3M Allergen Protein Rapid Kit Operating instructions

Type
Operating instructions
1
(English)
EN
Issue Date: 2017-11
Product Instructions
Bovine Total Milk Protein Rapid Kit
Lateral Flow Devices (LFD) for qualitative analysis of bovine total milk proteins
Product Description and Intended Use
The 3M™ Bovine Total Milk Protein Rapid Kit is intended for screening for the presence of bovine total milk proteins in
clean-in-place (CIP) nal rinse water, environmental swab samples, food ingredients and processed food products.
The 3M Bovine Total Milk Protein Rapid Kit utilizes a lateral ow device (LFD) that is an immunochromatographic test
method utilizing a poly-clonal antibody which is specic for the detection of bovine milk proteins. Positive results are
visualized by the presence of three lines; the test line, the hook line and the control line, when milk protein is present at
or above 3 ppm for food raw ingredients, processed food products and CIP or rinse water solution, and at above
2.5 g/mL per 100 cm for surfaces. These limits may vary depending on the matrix. Samples containing more than 3%
milk may result in an invalid test which will be noticed by the absence of the hook line and/or test line. The dynamic
range of the 3M Bovine Total Milk Protein Rapid Kit has been shown to be 1.25 ppm and 1,500 ppm from bovine milk.
The upper limit of detection has been shown to be approximately 1.5 mg/mL of NISTa 1549 in distilled water.
The 3M Bovine Total Milk Protein Rapid Kit is intended for use in the food and beverage industry by trained personnel.
3M has not documented the use of this product in industries other than food or beverage. For example, 3M has not
documented this product for testing pharmaceutical, cosmetic, clinical or veterinary samples. The 3M Bovine Total Milk
Protein Rapid Kit has not been evaluated with all possible food products, food processes and testing protocols.
The 3M Bovine Total Milk Protein Rapid Kit contains 25 tests, described in Table 1.
Table 1. Kit components
Item Identication Quantity Storage
3M
TM
Bovine Total Milk
Protein Lateral Flow Device
(LFD)
Lateral ow device in a
plastic cassette
25 devices individually
packed.
Store at 2-8°C.
Do not freeze.
3M
TM
Extraction Buer Bottle with Extraction Buer 1 bottle containing 50 mL Store at 2-8°C.
Do not freeze.
Dilution Tubes Microcentrifuge tube
(2.2 mL volume capacity)
26 tubes Store in a clean dry place.
Materials not provided in the kit:
a. Swabs and pipettes.
b. The use of vortex, timer and balance are recommended but not required for all samples.
c. The use of a centrifuge is required for all chocolate and gum samples and it is recommended, but not required
for all solid samples.
Safety
The user should read, understand, and follow all safety information in the instructions for the 3M Bovine Total Milk Rapid
Kit. Retain the safety instructions for future reference.
WARNING: Indicates a hazardous situation, which, if not avoided, could result in death or serious injury and/or
property damage.
NOTICE: Indicates a potentially hazardous situation, which, if not avoided, could result in property damage.
W WARNING
To reduce the risks associated with inaccurate results:
3M has not documented the use of 3M Bovine Total Milk Protein Rapid Kit in industries other than food or
beverage. For example, 3M has not documented this product for testing pharmaceutical, cosmetic, clinical or
veterinary samples.
3
2
(English)
EN
3M Bovine Total Milk Protein LFD should be read 11 ± 1 minutes after sample has been loaded on the lateral ow
device.
The 3M Extraction Buer is designated for use with a specic lot of 3M Bovine Total Milk Protein LFD. Do NOT
interchange 3M Bovine Total Milk Protein Rapid Kit components with other lots or kits.
The 3M Extraction Buer is designated for use with a specic lot of 3M Bovine Total Milk Protein LFD. Dispose of
any remaining 3M Extraction Buer once all 3M Bovine Total Milk Protein Lateral Flow Devices have been used.
Store the 3M Bovine Total Milk Protein Rapid Kit as indicated on the package and in the product instructions.
Always use the 3M Bovine Total Milk Protein Rapid Kit by the expiration date.
Always use the 3M Bovine Total Milk Protein Rapid Kit at 20-25°C temperature.
