30 421-01

13765 D - en - 2015/06

VIDAS Creatine Kinase MB (CK-MB)

The VIDAS Creatine Kinase MB (CKMB) Assay is intended for use on the instruments of the VIDAS family (Vitek
ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the
quantitative determination of creatine kinase MB isoenzyme concentration in human serum or plasma (heparin or
EDTA). It is intended for use as an aid in the diagnosis of acute myocardial infarctions.
SUMMARY AND EXPLANATION OF THE TEST
A pipette tip-like disposable device, the Solid Phase
(SPR ), serves as a solid phase for the assay
Creatine kinase is a key enzyme of muscle metabolism.Receptacle
It
as
well
as
a pipetting device. The SPR is coated at the
is present in all tissues, but in variable concentrations and
time
of
manufacture
with mouse monoclonal anti-Creatine
in different isoforms (CKMM, CKMB, and CKBB)(1). In
MB antibodies. The VIDAS Creatine Kinase MB
skeletal muscle creatine kinase is essentially found in Kinase
the
assay configuration prevents nonspecific
MM isoform (1). The BB isoform is found predominantly(CKMB)
in
reactions
with the SPR. Reagents for the assay are
the brain, and the MB form is found principally in the
located in the sealed Reagent Strips. A prewash step
heart
prepares the SPR for the reaction then the sample is
tissue
(1,2). In the
absenceCKMB
of anyconcentration
major muscularsignals
trauma
an
elevation
of serum
transferred into the well containing the sample
necrotic injury to the heart occurring in consequence to
diluent.
a
The sample/sample diluent mixture is cycled in and out of
myocardial
detectable
hours
after infarction.
the onsetGenerally
of chest CKMB
painsisand
peak five
the CKMB
will bindunbound
to antibodies
coated
on
the SPR
SPR. and
Wash
steps remove
material.
The
concentrations are often reached eleven to eighteen
conjugate is then cycled in and out of the SPR. This step
hours after the infarction (3,4). There exists however, a
allows the conjugate to attach to the CKMB already fixed
certain number of other conditions, pathological or not, in
to the SPR: thus forming a "sandwich". Wash steps
which an elevation of CKMB can be observed, such as
remove unbound conjugate.
Duchennes muscular dystrophy, muscular hyperactivity,
A fluorescent substrate, 4-methylumbelliferyl phosphate,
hypo and hyperthermia, and myocarditis (2).
is cycled through the SPR. Enzyme remaining on the SPR
wall will catalyze the conversion of the substrate to the
PRINCIPLE OF THE PROCEDURE
fluorescent product 4-methylumbelliferone. The intensity
The VIDAS Creatine Kinase MB (CKMB) assay is anof fluorescence is measured by the optical scanner in the
enzyme-linked fluorescent immunoassay (ELFA) that instrument;
is
it is proportional to the Creatine Kinase MB
performed in an automated instrument. All assay steps
concentration present in the sample.
and assay temperature are controlled by the instrument.
When the VIDAS Creatine Kinase MB (CKMB) Assay is
completed, the results are analyzed automatically by the
instrument, and a report is printed for each sample.
KIT COMPOSITION (30 TESTS):
30 CKMB Reagent
STR
Ready-to-use.
Strips
30 CKMB SPRs
(1 x 30)
CKMB Control
1 x 3 ml (lyophilized)

CKMB Calibrator
1 x 3 ml (lyophilized)

SPR

Ready-to-use. SPRs coated with mouse monoclonal anti-Creatine Kinase MB

antibodies.

C1

Reconstitute with 3 ml of CKMB reconstitution solvent. Wait 10 to 15 minutes. Mix.

Stable after reconstitution for 24 hours at 2-8C. In aliquots and frozen at
25 6C, stable until the expiration date on kit. Five freeze/thaw cycles are
possible. Protein base (BSA) + chemical stabilizers + human CKMB. MLE data
indicate the confidence interval in ng/mL ("Control C1 Dose Value Range").

S1

Reconstitute with 3 ml of CKMB reconstitution solvent. Wait 10 to 15 minutes. Mix.

