0% found this document useful (0 votes)
74 views11 pages

VIDAS Salmonella (SLM)

VIDAS Salmonella is an automated qualitative test designed for detecting Salmonella in food and environmental samples using the ELFA technique. The test simplifies and accelerates Salmonella detection, which traditionally takes up to 5 days, by utilizing specific antibodies and automated processes. The kit includes ready-to-use components for efficient testing and requires proper sample preparation and incubation conditions.

Uploaded by

adriano.120477
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
74 views11 pages

VIDAS Salmonella (SLM)

VIDAS Salmonella is an automated qualitative test designed for detecting Salmonella in food and environmental samples using the ELFA technique. The test simplifies and accelerates Salmonella detection, which traditionally takes up to 5 days, by utilizing specific antibodies and automated processes. The kit includes ready-to-use components for efficient testing and requires proper sample preparation and incubation conditions.

Uploaded by

adriano.120477
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 11

BIOMÉRIEUX

30702 06984 Y - en - 2018/06

®
VIDAS Salmonella (SLM)
® ®
For microbiological control only
VIDAS Salmonella is an automated qualitative test for use on the VIDAS family of instruments, for the detection of
Salmonella in food and environmental samples, using the ELFA technique (Enzyme Linked Fluorescent Assay).

®
SUMMARY AND EXPLANATION The Solid Phase Receptacle (SPR ) serves as the solid
Salmonella is one of the main causes of food poisoning. phase as well as the pipetting device. The interior of the
®
Salmonella detection using time-consuming protocols, can SPR is coated with anti-Salmonella antibodies adsorbed
take up to 5 days to confirm a sample is negative (1). on its surface. Reagents for the assay are ready-to-use
Enzyme immunoassay (EIA)-based screening techniques and pre-dispensed in the sealed reagent strips.
have the potential to simplify and accelerate this All of the assay steps are performed automatically by the
detection. instrument. The reaction medium is cycled in and out of
®
Salmonella are antigenically complex with over 2 400 the SPR several times.
serovars differentiated by somatic (O) lipopolysaccharide Part of the enrichment broth is dispensed into the reagent
and flagellar (H) protein antigens (2). The VIDAS
® strip. The antigens present will bind to the anti-Salmonella
®
Salmonella (SLM) automated EIA test for the detection of antibodies coating the interior of the SPR . Unbound
Salmonella in food and environmental samples, uses a components are eliminated during the washing steps.
cocktail of highly specific capture antibodies directed Antibodies conjugated with alkaline phosphatase are
®
against both O and H antigens which enables the cycled in and out of the SPR and will bind to any
detection of both motile and non-motile Salmonella. Salmonella antigens which are themselves bound to the
®
antibodies on the SPR wall.
PRINCIPLE Further wash steps remove unbound conjugate.
During the final detection step, the substrate (4-Methyl-
VIDAS® Salmonella is an enzyme-linked fluorescent umbelliferyl phosphate) is cycled in and out of the SPR .
®
®
immunoassay for use on the instruments of the VIDAS The conjugate enzyme catalyzes the hydrolysis of this
family (see the User Manual) for the detection of substrate into a fluorescent product (4-Methyl-
Salmonella antigens using the ELFA technique (Enzyme umbelliferone), the fluorescence of which is measured at
Linked Fluorescent Assay). 450 nm.
At the end of the assay, the results are analyzed
automatically by the instrument which generates a test
value for each sample. This value is compared to a set of
stored standards (thresholds) and each result is
interpreted (positive, negative).

CONTENT OF THE KIT (60 TESTS)


60 SLM Strips STR Ready-to-use.
60 SLM SPR®s SPR® Ready-to-use.
®
Interior of SPR s coated with antibodies directed against Salmonella-specific surface
antigens.
SLM Standard S1 Ready-to-use.
(1 x 6 mL) Purified and inactivated Salmonella antigen + preservative + protein stabilizer.
MLE data indicate the confidence interval in Relative Fluorescence Value ("Standard
(S1) RFV Range").
SLM Positive C1 Ready-to-use.
Control Purified and inactivated Salmonella antigen + preservative + protein stabilizer.
(1 x 6 mL) MLE data indicate the confidence interval in test value ("Control C1 (+) Test Value
Range").
Negative Control C2 Ready-to-use.
(1 x 6 mL) TRIS Buffered Saline (TBS) (150 mmol/L) - Polysorbate 20 pH 7.6 + preservative.
MLE data indicate the maximum acceptable value in Test Value ("Control C2 (-) Test
Value Range").
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 downloadable from www.biomerieux.com/techlib

