Allergy IgE Allergy Test Sensitivity and Specificity 6/23/17

Size: px

Start display at page:

Download "Allergy IgE Allergy Test Sensitivity and Specificity 6/23/17"

Anthony Barrett
6 years ago
Views:

1 Allergy IgE Allergy Test Sensitivity and Specificity 6/23/17 1

2 Sensitivity and Specificity Benchmarking Goal Test pooled human sera with known positive and negative reactivity to determine Allergy sensitivity and specificity. 6/23/17 2

Sensitivity and Specificity Definitions Sensitivity measures the percentage of positives that are correctly identified as such. Sensitivity provides a measure of the false negative rate.

3 Sensitivity and Specificity Definitions Sensitivity measures the percentage of positives that are correctly identified as such. Sensitivity provides a measure of the false negative rate. Specificity measures the percentage of negatives that are correctly identified as such. Specificity provides a measure of the false positive rate. According to WebMD, one in five Americans have allergy or asthma symptoms. 6/23/17 3

4 Sensitivity and Specificity Benchmarking Design Test 10 pooled serum specimens with known positive reactivity to measure sensitivity. Test 10 pooled serum specimens with known negative reactivity to measure specificity. Generate Allergy Test results on the 20 pooled specimens. Calculate sensitivity and specificity percentages for Total IgE, 58 Inhalants and 33 Non- Inhalants. 6/23/17 4

5 Allergy Validation Specimens Specimen ID Description Specimen ID Description A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens A Positive to IgE and Allergens N Negative to IgE and Allergens The 10 positive specimens A to A were pooled and run as 10 separate aliquots on 10 Allergy Tests to measure sensitivity. The 10 negative specimens N to N were pooled and run as 10 separate aliquots on 10 Allergy Tests to measure specificity. 6/23/17 5

Allergy Total IgE Sensitivity 1000 800 600 400 200 0 Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU).

6 Allergy Total IgE Sensitivity Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU). 1 ASU = 1 ImmunoCAP IU/L. Allergy resulted 10 out of 10 positive scores for the 10 positive specimens for 100% Total IgE sensitivity. 6/23/17 6

Allergy Total IgE Specificity 1000 800 600 400 200 0 Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU).

7 Allergy Total IgE Specificity Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU). 1 ASU = 1 ImmunoCAP IU/L. Allergy resulted 10 out of 10 negative scores for the 10 negative specimens for 100% Total IgE specificity. 6/23/17 7

Allergy Total IgE Composite 900 800 700 600 500 400 300 200 100 0 Nega%ve IgE Posi%ve IgE 1 2 3 4 5 6 7 8 9 10 Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU).

8 Allergy Total IgE Composite Nega%ve IgE Posi%ve IgE Allergy Total IgE test scale is 0-1,000 antibody standard units (ASU). 1 ASU = 1 ImmunoCAP IU/L. Allergy resulted 10 out of 10 positive scores for the 10 positive specimens and 10 out of 10 negative scores for the 10 negative specimens for 100% Total IgE sensitivity and 100% total IgE specificity. 6/23/17 8

Allergy Inhalant Sensitivity 70000 60000 50000 40000 30000 20000 10000 0 Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax Bermuda grass Birch white Box

9 Allergy Inhalant Sensitivity Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax Bermuda grass Birch white Box elder Cat hair Cattle hair Cedar red Cedar mountain Cladosporium (f) Cocklebur Cockroach Cottonwood Dog hair Elm american Elm chinese English planain Epicoccum Horse hair Johnson grass June grass Juniper Kochia Lamb's quarters Maple pollen Mite farinae Mouse hair Mugwort Olive russian Pecan pollen Perennial ryegrass Phoma herbarum Poplar white Privet Queen palm Ragweed false Ragweed western Red birch Red mulberry Red oak Rough marsh elder Rough pigweed Sagebrush Short ragweed Sycamore american Tall ragweed Timothy grass Virginia live oak Walnut black pollen White ash White oak Willow black Allergy Total IgE test scale is 0-65,535 antibody standard units (ASU). 1,000 ASU = 1.5 ImmunoCAP KU/L. Allergy resulted 580 out of 580 positive scores for the 10 positive specimens across 58 analytes for 100% inhalant allergen sensitivity. 6/23/17 9

