BIOMÉRIEUX
30 448
VIDAS® TROPONIN I Ultra (TNIU)
VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS family instruments for the determination
of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent
Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in the diagnosis of myocardial infarction.
SUMMARY AND EXPLANATION
Troponin is a regulatory protein of the thin filament of
striated muscle, and consists of three subunits I, T and C,
which are implicated together in muscle contractions.
Troponin I has a cardiac isoform which enables highly
specific detection of myocardial injury. This isoform is
rapidly released after acute myocardial infarction (AMI)
th
and can be detected in blood between the 4 and 8 hour
th
th
after the onset of chest pain, with a peak between the 14
th
and 36 hour; concentrations in blood remain high for 3 to
7 days (1, 2, 3). Cardiac troponin is the biomarker of
choice for detection of myocardial necrosis as it is more
specific and sensitive than the classic cardiac
enzymes (4).
Due to the specificity of cardiac troponin I, its detection
can be interpreted even in patients with skeletal muscle
diseases (5).
The recommendations of the consensus committee of the
European Society for Cardiology (ESC) and the American
College of Cardiology (ACC) specify that the diagnosis of
myocardial necrosis can be made when the level of
th
cardiac troponin in the blood is greater than the 99
percentile of a healthy population, in the clinical setting of
acute ischemia. Acceptable imprecision (coefficient of
th
variation) at the 99 percentile for each assay should be
defined as 10% (4).
Patients presenting an acute coronary syndrome and high
concentrations of cardiac troponin I and/or CKMB, are
considered to be victims of myocardial infarction, whereas
the diagnosis of unstable angina will be made if the
concentrations of cardiac troponin I and CKMB are
situated in the reference range (6).
Several published guidelines agree that a single test for
troponin on arrival of the patient in the hospital is
insufficient (7). The collection of at least 3 blood samples
during the early triage period has been recommended (8).
Apart from its role in the diagnosis of AMI (9, 10, 11), the
determination of cardiac troponin I is useful for assessing
the effect of thrombolytic therapy and estimating the
extent of necrosis (12).
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For patients with acute coronary syndrome, Troponin is a
prognosis indicator and allows to stratify the risk of
cardiac events and mortality (13, 14).
In certain clinical contexts, myocardial cell injury leading
to an increased troponin concentration in the blood may
be observed (15).
The VIDAS Troponin I Ultra assay is an aid in the
diagnosis of myocardial infarction.
PRINCIPLE
The assay principle combines a one-step immunoassay
sandwich method with a final fluorescent detection
(ELFA).
®
The Solid Phase Receptacle (SPR ), serves as the solid
phase as well as the pipetting device for the assay.
Reagents for the assay are ready-to-use and pre-
dispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the
instrument. The sample is transferred into the wells
containing anti-cardiac troponin antibodies labeled with
alkaline phosphatase (conjugate). The sample/conjugate
mixture is cycled in and out of the SPR several times. This
operation enables the troponin I to bind with the
immunoglobulins fixed to the interior wall of the SPR and
the conjugate to form a sandwich. Unbound components
are eliminated during washing steps.
Two detection steps are then performed successively.
During each step, the substrate (4-Methyl-umbelliferyl
phosphate) is cycled in and out of the SPR. The conjugate
enzyme catalyzes the hydrolysis of this substrate into a
product (4-Methyl-umbelliferone) the fluorescence of
which is measured at 450 nm. The intensity of the
fluorescence is proportional to the concentration of
antigen present in the sample.
At the end of the assay, the results are automatically
calculated by the instrument in relation to two calibration
curves stored in memory corresponding to the two
detection steps. A fluorescence threshold value
determines the calibration curve to be used for each
sample. The results are then printed out.
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VIDAS Troponin I Ultra (TNIU) 13339 H - en - 2015/06

CONTENT OF THE KIT (60 tests) – RECONSTITUTION OF REAGENTS:

