1. ARCHITECT cSystems & AEROSET System
QUANTIA Antistreptolysin-O
6K38-50
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
Additional Assay Parameter Configuration Tip
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 Antistreptolysin-O 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
Antistreptolysin-O parameters (ASO, Assay number 2902) 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 Antistreptolysin-O (ASO) immunoassay is intended for the quantitative determination of antistreptolysin-O in human serum 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 used to diagnose Group A Streptococcal infections.
Source(s): Quantia ASO 6K38 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
Group A Streptococci produce various exotoxins, such as streptolysin-O, that can act as antigens. Streptolysin-O antibodies can be measured to determine whether a previous Group A Streptococcus infection has caused a post-streptococcal disease, such as:
Scarlet Fever
Rheumatic Fever
Glomerulonephritis
Source(s): Quantia ASO 6K38 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. QUANTIA Antistreptolysin-O Reaction Methodology
Step 1: Sample containing ASO is added to Reagent 1 (Reaction Buffer)
Step 2: Reagent 2 containing streptolysin coated Latex Particles is added to the sample/Reagent 1 mix
Sample/ Reagent 1
Reagent 2 → Y + Y Y ↑
Latex with
Streptolysin-O Coating Y ↑
ASO
(Latex Particles < 200nm in Diameter)
Step 3: When sample containing ASO 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 ASO 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

9. Quantia ASO 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

10. QUANTIA Antistreptolysin-O Sample Handling
Specimen Requirements:
Serum is the acceptable specimen
Gel separator tubes have not been tested.
There is no specification for tube type (glass or plastic)
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

11. QUANTIA Antistreptolysin-O Sample Handling
Serum only
Analyze fresh specimens if possible
Sample Volume = 3.0 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
20 to 25°C
2 to 8°C
-20°C
2 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

12. QUANTIA Antistreptolysin-O 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 – 35 days (840 hours)
REF 6K38-50
Kit Configuration R1
2 x 52 mL R2
2 x 9 mL
324 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

13. QUANTIA Antistreptolysin-O Calibration
Calibration is stable for 35 days (840 hours) and is required with each change in reagent lot number.
Use the QUANTIA ASO Calibrator K46-02
Calibrator values are determined and traceable to the WHO International Standard for ASO, National Institute for Biological Standards and Control (NIBSC) code: 97/662
REF
Name
Size
ASO Calibrator 1
6 x 1 mL
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 Antistreptolysin-O Calibration
The single calibrator is prepared with a purified human IgG (ASO) in a buffer solution.
The concentration of the calibrator is indicated on the QUANTIA ASO Calibrator vial label in IU/mL.
Calibrator is a lyophilized product:
Reconstitute with 1 mL of deionized water or equivalent.
Let stand for five (5) minutes.
Prior to use, gently swirl the vial.
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 Antistreptolysin-O Calibration
Calibrator is packaged as one (1) vial with concentration indicated on the label. Both the AEROSET and cSystems will automatically prepare five (5) different concentration levels of calibrators from the one (1) calibrator vial provided.
The assay must be calibrated using a full calibration (6 point calibration) procedure by using a water blank and the five levels of the Quantia ASO Calibrator.
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 Antistreptolysin-O 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 Antistreptolysin-O 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 Antistreptolysin-O Quality Control
Uses the QUANTIA ASO Control I K54-21 and QUANTIA ASO Control II K55-22
QUANTIA ASO Controls contain:
This is the only control approved for use with this assay.
REF
REF
Control Product Name
Configuration
ASO Control I (lyophilized)
6 x 1 mL
ASO Control II (lyophilized)
3 x 1 mL
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 Antistreptolysin-O Quality Control
The controls are prepared from human sera containing IgG (ASO).
The control concentrations are indicated on the corresponding value sheet in IU/mL.
The controls require no preparation and are ready to use.
The controls are stable until the expiration date on the label if 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

