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National Measurement
Institute” and the Allergen
Testing Special Interest
Group
March 2013
National Measurement Institute Port Melbourne, Australia
National Measurement Institute
The National Measurement Institute is Australia’s peak
measurement organisation, responsible for the national
measurement infrastructure (biological, chemical, legal,
physical and trade measurement) and for maintaining
Australia’s primary standards of measurement
We are a division within the
Department of Innovation, Industry, Climate Change
Science and Research and Tertiary Education
(DIICCSRTE)
http://www.measurement.gov.au
National Measurement Institute
Microbiology Laboratory
Allergen Laboratory
Budapest Treaty Collection (Patent organisms)
Food Chemical Analysis
Environmental Analysis
Sports Drug Testing
Illicit Drug analysis
Time (Australia’s Atomic Clocks)
Physical Metrology – Mass, Length, Frequency
Legal Metrology – Patent Approvals
Reference Material Production
Proficiency Testing Schemes
Trade Measurement (Fuel pumps and Commercial scales)
NMI – Allergen Background National Measurement Institute – 20 years of food allergen analysis
Chromatography expertise within NMI – GC, LC, CE, MS, Bioanalyzer
Current Food Allergen analysis:
Gluten, Peanut, Sesame, Soy, Egg, Milk (Casein, Beta lactoglobulin),
Crustaceans, Almonds, Hazelnuts, Walnut, Pistachio, Macadamia, Cashew
PCR experience - GMO, food pathogens, digital PCR and some food
allergens
Implemented an automated ELISA analysis system
– Hamilton’s Micro Star liquid handling robot
Developing Chromatographic methods for allergen protein detection
– Mass accurate, Waters G2 Q-TOF
Allergen Activities – Education and
Participation Allergen Testing Special Interest Group
Australian Standards committee on Allergens
Proficiency rounds and materials
NATA assessors for allergen labs
Confirmation techniques
TIA (Technical Infrastructure Alliance) proposal
Technical workshops : – NMI Allergen Measurement Workshops – July 2009, in 3 states, 2 workshops, 3 evening seminars over 100
attendees from Industry – targeting SME
– Technical workshops in 2011 Brisbane as part of GFAC
Proficiency Testing
Proficiency testing is a means of assessing the ability of
laboratories to competently perform specific tests and
measurements
Proficiency testing can setup so the samples
are tested:
• internally (results compared within the laboratory)
• externally (results compared between different
laboratories)
Proficiency Testing & Quality
Control Materials
Benefits:
• Satisfy accreditation requirements
• Verify methods and procedures
• Satisfy regulators
• Identify problems
• Enhance accuracy
• Monitor analysis
• Compare with peers
• Demonstrate and Build confidence
Quality Control Materials
Used with every kit run
Provide:
– Within run control checks – assay drift
– Between run variations
– Batch to batch kit variations
– Comparison between kits
– Comparison between labs
– Measurement uncertainty data
Proficiency Round on Gluten in Custard
Powder AQA 10-21
Samples prepared by NMI PT section
Gluten in custard powder selected as a representative matrix
11 labs
Custard powder obtained for a commercial supplier
– Gluten containing product
– gluten free product
sieved and mixed
packaged into 100 g portions
Gluten test kits from different manufacturers can give very different results
All distinguish between gluten-containing and gluten-free, but quantitative results from different kits are not comparable
Proficiency Round on Sesame in Chocolate
Cake AQA 12-10
Real world (not incurred) sample of cake mix containing low level
sesame protein
recalled product with history of reactions in allergic individuals
7 labs participating
All correctly identified positive and negative samples
MU quoted ranged from 7.7 to 290%
Included re-run of gluten custard powder proficiency samples
11 labs participating – nine submitted resultS
Much better co-relation of results in follow up round
Allergen Quality Control Material
What does this “simple” reference material give us?
An inexpensive regular use material
Comparison between labs and kits
An ability to track kit variations and variations between different kit manufactured kits
Option to tailor-make a material with desired target level by mixing target containing and target free materials.