60 TNUI strips STR Ready-to-use.

60 TNIU SPRs SPR® Ready-to-use.

2 x 30 Interior of SPRs coated with mouse monoclonal anti-cardiac troponin I
immunoglobulins.
TNIU controls Reconstitute with 2 mL of distilled water. Let stand for 5 - 10 minutes then mix.
Control C1 C1 Stable after reconstitution for 8 hours at 2-8°C, or until the expiration date on the
2 x 2 mL (lyophilized) kit at - 25  6°C. 4 freeze/thaw cycles are possible.
Control C2 C2 Human serum* + troponin I + preservatives.
2 x 2 mL (lyophilized) MLE data indicate the confidence interval in µg/L ("Control C1 Dose Value Range"
or Control C2 Dose Value Range").
TNIU calibrators Reconstitute with 2 mL distilled water. Let stand for 5 - 10 minutes then mix.
Calibrator S1 S1 Stable after reconstitution for 8 hours at 2-8°C, or until the expiration date on the
2 x 2 mL (lyophilized) kit at - 25  6°C. 4 freeze/thaw cycles are possible.
Calibrator S2 S2 Human serum* + troponin I + preservatives.
2 x 2 mL (lyophilized) MLE data indicate the calibrator concentration in µg/L ("Calibrator (S1) Dose
Value" or "Calibrator (S2) Dose Value") and the confidence interval in "Relative
Fluorescence Value ("Calibrator (S1) RFV Range” or "Calibrator (S2) RFV
Range”).
TNIU diluent R1 Ready-to-use.
1 x 2 mL (liquid) Human serum* + preservative.
Specifications for the factory master data required to calibrate the test:
 MLE data (Master Lot Entry) provided in the kit
or
 MLE barcodes printed on the box label.
1 Package insert provided in the kit or downloadable from www.biomerieux.com/techlib
* 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 The strip

The interior of the SPR is coated during production with The strip consists of 10 wells covered with a labeled, foil
mouse monoclonal anti-cardiac troponin I seal. The label comprises a bar code which mainly
immunoglobulins. Each SPR is identified by the TNIU indicates the assay code, kit lot number and expiration
code. Only remove the required number of SPRs from the date. The foil of the first well is perforated to facilitate the
pouch and carefully reseal the pouch after opening. 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 TNIU strip
Wells Reagents
1 Sample well.
2-3-4 Empty wells.
5 Conjugate: alkaline phosphatase-labeled monoclonal anti-cardiac troponin (mouse) +
preservatives (400 µL).
6 -7 - 8 Wash buffer: Tris HCl pH 7.3 + preservative (600 µL).
9 Empty wells.
10 Reading cuvette with substrate: 4-Methyl-umbelliferyl phosphate (0.6 mmol/L) + diethanolamine*
(DEA) (0.62 mol/L or 6.6%, pH 9.2) + sodium azide (300 µL).

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.