To reduce the risks associated to false negative results:
Use the 3M Bovine Total Milk Protein Rapid Kit for food and environmental samples that have been validated
internally or by a third party.
To reduce the risks associated with exposure to chemicals:
3M Bovine Total Milk Protein Rapid Kit is intended for use in the food and beverage industries by trained personnel.
NOTICE
To reduce the risks of inaccurate results:
Refer to the Interpretation of Results section of the product instructions, to ensure accurate interpretation of the
3M Bovine Total Milk LFD.
Consult the Safety Data Sheet for additional information.
For information on documentation of product performance, visit our website at www.3M.com/foodsafety or contact
your local 3M representative or distributor.
User Responsibility
Users are responsible for familiarizing themselves with product instructions and information. Visit our website at
www.3M.com/foodsafety, or contact your local 3M representative or distributor for more information.
As with all test methods used for food analysis the test matrix can inuence the results. When selecting a test
method, it is important to recognize that external factors such as sampling methods, testing protocols, sample
preparation, handling, and laboratory technique may inuence results. The food sample itself may inuence results.
It is the user’s responsibility in selecting any test method or product to evaluate a sucient number of samples to satisfy
the user that the chosen test method meets the user’s criteria.
It is also the user’s responsibility to determine that any test methods and results meet its customers’ and suppliers’
requirements.
As with any test method, results obtained from use of any 3M Food Safety product do not constitute a guarantee of the
quality of the matrices or processes tested.
Limitation of Warranties/Limited Remedy
EXCEPT AS EXPRESSLY STATED IN A LIMITED WARRANTY SECTION OF INDIVIDUAL PRODUCT PACKAGING, 3M
DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE. If any 3M Food Safety Product is defective, 3M or its
authorized distributor will, at its option, replace or refund the purchase price of the product. These are your exclusive
remedies. You must promptly notify 3M within sixty days of discovery of any suspected defects in a product and return
it to 3M. Please call Customer Service (1-800-328-1671 in the U.S.) or your ocial 3M Food Safety representative for a
Returned Goods Authorization.
Limitation of 3M Liability
3M WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGES, WHETHER DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS. In no event shall 3M’s liability under
any legal theory exceed the purchase price of the product alleged to be defective.
Storage and Disposal
Store all 3M Bovine Total Milk Protein Rapid Kit components at 2-8°C.
3M Bovine Total Milk Protein Rapid Kit components should not be frozen, exposed to UV light or exposed to prolonged
heat (>30°C).
3
(English)
EN
3M Bovine Total Milk Protein Rapid Kit components should not be used past the expiration date. Expiration date and lot
number are noted on the outside label of the box.
Please note that each 3M Extraction Buer lot is validated specically for each LFD lot and is not interchangeable
with any other lots or kits.
Dispose according to current local/regional/industry standards and regulations.
Instructions for Validated Methods
AOAC
®
Performance Tested Method
SM
#091701
In AOAC Research Institute PTM
SM
studies, the3M Bovine Total Milk Protein Rapid Kit was found to be a reliable robust
method suitable for detecting bovine milk protein down to 3 ppm from multiple reference sources in food products and
rinse materials, and 2.5 g/mL per 100 cm on surfaces.
This method has been validated to detect milk in: soy milk, baked sugar cookies, chocolate dessert, CIP rinse water
and 100 cm samples from stainless steel surfaces.
The dynamic range of the assay was determined to be between 1.25 ppm and 1,500 ppm for protein from bovine
milk.
Instructions for Use
Follow all instructions carefully. Failure to do so may lead to inaccurate results. Ensure that all 3M Bovine Total Milk
Protein Rapid Kit components are at ambient temperature (20-25°C) prior to use.
Sample analysis
1. CIP Final Rinse Water Samples
1.1 Label one microcentrifuge tube for each CIP sample.
1.2 Add 800 L of 3M Extraction Buer to a labeled microcentrifuge tube.
1.3 Add 200 L of CIP nal rinse water sample. Shake vigorously or vortex for 15 seconds to mix thoroughly to
obtain an extracted sample.
Note: The pH of extracted sample should be between 5 and 10. Proceed to Troubleshooting section for
additional information.
