MAGLUMI FT3 (CLIA)

INTENDED USE
The kit has been designed for the quantitative determination of
130203005M 100 Free Triiodothyronine (FT3) in human serum.
The method can be used for samples over the range of 0-50 pg/ml.
The test has to be performed on the MAGLUMI
chemiluminescence immunoassay (CLIA) fully auto analyzer
(Including MAGLUMI 1000, MAGLUMI 2000, MAGLUMI 2000
Plus and new developed models).
Shenzhen New Industries Lotus Global Co., Ltd
Biomedical Engineering Co., Ltd 15 Alexandra Road SUMMARY AND EXPLANATION OF THE TEST
4F,Wearnes Tech Bldg, London In healthy subject, the thyroid secretes approx. 5-10 μg
Science & Industry Park, NW8 0DP triiodothyronine per day. Circulating T3 is, however, for the most
Nanshan,Shenzhen,518057CHINA UK part produced by peripheral deiodination so that the overall daily
Tel. + 86-755-86028224 Tel. + 44-20-75868010 secretion rate of total T3 amounts to approx. 20ug. In serum, the
Fax.+ 86-755-26654850 Fax.+ 44-20-79006187 thyroid hormones are bound to carrier proteins, and only their free
fraction is physiologically active.
Both total T3 and Free Triiodothyronin (FT3) are good biochemical
indicators of the severity of thyrotoxicity in hyperthyroidism. The
advantage of FT3 compared with T3 is that the assay should
FOR PROFESSIONAL USE ONLY correct for alterations in the T3-binding proteins. The major clinical
Store at 2...8 °C significance for FT3 (orT3) measurements is for the identification
of patients with thyrotoxicosis whose T4 and FT4 concentrations
COMPLETELY READ THE INSTRUCTIONS BEFORE are normal, while T3 titres are elevated. Determination of FT3 is
PROCEEDING also useful to identify patients with subclinical hyperthyroidism who
have suppressed serum TSH and normal FT4 and FT3 levels.
Pregnancy or the use of oral contraceptives or estrogens may
increase total T3 levels, while concentrations of free T3 remain
SYMBOLS EXPLANATIONS basically unchanged.

Authorized Representative in Europe PRINCIPLE OF THE TEST

Competitive immunoluminometric assay:
Manufacturer Use an anti-T3 monoclonal antibody to label ABEI, and use a
purified T3 antigen to label FITC. Sample, Calibrator or Control
with ABEI Label, FITC Label and nano magnetic microbeads
Attention. See Instructions For Use coated with sheep anti-FITC are mixed thoroughly and incubated
at 37℃, forming antibody-antigen complexes; after sediment in a
magnetic field, decant the supernatant, then cycle washing it for 1
Contents of kit
time. Subsequently, the starter reagents are added and a flash
chemiluminescent reaction is initiated. The light signal is measured
In vitro diagnostic medical device by a photomultiplier as RLU within 3 seconds and is proportional to
(In vitro diagnostic use)
the concentration of FT3 present in controls or samples.

Lot number

KIT COMPONENTS
Catalogue Code
Material Supplies
Nano magnetic microbeads: TRIS buffer,
1.2% (W/V), 0.2%NaN3, coated with sheep 2.5ml
Expiry date (Use by…)
anti- FITC polyclonal antibody.
Calibrator Low : bovine serum, 0.2%NaN3 2.5ml
Calibrator High : bovine serum, 0.2%NaN3 2.5ml
Temperature limitation FITC Label: purified T3 antigen labeled FITC,
( store at 2...8 °C) 6.5ml
containing BSA, 0.2%NaN3.
ABEI Label: anti-T3 monoclonal antibody
6.5ml
Number of tests labeled ABEI, containing BSA, 0.2% NaN3.
All reagents are provided ready-to-use.