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VIDAS Troponin I Ultra (TNIU)
Precautionary statement
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, refer to the Material Safety Data Sheet.
MATERIALS AND DISPOSABLES REQUIRED BUT
NOT PROVIDED
 Pipette with disposable tip to dispense 2 mL and 200 µL.
 Powderless, disposable gloves.
 For other specific materials and disposables, please
refer to the Instrument User’s Manual.
 VIDAS family instrument.
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 or inhale).
 Do not use the SPRs if the pouch is pierced.
 Do not use visibly deteriorated STRs (damaged foil or
plastic).
 Do not use reagents after the expiration date indicated
on the 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 the precautionary statements "P" above.
 Spills should be wiped up thoroughly after treatment
with liquid detergent and a solution of household bleach
containing at least 0.5% sodium hypochlorite. See the
User’s Manual for cleaning spills on or in the instrument.
Do not autoclave solutions containing bleach.
 The instrument should be regularly cleaned and
decontaminated (see the User’s Manual).
STORAGE CONDITIONS
 Store the VIDAS Troponin I Ultra kit at 2-8°C.
 Do not freeze the kit.
 Do not freeze reagents, with the exception of
calibrators and controls after reconstitution.
 Store all unused reagents at 2-8°C.
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 After opening the kit, check that the SPR pouch is
correctly sealed and undamaged. If not, do not use the
SPRs.
 Carefully reseal the pouch with the desiccant inside
after use to maintain stability of the SPRs and return
the complete kit to 2-8°C.
 If stored according to the recommended conditions, all
components are stable until the expiration date indicated
on the label. Refer to the kit composition table for
special storage conditions.
SPECIMENS
Specimen type and collection
Human serum or plasma (lithium heparin).
For a given patient, serial troponin testing must be
performed using the same type of sample tube.
Samples containing suspended fibrin particles or
erythrocyte stroma should be centrifuged before testing.
Sample preparation
 Plain tubes: wait for samples to coagulate and
centrifuge according to the tube manufacturer’s
recommendations to eliminate fibrin.
 Other tubes: follow the tube manufacturer’s
recommendations for use.
 Frozen-stored samples: after thawing, all these samples
must be clarified by centrifuging.
Note: Blood sampling tube results may vary from one
manufacturer to another depending on the materials and
additives use.
It is the responsibility of each laboratory to validate the
type of sample tube used and to follow the manufacturer’s
recommendations for use.
Sample stability
Samples separated from the clot can be stored at 2-8°C in
stoppered tubes for up to 48 hours after collection; if
longer storage is required, freeze the sera or plasma for
up to 4 months at < - 60°C. Avoid successive freezing and
thawing.
Sample-related interferences
None of the following factors have been found to
significantly influence this assay:
 hemolysis (after spiking samples with hemoglobin: up to
330 µmol/L (monomer) or 532 mg/dL),
 lipemia (after spiking samples with lipids: up to 30 g/L
equivalent in triglycerides),
 bilirubinemia (after spiking samples with bilirubin: up to
510 µmol/L or 29 mg/dL).
However, it is recommended not to use samples that are
clearly hemolyzed, lipemic or icteric and, if possible, to
collect a new sample.
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VIDAS Troponin I Ultra (TNIU)
INSTRUCTIONS FOR USE
For complete instructions, see the User’s Manual.
Reading VIDAS® Protocole Test Change (PTC)
protocol data and MLE data
When using the assay for the first time:
With the external instrument barcode reader,
1. Scan the PTC barcode(s) at the end of the package
insert. or downloadable from
www.biomerieux.com/techlib. 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.
Note: If the MLE data have been read before the
®
VIDAS PTC protocol, read the MLE data again.
When opening a new lot of reagents:
Enter the specifications (or factory master data) into the
instrument using the master lot entry (MLE) data.
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’s Manual).
Calibration
Calibration, using the two calibrators provided in the kit,
must be performed each time a new lot of reagents is
opened, after the master lot data have been entered, and
then every 28 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 calibrators, identified by S1 and S2, must be tested
in duplicate (see User’s Manual) in the same run. The
calibration values must be within the set RFV ("Relative
Fluorescence Value"). If this is not the case, recalibrate
using S1 and S2 as the mean will not be stored in
memory.
Procedure
1. Remove the required reagents from the refrigerator.
2. Use one "TNIU" strip and one "TNIU" SPR for each
sample, control or calibrator to be tested. Make sure
the storage pouch has been carefully resealed after
the required SPRs have been removed.
3. The test is identified by the "TNIU" code on the
instrument. The calibrators must be identified by "S1"
and “S2”, and tested in duplicate. If the controls need
to be tested, they should be identified by “C1” and
“C2”, and tested in simple.
4. Mix the calibrator and/or controls and/or samples
using a vortex-type mixer (for serum or plasma
separated from the pellet).
5. For this test, the calibrator, control, and sample
test portion is 200 µL.
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6. Insert the "TNIU" SPRs and "TNIU" strips into the
instrument. Check to make sure the color labels with
the assay code on the SPRs and the Reagent Strips
match.
7. Initiate the assay immediately. All the assay steps are
performed automatically by the instrument.
8. Reclose the vials and return them to the required
temperature after pipetting.
9. The assay will be completed within approximately
20 minutes. After the assay is completed, remove the
SPRs and strips from the instrument.
10. Dispose of the used SPRs and strips into an
appropriate recipient.
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 results are automatically calculated by the instrument
and the concentrations are expressed in µg/L (or ng/mL).
With VIDAS PC, if a result which is < 0.01 µg/L is
obtained, the printed report will include the alarm “J2 > J4
& J2 – J0 < RFV threshold” and **** will be indicated for
the RFV. This alarm, which is linked with the reading
mode of the VIDAS Troponin I Ultra technique (dual
reading), does not call into question the concentration
measured.
The VIDAS Troponin I Ultra assay is standardized against
the “Standard Reference Material 2921”.
Samples with cardiac troponin I concentrations > 30 µg/L
should be retested after being diluted 1/5 in the
VIDAS Troponin Ultra I kit diluent (1 volume of sample +
4 volumes of diluent).
If the dilution factor has not been entered when the Work
List was created (see User’s Manual), multiply the result
by the dilution factor to obtain the sample concentration.
QUALITY CONTROL
Two controls are included in each VIDAS Troponin I Ultra
kit. These controls 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 these controls. The instrument will only be able to
check the control values if they are identified by C1 and
C2.
Results cannot be validated if the control values deviate
from the expected values. Samples tested in the same run
must be reassayed.
Note
It is the responsibility of the user to perform Quality
Control in accordance with any local applicable
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 history,
and the results of any other tests performed.
Certain diseases, which are not connected with
myocardial ischemia, may be accompanied by an
increase in the troponin concentration (amyloidosis,
cardiac trauma, pericarditis, sepsis, etc.) (16).
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VIDAS Troponin I Ultra (TNIU) 13339 H - en - 2015/06