20. QUANTIA Antistreptolysin-O Performance Data
Reportable Range:
50 to 850 IU/mL
Limit of Quantitation (LOQ) = 50.0 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) = 15.0 IU/mL
LOD is defined as the mean concentration of an analyte-free
sample + 2SD, where SD is the within-run standard deviation.
*Reported Expected Range:
Preschool children < 100 IU/mL
School Age/Young Adults 166 – 250 IU/mL
Average can be established at < 200 IU/mL
*Klein GC, Baker CN, Jones WL. “Upper limits of Normal” Antistreptolysin-O and Antideoxyribonuclease B Titers. Applied Microbiology 21: , 1971.
*Thomas L. Streptococcus pyogenes infection. In: Thomas L, ed. Clinical Laboratory Diagnostics. Use and Assessment of Clinical Laboratory Results. 1st Edition. TH-Books, Frankfurt / Main, Germany, 1998.
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 Antistreptolysin-O Interference
Interference studies were conducted using an acceptance criteria of +/- 5% deviation from the target value:
Interfering Substance
Interferent Concentration
Target (IU/mL)
Observed
(% of Target)
Lipemia
2.1 AU/cm at 660 nm
258.9
100.7
Triglycerides
1327 mg/dL (14.99 mmol/L)
270.5
103.6
Bilirubin
20.8 mg/dL (355.7 µmol/L)
257.9
99.9
Hemoglobin
482 mg/dL (4.82g/L)
255.4
100.1
Rheumatoid factor
800 IU/mL (800,000 U/L)
108.1
104.2
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 Antistreptolysin-O Precision - cSystems
Representative data from precision study are summarized
below.
The precision acceptance criteria for the ASO assay is
< 6% Total CV.
Representative Data - cSystem
LEVEL N
Concentration Mean
(IU/mL)
CV (%)
Within Run
Total
Quantia Control Level 1 (6K54-21) 50
175.7
1.2
2.5
Quantia Control Level 2 (6K55-22)
379.0
0.7
1.3
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 Antistreptolysin-O Precision - AEROSET
Representative data from precision study are summarized below.
The precision acceptance criteria for the ASO assay is < 6% Total CV.
Lyophilized sample level 3 is an internal manufacturing QC used by the vendor during production.
Representative Data - AEROSET
LEVEL N
Concentration Mean
(IU/mL)
CV (%)
Within Run
Total
Quantia Control Level 1 (6K54-21) 80
177.3
1.2
2.0
Quantia Control Level 2 (6K55-22)
384.9
1.4
1.9
Lyophilized Sample Level 3
531.7
0.5
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 Antistreptolysin-O Method Comparison
Serum results from the Quantia ASO assay on an ARCHITECT c System were compared with the results on the AEROSET system.
Serum results from the Quantia ASO assay on an AEROSET system were compared with results from an ILab 600 analyzer.
ARCHITECT cSystem vs.
AEROSET
AEROSET vs.
Comparative Method N 65 80
Y – Intercept
-2.8
26.5
Correlation Coefficient
0.9990
0.9977
Slope
0.976
0.961
Range (mg/dL)
54.6 – 823.8
40.0 – 795.5
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 Antistreptolysin-O Product Summary
Assay Method: Turbidimetric /
Immunoturbidimetric
Reagent LN: K38-50
Reaction Mode: End-Up
Calibration:
Spline
QUANTIA ASO Calibrator
6K46-02
cSystems Reagent Volumes:
R1 Reagent: 225 L
R2 Reagent: 38 L
AEROSET Reagent Volumes:
Water: 10 L
Sample Volume: 3.0 L
Acceptable specimen: Serum
Assay Stability:
Onboard stability = 35 days
Calibration stability = 35 days
Precision: Total CV < 6%
Reportable Range:
50.0 to IU/mL
LOQ: IU/mL
LOD: IU/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. Not for customer distribution
QUANTIA Antistreptolysin-O Additional Assay Parameter Configuration Tips
ARCHITECT cSystems Assay:
The Architect cSystems use the highest calibrator concentration (300 IU/mL). This calibrator concentration should be entered for all calibrators, C1-C5.
The Architect cSystem software then calculates each calibrator concentration mathematically based upon dilutions by diluent and in reduction of sample volumes. This calculation also factors in reagent/sample volume ratios vs. total reaction volume.
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
QUANTIA Antistreptolysin-O Additional Assay Parameter Configuration Tips
AEROSET Assay:
The AEROSET software calculates differently than the Architect cSystem software. AEROSET uses the linear high concentration considering dilutions and total reaction volumes). Because of this, IU/mL is entered for C1, C2, C3, C4, and C5 calibrator concentrations.
The calibrator concentrations in the assay parameter table must be used for this assay due to the calculations used by the AEROSET software.
Aeroset Reagent 2 uses water volume 10 µL with Type 0 dispense. Architect c Systems do not need the water because Type 2 dispensing is used for Reagent 2.
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