Reagent Vials in kit box

Keep away from sunlight
Internal Quality Control: containing BSA,
0.2%NaN3. (target value refer to Quality 2.0ml
Control Information date sheet)
Keep upright

Accessories Required But Not Provided

MAGLUMI Reaction Module REF: 630003

003120607-v1.0-EN 1/4
 MAGLUMI Starter 1+2 REF: 130299004M (c) Obvious microbial contamination.
MAGLUMI Wash Concentrate REF: 130299005M • Use caution when handling patient specimens to prevent cross
MAGLUMI Light Check REF: 130299006M contamination. Use of disposable pipettes or pipette tips is
recommended.
• Inspect all samples for bubbles. Remove bubbles with an
applicator stick prior to analysis. Use a new applicator stick for
each sample to prevent cross contamination.
Preparation of the Reagent Integral
• Serum specimens should be free of fibrin, red blood cells or
Before the sealing is removed, gentle and careful horizontal
other particulate matter.
shaking of the Reagent Integral is essential (avoid foam formation!)
• Ensure that complete clot formation in serum specimens has
Remove the sealing and turn the small wheel of the magnetic
taken place prior to centrifugation. Some specimens,
microbeads compartment to and fro, until the colour of the
especially those from patients receiving anticoagulant or
suspension has changed into brown. Place the Integral into the
thrombolytic therapy, may exhibit increased clotting time. If the
reagent area and let it stand there for 30 min. During this time, the
specimen is centrifuged before a complete clot forms, the
magnetic microbeads are automatically agitated and completely
presence of fibrin may cause erroneous results.
resuspended.
Do not interchange integral component from different
Preparation for Analysis
reagents or lots!
• Patient specimens with a cloudy or turbid appearance must be
centrifuged prior to testing. Following centrifugation, avoid the
Storage and Stability
lipid layer (if present) when pipetting the specimen into a
 Sealed: Stored at 2-8 ℃ until the expiry date.
sample cup or secondary tube.
 Opened: Stable for 4 weeks. To ensure the best kit performance,
• Specimens must be mixed thoroughly after thawing by low
it is recommended to place opened kits in the refrigerator if it’s not
speed vortexing or by gently inverting, and centrifuged prior to
going to be used on board during the next 12 hours.
use to remove red blood cells or particulate matter to ensure
consistency in the results. Multiple freeze-thaw cycles of
specimens should be avoided.
 Keep upright for storage. • All samples (patient specimens or controls) should be tested
within 3 hours of being placed on board the MAGLUMI
System. Refer to the SNIBE service for a more detailed
 Keep away from direct sunlight. discussion of onboard sample storage constraints.

CALIBRATION AND TRACEABILITY Storage

1) Traceability • If testing will be delayed for more than 8 hours, remove serum
To perform an accurate calibration, we have provided the test or plasma from the serum or plasma separator, red blood cells
calibrators check by ID-GC/MS (isotope dilution gas or clot. Specimens removed from the separator gel, cells or
chromatography mass spectrometry) on various control materials. clot may be stored up to 24 hours at 2-8°C.
• Specimens can be stored up to 30 days frozen at -20°C or
2) 2-Point Recalibration colder.
Via the measurement of calibrators, the predefined master curve is
adjusted (recalibrated) to a new, instrument-specific measurement Shipping
level with each calibration. • Before shipping specimens, it is recommended that specimens
be removed from the serum or plasma separator, red blood
3) Frequency of Recalibration cells or clot. When shipped, specimens must be packaged
 After each exchange of lot (Reagent Integral or Starter and labeled in compliance with applicable state, federal and
Reagents). international regulations covering the transport of clinical
 Every week and/or each time a new Integral is used specimens and infectious substances. Specimens must be
(recommendation). shipped frozen (dry ice). Do not exceed the storage time
 After each servicing of the MAGLUMI Fully Auto analyzer. limitations identified in this section of the package insert.
 If controls are beyond the expected range.

WARNING AND PRECAUTIONS FOR USERS

SPECIMEN COLLECTION AND PREPARATION
Sample material: serum
Collect samples using standard procedures.  For use in IN-VITRO diagnostic procedures only.
Store at 2-8 ℃: 24 hours,