1.4 Remove one 3M Bovine Total Milk Protein LFD from package and place on a clean, dry, at surface.
1.5 Transfer 100 L of the extracted sample prepared in 1.3 using a clean pipette or pipette tip and apply it
to the sample well on the 3M Bovine Total Milk Protein LFD. Start the timer for 11 ± 1 minutes. Proceed to
Interpretation of Results section.
or
00:00:15
2. Environmental Swab Samples
2.1 Label one microcentrifuge tube for each Environmental Swab Sample.
2.2 Add 500 L of 3M Extraction Buer into a labeled microcentrifuge tube.
4
(English)
EN
2.3 Take a clean swab and dip the entire tip into the microcentrifuge tube wetting the tip with 3M Extraction
Buer. Gently express excess liquid from tip by pressing swab tip lightly on the inside of the tube.
2.4 Take wetted swab and survey a 10 X 10 cm
surface area maintaining the swab at a 30° angle with the surface.
Rub the swab slowly and thoroughly over the surface area. Rub the swab three times over this surface,
reversing direction between alternating strokes.
2.5 Take swab and insert it back into the pre-labeled tube and swirl swab several times to release any residues
that might be on the surface of swab into the 3M Extraction Buer. Break o swab tip in tube, cap tightly and
mix well to obtain an extracted sample.
2.6 Remove one 3M Bovine Total Milk Protein LFD from the package and place on a clean, dry, at surface.
2.7 Transfer 100 L of the extracted sample prepared in 2.5 using a clean pipette or pipette tip and apply it
to the sample well on the 3M Bovine Total Milk Protein LFD. Start the timer for 11 ± 1 minutes. Proceed to
Interpretation of Results section.
or
00:00:15
3. Liquid Samples Except Liquid Chocolate Samples
3.1 Label one microcentrifuge tube for each liquid sample.
3.2 Measure 900 L of 3M Extraction Buer into a labeled microcentrifuge tube.
3.3 Add 100 L of a well-mixed sample. Shake vigorously or vortex for 15 seconds to mix thoroughly to obtain an
extracted sample.
Note: The pH of extracted sample should be between 5 and 10. Proceed to Troubleshooting section for
additional information.
3.4 Remove one 3M Bovine Total Milk Protein LFD from package and place on a clean, dry, at surface.
3.5 Transfer 100 L of the extracted sample prepared in 3.3 from the middle (aqueous) layer using a clean pipette
or pipette tip and apply it to the sample well on the 3M Bovine Total Milk Protein LFD. Start the timer for 11 ± 1
minutes. Proceed to Interpretation of Results section.
5
(English)
EN
or
00:00:15
4. Liquid Chocolate Samples
4.1 Label two microcentrifuge tubes for each Liquid Chocolate Sample.
4.2 To make a prepared sample, add 500 L of a well-mixed Liquid Chocolate Sample and add 500 L of 3M
Extraction Buer into one labeled microcentrifuge tube and shake vigorously to mix thoroughly or vortex for
approximately 15 seconds.
4.3 Add 900 L of 3M Extraction Buer into the second labeled microcentrifuge tube and add 100 L of the
Prepared Sample from step 4.2. Shake vigorously to mix thoroughly or vortex for approximately 15 seconds.
4.4 Centrifuge for 20-30 seconds at 5000-7000 rpm (3000 x g). The supernatant is the extracted sample.
4.5 Remove one 3M Bovine Total Milk Protein LFD from package and place on a clean, dry, at surface.
4.6 Transfer 100 L of the extracted sample prepared in 4.4 from the middle (aqueous) layer using a clean pipette
or pipette tip and apply it to the sample well on the 3M Bovine Total Milk Protein LFD. Start the timer for 11 ± 1
minutes. Proceed to Interpretation of Results section.
or
00:00:15
6
(English)
EN
5. Solid Samples
5.1 Label one microcentrifuge tube for each non-liquid sample.
5.2 Grind sample into a ne homogeneous powder.
5.3 Measure 0.2 g of sample into a labeled microcentrifuge tube.
5.4 Add 1.8 mL of the 3M Extraction Buer to the sample in the microcentrifuge tube. Shake vigorously or vortex
for 15 seconds to mix thoroughly to obtain an extracted sample.
Note: Melt chocolate samples.