RANGE OF EXPECTED VALUES

These figures are given as a guide; it is recommended that each laboratory establishes its own reference values from a
rigorously selected population.
For VIDAS Troponin I Ultra, the 99th percentile value was obtained using 747 heparinized plasmas from subjects
(308 men and 439 women aged 20-81 years) with no cardiac symptoms. This value was < 0.01 µg/L.
In 2000, the consensus committee of the European Society for Cardiology (ESC) and the American College of
Cardiology (ACC) recommended that the diagnosis of myocardial necrosis be made when the level of cardiac troponin is
th
greater than the 99 percentile of a reference control group with imprecision < 10%.
The imprecision study was performed using 6 plasma pools tested in duplicate in 20 different runs (2 runs per day) with
2 reagent lots at 3 sites (per pool n= 240). The smallest measurable concentration of troponin I, with an inter-lot
coefficient of variation < 10%, is 0.11 µg/L. No significant difference was observed for this concentration between plasma
and serum specimens.
Any cardiac troponin I values lower than the reference value, combined with a negative ECG and chest pain lasting less
than 6 hours, must be confirmed by a second specimen 6 hours later, in order to rule out the diagnosis of AMI (4).
Interpretation of test results should be made taking into consideration the patient’s history, and the results of any other
tests performed.

PERFORMANCE
Studies performed using VIDAS Troponin I Ultra gave the following results:
Measurement range
The measurement values of the VIDAS Troponin I Ultra kit range from 0.01 to 30 µg/L.
Analytical detection limit
The analytical detection limit, defined as the smallest concentration of cardiac troponin I which is significantly different
from the zero concentration with a probability of 95%, is < 0.01 µg/L.
Hook effect
No hook effect was found up to cardiac troponin I concentrations of 1 000 µg/L.
Precision
Four samples were tested in duplicate in 20 different runs (2 runs per day) with 2 reagent lots at 3 sites (n=240).
The repeatability (intra-run precision), inter-lot reproducibility and inter-site reproducibility were calculated using this
protocol, based on the recommendations of CLSI/NCCLS document EP5-A2:
Repeatability Inter-lot reproducibility Inter-site reproducibility
Sample Mean Standard CV (%) Standard CV (%) Standard CV (%)
concentration deviation deviation deviation
µg/L
Sample 1 0.58 0.007 1.28 0.020 3.44 0.022 3.74
Sample 2 3.55 0.055 1.56 0.122 3.44 0.149 4.19
Sample 3 6.66 0.126 1.90 0.275 4.13 0.281 4.22
Sample 4 17.05 0.460 2.70 1.127 6.61 1.340 7.86