A real “incurred sample”
Small dry particles for stability
Shelf stable storage
Supporting quality assurance that the daily ELISA run is performing appropriately
Food Allergy in Australia
Australia and New Zealand among the highest prevalence of allergic disorders in the developed world
Estimated 4.1 million Australians have at least one allergy (19.6%)
Hospital admission x2 in last 10yrs
Increase of 5 fold for 0-4 year olds
Peanut allergy x2 in 5yr period
Financial cost of Allergies 7.8 billion in 2007
Data published in October Issue of Journal of Allergy and Clinical Immunology
Precautionary Labeling
May contain occasional nut
May contain peanuts, nuts and other allergens not listed on the label
Allergy information: Baked in a facility that uses dairy
May contain unknowns substances
May contain traces of vitamins and water (snack bar)
Coconut milk is gluten free and therefore is suitable for those with cow’s milk allergy
Global differences and definitions
Australia and New Zealand – Coconut not generally considered a tree nut
EU – following tree nuts defined – Almonds, Brazil nuts, Cashews, Hazelnuts, Pecan nut, Pistachio nut, Walnuts, Macadamia or Queensland Nut
USA : tree nuts defined – Almond, Beech, Brazil nut, Butternut, Cashew, Chestnut, Chinquapin, Coconut, Filbert/hazelnut, Ginko nut, Hickory, nut, Lichee nut, Macadamia nut/ Bush nut, Pecan, Pine nut/ Pinon nut, Pistachio, Sheanut, Walnut
Canada - almonds, Brazil nuts, cashews, hazelnuts [filberts], macadamia nuts, pecans, pinenuts, pistachios, walnuts
Peanuts which are legumes - earthnuts, ground nuts, goober peas, monkey nuts, pygmy nuts and pig nuts
Global differences and definitions
EU Cereals defined: Wheat, Oats, Barley, Rye, Kamut, Spelt, Triticale
USA - The term "wheat" in regulation refers to any species in the genus Triticum…. so wheat would include semolina, Einkorn, emmer in addition to EU list
Japan – Mandatory and Recommended list - Buckwheat
Codex Alimentarius etc
Driven by available analysis tools
Food Allergen Management in
Australia
FSANZ mandatory labelling 2002
Advisory or precautionary
statements
Allergen Bureau – Info resource
GMP – Hygiene control
Recalls
Raw ingredient and final product
testing
Industry Tool Kit
AFGC – Allergen Management and
Labelling Guide
Allergen bureau
Food Industry Product Information Form (PIF)
The VITAL tool
Analysis tools
Metrology or Measurements
Physical Measurements – Amount (length, time, mass)
Chemical Measurements – Amount (ppm) Type of substance (Benzene
Biological Measurements – Amount (mg/kg)
Allergen protein (Ara h1 peanut etc)
Activity / Allergenicity (digestibility, stability,
heat resistance, irraditated,
active sites available ,
modified or concealed)
Accuracy & Precision
Accuracy is the degree of
closeness of a measured
or calculated quantity to
its actual (true) value
Precision, also called
reproducibility or
repeatability, the degree
to which further
measurements or
calculations show the
same or similar results
Accuracy & Precision
Accuracy
Accuracy in Food Allergen analysis is very difficult to
estimate due to: • difficultly in defining the test parameter, target or measurand – gluten,
gliadin, ethanol/water extractable component, penta peptide, G12
sequence
• Modifications to target protein
• inherent variations in biological systems
• lack of reference standards
• Inhibitory or matrix impacts of food – salt, pH etc
• Sampling variation due to uneven distribution of allergen
Precision
Easier to estimate when compared to accuracy of food
biological measurements
Referred to as reproducibility or repeatability
The reproducibility of results is what is often used to
estimate measurement uncertainty for Biological
measurements
Measurement Uncertainty
(MU)
MU Introduction “A parameter associated with the result of a measurement that
characterises the dispersion of the values that could reasonably
be attributed to the measurand.”1,2
1 “International vocabulary of basic and general terms in metrology” (VIM), (1993), 2nd ed., ISO, Geneva, Switzerland. 2 “ISO/TS 19036 (ISO GUM).
Biological MU
• A “top-down” or “global” approach is preferred world wide
for Biological MU
• Based on the standard reproducibility of the final
measurement process
• Based on the overall variability of the analytical process
• Estimation of the laboratories analytical method as a
whole, ignoring individual analytical components
Decision Making
(a) When compliance decisions are clear, then only rough estimates of MU are needed.
(b) When measured results are close to decision points, good estimates of MU and MU values will improve decision making.
(c) Where false positive decisions are undesirable, underestimation of MU can lead to inappropriate decisions.