5.5 Centrifuge for 20-30 seconds at 5000-7000 rpm (3000 x g). The supernatant is the extracted sample.
5.6 Remove one 3M Bovine Total Milk Protein LFD from package and place on a clean, dry, at surface.
5.7 Transfer 100 L of the extracted sample prepared in 5.5 from the middle (aqueous) layer using a clean pipette
or pipette tip and apply it to the sample well on the 3M Bovine Total Milk Protein LFD. Start the timer for 11 ± 1
minutes. Proceed to Interpretation of Results section.
1.8mL
00:00:15
or
Interpretation of Results
The control line is next to the letter C on the 3M Bovine Total Milk Protein LFD. The test line is next to the letter T on the
3M Bovine Total Milk Protein LFD. The hook line is next to the letter H and/or in between the T and C lines. Note: Some
LFD cassettes might not have an H marking on the side of the plastic cassette.
Read LFD at 11 ± 1 minutes after application of the sample. A sample is considered to be:
a. Negative for bovine total milk protein when only the two lines furthest from the well; the control and the hook
line, are visible on the 3M Bovine Total Milk Protein LFD.
b. Positive for bovine total milk protein when all three lines (test, hook and control line) are visible on 3M Bovine
Total Milk Protein LFD.
c. Invalid, if the 3M Bovine Total Milk Protein LFD does not develop the middle hook line. The sample may be
overloaded with bovine total milk protein and needs to be diluted.
d. Invalid, if the 3M Bovine Total Milk Protein LFD does not develop the control line.
7
(English)
EN
C = Control line
H = Hook line
(except Gluten)
T = Test line
Any reading after 12 minutes from the initial application of the sample into the 3M Bovine Total Milk Protein LFD should
be considered invalid. A reading at this time cannot be interpreted and can lead to erroneous results.
Troubleshooting
1. Sample fails to migrate across the strip within the rst 5 minutes after application of the sample in the 3M Bovine
Total Milk Protein LFD.
The sample may be too viscous and needs to be centrifuged if this was not already done during the preparation of
the sample. If sample was already centrifuged, then preparing a 1:1 dilution with the 3M Extraction Buer may be
necessary. (Note: Detection limit may be higher depending on the dilution factor.)
2. A red dot appears on the test line but remainder of test line does not change color.
Sample particulate may have passed around the lter in the cassette, simply re-run the sample by taking a new 3M
Bovine Total Milk Protein LFD from the kit and repeat the test.
3. The pH of extracted sample should be between 5 and 10. If pH is outside this range, further dilution may be
required (i.e., prepare a 1:1 dilution with 100 L of the extracted sample and 100 L of 3M Extraction Buer.
Detection limit may be higher depending on the dilution factor.)
If you have questions about specic applications or procedures, please contact your 3M Food Safety representative or
distributor.
Minimum Performance Characteristics
Lowest Limit of Detection
(a)
3 ppm
Upper Limit of Detection 1.5 mg/mL
(a)
The lowest limit of detection is dened as the lowest concentration of the allergen in a test sample that can be
distinguished from a true blank sample at a specied probability level
1
.
References
1. Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F., Van Hengel, A. J., Roberts, J., Akiyama, H., Popping,
B., Yeung, J.M., Wehling, P., Taylor, S., Poms, R.E., and Delahaut, P. (2010). Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. J. AOAC Int. 93, 442-450.
Explanation of Symbols
www.3M.com/foodsafety/symbols
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
(Français)
FR
8
Caractéristiques des performances minimales
Seuil minimal de détection
(a)
3ppm
Seuil maximal de détection 1,5 mg/mL
(a)
Le seuil minimal de détection correspond à la concentration la plus faible de l’allergène dans un échantillon de test
qui peut être distingué d’un véritable échantillon blanc à un niveau spécié de probabilité
1
.
Références
1. Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F., Van Hengel, A. J., Roberts, J., Akiyama, H., Popping,
B., Yeung, J.M., Wehling, P., Taylor, S., Poms, R.E., and Delahaut, P. (2010). Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. J. AOAC Int. 93, 442-450.
Explication des symboles
www.3M.com/foodsafety/symbols
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
(Italiano)
IT
8
3. Il pH del campione estratto deve essere compreso tra 5 e 10. Se il pH è al di fuori di questo intervallo, potrebbe
essere necessaria un'ulteriore diluizione (ovvero, preparare una diluizione 1:1 con 100 l di campione estratto e
100 l di tampone di estrazione 3M. Il limite di rilevamento potrebbe essere superiore a seconda del fattore di
diluizione).
