1. ARCHITECT cSystems & AEROSET System
QUANTIA Ferritin K41
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 Ferritin 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
Ferritin parameters, Assay number 2906, (Assay number 2909) 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. Assays can be manually configured.
Perform assay configuration per the parameters 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 Ferritin immunoassay is intended for the quantitative determination of ferritin 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 and is useful in the evaluation and monitoring of anemias.
Source(s): Quantia Ferritin 6K41 Package Insert
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
Ferritin is a large macromolecule consisting of a protein shell of 24 subunits and an interior iron core. Isoferritins differ in the proportion of basic “L” and acidic “H” subunits.
The basic “L” isoferritins are found in the liver, spleen and bone marrow, and are responsible for long-term iron storage.
The acidic “H” isoferritins are found mainly in myocardium, placenta and tumor tissue and serve as intermediaries for the transfer of iron.
Source(s): Quantia Ferritin 6K41 Package Insert
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 Ferritin levels are associated with:
Iron overload due to hemolytic anemia
Multiple transfusions
Acute Phase Response (infection, surgery, inflammation)
Liver disease
Cirrhosis
Thalassemia
Decreased Ferritin levels are associated with:
Iron Deficiency Anemia
Chronic blood loss
Pregnancy
Source(s): Quantia Ferritin 6K41 Package Insert, FBR Guide
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 Ferritin Reaction Methodology
Step 1: Sample containing Ferritin is added to Reagent 1 (Hepes Buffer).
Step 2: Reagent 2 containing latex particles coated with anti-human ferritin is added to the sample/Reagent 1 mix
Sample/ Reagent 1
Reagent 2 ↑
Latex
<200nm Diameter ↑
Ferritin Specific Antibody ↑
Ferritin
Step 3: When sample containing Ferritin is added to R1and mixed with the antibody in Reagent 2 insoluble aggregates form. The degree of agglutination is directly proportional to the concentration of Ferritin in the sample. This is determined by measuring the decrease of transmitted light caused by the aggregates at a wavelength of 572 nm.
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 Ferritin Methodology
Turbidimetric/Immunoturbidimetric
Available in the CAP General Chemistry/Therapeutic Drugs Survey
(C3/C3X 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 Ferritin Sample Handling
Specimen Requirements:
Serum
Gel separator tubes have not been tested.
Plasma
Gel separator tubes have not been tested
Acceptable anticoagulant – EDTA
Note: Use fresh sample collected by standard venipuncture techniques
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 Ferritin Sample Handling
Serum and Plasma
Analyze fresh specimens if possible
Sample Volume = 25.0 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
1 year
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 Ferritin 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 6K41-50
Kit Configuration R1
2 x 37 mL R2
2 x 10 mL
288 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 Ferritin Calibration
Calibration is stable for 30 days (720 hours) and is required with each change in reagent lot number.
Use the QUANTIA Ferritin Calibrator K49
Calibrator values are determined and traceable to the WHO International Standard for Ferritin, National Institute for Biological Standards and Control (NIBSC) code 94/572.
REF
Name
Size
Ferritin Calibrator 1
1 x 1 mL
Ferritin Calibrator 2
Ferritin Calibrator 3
Ferritin Calibrator 4
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 Ferritin Calibration
Do not freeze calibrators.
The assay must be calibrated using a full calibration (5 point calibration) procedure by using a water blank and the four levels of QUANTIA Ferritin Calibrator.
The calibrator is prepared with a purified human ferritin in a buffer solution.
The concentration of the calibrator is indicated on the QUANTIA Ferritin calibrator vial labels in ng/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 Ferritin 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 Ferritin 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 Ferritin 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 Ferritin Quality Control
Do not freeze controls.
The multi-constituent controls are prepared from human sera containing ferritin, myoglobin, and IgE.
The control concentrations are indicated on the corresponding control data sheet.
The lyophilized control should be reconstituted with 3.0 mL deionized water or equivalent.
The 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 Ferritin Performance Data
Reportable Range:
10.0 to ng/mL
10.0 to ng/mL using the on-board dilution protocol
Limit of Quantitation (LOQ)
There is NO LOQ claim in the reagent package insert. Testing has been performed on c and c4000 which confirms an LOQ of 10 ng/mL, but the reagent vendor did not update their 510K with this information, therefore no claim can be made.
Limit of Detection (LOD) = 7.0 ng/mL
LOD is defined as the mean concentration of an analyte-free
sample + 3 SD, where SD is the within-run standard deviation.
Results:
Results for the Quantia Ferritin can be reported in ng/mL or g/L, which are equivalent.
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 Ferritin Performance Data
*Expected Range :
Newborn ng/mL
1 month ng/mL
2-5 months ng/mL
6 months – 15 yrs ng/mL
Adult Males ng/mL
Adult Females ng/mL
*Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:980.
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 Ferritin Interference
Interference studies were conducted using an acceptance criteria of +/- 5% deviation from the target value except for *Triglyceride which uses+/- 15%):
Interfering Substance
Interferent Concentration
Target
(ng/mL)
Observed
(% of Target)
Bilirubin
20.8 mg/dL
(355 µmol/L)
105.6
99.1
Hemoglobin
482 mg/dL
(4.8 g/L)
104.8
100.0
Rheumatoid
factor
800 IU/mL
(800,000 U/L)
319.0
99.6
Lipemia (*Triglycerides)
496 mg/dL
(4.96 g/L)
243.8
113.6
* Triglycerides are a 20% Lipofundin solution used to mimic triglycerides in serum or plasma.
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 Ferritin Precision
Representative data from precision study are summarized below.
The precision acceptance criteria for the Ferritin assay is < 6%
for control levels 2 and 3. See Q&A Slide 27 for control levels used.
Precision Representative Data
LEVEL N
Concentration Mean
(ng/mL)
CV (%)
Within Run
Total
Control Level 1 50
29.3
13.4
15.5
Control Level 2
106.4
2.3
2.5
Control Level 3
428.5
0.7
0.9
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 Ferritin Method Comparison
Serum results from the Quantia Ferritin assay on an ARCHITECT c System were compared with the results on the AEROSET system.
Serum results from the Quantia Ferritin assay on an AEROSET system were compared with results from the ILab 900 Analyzer.
ARCHITECT cSystem vs.
AEROSET
AEROSET vs.
Comparative Method N 66
115
Y – Intercept
0.5
-32.9
Correlation Coefficient
0.999
0.997
Slope
0.967
1.011
Range (ng/mL)
13.0 –
13.0 –
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 Ferritin Product Summary
Assay Method: Turbidimetric /
Immunoturbidimetric
Reagent LN: K41-50
Reaction Mode: End-Up
Calibration:
Spline
QUANTIA Ferritin Calibrator
6K49-02
cSystems Reagent Volumes:
R1 Reagent: 160 L
R2 Reagent: 50 L
AEROSET Reagent Volumes:
Water: 10 L
Sample Volume: 25.0 L
Acceptable specimen: Serum/Plasma
Assay Stability:
Onboard stability = 20 days
Calibration stability = 30 days
Precision:
< 20% Total CV at levels < 110 ng/mL
< 6% Total CV for levels > 110 ng/mL
Reportable Range:
10.0 to ng/mL
LOQ:
No claim in reagent insert
LOD:
7.0 ng/mL
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

26. QUANTIA Ferritin Product Summary
SmartWash: Assay parameters for ARCHITECT cSystems
SmartWash: Assay parameters for AEROSET
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