bioMérieux SA English - 1
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

The SPR® The Reagent Strip


The interior of the SPR® is coated during production The strip consists of 10 wells covered with a labeled foil
with antibodies directed against Salmonella-specific
surface antigens.
®
Each SPR is identified by the "SLM" code. Only
®
remove the required number of SPR s from the pouch
and carefully reseal the pouch after opening.

bioMérieux SA English - 2
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

 Do not use the SPR®s if the pouch is pierced or if the Note 3: For 50 to 375 g test samples, preheat the
dot sealing a SPR® has come unstuck. Buffered Peptone Water at 37°C ± 1°C.
 Do not use visibly deteriorated STRs (damaged foil or  Mix using a paddle blender.
plastic).  Incubate for 16-20 hours at 37  1°C.
 Do not use reagents after the expiration date indicated
Enrichment
on the label.
 Do not mix reagents (or disposables) from different lots.  After incubation,
 Kit reagents contain sodium azide which can react with - transfer 1 mL of the suspension into 10 mL of Muller-
lead or copper plumbing to form explosive metal azides. Kauffmann Tetrathionate Novobiocin broth (MKTTn).
If any liquid containing sodium azide is disposed of in - Incubate for 6-8 hours at 37  1°C.
the plumbing system, drains should be flushed with  In parallel, transfer 0.1 mL of pre-enrichment broth into
water to avoid build-up. 10 mL of Rappaport Vassiliadis Soy (RVS) broth.
 The substrate in well 10 contains an irritant agent (6.6% Incubate for 6-8 hours at 41.5  1°C.
diethanolamine). Refer to the hazard statements "H" Post-enrichment
and the precautionary statements "P" above.
 After incubation,
 Spills should be wiped up thoroughly after treatment
- transfer 0.1 mL of MKTTn broth into 10 mL of M broth.
with liquid detergent or a solution of household bleach
- Into another tube of M broth, transfer 1 mL of RVS
containing at least 0.5% sodium hypochlorite. See the
broth.
User Manual for cleaning spills on or in the instrument.
- Re-incubate the MKTTn and RVS broths at their
Do not autoclave solutions containing bleach.
respective temperatures for 16–20 hours.
 The instrument should be regularly cleaned and
 Incubate both M broths for 16-20 hours at 41.5  1°C.
decontaminated (see the User Manual).
 After incubation, mix both M broths.
If a water-bath is used, transfer 1 mL of each M broth
STORAGE CONDITIONS into a single tube. Seal the tube. Heat for 15  1 minutes
®
 Store the VIDAS SLM kit at 2-8°C. at 95-100°C. Cool the tube. Mix the boiled broth using a
 Do not freeze reagents. vortex-type mixer and transfer 0.5 mL into the sample
®
 Store all unused reagents at 2-8°C. well on the VIDAS strip.
® ®
 After opening the kit, check that the SPR pouch is If the VIDAS Heat and Go is used, transfer 0.25 mL of
correctly sealed and undamaged. If not, do not use the each M broth into the sample well on the strip. Heat for
® ®
SPR s. 15  1 minutes (see the VIDAS Heat and Go User
 Carefully reseal the pouch with the desiccant inside Manual). Remove the strip and leave to cool for at least
®
after use to maintain stability of the SPR s and 10 minutes.
®
return the complete kit to 2-8°C.  Perform the VIDAS assay.
 If stored according to the recommended conditions, all Note: The non-heated post-enrichment broths and the
components are stable until the expiration date indicated selective broths can be stored for 24 hours at 2-8°C
®
on the label. before the VIDAS assay is performed.
 Confirm the positive results.
SAMPLES (PREPARATION) Note: If confirmation is not initiated immediately after a
®
Allow the pre-enrichment and enrichment broths to come positive VIDAS test, store the M, MKTTn and RVS
to room temperature (18-25°C) before use. broths at 2-8°C. Confirmation must be initiated within
24 hours following the end of incubation.
Methods certified NF VALIDATION
Single enrichment method certified NF VALIDATION
Dual enrichment method certified NF VALIDATION (BIO-12/10-09/02) for all human and pet food products
(BIO-12/1-04/94) for all human and pet food products
Pre-enrichment
Pre-enrichment  In a blender bag, aseptically place:
 In a blender bag, aseptically place: -
- X g (or X mL) of sample.
For certain matrices, follow the specific preparation
techniques described in the EN ISO 6887-1 to 6887-5
and EN ISO 6579 standards (5, 6).
Note 1: Milk powder: To obtain optimum dissolution of
the product, it is recommended to first introduce the
Buffered Peptone Water into the blender bag and then
sprinkle the product on the surface of the broth. Leave
at room temperature for 30 minutes to allow
rehydratation before incubating.
Note 2: In the context of NF VALIDATION mark:
- test samples up to 375 g were tested for the “milk
powder and derivatives with or without probiotics”
category and the “chocolate/cocoa” category.
- test samples over 25 g were not tested for the other
categories.
- 9X mL of Buffered Peptone Water or one volume of
sample to nine volumes of pre-enrichment broth.