Per qualsiasi domanda su applicazioni o procedure speciche, contattare il distributore o il rappresentante 3M Sicurezza
Alimentare.
Caratteristiche minime di funzionamento
Limite minimo di rilevamento
(a)
3 ppm
Limite massimo di rilevamento 1,5 mg/ml
(a)
Il limite minimo di rilevazione è denito come la concentrazione più bassa dell'allergene in un campione di test che
può essere distinta da un campione veramente bianco a un livello di probabilità specicato
1
.
Bibliograa
1. Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F., Van Hengel, A. J., Roberts, J., Akiyama, H., Popping,
B., Yeung, J.M., Wehling, P., Taylor, S., Poms, R.E., and Delahaut, P. (2010). Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. J. AOAC Int. 93, 442-450.
Legenda dei simboli
www.3M.com/foodsafety/symbols
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
(Español)
ES
8
Si tiene preguntas sobre aplicaciones o procedimientos especícos, comuníquese con su representante o distribuidor
de 3M Food Safety.
Características mínimas de rendimiento
Límite inferior de detección
(a)
3ppm
Límite superior de detección aproximadamente 1,5mg/ml
(a)
El límite inferior de detección más bajo se dene como la menor concentración del alérgeno en una muestra de
prueba que se pueda distinguir de una verdadera muestra blanca en un nivel de probabilidad especicado
1
.
Referencias
1. Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F., Van Hengel, A. J., Roberts, J., Akiyama, H., Popping,
B., Yeung, J.M., Wehling, P., Taylor, S., Poms, R.E., and Delahaut, P. (2010). Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. J. AOAC Int. 93, 442-450.
Explicación de los símbolos
www.3M.com/foodsafety/symbols
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
(Nederlands)
NL
8
Minimale prestatiekenmerken
Onderste detectiegrens
(a)
3 ppm
Bovenste detectiegrens 1,5 mg/ml
(a)
De onderste detectiegrens wordt gedenieerd als de laagste concentratie van het allergeen in een testmonster dat
kan worden onderscheiden van een blanco monster op een speciek waarschijnlijkheidsniveau
1
.
Referenties
1. Abbott, M., Hayward, S., Ross, W., Godefroy, S.B., Ulberth, F., Van Hengel, A. J., Roberts, J., Akiyama, H., Popping,
B., Yeung, J.M., Wehling, P., Taylor, S., Poms, R.E., and Delahaut, P. (2010). Appendix M: Validation Procedures for
Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices. J. AOAC Int. 93, 442-450.
Verklaring van symbolen
www.3M.com/foodsafety/symbols
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3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
3M Health Care
2510 Conway Ave
St. Paul, MN 55144 USA
www.3M.com/foodsafety
© 2018, 3M. All rights reserved.
3M is a trademark of 3M. Used under license in Canada.
34-8721-9185-2
3
3M Food Safety
3M United States
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-800-328-6553
3M Canada
Post Oce Box 5757
London, Ontario N6A 4T1
Canada
1-800-563-2921
3M Latin America
3M Center
Bldg. 275-5W-05
St. Paul, MN 55144-1000
USA
1-954-340-8263
3M Europe and MEA
3M Deutschland GmbH
Carl-Schurz-Strasse 1
D41453 Neuss/Germany
+49-2131-14-3000
3M United Kingdom PLC
Morley Street,
Loughborough
Leicestershire
LE11 1EP
United Kingdom
+(44) 1509 611 611
3M Österreich GmbH
Euro Plaza
Gebaude J, A-1120 Wien
Kranichberggasse 4
Austria
+(43) 1 86 686-0
3M Asia Pacic
No 1, Yishun Avenue 7
Singapore, 768923
65-64508869
3M Japan
3M Health Care Limited
6-7-29, Kita-Shinagawa
Shinagawa-ku, Tokyo
141-8684 Japan
81-570-011-321
3M Australia
Bldg A, 1 Rivett Road
North Ryde, NSW 2113
Australia
61 1300 363 878
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3M Allergen Protein Rapid Kit Operating instructions

Type
Operating instructions

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