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VIDAS CEA (S) (CEAS)
VIDAS CEA (S) is an automated quantitative test for use on the VIDAS family instruments, for the quantitative
measurement of Carcinoembryonic antigen (CEA) in human serum or plasma (lithium heparin) using the ELFA technique
(Enzyme Linked Fluorescent Assay).

SUMMARY AND EXPLANATION PRINCIPLE

VIDAS CEA (S) is intended for use on the VIDAS
instrument as an automated assay for the quantitative
measurement of Carcinoembryonic antigen (CEA) in
human serum or plasma (lithium heparin).
Carcinoembryonic antigen is a glycoprotein with a
molecular weight of approximately 200,000 daltons (1, 2).
CEA was first described in 1965 by Gold and Freedman
(1). CEA is produced by cells during embryonic and fetal
life and production ceases at birth. A very low serum
concentration can be detected in healthy individuals.
Increased CEA levels can be found in certain cases of
cancer (colorectal, breast, lung cancer, etc.) (2-4), but
also in non-malignant diseases. Serum CEA levels
decrease after treatment and increase in the event of
cancer recurrence, residual disease and metastases (5).
The VIDAS CEA (S) test can be used as a
complementary test for prognosis and therapeutic
monitoring of patients with diagnosed malignant
carcinomas.
It enables the efficacy of treatment to be evaluated. In
particular, high postoperative levels are an indication of
incomplete exeresis. Recurrence can also be diagnosed,
allowing the decision to re-operate to be made at an early
stage.
The assay principle combines a 2-step enzyme
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. It is coated with
anti-CEA monoclonal immunoglobulins (mouse). The
other reagents for the assay are pre-dispensed in the
strip.
All of the assay steps are performed automatically by the
instrument. The reaction medium is cycled in and out of
the SPR several times.
After dilution, the sample is incubated with the SPR, which
will bind the CEA antigen present in the sample. A first
wash step eliminates unbound components.
A second incubation step is then performed with alkaline
phosphatase-labeled anti-CEA polyclonal antibodies
(goat). The unbound conjugate is then eliminated during
washing steps.
During the final detection 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 fluorescent 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 the calibration
curve stored in memory, and then printed out.

CONTENT OF THE KIT (60 TESTS) – RECONSTITUTION OF REAGENTS

60 CEAS Strips STR Ready-to-use.
60 CEAS SPRs SPR Ready-to-use.
2 x 30 Interior of SPRs coated with anti-CEA monoclonal immunoglobulins (mouse).
CEAS Control C1 Reconstitute with 2 mL of distilled water. Wait for 5 to 10 minutes, then mix. After
1 x 2 mL (lyophilized) reconstitution, the control is stable for 1 month at 2-8°C or until the expiration
date at - 25 ± 6°C. 3 freeze / thaw cycles are possible.
Bovine albumin + human CEA + preservative.
MLE data indicate the confidence interval in ng/mL ("Control C1 Dose Value
Range").
CEAS Calibrator S1 Reconstitute with 2 mL of distilled water. Wait for 5 to 10 minutes, then mix. After
3 x 2 mL (lyophilized) reconstitution, the calibrator is stable for 1 month at 2-8°C or until the
expiration date at - 25 ± 6°C. 3 freeze / thaw cycles are possible.
Bovine albumin + human CEA + preservative.
MLE data indicate the concentration in ng/mL (“Calibrator (S1) Dose Value”) and
the confidence interval in “Relative Fluorescence Value” (“Calibrator (S1) RFV
Range”).
CEAS Diluent R1 Ready-to-use.
3 x 6.7 mL (liquid) Bovine albumin + 1 g/L sodium azide.
Specifications for the factory master data required to calibrate the test:
 MLE data (Master Lot Entry) provided in the kit,
or
 MLE bar code printed on the box label.
1 Package insert provided in the kit or downloadable from www.biomerieux.com/techlib.

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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
anti-CEA monoclonal immunoglobulins (mouse). Each seal. The label comprises a bar code which mainly
SPR is identified by the "CEAS" code. Only remove the indicates the assay code, kit lot number and expiration
required number of SPRs from the pouch and carefully date. The foil of the first well is perforated to facilitate the
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 CEAS strip
Well Reagents
1 Sample well.
2-3-4 Empty wells.
5 Conjugate: alkaline phosphatase labeled anti-CEA polyclonal immunoglobulins
(goat) + 1 g/L sodium azide (400 µL).
6-7 Wash solution: sodium phosphate (0.01 mol/L, pH 7.4) + 1 g/L sodium azide
(600 µL).
8 Diluent: Tris (0.1 mol/L) + calf serum (5%) + 1 g/L sodium azide (400 µL).
9 Wash solution: diethanolamine* (1.1 mol/L or 11.5%, pH 9.8) + 1 g/L sodium azide
(600 µL).
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) + 1 g/L sodium azide
(300 µL).