bioMérieux SA English - 3
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

Note 3: For 50 to 375 g test samples, preheat the


Buffered Peptone Water at 37°C ± 1°C. Easy Salmonella method certified NF VALIDATION
 Mix using a paddle blender. (BIO-12/16-09/05) for all human and animal food
products and environmental samples (excluding
 Incubate for 16-20 hours at 37  1°C.
primary production)
Enrichment
Pre-enrichment
 After incubation, transfer 0.1 mL of suspension into 10
mL of Rappaport Vassiliadis Soy (RVS) broth.  In a blender bag, aseptically place:
 Incubate for 6-8 hours at 41.5  1°C. - X g (or X mL) of sample.
For certain matrices, follow the specific preparation
Post-enrichment techniques described in the EN ISO 6887-1 to 6887-5
 After incubation, and EN ISO 6579 standards (5, 6).
- transfer 1 mL of RVS broth into 10 mL of M broth. Note 1: For milk powder, to obtain optimum dissolution
- Re-incubate the RVS broth for 16-20 hours at of the product, it is recommended to first introduce the
41.5  1°C. Buffered Peptone Water into the blender bag and then
 Incubate the M broth for 16-20 hours at 41.5  1°C. sprinkle the product on the surface of the broth. Leave
 After incubation, mix the M broth. at room temperature for 30 minutes to allow
If a water-bath is used, transfer 1-2 mL of M broth into a rehydratation before incubating.
tube. Seal the tube. Heat for 15  1 minutes at Note 2: For environmental surface samples, the
95-100°C. Cool the tube. Mix the boiled broth using a collection device should first be dampened with a
vortex-type mixer and transfer 0.5 mL into the sample sterile diluent (e.g. Buffered Peptone Water)
®
well on the VIDAS strip. containing a suitable neutralizing agent (e.g. Lecithin-
®
If the VIDAS Heat and Go is used, transfer 0.5 mL of M Polysorbate-L.Histidine-Sodium Thiosulfate mixture), if
broth into the sample well on the strip. Heat for necessary. After collection, place the device in a
®
15  1 minutes (see the VIDAS Heat and Go User suitable volume of enrichment broth (e.g.: swab in
Manual). Remove the strip and leave to cool for at least 10 mL, sampling pad in 100 mL).
10 minutes. Note 3: In the context of NF VALIDATION mark,
®
 Perform the VIDAS assay. - test samples up to 375 g were tested for the “milk
Note: The non-heated post-enrichment broth and the powder and derivatives with or without probiotics”
selective broth can be stored for 24 hours at 2-8°C category and the “chocolate/cocoa” category.
®
before the VIDAS assay is performed. - test samples over 25 g were not tested for the other
 Confirm the positive results. categories.
Note: If confirmation is not initiated immediately after a - 9X mL of Buffered Peptone Water.
®
positive VIDAS test, store the M and RVS broths at Note 4: For 50 to 375 g test samples, preheat the
2-8°C. Confirmation must be initiated within 24 hours Buffered Peptone Water at 37°C ± 1°C.
following the end of incubation.  Mix using a paddle blender.
 Incubate for 16-22 hours at 37 ± 1°C.
Confirmation of positive results obtained with single
and dual enrichment methods certified NF Enrichment
VALIDATION  After incubation, transfer 0.1 mL of suspension into 10
In the context of NF VALIDATION mark, all positive mL of SX2 broth.
®
results obtained with VIDAS SLM must be confirmed.  Incubate for 22-26 hours at 41.5 ± 1°C.
 Isolate the RVS broth (single and dual enrichment  After incubation, mix the SX2 broth.
methods) and the MKTTn broth (dual enrichment If a water-bath is used, transfer 1-2 mL of SX2 broth into
method) on a selective agar. a tube. Seal the tube. Heat for 15 1 minutes at 95-
 Incubate the agar following the instructions in the 100°C. Cool the tube. Mix the boiled broth using a
package insert. vortex-type mixer and transfer 0.5 mL into the sample
®
 Identify between one and five typical colonies using the well on the VIDAS strip.
®
conventional tests described in the methods If the VIDAS Heat and Go is used, transfer 0.5 mL of
standardized by the CEN or ISO (including the SX2 broth into the sample well on the strip. Heat for
®
purification step) (6). 15  1 minutes (see the VIDAS Heat and Go User
Manual). Remove the strip and leave to cool for at least
In the event of discordant results (positive with the 10 minutes.
®
alternative method, non confirmed with the method  Perform the VIDAS assay.
described above), the laboratory must take the necessary Note: The non-heated SX2 broth can be stored for
®
steps to ensure that the results obtained are accurate. 72 hours at 2-8°C before the VIDAS assay is
performed.
It is recommended to perform the following additional
 Confirm the positive results.
protocol:
Note: If confirmation is not initiated immediately after a
 Transfer 0.1 mL of M broth (from the RVS enrichment) ®
positive VIDAS test, store the SX2 broth at 2-8°C.
into 10 mL of RVS broth, and 1 mL of M broth (from the
Confirmation must be initiated within 72 hours following
MKTTn enrichment) into 10 mL of MKTTn broth.
the end of incubation.
 After incubation for 18-24 hours respectively at
41.5  1°C and 37  1°C, isolate onto 2 selective agars.
 Identify between one and five typical colonies using the
conventional tests described in the methods
standardized by the CEN or ISO (including the
purification step) (6).