for longer
Package storage
insert periods:must
instructions freeze
be tocarefully followed.
below - 20 ℃ Reliability of assay results cannot be guaranteed if there are
Avoid repeated freezing and thawing cycles, stored samples any deviations from the instructions in this package insert.
should be thoroughly mixed prior to use (Vortex mixer).
Please ask local representative of SNIBE for more details if you Safety Precautions
have any doubt. CAUTION: This product requires the handling of human
specimens.
Vacuum Tubes  The calibrators in this kit are prepared from bovine serum
(a) Blank tubes are recommended type for collecting samples. products. However, because no test method can offer
(b) Please ask SNIBE for advice if special additive must be used in complete assurance that HIV, Hepatitis B Virus or other
sample collecting. infectious agents are absent; these reagents should be
considered a potential biohazard and handled with the same
Specimen Conditions precautions as applied to any serum or plasma specimen.
• Do not use specimens with the following conditions:  All samples, biological reagents and materials used in the
(a) heat-inactivated specimens; assay must be considered potentially able to transmit
(b) Cadaver specimens or body fluids other than human serum; infectious agents. They should therefore be disposed of in
003120607-v1.0-EN 2/4
 accordance with the prevailing regulations and guidelines of range.
the agencies holding jurisdiction over the laboratory, and the
regulations of each country. Disposable materials must be LIMITATIONS OF THE PROCEDURE
incinerated; liquid waste must be decontaminated with
1) Limitations
sodium hypochlorite at a final concentration of 5% for at
Severe non-thyroidal conditions (e.g. expressed as low T3
least half an hour. Any materials to be reused must be
syndrome) as well as medication with certain drugs (e.g.
autoclaved using an overkill approach (USP 24, 2000,
glucocorticoids) can lead to decreased FT3 values.
p.2143). A minimum of one hour at 121 ℃ is usually
Serum FT3 levels alone give no evidence of the presence or
considered adequate, though the users must check the
absence of thyroid disease. They must always be interpreted in
effectiveness of their decontamination cycle by initially
context with the clinical picture and other diagnostic procedures
validating it and routinely using biological indicators.
 It is recommended that all human sourced materials be
2) Interfering Substances
considered potentially infectious and handled in accordance
No interference with test results is seen by concentrations of
with the OSHA Standard on Bloodborne Pathogens 13.
bilirubin<0.125mg/ml, haemoglobin<16mg/dl or triglycerides<
Biosafety Level 214 or other appropriate biosafety practices
12.5mg/ml.
should be used for materials that contain or are suspected
.
of containing infectious agents.
3) HAMA
 This product contains Sodium Azide; this material and its
Patient samples containing human anti-mouse antibodies (HAMA)
container must be disposed of in a safe way.
may give falsely elevated or decreased values. Although
 Safety data sheets are available on request.
HAMA-neutralizing agents are added, extremely high HAMA
serum concentrations may occasionally influence results.
Handling Precautions
• Do not use reagent kits beyond the expiration date.
RESULTS
• Do not mix reagents from different reagent kits.
1) Calculation of Results
• Prior to loading the Reagent Kit on the system for the first time,
 The analyzer automatically calculates the FT3 concentration
the microbeads requires mixing to resuspend microbeads that
in each sample by means of a calibration curve which is
have settled during shipment.
generated by a 2-point calibration master curve procedure.
• For microbeads mixing instructions, refer to the KIT
The results are expressed in pg/ml. For further information
COMPONENTS, Preparation of the Reagent Integral section
please refer to the MAGLUMI Chemiluminescence Analyzer
of this package insert.
Operating Instructions.
• To avoid contamination, wear clean gloves when operating
 Conversion factor: 1 pg /ml = 1.54 pmol/L
with a reagent kit and sample.
• Over time, residual liquids may dry on the kit surface, please
2) Interpretation of Results
pay attention the silicon film still exists on the surface of the kit.
 Results of study in clinical centers with group of individuals,
• For a detailed discussion of handling precautions during
95% of the results were: 1.21-4.18 pg/ml.
system operation, refer to the SNIBE service information.
 Results may differ between laboratories due to variations in