Allergy Inhalant Specificity 70000 60000 50000 40000 30000 20000 10000 0 Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax myrtle) Bermuda grass Birch

10 Allergy Inhalant Specificity Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax myrtle) Bermuda grass Birch white Box elder Cat hair Cattle hair Cedar red Cedar mountain Cladosporium (f) Cocklebur Cockroach Cottonwood Dog hair Elm american Elm chinese English planain Epicoccum Horse hair Johnson grass June grass Juniper Kochia Lamb's quarters Maple pollen Mite farinae Mouse hair Mugwort Olive russian Pecan pollen Perennial ryegrass Phoma herbarum Poplar white Privet Queen palm Ragweed false Ragweed western Red birch Red mulberry Red oak Rough marsh elder Rough pigweed Sagebrush Short ragweed Sycamore american Tall ragweed Timothy grass Virginia live oak Walnut black pollen White ash White oak Willow black Allergy Total IgE test scale is 0-65,535 antibody standard units (ASU). 1,000 ASU = 1.5 ImmunoCAP KU/L. Allergy resulted 580 out of 580 negative scores for the 10 negative specimens across 58 analytes for 100% inhalant allergen specificity. 6/23/17 10

Allergy Inhalant Composite 70000 60000 50000 40000 30000 20000 10000 0 Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax myrtle) Bermuda grass Birch

11 Allergy Inhalant Composite Alder Alternaria Aspergillus Aureobasidum Australian pine Bahia grass Bald cypress Bayberry (wax myrtle) Bermuda grass Birch white Box elder Cat hair Cattle hair Cedar red Cedar mountain Cladosporium (f) Cocklebur Cockroach Cottonwood Dog hair Elm american Elm chinese English planain Epicoccum Horse hair Johnson grass June grass Juniper Kochia Lamb's quarters Maple pollen Mite farinae Mouse hair Mugwort Olive russian Pecan pollen Perennial ryegrass Phoma herbarum Poplar white Privet Queen palm Ragweed false Ragweed western Red birch Red mulberry Red oak Rough marsh elder Rough pigweed Sagebrush Short ragweed Sycamore american Tall ragweed Timothy grass Virginia live oak Walnut black pollen White ash White oak Willow black 6/23/17 11

12 Allergy Inhalant Data Summary Analyte Sensitivity Specificity Analyte Sensitivity Specificity Alder Mite farinae Alternaria Mouse hair Aspergillus Mugwort Aureobasidum Olive russian Australian pine Pecan pollen Bahia grass Perennial ryegrass Bald cypress Phoma herbarum Bayberry (wax myrtle) Poplar white Bermuda grass Privet Birch white Queen palm Box elder Ragweed false Cat hair Ragweed western Cattle hair Red birch Cedar red Red mulberry Cedar mountain Red oak Cladosporium (f) Rough marsh elder Cocklebur Rough pigweed Cockroach Sagebrush Cottonwood Short ragweed Dog hair Sycamore american Elm american Tall ragweed Elm chinese Timothy grass English planain Virginia live oak Epicoccum Walnut black pollen Horse hair White ash Johnson grass White oak June grass Willow black Juniper Kochia Lamb's quarters /23/17 Maple pollen

Allergy Non-Inhalant Sensitivity 70000 60000 50000 40000 30000 20000 10000 0 Almond Barley Benzylpenicilloyl Brazil nut Buckwheat Carrot Casein Clam CodFish Crab Egg white Egg yolk Flounder Garlic

13 Allergy Non-Inhalant Sensitivity Almond Barley Benzylpenicilloyl Brazil nut Buckwheat Carrot Casein Clam CodFish Crab Egg white Egg yolk Flounder Garlic Halibut Honey bee Lobster Milk Mosquito Mustard seed Oat grain Oyster Peanut Pork Salmon Sesame seed Shrimp Soybean Tomato Walnut Wasp Wheat grain Latex Allergy Total IgE test scale is 0-65,535 antibody standard units (ASU). 1,000 ASU = 1.5 ImmunoCAP IU/L. Allergy resulted 330 out of 330 positive scores for the 10 positive specimens across 33 analytes for 100% non-inhalant allergen sensitivity. 6/23/17 13