bioMérieux SA English - 4
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

Confirmation of positive results obtained using the Easy


Salmonella method certified NF VALIDATION
In the context of NF VALIDATION mark, all positive
®
results obtained with VIDAS SLM must be confirmed.
 Isolate the SX2 broth on a selective agar.
 Incubate the agar following the instructions in the
package insert. Then perform one of the following three
procedures:
1. Identify between one and five typical colonies using
the conventional tests described in the methods
standardized by the CEN or ISO (including the
purification step) (6).
®
2. If a chromID Salmonella or an ASAP™ agar is used,
or if a new isolation is performed on Trypcase Soy
agar, perform a latex test with Salmonella spp Latex
directly using an isolated colony (follow the
instructions in the package insert).
3. Using an isolated colony on ASAP™ agar or a
purified colony on Trypcase Soy agar, perform a
VITEK

bioMérieux SA English - 5
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

Post-enrichment
 After incubation,
- transfer 1 mL of RV broth into 10 mL of M broth.
- Into another tube of M broth, transfer 1 mL of
Tetrathionate broth.
 Incubate M broths for 18-24 hours at 41-42°C (except
raw foods or foods with high microbial load).
For raw foods or foods with a high microbial load,
incubate the M broths for 6-8 hours at 41-42 °C.
 Re-incubate the selective enrichment broths, to be used
®
for confirmation of positive VIDAS results, at 41-42°C
for a total incubation time of 24  2 hours.
 After incubation, mix both M broths.
If a water-bath is used, transfer 1 mL of each M broth
into a single tube. Seal the tube. Heat for 151 minutes
at 95-100°C. Cool the tube. Mix the boiled broth using a
vortex-type mixer and transfer 0.5 mL into the sample
®
well on the VIDAS strip.

