordance with any applicable local regulations.

Limitations of the Method

Interference may be encountered with certain sera containing antibodies directed against reagent components. For this
reason, assay results should be interpreted taking into consideration the patient's clinical history and the results of any
other tests performed.

Expected Values
These results are given as a guide. It is recommended that each laboratory establish its own reference interval from a
rigorously selected population.
As a guideline, 95% of values corresponding to 148 adults who are clinically or biologically euthyroid without any
associated serious illness are within the range: 0.92-2.33 nmol/L.

Performance
Studies performed using the VIDAS® T3 assay gave the following results:
Measurement range
The measurement range of the VIDAS® T3 assay is: 0.4-9 nmol/L.
Analytical detection limit
Defined as the smallest concentration of T3 which is significantly different from the zero concentration with a probability
of 95% < 0.4 nmol/L.
Precision
Within‑run reproducibility:
Five samples were tested 30 times in the same run.

Sample Mean concentration (nmol/L) CV (%)

1 0.68 11.0
2 1.80 5.3

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Sample Mean concentration (nmol/L) CV (%)

3 3.16 4.4
4 6.17 2.7
5 8.71 2.3

* CV: Coefficient of Variation

Between‑run reproducibility:
Five samples were tested singly in 29 different runs over a period of 8 weeks on the same VIDAS®.

Sample Mean concentration (nmol/L) CV (%)

1 0.76 12.4
2 1.93 5.7
3 3.34 4.2
4 5.84 2.8
5 6.42 3.2

Specificity
The specificity of anti-T3 antibody used in this kit is:
Tested compound Cross-reactivity %
L-Triiodothyronine 100
D-Triiodothyronine 100
L-Thyroxine 0.21
D-Thyroxine 0.04
Diido-L-thyronine 3.3
Monoiodotyrosine < 0.01
Diiodotyrosine < 0.01
Diphenylhydantoin < 0.01
Propylthiouracile < 0.01
Triiodothyroacetic acid 100
Triiodothyropropionic acid 100
Sodium salicylate < 0.01
Phenyl butazone < 0.01
Propionic acid 50

Accuracy
Dilution test:
Three samples were diluted in human serum containing normal T3 concentrations and tested singly in 3 runs. The ratio
of the mean concentration measured over the expected concentration is expressed as a mean recovery percentage.
Expected Measured Recovery percentage
Sample Dilution factor concentration (nmol/L) concentration (nmol/L) (%)
1:1 6.33 6.33 100
1:2 4.07 4.44 109
1
1:4 2.93 3.13 107
1:8 2.37 2.57 109

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Expected Measured Recovery percentage

Sample Dilution factor concentration (nmol/L) concentration (nmol/L) (%)
1:1 7.53 7.53 100
1:2 4.53 5.22 115
2
1:4 3.02 3.63 120
1:8 2.27 2.55 112
1:1 3.99 3.99 100
1:2 2.76 2.90 105
3
1:4 2.14 2.15 101
1:8 1.83 1.83 100

Comparison with other test methods

199 samples (heparined serum and plasma) were assayed in parallel using VIDAS® T3 (Y) and a radio-immunoassay kit
(X).
The allometric curve equation obtained is:
Y = 1.01 X + 0.35
r = 0.95 (n = 199)

Waste Disposal
Dispose of used or unused reagents, as well as any other contaminated disposable materials, following procedures for
infectious or potentially infectious products.
It is the responsibility of each laboratory to handle waste and effluents produced, according to their nature and degree of
hazardousness, and to treat and dispose of them (or have them treated and disposed of) in accordance with any
applicable regulations.

Literature References
1. BECKER C. Thyroid hormone synthesis and circulating thyroid hormones. In thyroid diseases, World federation of
nuclear medicine and biology. Ed; C. Beckers, Pergamon Press, 1982, 1-21.
2. RACADOT A. Biosynthèse des hormones thyroïdiennes. Aspects biochimiques. Immunoanal. Biol. Spéc., 1991, 30,
27-32.
3. BIERSACK H.J. and HOTZE A. The clinician and the thyroid. Eur. J. Nucl. Med., 1991, 18, 761-778.
4. EVERED D.C., TUNBRIDGE W.M.G., HALL R., APPLETON D., BREWIS M., CLARK F., MANUEL P., YOUNG E.
Thyroid hormone concentrations in a large scale community survey. Effect of age, sex, illness and medication. Clinica
Chimica Acta, 1978, 223-229.
5. P. CARAYON, P. NICCOLI-SIRE, P.-J. LEJEUNE, J. RUF, B. CONTE-DEVOLX. Recommandations de consensus sur
le diagnostic et la surveillance des maladies de la glande thyroïde. Annales de Biologie Clinique. 2002;60(3):331-8.

Index of Symbols

Symbol Meaning
Catalogue number

In Vitro Diagnostic Medical Device

Manufacturer

Temperature limit

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Symbol Meaning
Use by date

Batch code

Consult Instructions for Use

Contains sufficient for <n> tests

Date of manufacture

Limited Warranty
bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage,
storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for
use (IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any implied warranties of
merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or
consequential, for any use of the reagent, software, instrument and disposables (the "System") other than as set forth in
the IFU.

Revision History
Change type categories
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user

Note: Minor typographical, grammar, and formatting changes are not included in the revision
history.

Release Date Part Number Change Type Change Summary

Index of Symbols
Administrative Revision History

2015/01 07204I Content of the Kit (60 tests)

Technical change Warnings and Precautions
Instructions for Use
2018/08 07204J Administrative Limited Warranty
Principle
2019-05 07204K Technical change
Content of the Kit (60 tests)

2020-05 051943-03 Technical change Content of the Kit (60 tests)

Administrative Formatting and wording changes.
2020-09 051943-04 Technical change Content of the Kit (60 tests)
Calibration
2022-05 051943-05 Technical change Content of the Kit (60 tests)
Instructions for Use

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BIOMÉRIEUX, the BIOMÉRIEUX logo, SPR and VIDAS are used, pending, and/or registered trademarks belonging to
bioMérieux, or one of its subsidiaries or one of its companies
Any other name or trademark is the property of its respective owner.

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