Specificity
Tested compound Tested concentration Cross-reactivity %
Skeletal Troponin I 1000 µg/L < 0.001
Cardiac Troponin C 1000 µg/L < 0.001
Cardiac Troponin T 1000 µg/L 0.2
Skeletal Troponin T 1000 µg/L < 0.001

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Drug interference
The following drugs were tested by spiking a 2.3 µg/L mean concentration serum pool. No interference was encountered
as the concentrations obtained did not vary significantly.
Drug Tested Drug Tested
concentration concentration
Ascorbic acid 30 mg/L Digoxin 5 µg/L
Salicylic acid 500 mg/L Erythromycin 200 mg/L
Uric acid 200 mg/L Ethanol 3500 mg/L
Human albumin 60 mg/mL Gentamicin sulphate 120 mg/L
Amikacin 150 mg/L L-thyroxine 60 µg/L
Amoxicillin trihydrate 11 mg/mL Nicotine 20 mg/L
Ampicillin 50 mg/L Penicillin G 25 U/mL
Cephalexin 2 mg/mL Pristinamycin 100 mg/L
Chloramphenicol 250 mg/L Rifampicin 1 mg/mL
Lithium chloride 35 mg/L Streptomycin 4 mg/mL
Clindamycin HCl 2 mg/mL Urea 200 mg/L
Creatinine 300 mg/L

Linearity
Dilution test
4 heparinized plasmas with a titer > 30 µg/L were diluted up to 1/10 using the kit diluent. Each dilution was tested singly
in 3 runs.
The kit linearity was studied according to a procedure taken from the NCCLS guideline EP6-A. The kit is linear over the
measurement range considered.
Comparison with another test method
534 samples tested using the VIDAS Troponin I Ultra (Y) method were compared with a rival automated immunoenzyme
assay technique (X). The results obtained are indicated below (Passing & Bablok curve and correlation coefficient). The
equation represents the trend of the relation between the 2 techniques:
Y = 0.42 X
Confidence interval for the slope: 0.38 – 0.44
Correlation coefficient: 0.97
Due to the various circulating forms of cardiac troponin I, the difference in immunoreactivity linked with the antibodies
used, and the standardization, troponin I concentrations in a sample determined using reagents from different
manufacturers, may vary.

AID IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION: CLINICAL SENSITIVITY AND SPECIFICITY

A clinical study performed at two sites (France and USA) enabled the diagnostic performance of VIDAS Troponin I Ultra
to be determined.
For 16 weeks, assays were performed using 998 samples from patients admitted to the emergency department with
chest pain and suspected myocardial infarction. These samples were collected from the patients within 6 hours following
their admission, and then between 4 and 12 hours after the first collection:
- within 0-6 hours after admission, out of the 545 patients concerned, 152 were diagnosed as having myocardial
infarction (according to the definitions of the consensus committee).
- within 4-12 hours after the first sample collection, out of the 453 patients concerned, 113 were diagnosed as having
myocardial infarction.
The clinical sensitivity and specificity of VIDAS Troponin I Ultra for a sample collected at the time of admission and the
one subsequently collected, are presented in the tables below:
Clinical sensitivity and specificity: decisional cut-off with a 10% CV (0.11 µg/L)
Times 0-6 hours after admission 4-12 hours after first collection
Samples (n) 545 453
Sensitivity % 76.32 98.23
95% Confidence interval 68.80 - 82.48 93.64 - 99.52
Specificity % 94.40 95.29
95% Confidence interval 91.60 - 96.31 92.42 - 97.11

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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.
14. GALVANI M., OTTANI F., FERRININI D., et al. Prognostic
influence of elevated values of cardiac troponin I in patients
with unstable angina. Circulation 1997 ; 95: 2053-2059.
15. JAFFE A.S. Elevations in cardiac troponin measurements:
false false-positives: the real truth. Cardiovasc Toxicol. 2001;
1(2): 87-92.
16. PANTEGHINI et al. Role and importance of biochemical
markers in clinical cardiology European heart Journal, 2004,
25(14) 1187-1196.