Stable after reconstitution for 24 hours at 2-8C. In aliquots and frozen at
25 6C, stable until the expiration date on kit. Five freeze/thaw cycles are
possible. Protein base (BSA) + chemical stabilizers + human CKMB.
MLE data indicate the calibrator titer in ng/mL ("Calibrator (S1) Dose Value") and
the confidence interval in "Relative Fluorescence Value ("Calibrator (S1) RFV
Range").

R1
CKMB Reconstitution
Ready-to-use. H O with 1 g/L sodium azide.
solvent 1 x 20 ml
2
(liquid)
Specifications for the factory master data required to calibrate the
test:
MLE data (Master Lot Entry) provided in the kit,
MLE bar codes printed on the box label.
or
1 Package Insert provided in the kit or downloadable from www.biomerieux.com/techlib.

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

The SPR

The strip

The SPR is coated during production with monoclonal

The strip consists of 10 wells covered with a labeled, foil
anti-CK-MB immunoglobulins (mouse). Each SPR is
seal. The label comprises a bar code which mainly
identified by the "CKMB" code. Only remove the required
indicates the assay code, kit lot number and expiration
number of SPRs from the pouch and carefully reseal the
date. The foil of the first well is perforated to facilitate
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
Description of the Creatine Kinase MB (CKMB) Reagent various
Strip : reagents required for the assay.
Wells

Reagents

Sample well

Sample Diluent: 300 l TRIS buffered saline (0.05mol/l, pH 7.4) with protein and chemical stabilizers,
and 1 g/L sodium azide.

Prewash: 600 l TRIS buffered saline (0.05 mol/l, pH 7.4) with protein stabilizers, and 1 g/L sodium
azide.

4-5
6
7-8

Wash: 600 l TRIS buffered saline (0.05 mol/l, pH 7.4) with detergent and 1 g/L sodium azide.
Detector Antibody Conjugate: 400 l Goat anti-CKMM polyclonal antibodies conjugated to alkaline
phosphatase with 1 g/L sodium azide.
Wash: 600 l TRIS buffered saline (0.05 mol/l, pH 7.4) with detergent and 1 g/L sodium azide.

Empty well

10

Reading Cuvette with Substrate: 300 l 4-Methylumbelliferyl phosphate (0.6 mmol/l), Diethanolamine
(DEA*) (0.62 mol/l, or 6.6%, pH 9.2) pH 9.2+ 1 g/L (300 L) sodium azide.

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
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, consult the Safety Data Sheet.
MATERIALS REQUIRED BUT NOT PROVIDED

Consider all patient specimens potentially infectious and

observe routine biosafety precautions. Dispose of all
Pipette with disposable tips which will dispense 3 ml and
used components and other contaminated materials by
250 l.
acceptable procedures for potentially biohazardous
Powderless disposable gloves.
human blood products.
For other specific materials, please refer to the

This kit contains products of animal origin. Certified

Instrument Operators Manual.
knowledge
of the origin and/or sanitary state of the
Instrument of the VIDAS family.
animals does not totally guarantee the absence of
transmissible pathogenic agents. It is therefore
WARNINGS AND PRECAUTIONS
recommended that these products be treated as
For in vitro diagnostic use only
potentially infectious and handled observing the usual
For professional use only.
safety precautions (do not ingest or inhale).
This kit contains products of human origin. No Do not mix reagents or disposables from different lots.
known analysis method can totally guarantee the Powderless gloves are recommended as powder has
absence of transmissible pathogenic agents. It is been reported as a cause of false results in some
therefore recommended that these products be enzyme immunoassays(5).
treated as potentially infectious and handled
Kit reagents contain sodium azide which can react with
observing the usual safety precautions (see
lead or copper plumbing to form explosive metal azides.
Laboratory biosafety manual - WHO - Geneva - latest If any liquid containing sodium azide is disposed of in
edition).
the plumbing system, drains should be flushed with
water to avoid build-up.