(d) In some cases the risk of compliance/non-compliance can be shared. Careful consideration would need to be given to the level of MU and the reliability of the estimation.
MU from Within-Lab Derived Data
• Repeatability (common approach)
• Stable, consistent product
• Multiple runs on different days
• Different operators
• Different kit batches
• Upper and lower temperature range in Lab
MU from External Proficiency
Testing Data
• Use already existing data
• Represents a long term MU calculations
• Must be same methods
• Acceptable range for International PT +/- 50%
• Calculated MU +/- 30%
Measurement Uncertainty for
Biologists – Course run by NMI
This one-day course explains the general principles of estimating measurement uncertainty in
quantitative biological analysis. Interactive workshops with case studies based on real
analytical problems are used to reinforce these principles.
Objectives
– The course provides participants with the knowledge and skills to:
– understand the principles involved in measurement uncertainty and traceability
– apply uncertainty concepts when developing and conducting routine analysis
– make ISO/IEC 17025 compliant estimates of measurement uncertainty
Outline
– The topics covered include:
– uncertainty definitions and concepts
– sources of uncertainty in calibrants
– uncertainty from the measurement process
– combining uncertainties
– calculating and reporting expanded uncertainties
– worked examples
AT-SIG: Target audience
Allergen Bureau Membership
Testing Laboratories
Accreditation bodies
Regulators
Industry Bodies
Consumer Advocates
Kit Manufacturer or Distributor
AT-SIG: Group Aim
Improve food allergen analysis
Share challenges and issues - Address common or reoccurring issues
Keep labs talking – particularly on overlapping issues
Provide a forum for formal and informal networking
Encourage input from all parties
Forum to present emerging technology applicable to food allergen analysis
Assist Laboratory accreditation
Guide – Proficiency, Reference Materials and Confirmation Methods
Keep up to date with International (and local) Allergen Activities
AT-SIG: Activities
First meeting held: October 2010 @ NMI Port Melbourne
Second meeting held: June 2011 @ NMI Port Melbourne
Third meeting held: April 2012 @ NMI Port Melbourne
25-30 participants per meeting
AT-SIG - Meeting Topics
Case studies
Proficiency Testing
Laboratory Accreditation for Allergens
Reporting Issues
Up coming Food Allergen events (Local and International)
Reference Materials
New technology
Reporting document
Input from Stakeholders: - 'greater than' results - all but useless for risk assessment purposes - lack of clarity around 'less than' results i.e. less than the LOD, or detected but less than the LOQ - lack of clarity around the whether the kit is calibrated/reporting against the allergenic protein, total protein or whole food - variability of results, including detections with different kits - significant in survey work where a number of labs may be involved
To address: - Reporting results below LOQ but above LOD - Numbers vs ranges
- Analyte or measurand – target - Units (ppm,mg/kg)
- Assumptions or exclusions Swabs - Sampling & sample size
- Known or suspected cross-reactivities - Measurement Uncertainty
- What to do with unexpected / disputed results - etc
AT-SIG: What have we learnt?
Analysts are keen to discuss issues (reasonably open) – despite competing commercial interests
Labs keen to be there (or scared not to be)
Discussion time as important as presentation – in fact presentation are often the background information leading into the discussions
We (Labs) often share the identical problems, sample, matrix, disputed results etc
Confirmation methods are important and needed
Benefits and Outcomes
Directly linked into industry issues – valuable information and shared experiences
Forum for immerging issues that brings experts into a single space - a resource to address immediate and longer term food allergen concerns
Aims to be conscious of but not completely restricted by confidentiality issues
Informal opportunities to raise concerns
Opportunity to be involved in shared research and development of allergen relevant protocols and documents
Drives and guides future Allergen activities – PT, Reference Materials and Confirmation Methods
Benefits and Outcomes
Precompetitive environment to discuss critical issues
Mentoring of labs with less opportunity to see challenging of issues
Proficiency program for participants (and others)
Reporting document
and potentially other guidance documents
Links participants into National and International activities
Future of AT-SIG
1 meeting per year
Communication – web space
Continue to seek relevant participants
Keep up to date with International developments
through network contacts
Email: [email protected] for more
information
THANK YOU
National Measurement Institute
1/153 Bertie Street
Port Melbourne
Australia
Phone: + 61 3 9644 4888
Email: [email protected]