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
H373 : May cause damage to organs through prolonged or repeated exposure.
H315 : Causes skin irritation.
H302 : Harmful if swallowed.
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.
P309 + P311 : IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
** 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, refer to the Material Safety Data Sheet.

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VIDAS CEA (S) (CEAS)
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.
- Instrument 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 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 wash buffer in well 9 contains a harmful agent
(11.5% diethanolamine). %). Refer to the hazard
statements "H" and the precautionary statements "P"
above.
 The substrate in well 10 contains an irritant agent
(6.6% 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 CEA (S) kit at 2-8°C.
 Do not freeze reagents, with the exception of
calibrator and control after reconstitution.
 Store all unused reagents at 2-8°C.
 After opening the kit, check that the SPR pouch is
correctly sealed and undamaged. If not, do not use
the SPRs.
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 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:
Serum or plasma (lithium heparin). Do not use plasma
collected on EDTA.
Types of tubes tested:
 Tube with no additive.
 Tube with lithium heparin.
Sample preparation
Follow the tube manufacturer’s recommendations for use.
Tubes with no additive : wait for samples to coagulate and
centrifuge to eliminate fibrin.
Note: blood sampling tube results may vary from one
manufacturer to another depending on the materials and
additives used.
It is the responsibility of each laboratory to validate the
type of sample tube used and to follow the manufacturer’s
recommendations for use.
Specimen stability
Samples can be stored at 2–8°C in stoppered tubes for up
to 48 hours; if longer storage is required, freeze the sera
or plasma at -25  6°C. A study performed on frozen
samples over a period of two months showed that the
quality of results is not affected.
Three freeze/thaw cycles were validated.
Sample-related interference
None of the following factors have been found to
significantly influence this assay:
- hemolysis (after spiking samples with hemoglobin up to
300 µmol/L (monomer) or 484 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 30 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.
INSTRUCTION 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.
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VIDAS CEA (S) (CEAS)
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 calibrator provided in the kit, must
be performed each time a new lot of reagents is opened,
after the master lot data have been entered. Calibration
should then be performed every 14 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
duplicate (see the User’s Manual). The calibrator value
must be within the set RFV "Relative Fluorescence Value"
range. If this is not the case, recalibrate.
Procedure
1. Remove the required reagents from the
refrigerator.
2. Use one “CEAS” strip and “CEAS” 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 "CEAS" code on the
instrument. The calibrator must be identified by "S1",
and tested in duplicate. If the control is to be tested, it
should be identified by "C1".
4. Mix the calibrator, control and 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.
6. Insert the “CEAS” SPRs and “CEAS” 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 as directed in the User’s Manual. 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
60 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.
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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 is introduced into
the substrate. The second reading is taken after
incubating the substrate with the enzyme remaining on
the interior of the SPR. The RFV (Relative Fluorescence
Value) is calculated by subtracting the background
reading from the final result. This calculation appears on
the result sheet.
The results are automatically calculated by the instrument
using calibration curves which are stored by the
instrument (4-parameter logistic model). The CEA
concentrations are expressed in ng/mL.
The VIDAS CEA (S) assay is calibrated against an EIA
method.
1 ng/mL of VIDAS CEA (S) corresponds to 15.43 mIU/mL.
The International Units are defined according to the 1st
International Reference Preparation for CEA antigen
(NIBSC code 73/601) established by the WHO in 1976
(6).
Samples with CEA concentrations > 200 ng/mL should be
retested after being diluted, for example, by 1/10
(1 volume of sample + 9 volumes of diluent) in the
CEA (S) diluent (R1).
If the dilution factor has not been entered when the Work
List was created (see the User’s Manual), multiply the
result by the dilution factor to obtain the sample
concentration.
Interpretation of test results should be made taking into
consideration the patient’s history, and the results of any
other tests performed.
QUALITY CONTROL
A control is included in each VIDAS CEA (S) kit.
This control must be performed immediately after opening
a new kit to ensure that reagent 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 local applicable
regulations.
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LIMITATIONS OF THE METHOD RANGE OF EXPECTED VALUES

