1. ARCHITECT cSystems & AEROSET System
QUANTIA Immunoglobulin E
6K42-40
US only launch: June 2010
REF
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, version 1

2. Not for customer distribution
Agenda
Launch Strategy
Assay Disk Information
Clinical Utility
Reaction Methodology
Sample Handling
Reagent Handling
Calibration
Quality Control
Performance Data
Interference
Precision
Method Comparison
Product Summary
Q&A
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

3. QUANTIA Immunoglobulin E Launch Strategy
The QUANTIA assays are available for use on the AEROSET and ARCHITECT cSystems.
Assay will be available in the US only. Latin America and Canada are considered ex-US for this product.
There are no differences in the application or formulation between the U.S. and non-US products.
Complaint handling:
Abbott has responsibility for initial complaint registration.
BioKit (the vendor) will investigate Level II complaints.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

4. Assay Disk Information
Immunoglobulin E parameters (IgE, Assay number 2908) are available on the following recently released ARCHITECT cSystems assay disks.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

5. Assay Disk Information
There will be no AEROSET assay disk available.
Assay configuration is provided in the assay specific application sheets.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

6. Not for customer distribution
Clinical Utility
The QUANTIA Immunoglobulin E (IgE) immunoassay is intended for the quantitative determination of immunoglobulin E in human serum or plasma on the ARCHITECT cSystems (i.e. c4000, c8000, and c16000) and the AEROSET System. The assay is intended for use in clinical laboratories.
The measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies.
IgE antibodies are allergic, homocytotropic, anaphylactic, reaginic, atopic, and skin-sensitizing antibodies.
Source(s): Quantia IgE 6K42 Package Insert, FBR
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

7. Not for customer distribution
Clinical Utility
IgE antibodies are the chief immunoglobulin responsible for immediate hypersensitivity reactions in humans.
There is a certain correlation between chronic allergen exposure and the level of total IgE.
Verification of diagnosis can only be performed by appropriate in vitro and in vivo diagnostic tests.
The measurement of IgE is indicated in diagnosing allergies, extended investigation of allergies, illnesses associated with eosinophilia or fever of unknown origin, congenital immunodeficiency syndromes and acquired immunodeficiency syndromes.
Source(s): Quantia IgE 6K42 Package Insert, FBR
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

8. Not for customer distribution
Clinical Utility
Increased IgE levels are associated with:
IgE myeloma
Atopic dermatitis
Bronchial asthma
Hyper-IgE syndrome
Hay fever
Decreased IgE levels are associated with:
Hypogammaglobulinemia
Hypersensitivity
Some progressive neoplastic diseases
Source(s): Quantia IgE 6K42 Package Insert, FBR
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

9. QUANTIA IgE Reaction Methodology
Step 2: Reagent 2 containing latex particles coated with mouse anti-human IgE is added to the sample/Reagent 1 mix
Step 1: Sample containing IgE is added to Reagent 1 (Reaction Buffer)
Sample/ Reagent 1
Reagent 2 ↑
IgE ↑
IgE Specific Antibody ↑
Latex
<200nm Diameter
Step 3: When sample containing IgE is added to R1 and mixed with the antibody in R2 insoluble aggregates form. The degree of agglutination is directly proportional to the concentration of IgE in the sample. This is determined by measuring the decrease of transmitted light caused by the aggregates at a wavelength of 572.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

10. QUANTIA IgE Methodology
Turbidimetric/Immunoturbidimetric
Available in the CAP Diagnostic Immunology Survey (IG/IGX series)
Contact CAP for the current coding.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

11. QUANTIA Immunoglobulin E Sample Handling
Specimen Requirements:
Serum
Gel separator tubes have not been tested.
There is no specification for tube type (glass or plastic)
Use fresh serum collected by standard venipuncture techniques.
Plasma
Gel separator tubes have not been tested
Acceptable anticoagulants
Sodium EDTA
Potassium EDTA
Sodium Heparin
Lithium Heparin
Citrate
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