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

The reading cuvette with substrate (well 10) containsAssay

an Procedure
irritant agent (6.6% diethanolamine). Refer to the hazard
1. Remove necessary components from the kit and
statements "H" and the precautionary statements "P"return all unused components to storage at 2-8C.
above.
2. Use one "CKMB" strip and one "CKMB" SPR for each
Spills should be wiped up thoroughly after treatment
sample, control or calibrator to be tested. Make sure
with liquid detergent and a solution of household bleachthe storage pouch has been carefully resealed
containing at least 0.5 % sodium hypochlorite toafter the required SPRs have been removed.
inactivate infectious agents. See the Operator's Manual
3. The test is identified by the "CKMB" code on the
for cleaning spills on or in the Instrument. Do not place
instrument. The calibrator must be identified by "S1",
solutions containing bleach in the autoclave.
The instrument should be routinely cleaned and and tested in duplicate. If the control is to be tested, it
decontaminated. See the Operator's Manual for the should be identified by "C1".
4. If needed, label the "CKMB" Reagent Strips with the
appropriate procedures.
appropriate sample identification numbers.
STORAGE AND HANDLING
5. Mix the calibrator, controls, and. samples using a
Store the VIDAS Creatine Kinase MB (CKMB) kit at vortex- type mixer (for serum or plasma separated
from the pellet).
2-8C. Do not freeze the kit.
Do not freeze reagents, with the exception of6. For this test, the calibrator, control, and sample
calibrators and controls after reconstitution.
test portion is 250 l.
Return unused components to 2-8C. Do not leave kit

7. Insert the "CKMB" Reagent Strips and SPR s into the

components on laboratory bench for extended periods
appropriate position on the instrument. Check to make
of time.
sure the color labels with the assay code on the SPRs
The CKMB SPR s are provided in a resealable pouch.
and the Reagent Strips match.
Remove only the
required number of SPRs, closing the
8. Initiate the assay processing as directed in the
pouch completely after opening.
If stored according to the recommended conditions, Operators Manual. All the assay steps are performed
automatically by the instrument.
all
9. Reclose the vials and return them to the required
components are stable until the expiration date indicated
on the label. Refer to the kit composition table fortemperature after pipetting.
special storage conditions.
10. The assay will be completed within approximately
SPECIMEN COLLECTION AND PREPARATION
35 minutes. After the assay is completed, remove the
Acceptable specimens include serum or plasma (with SPRs and strips from the instrument.
heparin or EDTA anticoagulant). The use of heat11. Dispose of the used SPRs and strips into an
inactivated sera has not been established for this test - doappropriate recipient.
not heat sera. Samples can be stored at 2-8C in
stoppered tubes for up to 2 days. If longer storageQUALITY
is
CONTROL
required, freeze the sera or plasma at -25 6C for up to
A control is included in each VIDAS Creatine Kinase MB
five months. Avoid repeated cycles of freezing and
(CKMB) kit.
thawing. If necessary, clarify samples by centrifugation.This control must be performed immediately after opening
a new kit to check 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.
Reading Master lot data
Results cannot be validated if the control value deviates
Before each new lot of reagents is used, enter the
from the expected values.
specifications (or factory master data) into the
instrument
Note
using
master lot
entryperformed
(MLE) data.
If
thisthe
operation
is not
before initiating the
It is the responsibility of the user to perform
tests, the instrument will not be able to print results. Quality
Note: the master lot data need only be entered once Control in accordance with any local applicable
for each lot.
regulations.
It is possible to enter MLE data manually or
RESULTS AND INTERPRETATION
automatically depending on the instrument (refer to the
Two instrument readings for fluorescence in the Reagent
Users Manual).
Strip's reading cuvette are taken for each specimen
Calibration
tested. The first reading is a background reading of the
Calibration, using the calibrator provided in the kit, cuvette and substrate before the SPR is introduced into
the substrate. The second reading is taken after the
must
substrate has been exposed to the enzyme conjugate
be performed each time a new lot of reagents is opened,
remaining on the interior of the SPR. The background
after the master lot data have been entered.
reading is subtracted from the final reading to give a
Calibration
provides
instrument-specificcalibration curves and
Relative Fluorescence Value (RFV) for the test result.
should then be
everyvariations
14 days. in
This
operation
compensates
forperformed
possible minor
assay
signal
The Creatine Kinase MB concentrations are expressed in
throughout the shelf-life of the kit.
The calibrator, identified by S1, must be testedng/ml.
in
duplicate (see the Operator Manual). The calibrator value
must be within the set RFV "Relative Fluorescence Value"
range. If this is not the case, recalibrate.
INSTRUCTIONS FOR USE
For complete instructions, see the Users Manual.