Allergy Non-Inhalant Specificity 60000 50000 40000 30000 20000 10000 0 Almond Barley Benzylpenicilloyl Brazil nut Buckwheat Carrot Casein Clam CodFish Crab Egg white Egg yolk Flounder Garlic Halibut

14 Allergy Non-Inhalant Specificity Almond Barley Benzylpenicilloyl Brazil nut Buckwheat Carrot Casein Clam CodFish Crab Egg white Egg yolk Flounder Garlic Halibut Honey bee Lobster Milk Mosquito Mustard seed Oat grain Oyster Peanut Pork Salmon Sesame seed Shrimp Soybean Tomato Walnut Wasp Wheat grain Latex Allergy Total IgE test scale is 0-65,535 antibody standard units (ASU). 1,000 ASU = 1.5 ImmunoCAP IU/L. Allergy resulted 330 out of 330 positive scores for the 10 positive specimens across 33 analytes for 100% non-inhalant allergen sensitivity. 6/23/17 14

Allergy Non-Inhalant Composite 70000 60000 50000 40000 30000 20000 10000 0 Almond Barley

Flounder Garlic Halibut Honey bee Lobster Milk Mosquito Mustard seed Oat grain Oyster

15 Allergy Non-Inhalant Composite Almond Barley Benzylpenicilloyl Brazil nut Buckwheat Carrot Casein Clam CodFish Crab Egg white Egg yolk Flounder Garlic Halibut Honey bee Lobster Milk Mosquito Mustard seed Oat grain Oyster Peanut Pork Salmon Sesame seed Shrimp Soybean Tomato Walnut Wasp Wheat grain Latex 6/23/17 15

16 Allergy Non-Inhalant Data Summary Analyte Sensitivity Specificity Analyte Sensitivity Specificity Almond Mosquito Barley Mustard seed Benzylpenicilloyl polylysine Oat grain Brazil nut Oyster Buckwheat Peanut Carrot Pork Casein Salmon Clam Sesame seed CodFish Shrimp Crab Soybean Egg white Tomato Egg yolk Walnut Flounder Wasp Garlic Wheat grain Halibut Latex Honey bee Lobster Milk Allergy inhalant and non-inhalant sensitivity and specificity percentages were calculated based on determinations using 20 pooled serum specimens. Percentages may differ based on a larger sample set. 6/23/17 16

17 Allergy Sensitivity and Specificity Benchmarking Summary Allergy correctly scored 20 positive and negative serum specimens for 100% sensitivity and 100% specificity on Total IgE. Allergy correctly scored 20 positive and negative serum specimens across a total of 1,160 analytes for 100% sensitivity and 100% specificity for the inhalant allergens. Allergy correctly scored 20 positive and negative serum specimens across a total of 660 analytes for 100% sensitivity and 100% specificity for the non-inhalant allergens. According to the Asthma and Allergy Foundation of America, allergic disease including asthma is the fifth most common cause of chronic illness in the United States. 6/23/17 17

18 Allergy Advantages Finger stick sampling simplifies specimen collection, eliminates needles, and facilitates pediatric and geriatric testing. Blood card collection simplifies specimen storage and reduces the cost of shipping. Allergy microarray test measures total IgE, 120 allergens and controls simultaneously for improved accuracy. Allergy use technical replicates to enhance precision. Allergy uses a 120-allergen national panel to enhance clinical relevance in all geographical regions. Allergy provides a tool to assist healthcare professionals in allergy identification and treatment. According to Healthline, more than 17 million Americans are diagnosed with hay fever annually. 6/23/17 18

Milan Analytica AG Baslerstrasse Rheinfelden

Milan Analytica AG Baslerstrasse 15 4310 Rheinfelden www.milananalytica.ch Product list valid from 01.09.2012 Please ask for evaluation samples under Product Article number Circulating immune complexes