12. QUANTIA Immunoglobulin E Sample Handling
Serum or Plasma only
Analyze fresh specimens if possible
Sample Volume = 3.5 L
Specimen storage:
Repeated freeze/thaw cycles should be avoided to minimize potential protein degradation.
Stored specimens must be inspected for particulates. If present, mix and centrifuge to remove particulates prior to testing.
Temperature
Maximum Storage
Serum/Plasma
20 to 25°C
2 to 8°C
-20°C
7 days
6 months
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

13. QUANTIA Immunoglobulin E Reagent Handling
Reagent Kit Configuration
Estimated calculation is based on the minimum reagent fill volume per kit.
Reagent is liquid, ready-to-use, 2 reagent kit
Storage 2 to 8°C.
Unopened kit stable to expiration date
Remove any air bubbles, if present, with an applicator stick
Reagent onboard stability – 20 days (480 hours)
REF 6K42-40
Kit Configuration R1
2 x 13 mL R2
2 x 7 mL
138 tests/kit
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

14. QUANTIA Immunoglobulin E Calibration
Calibration is stable for 30 days (720 hours) and is required with each change in reagent lot number.
Use the QUANTIA IgE Calibrator K50-02
Calibration: The assay must be calibrated using a full calibration (6 point calibration) procedure by using a water blank and the five levels of QUANTIA IgE Calibrator.
REF
Name
Size
IgE Calibrator 1
1 x 1 mL
IgE Calibrator 2
IgE Calibrator 3
IgE Calibrator 4
IgE Calibrator 5
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

15. QUANTIA Immunoglobulin E Calibration
Do not freeze calibrators.
The calibrators are prepared with purified human IgE in a Hepes buffer.
Calibrator values are determined over multiple runs against Calibrator House Standards which are traceable to the 2nd WHO International Reference Preparation of Human Serum Immunoglobulin E (IgE) code 75/502.
The concentration of the calibrators are indicated on the vial labels in IU/mL.
Calibrators are liquid ready to use and stable until the expiration date indicated on the package when stored at 2-8 °C.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

16. QUANTIA Immunoglobulin E Calibration Curve – ARCHITECT cSystems
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

17. QUANTIA Immunoglobulin E Calibration Curve - AEROSET
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

18. QUANTIA Immunoglobulin E Quality Control
Uses the QUANTIA Ferritin/Myoglobin/IgE Control K56-21
QUANTIA Ferritin/Myoglobin/IgE Control contains:
This is the only control approved for use with this assay.
REF
Control Product Name
Configuration
Control I Low Level (lyophilized)
1 x 3 mL
Control II High Level (lyophilized)
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

19. QUANTIA Immunoglobulin E Quality Control
Do not freeze controls.
The controls are prepared from human sera containing ferritin, myoglobin, and IgE.
The control concentrations are indicated on the corresponding control value sheet.
The lyophilized control should be reconstituted with 3.0 mL of deionized water or equivalent.
The lyophilized controls are stable until the expiration date on the label if stored at 2-8 °C.
Once reconstituted, the controls can be used for 15 days if stored between 2-8 °C.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

20. QUANTIA Immunoglobulin E Performance Data
Serum and Plasma
Reportable Range:
25.0 to IU/mL
25.0 to IU/mL using the on-board dilution protocol
Limit of Quantitation (LOQ) = 25.0 IU/mL
LOQ represents the lowest measurable concentration at which the within-run CV < 20% and the recovery is within +/- 20% of expected value.
Limit of Detection (LOD) = 12.9 IU/mL
LOD is defined as the mean concentration of an analyte-free sample + 2SD, where SD is the within-run standard deviation.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

21. QUANTIA Immunoglobulin E Performance Data
Expected Values:
In clinically healthy subjects the serum IgE levels exhibit a wide distribution range and do not follow a normal distribution. Age related concentrations must be taken into account when interpreting IgE values in children. IgE does not cross the placental barrier so IgE is not detectable in neonates. The IgE concentration increases during the first year of life, reaching a peak at years and dropping subsequently in adults.
Reported Expected Range (varies with age and sex):
1 - 5 yrs < 60 IU/mL
6 - 9 yrs < 90 IU/mL
10 – 15 yrs < 200 IU/mL
Adults < 100 IU/mL
Source(s): Quantia IgE 6K42 Package Insert
Ringel KP, Dati F, Buchholz, E. IgE- Normalwerte bei Kindern. Laboratoriumsblätter 32, 26-34, 1982
Dati F, Ringel KP, Reference values for serum IgE in healthy non-atopic children and adults, Clin Chem 1982; 7:1556
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