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

The range of results for the VIDAS Creatine Kinase MB

Detection limit
(CKMB) assay is 0.8 - 300 ng/ml. Samples with results
The detection limit (assay sensitivity) is defined as the
less than 0.8 ng/ml are reported as " < 0.8 ng/ml".
lowest concentration that can be distinguished from zero
Samples with results greater than 300 ng/ml mustwith
be 95 % probability. The detection limit for the VIDAS
Kinase MB (CKMB) Assay is 0.8 ng/ml.
diluted in CKMB negative (<0.8 ng/mL) sera so results Creatine
will
be within assay range (a 1/4 dilution is recommended : 1
Hook effect
volume of sample and 3 volumes of CKMB negative sera).
If the dilution factor has not been entered when The Hook effect was evaluated using Creatine Kinase MB
solutions whose respective concentrations were from 0.6
the
to 10,000 ng/ml. A reaction curve plateau was observed at
analysis has been requested (see Operators Manual),
multiply the result by the dilution factor to obtainconcentrations greater than 2500 ng/ml, but no
hook
the
A report is printed which records :
effect was seen up to 10,000 ng/ml.
Creatine
Kinase
MB
sample
concentration.
the type of test performed,
HOOK EFFECT FOR CKMB
the sample identification,
the date and time,
the lot number and the expiration date of the reagent
kit
being
used, RFV and CKMB concentration.
each
sample's
PERFORMANCE DATA

RFV

Immunological Specificity
Immunological interference was tested by adding 10 ug/ml
of CKBB and CKMM to two samples containing
0.98 ng/ml and 18.92 ng/ml of Creatine Kinase MB
respectively.
Cross-reactivity Normal
percentage
Range of
Sample
Negative Serum
0.98
0.8-1.64
0.53
Negative Serum and
CKBB
SCRIPPS
(lot 607264,cat.C1124)
Negative Serum and
0.93
CKMM
SCRIPPS
(lot 755264,cat.C1324)
Tested compound

Positive Serum
Positive Serum and
CKBB
SCRIPPS
(lot 607264,cat.1124)
Positive Serum and
CKMM
SCRIPPS (lot
755264,cat.C1324)

18.92
19.37

<--------------------->

ng/ml

Calibration Range

18.16-19.68

18.83

No interference was observed with the creatine kinase

isoforms BB and MM.
Precision
Intra-assay reproducibility
:Five samples were tested for intra-assay precision. Thirty replicates of each sample were tested in the same run.
Sample

Mean
concentration
(ng/ml)

3.73

11.94

38.61

94.79

265.36

6.2

3.4

4.3

3.3

3.4

% CV

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

Inter-assay reproducibility on the same instrument

Five: samples were tested in 23 runs on the same instrument over an 8-week period (recalibration was performed every
14 days as described in the Operator's Manual).
Sample

Mean
concentration
(ng/ml)

3.90

12.49

39.38

89.87

281.90

7.2

5.0

4.0

4.5

5.5

% CV

Inter-instrument and inter-assay reproducibility

Five samples were tested in singlet in 9 runs on different instruments.
Sample

Mean
concentration
(ng/ml)

4.18

12.57

38.46

89.08

275.48

16.7

4.5

4.7

3.7

5.7

% CV
Accuracy

Parallelism (Dilution tests):

Three samples were diluted in creatine kinase MB negative sera and tested in singlet in 3 runs.
Sample

Expected mean
concentration
(ng/ml)

Measured mean
concentration
(ng/ml)

1/1

268.35

268.35

100

1/2

134.18

130.94

98

1/4

67.08

65.35

97

1/8

33.54

31.88

95

1/16

16.77

15.83

94

1/32

8.39

8.34

99

1/1

284.74

284.74

100

1/2

142.37

141.91

100

1/4

71.19

74.67

105

Dilution factor

Mean recovery
percentage

1/8

35.59

35.05

98

1/16

17.80

18.73

105

1/32

8.90

9.37

105

1/1

93.58

93.58

100

1/2

46.79

46.84

100

1/4

23.40

23.50

100

1/8

11.70

11.66

100

1/16

5.85

6.05

103

1/32

2.92

3.32

114

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

Recovery tests
Three samples were spiked with known quantities of creatine kinase MB isoenzyme and tested in singlet in three
instrument runs. The measured mean concentration compared to the expected mean concentration is shown below.
Amount spiked
(ng/ml)