bioMérieux SA English - 6
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

Enrichment Enrichment
 After incubation, transfer 0.1 mL of suspension into 10  After incubation, transfer 1 mL of the suspension into
mL of SX2 broth. 10 mL of Selenite Cystine broth.
 Incubate for 22-26 hours at 42 ± 1°C.  Incubate for 18-24 hours at 35-37°C.
 After incubation, mix the SX2 broth.  In parallel, transfer 0.1 mL of pre-enrichment broth into
If a water-bath is used, transfer 1-2 mL of SX2 broth into 10 mL of Rappaport Vassiliadis broth. Incubate for
a tube. Seal the tube. Heat for 15  1 minutes at 18-24 hours at 41  1°C.
95-100°C. Cool the tube. Mix the boiled broth using a Post-enrichment
vortex-type mixer and transfer 0.5 mL into the sample
®  After incubation,
well on the VIDAS strip.
® - transfer 1 mL of Selenite Cystine broth into 10 mL of
If the VIDAS Heat and Go is used, transfer 0.5 mL of
M broth.
SX2 broth into the sample well on the strip. Heat for
® - Into another tube of M broth, transfer 1 mL of
15  1 minutes (see the VIDAS Heat and Go User
Rappaport Vassiliadis broth.
Manual). Remove the strip and leave to cool for at least
- Re-incubate the Selenite Cystine and Rappaport
10 minutes.
® Vassiliadis broths at their respective temperatures.
 Perform the VIDAS assay.
 Incubate both M broths for 6-8 hours at 41  1°C.
Note: The non-heated SX2 broth can be stored for
®  After incubation46 0 Tio3f the suD-.0011 D-.001-1.1667 TD0 Tc0 Tw(-)T
72 hours at 2-8°C before the VIDAS assay is
performed.
 Confirm the positive results.
Note: If confirmation is not initiated immediately after a
®
positive VIDAS test, store the SX2 broth at 2-8°C.
Confirmation must be initiated within 72 hours following
the end of incubation.
Confirmation of positive results obtained using the Easy
Salmonella AOAC RI and AOAC OMA approved protocol
All positive results obtained with VIDAS® SLM must be
confirmed.
Perform one of the following 2 procedures:
 Products validated according to the FDA/BAM
procedure:
- Isolate the SX2 broth onto XLD, Bismuth Sulfate and
Hektoen agar plates or a combination of SM2 and XLD
or Hektoen agar plates.
- Incubate the plates.
- Identify between one and five typical colonies
according to the FDA/BAM guidelines (3)
 Products validated according to the USDA procedure:
- isolate the SX2 broth onto XLT4 and BGS agar plates
or a combination of SM2 and XLT4 or BGS agar
plates.
- Incubate the plates.
- Identify between one and five typical colonies
according to the conventional tests described in the
USDA/FSIS Microbiology Laboratory Guidebook (9).
Protocols outside the scope of NF VALIDATION, DIN
and AOAC: environmental samples

Production environmental samples (excluding


primary production)
Given the diversity of manufacturing processes,
bioMérieux recommends you validate the following
protocol:
Pre-enrichment
 Dilute the sample 1/10 in Buffered Peptone Water.
Note: For environmental surface samples, the collection
device should first be dampened with a sterile diluent
(e.g. Buffered Peptone Water) containing a suitable
neutralizing agent (e.g. Lecithin-Polysorbate-L.Histidine-
Sodium Thiosulfate mixture), if necessary. After
collection, place the device in a suitable volume of
enrichment broth (e.g.: swab in 10 mL, sampling pad in
100 mL).
 Incubate for 16-20 hours at 37  1°C.