22. QUANTIA Immunoglobulin E Performance Data
Reported Expected Range:
1 - 5 yrs < 60 IU/mL
6 - 9 yrs < 90 IU/mL
10 – 15 yrs < 200 IU/mL
Adults < 100 IU/mL
Note the expected range starts at age 1 year. This method should not be used for testing children less than the age of 1 year.
Reason(s):
Patients younger than 1 year typically have results lower than this method’s Limit of Quantitation- LOQ (25 IU/mL).
Results lower than LOQ will have too much imprecision for clinical use.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

23. QUANTIA Immunoglobulin E Interference
Interference studies were conducted using an acceptance criteria of +/- 5% deviation from the target value except for Rheumatoid Factor which uses +/- 10%:
Interfering Substance
Interferent Concentration
Target (IU/mL)
Observed
(% of Target)
Lipemia (chyle)*
2.38 AU/cm at 660 nm
91.0
99.8
Lipemia (triglycerides)
1327 mg/dL (14.99 mmol/L)
82.4
101.1
Bilirubin
20.8 mg/dL (355µmol/L)
87.3
97.3
Hemoglobin
480 mg/dL (4.8 g/L)
88.4
97.4
**Rheumatoid factor
80 IU/mL (80,000 U/L)
160 IU/mL (160,000 U/L)
44.1
107.7
121.3
*Solution manufactured to mimic chyle, which is a milky fluid consisting of lymph and emulsified fat extracted from chyme by the lacteals during digestion.
**Claim of RF interference less than 10% up to 138 IU/mL interpolated mathematically from 10 spiked interferent levels.
2 of the levels around the claim are shown here.
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

24. QUANTIA Immunoglobulin E Precision
Representative data from precision study are summarized below. See Q&A Slide 27 for control levels used.
The precision acceptance criteria for the IgE assay is < 15% Total CV for the Level 1 Control and < 6% Total CV for the Level 2 and 3 Controls
Representative Data
LEVEL N
Concentration Mean
(IU/mL)
CV (%)
Within Run
Total
Control Level 1 50
46.3
13.8
14.5
Control Level 2
228.3
2.9
3.4
Control Level 3
414.6
2.1
2.4
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

25. QUANTIA Immunoglobulin E Method Comparison
Serum results from the IgE assay on an ARCHITECT c System were compared with the results on the AEROSET system.
Serum results from the Quantia IgE assay on an AEROSET system were compared with results from the UNI -CAP® 100 (Pharmacia)Total IgE fluoroenzymeimmunoassay method.
ARCHITECT cSystem vs.
AEROSET
AEROSET vs.
Comparative Method N 67
101
Y – Intercept
-7.1
-17.4
Correlation Coefficient
0.9965
0.9750
Slope
1.007
0.965
Range (mg/dL)
10 – 2269
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

26. QUANTIA Immunoglobulin E Product Summary
Sample Volume: 3.5 L
Acceptable specimen: Serum, plasma
Assay Stability:
Onboard stability = 20 days
Calibration stability = 30 days
Precision:
< 15% Total CV for Level 1 Control
< 6% Total CV for Level 2 and 3 Controls
Reportable Range:
25.0 to IU/mL
LOQ:
25.0 IU/mL
LOD:
12.9 IU/mL
Assay Method: Turbidimetric /
Immunoturbidimetric
Reagent LN: K42-40
Reaction Mode: End-Up
Calibration:
Spline
QUANTIA IgE Calibrator
6K50-02
cSystems Reagent Volumes:
R1 Reagent: 140 L
R2 Reagent: 70 L (Type 2)
AEROSET Reagent Volumes:
R2 Reagent: 70 L (Type 0)
Water: 10 L
REF
REF
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

27. Not for customer distribution
Q&A
There are only 2 levels of Quantia controls, what sample was used for the 3rd level in precision testing?
A 1:1 mixture of Level 1 and Level 2 was used to create a third level for this testing.
END OF DOCUMENT
Not for customer distribution
For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1