 Interference may be encountered with certain sera The reference values were determined from a blood donor
containing antibodies directed against reagent population including 505 samples from 253 non-smokers
components. For this reason, assay results should be (including 126 men and 127 women) and 252 smokers
interpreted taking into consideration the patient's (including 122 men and 130 women).
history, and the results of any other tests performed.
Percentage of the population (%)
 It is not advisable to perform a CEA assay on patients
who have received a contrast medium less than No. of according to the range of values in
subjects ng/mL
24 hours previously (7).
 Sample CEA concentrations determined using kits 0-3.00 3.01-5.00 5.01-10 > 10
from different manufacturers may vary according to the Non-
assay technique and reagent specificity. To ensure 253 96.84 1.98 0.79 0.39
smokers
correct patient follow-up when changing techniques,
previously determined concentrations must be Smokers 252 89.29 8.33 2.38 0.00
confirmed by the laboratory (8-9). Total 505 93.07 5.15 1.58 0.20
 CEA concentrations should be interpreted as part of a
complete clinical profile and in relation to other - Among the 253 healthy non-smokers, 95% of the
diagnostic techniques. values obtained with VIDAS CEA (S) are less than or
 The VIDAS CEA (S) assay is not intended for use as a equal to 2.30 ng/mL.
screening test for cancer (8-9). - Among the 252 healthy smokers, 95% of the values
obtained with VIDAS CEA (S) are less than or equal
to 4.10 ng/mL.

Using 319 samples from 319 subjects with a diagnosed malignant carcinoma, the following results were observed:

Number Percentage of the population (%) according to the range of

CANCER of values in ng/mL
subjects 0 - 3.00 3.01 - 5.00 5.01 - 10 > 10
COLORECTAL 136 23.53 5.15 3.68 67.64
Including diagnostic colorectal 80 33.75 8.75 5.00 52.50
Including recurrent colorectal 56 8.93 0.00 1.79 89.28

DIGESTIVE
including stomach (n=10),
35 54.29 14.29 8.57 22.85
pancreas (n=10), liver (n=10),
esophagus (n=5)

GYNECOLOGICAL
including endometrium (n=10), 70 77.14 14.29 2.86 5.71
ovary (n=30), breast (n=30)
ovary 30 90.00 10.00 0.00 0.00
breast 30 63.33 20.00 6.67 10.00

UROLOGICAL
including prostate (n=10), testicle (n=10), 38 65.79 15.79 5.26 13.16
bladder (n=10), kidney (n=8)

OTHER CANCERS
40 62.50 12.50 5.00 20.00
including lung (n=30), thyroid (n=10)
lung 30 50.00 16.67 6.67 26.66
In this study, the titers obtained for subjects with colorectal cancer were significantly higher in the presence of metastases.
These figures are given as a guide, it is recommended that each laboratory establishes its own reference values from a
rigorously selected population.

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PERFORMANCE
Studies performed using the VIDAS CEA (S) assay gave the following results:
Measurement range
The measurement range of the VIDAS CEA (S) assay is: 0.5 - 200 ng/mL.
Detection limits
The analytical detection limit, defined as the smallest concentration of CEA which is significantly different from the zero
concentration with a probability of 95%, is < 0.5 ng/mL.
The functional detection limit, corresponding to the smallest concentration of CEA measured, with a 20% inter-lot
coefficient of variation is < 0.5 ng/mL.
Hook effect
No hook effect was found up to CEA concentrations of 100,000 ng/mL.
Precision
Four samples were tested in duplicate in 2 runs per day and with 2 reagent lots. Each lot was tested in parallel over a
period of 5 days using two instruments (N = 80 per sample). This protocol is based on the recommendations of the
document CLSI EP5-A2.

The repeatability (intra-run precision), the inter-run reproducibility (inter-run precision) and the inter-lot reproducibility
(total precision = intra-run, inter-run, inter-day, inter-instrument, inter-lot) were calculated:

Intra-run precision Inter-run precision Total precision

Mean
Standard Standard Standard
Sample concentration CV (%) CV (%) CV (%)
deviation deviation deviation
ng/mL
1 6.00 0.22 3.75 0.28 4.69 0.36 5.98
2 48.26 1.77 3.67 2.23 4.62 2.56 5.30
3 106.16 5.00 4.71 5.58 5.25 7.11 6.69
4 159.90 8.64 5.40 9.67 6.05 10.93 6.84

Analytical specificity
No cross-reactivity was observed with the alpha fetoprotein (AFP).