bioMérieux SA English - 7
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

Post-enrichment Procedure
 After incubation, transfer 0.1 mL of Muller-Kauffman 1. Only remove the required reagents from the
broth into 10 mL of M broth (imperatively preheated at refrigerator and allow them to come to room
41  1°C). temperature for 30 minutes before use.
 Incubate for a minimum of 6 hours at 41  1°C. ®
2. Use one “SLM” strip and one “SLM” SPR for each
Incubation can be extended to up to 24 hours.
sample, control or standard to be tested. Make sure
 After incubation, mix the M broth.
the storage pouch has been carefully resealed
If a water-bath is used, transfer 1-2 mL of M broth into a ®
after the required SPR s have been removed.
tube. Seal the tube. Heat for 15  1 minutes at
95-100°C. Cool the tube. Mix the boiled broth using a 3. The test is identified by the "SLM" code on the
vortex-type mixer and transfer 0.5 mL into the sample instrument. The standard must be identified by "S1",
®
well on the VIDAS strip. and tested in duplicate.
®
If the VIDAS Heat and Go is used, transfer 0.5 mL of M If the positive control needs to be tested, it should be
broth into the sample well on the strip. Heat for identified by "C1".
®
15  1 minutes (see the VIDAS Heat and Go User If the negative control needs to be tested, it should be
Manual). Remove the strip and leave to cool for at least identified by "C2".
10 minutes.
®
 Perform the VIDAS assay.
Note: The non-heated post-enrichment broth (M broth)
®
can be stored for 24 hours at 2-8°C before the VIDAS
assay is performed.
 Confirm the positive results.
Confirmation of positive results
All positive results obtained with VIDAS® SLM must be
confirmed.
Using the non-heated M broth,
 Isolate on selective agar (preferably chromogenic agar
®
such as chromID Salmonella or ASAP™ agar).
 Incubate the agar at 37  1°C for 24 hours.
 Identify typical colonies.
Caution: any deviation from the recommended protocols
must be validated prior to use.

INSTRUCTIONS FOR USE


For complete instructions, see the User Manual.
Reading MLE data
When opening a new lot of reagents, enter the
specifications (or factory master data) into the instrument
using the MLE data. If this operation is not performed
before initiating the tests, the instrument will not be able
to print results.
It is possible to enter the MLE data manually or
automatically depending on the instrument (refer to the
User Manual).
Note: The master lot data need only be entered once
for each lot.
Calibration
Calibration, using the standard 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 standard, identified by S1, must be tested in
duplicate (see User Manual). The standard value must
be within the set RFV "Relative Fluorescence Value"
range. If this is not the case, recalibrate.

bioMérieux SA English - 8
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

The VIDAS® Heat and Go system has been evaluated on


A result with a test value that is less than the threshold
a large number of food matrices. Given the wide variety of
value indicates that the sample does not contain
food matrices and manufacturing procedures, when
Salmonella antigens or contains Salmonella antigens at a
commissioning the system, it is recommended to verify
concentration below the detection limit.
that the heating step does not result in a substantial
A result with a test value that is greater than or equal to coagulation or precipitation of the sample in the sample
the threshold value indicates a sample contaminated with well as this could lead to an incorrect volume of sample
®
Salmonella. In this case, refer to the section on being taken into the SPR .
"Confirmation of positive results". PERFORMANCE
Invalid results are reported: The performance data obtained in the context of NF
 when the background reading is above a pre- VALIDATION certification are available in the synthesis
determined cut-off (indicating substrate contamination). report on the AFNOR certification website: http://nf-
In this case, repeat the assay with the heated broth or validation.afnor.org/en.
the reagent concerned (S1, C1 or C2).
 if there is no standard available for the lot number of the The performance data were obtained using bioMérieux
sample test strip. culture media.
In this case, run a standard in duplicate in strips with the
®
same lot number as the invalid sample test. The sample The VIDAS Salmonella single and dual enrichment
test result can then be recalculated using the new stored methods have been certified NF VALIDATION as an
standards. See the User Manual for complete alternative analysis method for the detection of
information. Salmonella in all human and pet food products.
This validation has been obtained by comparison with
QUALITY CONTROL the reference method described in the international
standard EN ISO 6579 (6) according to the standard
One positive control and one negative control are included
® EN ISO 16140-2 (11).
in each VIDAS SLM kit.
The BIO-12/1-04/94 (dual path protocol) and the BIO-
These controls must be performed each time a new lot of
12/10-09/02 (single path protocol) validation
reagents is opened to verify the calibration (see section
certificates can be obtained from our Technical
“Calibration”).
Assistance Service or from AFNOR Certification. The
It is also recommended to perform the controls each time
dates of end of validity for the NF VALIDATION
new kits are received to ensure that reagent performance
certification are indicated on the certificates.
has not been altered.
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. BIO-12/1-04/94
BIO-12/10-09/02
Note ALTERNATIVE ANALYTICAL METHODS FOR AGRIBUSINESS
Certified by AFNOR Certification
It is the responsibility of the user to perform Quality http://nf-validation.afnor.org/en
Control in accordance with any applicable local
regulations. The VIDAS® Easy Salmonella method has been
certified NF VALIDATION as an alternative analysis
LIMITATIONS OF THE METHOD
 Although the most prevalent serovars of Salmonella are
detected using the Salmonella spp Latex test, reference
MGNF42, it should be noted that during the extension of
the NF VALIDATION certification for the
®
VIDAS Salmonella method, the latex test did not detect
41 or 47 out of the 150 Salmonella strains tested, with
®
the chromID Salmonella and ASAP agars
respectively.
 Rare cases of cross-reactivity may be observed with
certain enterobacteria strains (for example, Citrobacter).
Caution
®
The VIDAS SLM assay has been evaluated on a large
number of products. Given the wide variety of products
and manufacturing procedures, it is recommended to
check that the composition of the matrices tested does not
®
affect the reliability of the VIDAS SLM results.