Sample

Expected mean
concentration
(ng/ml)

Measured mean
concentration
(ng/ml)

Mean recovery
percentage

0.41

0.41

100

2.07

2.48

2.19

88

3.32

3.73

3.76

101

4.35

4.76

4.02

84

10.46

10.87

8.77

81

51.81

52.22

44.91

86

11.04

11.04

100

2.07

13.11

13.09

100

3.32

14.35

12.91

90

4.35

15.38

15.93

104

10.46

21.50

21.94

102

51.81

62.84

56.51

90

3.31

3.31

100

2.07

5.38

5.49

102

3.32

6.62

6.90

104

4.35

7.65

7.92

104

10.46

13.77

13.21

96

51.81

55.11

50.70

92

INFLUENCE OF SPECIMEN COLLECTION

Blood samples were collected from twenty eight patients. For each patient, 4 specimens were collected at the same time:
in a dry glass tube with a glyceroled cap; in a tube with separating gel; in a siliconized tube; and in a non siliconized tube.
Blood samples were also collected from eighteen patients and collected in a dry glass tube with a glyceroled cap; in a
EDTA tube; and in a heparinized tube. Each sample collected was tested in duplicate and sera from the same donor
were tested in the same run. The dry glass tube with the glyceroled cap was the reference to which the other tubes were
compared.
Collection tube

Equation of the line

Tube with separating gel

1.01 x + -0.30

0.99

Silicone tube

1.02 x + -0.07

0.99

Non siliconized tube

1.12 x + -0.44

0.99

1.03 x + 0.076

0.99

0.99 x + 0.057

0.99

Tube with EDTA

Tube with heparin (lithium)

Correlation coefficient

INTERFERENCE STUDIES
Heparin
Two pools of human sera were spiked with increasing quantities of heparin.
Amount of heparin spiked (U/ml)
0

0.5

50

CKMB

Pool 1

4.8

4.8

5.1

5.0

(ng/ml)

Pool 2

93.5

95.7

94.9

91.8

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

EDTA
Two pools of human sera were spiked with increasing quantities of EDTA.
Amount of EDTA spiked (mg/ml)
0

10

CKMB

Pool 1

4.8

5.1

5.0

4.8

(ng/ml)

Pool 2

93.5

91.4

91.5

95.5

Hemoglobin
Two pools of human sera were spiked with increasing quantities of hemoglobin.
Amount of hemoglobin spiked (mol/l)
0

12.5

25

50

100

500

1000

CKMB

Pool 1

4.7

5.1

4.7

4.4

3.9

3.7

5.4

(ng/ml)

Pool 2

92.6

95.7

95.0

95.9

94.0

89.1

91.5

Turbidity
Two pools of human sera were spiked with increasing quantities of a lipid solution.
Amount of triglycerides spiked (g/l)
0

0.25

0.5

1.0

2.0

5.9

5.4

78.3

72.3

CKMB

Pool 1

5.7

5.2

5.5

(ng/ml)

Pool 2

69.3

71.3

71.6

Appearance

Clear

Opalescent

Turbid

Bilirubin
Two pools of human sera were spiked with increasing quantities of bilirubin.
Amount of bilirubin spiked (mol/l)
0

1.29

2.28

3.68

10.80

15.00

19.25

CKMB

Pool 1

6.4

5.9

6.4

6.1

7.0

6.2

6.0

(ng/ml)

Pool 2

85.0

80.4

80.5

72.9

77.6

80.5

80.2

Although interference linked to the presence of hemoglobin, bilirubin or to turbidity has not been observed, using
hemolyzed, icteric or lipemic samples is not recommended. If possible, collect a new specimen.
EXPECTED VALUES
The 99% confidence limit for the normal range of CKMB tested in 68 healthy individuals was determined to be 6.8 ng/ml.
It is recommended that each laboratory establish its own expected values on a well-defined population.
CORRELATION