population and test method. If necessary, each laboratory

TEST PROCEDURE
should establish its own reference range.
To ensure proper test performance, strictly adhere to the operating
instructions of the MAGLUMI Fully Auto analyzer. Each test
PERFORMANCE CHARACTERISTICS
parameter is identified via a RFID tag on the Reagent Integral. For
1) Precision
further information please refer to the MAGLUMI
Intra-assay coefficient of variation was evaluated on 3 different
Chemiluminescence Analyzer Operating Instructions.
levels of control serum repeatedly measured 20 times in the same
40μl Sample, calibrator or controls
run, calculating the coefficient of variation.
+40μl ABEI label
+40μl FITC label Intra-assay precision
+20μl Nano magnetic microbeads Control Mean(pg/ml) SD(pg/ml) CV%
Level 1 7.29 0.40 5.49%
15 min Incubation Level 2 9.01 0.63 6.99%
400μl Cycle washing Level 3 12.51 0.55 4.43%
3 s Measurement Inter-assay coefficient of variation was evaluated on three batches
of kits. Repeatedly measured 3 different levels of control serum 21
times, calculating the coefficient of variation.
DILUTION
Inter-assay precision
Sample dilution by analyzer is not available in this reagent kit.
Control Mean(pg/ml) SD(pg/ml) CV%
Samples with concentrations above the measuring range can be Level 1 5.10 0.45 8.83%
diluted manually. After manual dilution, multiply the result by the Level 2 8.32 0.78 8.79%
dilution factor. Level 3 11.82 1.09 9.22%
Please choose applicable diluents or ask SNIBE for advice before
manual dilution must be processed. 2) Analytical Sensitivity
The sensitivity is defined as the concentration of FT3 equivalent to
the mean RLU of 20 replicates of the zero standard plus two
QUALITY CONTROL
standard deviations corresponding to the concentration from the
 Observe quality control guidelines for medical laboratories.
standard curve. The sensitivity is typically less than 0.38 pg/ml.
 Use suitable controls for in-house quality control. Controls
should be run at least once every 24 hours when the test is in
3) Specificity
use, once per reagent kit and after every calibration. The
The specificity of the FT3 assay system was assessed by
control intervals should be adapted to each laboratory’s
measuring the apparent response of the assay to various
individual requirements. Values obtained should fall within the
potentially cross reactive analytes.
defined ranges. Each laboratory should establish guidelines
for corrective measures to be taken if values fall outside the Compound Concentration Cross reactivity

003120607-v1.0-EN 3/4
T4 300 ng/ml 0.3%
rT3 100 ng/ml 0.2%

4) Recovery
Consider calibrator high of known concentration as a sample,
dilute it by 1:2 ratio with diluents, and measure its diluted
concentration for 10 times. Then calculate the recovery of
measured concentration and expected concentration. The
recovery should be within 90% -110%.
Expected Mean Measuring Recovery
32.256 pg/ml 32.826 pg/ml 102%

5) Linearity
Use FT3 calibrator to prepare the six-point standard curve,
measuring all points’ RLU except point A, and then do
four-parameter linear fitting in double logarithm coordinate, the
absolute linear correlation coefficient(r) should be bigger than
0.9800.
Calibrator Concentration Absolute linear
Point pg/ml correlation coefficient (r)
A 0 r=0.9885
B 1.5
C 4.5
D 9.0
E 18
F 36

6) Method comparison
A comparison of MAGLUMI FT3(y) with a commercially available
FT3(x) using clinical samples gave the following
correlations(pg/ml):
Linear regression
y=0.95x+5.6
r=0.956
Sy.x=12.3

Number of samples measured:200

The sample concentrations were between 0.91-45.2pg/ml

REFERENCES
1. Kaplan MM. Assessment of Thyroid Function During
Pregnancy. Thyroid 1992;2(2):57-61.
2. Keffer JH. Preanalytical considerations in testing thyroid
function. Clin. Chem 1996: 42(1): 125-134.
3. Klee GG. Clinical usage recommendations and analytic
performance goals for total and free triiodothyronie
measurements. Clin Chem 1996: 41 (1): 155-159.
4. Lindstedt G, Berg G., Jansson S,Torring O, Valdemarsson S,
Warin B, Nystrom E. Clinical Use of Laboratory Thyroid Tests
end lnvestigations. JIFCC 1994: 6 (4): 136-141.
5. Piketty ML, D'Herbomez M, Le Guillouzic D. Lebtahi R. Cosson
E, Dumont A. Dilouya A.Helal BO. Clinical comparison of three
labeled-antibody immunoassays of free triiodothyronie. Clin
Chem 1996:42 (6): 933-941.
6. White GH. Recent Advances in Routine Thyroid Function
Testing. CRC Critical Reviews of Clinical Laboratory Sciences
1997: 24 (4): 315- 362.
7. Pagana, K. D. & Pagana, T. J. (© 2011). Mosby's Diagnostic
and Laboratory Test Reference 10th Edition: Mosby, Inc., Saint
Louis, MO. Pp 976-977.
8. Thomas, Clayton L., Editor (1997). Taber's Cyclopedic Medical
Dictionary. F.A. Davis Company, Philadelphia, PA [18th
Edition].

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