bioMérieux SA English - 9
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

®
The VIDAS Salmonella method has been validated
and certified by AOAC INTERNATIONAL as an Official
Method of Analysis (Certificate No. 2004.03) for the
detection of Salmonella spp. in a variety of foods.
The following matrices were included in the AOAC
validation: egg powder, nonfat dry milk, cheese powder,
raw peeled shrimp, raw cod, roast beef, pork sausage,
raw ground pork, raw turkey, meat and bone meal, milk
chocolate, orange juice, coconut, cauliflower, black
pepper, pecans, peanut butter, dry pasta, cake mix, soy
flour, yeast, lactic casein, gelatine, spent irrigation water.

®
The VIDAS Salmonella method has been validated
and certified by AOAC INTERNATIONAL as an Official
Method of Analysis (Certificate No. 996.08) for the
detection of Salmonella spp. in a variety of foods.
The following matrices were included in the AOAC
validation: egg powder, nonfat dry milk, cheese powder,
raw shrimp, raw fish, roast beef, raw pork, raw turkey,
bone meal, milk chocolate, coconut, black pepper,
pecans, peanut butter, dry pasta, cake mix, soy flour,
yeast, lactic casein, gelatine.

The VIDAS®

bioMérieux SA English - 10
VIDAS Salmonella (SLM) 06984 Y - en - 2018/06

INDEX OF SYMBOLS LIMITED WARRANTY


Symbol Meaning bioMérieux warrants the performance of the product for its
stated intended use provided that all procedures for
Catalog number usage, storage and handling, shelf life (when applicable),
and precautions are strictly followed as detailed in the
Manufacturer instructions for use (IFU).
Except as expressly set forth above, bioMérieux hereby
disclaims all warranties, including any implied warranties
Temperature limit
of merchantability and fitness for a particular purpose or
use, and disclaims all liability, whether direct, indirect or
Use by date consequential, for any use of the reagent, software,
instrument and disposables (the “System”) other than as
set forth in the IFU.
Batch code

Consult Instructions for Use

Contains sufficient for <n> tests

Date of manufacture

REVISION HISTORY

Change type categories:


N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the
revision history.

Release date Part Number Change Type Change Summary


Reagents, materials and disposables required but not
Administrative provided
2016/07 06984W Performance
Technical change Samples
Reagents, materials and disposables required but not
Administrative provided
Limited Warranty
2017/10 06984X Samples
Limitations of the method
Technical Change
Performance
Literature references

BIOMERIEUX, the BIOMERIEUX logo, API, ASAP, CHROMID, SMASHER, SPR, VIDAS and VITEK 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.

673 620 399 RCS LYON


bioMérieux SA Tel. 33 (0)4 78 87 20 00
376 Chemin de l’Orme Fax 33 (0)4 78 87 20 90
69280 Marcy-l'Etoile - France www.biomerieux.com

You might also like