Linearity
The VIDAS CEA (S) kit linearity and the diluent validation were studied according to a protocol based on the
recommendations of the document CLSI EP6-A.
- Linearity range: 2 samples, one with a low titer and one with a high titer, were mixed in varying proportions in
order to obtain 9 dilutions distributed over the measurement range. Each dilution was tested 4 times on 2 lots
(N = 8). VIDAS CEA (S) is linear over the measurement range considered.
- Validation of the diluent: 6 samples (including 3 > 200 ng/mL) were diluted up to 1/15 using the R1 diluent in the
kit. Each dilution was tested 3 times on 2 lots (N = 6). VIDAS CEA (S) is linear when the diluent is used.
Comparison with another test method
101 samples distributed over the measurement range were tested in parallel using the VIDAS CEA (S) method and
another automated immunoenzyme assay technique (X) from a competitor. The results of the comparison between the
2 methods are shown below (Passing & Bablok curve and correlation coefficient).
VIDAS CEA (S) = 1.17 X – 0.29
Correlation coefficient: 0.90

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VIDAS CEA (S) (CEAS) 13718 E - en - 2015/01

WASTE DISPOSAL INDEX OF SYMBOLS

Dispose of used or unused reagents as well as any
other contaminated disposable materials following Symbol Meaning
procedures for infectious or potentially infectious
products. Catalog number
It is the responsibility of each laboratory to handle
waste and effluents produced according to their nature In Vitro Diagnostic Medical
and degree of hazardousness and to treat and dispose Device
of them (or have them treated and disposed of) in
accordance with any applicable regulations. Manufacturer

LITERATURE REFERENCES
Temperature limit
1. GOLD P., FREEDMAN S.O. Demonstration of Tumor-
Specific Antigens in Human Colonic Carcinomata by
Immunological Tolerance and Absorption Techniques. J.
Exp. Med. 1965, 121, 439-471.
Use by date
2. HERNANDO J.J., VON KLEIST S., GRUNERT F. A
repertoire of monoclonal antibodies reveals extensive Batch code
epitope heterogeneity in CEA purified from neoplasms
originating from different organs. Int. J. Cancer, 1994, 56, Consult Instructions for Use
655-661.
3. THERIAULT R.L., HORTOBAGYI G., FRITSCHE H.,
Contains sufficient for <n> tests
FRYE D., MARTINEZ R., BUZDAR A. The role of serum
CEA as a prognostic indicator in stage II and III Breast
cancer patients treated with adjuvant chemotherapy. Date of manufacture
Cancer, 1989, 63, 825-835.
4. MOERTEL C.G., FLEMING T., MACDONALD J.,
HALLER D, LAURIE J., TANGEN C. An evaluation of the WARRANTY
Carcinoembryonic Antigen (CEA) Test for monitoring
patients with resected colon cancer. JAMA. 1993, 270, bioMérieux disclaims all warranties, express or implied,
943-947. including any implied warranties of
5. BORMER O.P. Immunoassays for carcinoembryonic MERCHANTABILITY AND FITNESS FOR A
antigen: specificity and interferences. Scand. J. Clin. Lab. PARTICULAR USE. BioMérieux shall not be liable for
Invest., 1993, 53, 1-9. any incidental or consequential damages. IN NO
6. LAURENCE D.J.R. et al. First British Standard for EVENT SHALL BIOMERIEUX’S LIABILITY TO
Carcinemembryonic Antigen (CEA). Br. J. Cancer, 1975, CUSTOMER UNDER ANY CLAIM EXCEED A
32, 295. REFUND OF THE AMOUNT PAID TO BIOMERIEUX
7. WATANABE N. et al. In vitro effect of contrast agents FOR THE PRODUCT OR SERVICE WHICH IS THE
during immunoradiometric assay for tumour-associated SUBJECT OF THE CLAIM.
antigens. Nuclear Medicine Communications, 1998, 19,
63-70.
8. ZWIRNER M. Longitudinal quality control of tumor marker
assays : results of an international proficiency study with
CEA in R. KLAPDOR (ed). Tumor associated antigens,
oncogenes, receptors, cytokines in tumor diagnosis and
therapy at the beginning of the nineties. Cancer of the
breast. State and trends in diagnosis and therapy, W.
Zuckschwerdt Verlag München, Bern, Wien, New-York,
1992, 283-290.
9. NAUDIN C. Tentative d'harmonisation des résultats des
dosages de marqueurs tumoraux. Groupe de travail ACE
SFBC/CORATA/SFRL. Forum du 15 septembre 1992.

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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
Note: 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 13718E CONTENT OF THE KIT (60 TESTS) - RECONSTITUTION
Technical OF REAGENTS
WARNINGS AND PRECAUTIONS
INSTRUCTIONS FOR USE

BIOMERIEUX, the blue 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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