One hundred seventy five samples were tested within the range of 0.8 - 300 ng/ml using the VIDAS creatine kinase MB
(CKMB) Assay and a commercially available EIA. Samples were obtained from healthy blood donors and hospitalized
patients from internal medicine and cardiac-vascular divisions. A summary of the results is shown below.
# of Samples
175

Slope

Intercept

0.83

-0.656

Correlation coefficient
0.97

VIDAS Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

WASTE DISPOSAL

INDEX OF SYMBOLS

Dispose of used or unused reagents as well as any other

Symbol
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 (or have them treated and disposed of) in
them
degree of hazardousness
accordance
with any applicable
and regulations.
to treat and dispose of

Meaning
Catalog number
In Vitro Diagnostic Medical Device
Manufacturer

LITERATURE REFERENCES
1. Landt, Y., H. Vaidya, S. Porter, D. Dietzier, J. Ladenson.
1989. Immunoaffinity Purification of Creatine Kinase-MB from
Human, Dog, and Rabbit Heart with Use of a Monoclonal
Antibody Specific for CK-MB. Clinical Chemistry vol. 35. no
6. 985-989.
2. Revenko, I., M. Manchon. 1993. Interet Actuel de la CK-MB
dans le Diagnostic de Linfactus du Myocarde. Lyon
Pharmaceutique. Elsevier, Paris. 83-90.
3. Gerhardt, W., L. Ljungdahl., 1993. Rational Diagnostic
Strategy in Diagnosis of Ischemic Myocardial Injury.
Stroponin and S-CKMB (mass) Times Series Using Individual
Baseline Values. Scand J. Clin Lab Invest. 53(Suppl 215).
47-59.

Temperature limit
Use by date
Batch code
Consult Instructions for Use
Contains sufficient for <n>
tests

4. Bhayana, V., S. Cohoe, F. Leung, G. Jablonsky, A.

Henderson. 1993. Diagnostic Evaluation of Creatine KinaseDate of manufacture
2 Mass and Creatine Kinase-3 and -2 Isoform Ratios in Early
Diagnosis of Acute Myocardial Infarction. Clinical Chemistry,
WARRANTY
488-495.
5.
Lampe, A.S., H.J. Peiterse-Bruins, and J.C.R. EgtervanbioMrieux, Inc. disclaims all warranties, express
implied warranties of
Wisserderke. 1988. Wearing gloves as cause of false implied, including any
A
MERCHANTABILITY
AND
FITNESS
FOR
negative HIV tests. Lancet ii 1140-1144.

REVISION HISTORY
Change type categories :
N/A
Correction
Technical change
Administrative
Note:
Release
date

Part Number

PARTICULAR USE. bioMrieux shall not be liable for any

incidental or consequential damages. IN NO EVENT
SHALL BIOMERIEUXS LIABILITY TO CUSTOMER
UNDER ANY CLAIM EXCEED A REFUND OF THE
AMOUNT PAID TO BIOMERIEUX FOR THE PRODUCT
OR SERVICE
WHICH IS THE SUBJECT OF THE
CLAIM.

Not applicable (First publication)

Correction of documentation anomalies
Addition, revision and/or removal of information related to the
product
Implementation of non-technical changes noticeable to the user
Minor typographical, grammar, and formatting changes are not included in the
revision history.
Change Type
Administrative

2015/01

13765C

2015/06

13765D

or

Change Summary
INDEX OF SYMBOLS
REVISION HISTORY

Technical

KIT COMPOSITION (30 tests)

WARNINGS AND PRECAUTIONS

Technical

KIT COMPOSITION (30 tests)

INSTRUCTIONS FOR USE

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

bioMrieux SA
376 Chemin de lOrme
69280 Marcy-l'Etoile France Distributed by
bioMrieux, Inc.
673 620 399 RCS LYON
100 Rodolphe Street
Tel. 33 (0)4 78 87 20 00
Durham, North Carolina 27712 - USA
Fax 33 (0)4 78 87 20 90
www.biomerieux.com
www.biomerieux.com