LITERATURE REFERENCES INDEX OF SYMBOLS

1. APPLE FS, Cardiac Troponin I in: Wu AHB Pathology and Symbol Meaning
Laboratory medicine: Cardiac Markers, humana Press Inc.
ed, Totowa, NJ (07/1998).
Catalogue number
2. CHRISTENSON R.H., AZZAZY H.M.E. Biochemical markers
of the acute coronary syndromes. Clin Chem 1998 ; 44:
1855-1864. In Vitro Diagnostic Medical Device
3. WU AHB, et al. Characterization of cardiac troponin subunit
release into serum after acute myocardial infarction and
comparison of assays for troponin T and I. Clin Chem 1998 ; Manufacturer
44: 1198-1208.
4. THE JOINT EUROPEAN SOCIETY OF CARDIOLOGY
/AMERICAN COLLEGE OF CARDIOLOGY COMMITTEE. Temperature limit
Myocardial Infarction Redefined – A consensus Document of
the The joint European Society of Cardiology/American
College of Cardiology Committee for the redefinition of Use by date
Myocardial Infarction. JACC 2000, 36(3),: 959-69.
5. BODOR GS, et al. Cardiac Troponin-I is not expressed in Batch code
fetal and healthy or decreased adult human skeletal muscle
tissue. Clin Chem 1995 ; 41: 1710-1715.
Consult Instructions for Use
6. APPLE FS, WU AHB. Myocardial infarction redefined: Role
of cardiac troponin Testing. Clin Chem 2001, 47: 377-379.
Contains sufficient for <n> tests
7. HAMM CW, et al., Acute coronary syndrome without ST
elevation: implementation of new guidelines. The Lancet 358,
November 3, 2001. 1533-1538.
Date of manufacture
8. WU AHB, et al., National Academy of Clinical Biochemistry
Standards of Laboratory Practice: recommendations for the
Use of Cardiac Markers in Coronary Artery Diseases. Clin
Chem, 1999, 45: 1104-1121. WARRANTY
9. ADAMS J.E., et al. Cardiac troponin I. A Marker with high bioMérieux disclaims all warranties, express or implied,
specificity for cardiac injury. Circulation. 1993 ; 88:101-106. including any implied warranties of MERCHANTABILITY
10. CHAPELLE JP. Cardiac troponin I and troponin T: Recent AND FITNESS FOR A PARTICULAR USE. bioMérieux
players in the field of Myocardial Markers. Clin Chem Lab shall not be liable for any incidental or consequential
Med 1999 ; 37: 11-20. damages. IN NO EVENT SHALL BIOMERIEUX’S
11. PANTEGHINI M et al., The sensitivity of cardiac markers: an LIABLITY TO CUSTOMER UNDER ANY CLAIM
evidence-based approach. Clin Chem Lab Med, 1999 ; 37, EXCEED A REFUND OF THE AMOUNT PAID TO
1097-1106. BIOMERIEUX FOR THE PRODUCT OR SERVICE
12. APPLE FS, et al. Early monitoring of serum cardiac troponin I WHICH IS THE SUBJECT OF THE CLAIM.
for assessment of coronary reperfusion following thrombolitic
therapy. Am J Clin Pathol 1996 ; 105: 6-10.
13. ANTMAN E.M., et al. Cardiac-specific troponin I levels to
predict the risk of mortality in patients with acute coronary
syndromes. N.Engl.J.Med.1996 ; 335:1342-1349.

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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
Minor typographical, grammar, and formatting changes are not included in the
revision history.
Release
Part Number Change Type Change Summary
date
INDEX OF SYMBOLS
Administrative
REVISION HISTORY
2015/01 13339G CONTENT OF THE KIT (60 tests) –
Technical RECONSTITUTION OF REAGENTS
WARNINGS AND PRECAUTIONS
CONTENT OF THE KIT (60 tests) –
2015/06 13339H Technical RECONSTITUTION OF REAGENTS
INSTRUCTIONS FOR USE

BIOMERIEUX, the BIOMERIEUX 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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