1. AEROSET® & ARCHITECT® cSystem™
MULTIGENT® Iron
REF 6K95-50

2. Agenda Clinical Utility Methodology Sample Handling Reagent Handling
Calibration
Quality Control
Reportable Range
Interference
Precision
Method Comparison
CAP Performance
Troubleshooting tips
Questions and Answers

3. MULTIGENT ® Iron Liquid
Abbott will not market controls for U.S. use (Ranges for appropriate Bio-Rad controls have been established)
Complaint handling:
Abbott has responsibility for initial complaint registration.
Sentinel (the vendor) will investigate level II complaints.

4. MULTIGENT ® Iron Liquid
Assay disk
ARCHITECT® MULTIGENT Assay Disk Version 2.00
8K50-02 Conventional/Alternate Units
8K51-02 SI/Alternate Units
No AEROSET® Disk will be produced

5. Clinical Utility of Iron
Iron exists in biological fluids as a component of hemoglobin and myoglobin and is bound in plasma to transferrin, which acts as a carrier protein.
Increased iron concentrations occur in hemochromatosis and liver damage.
Decreased iron levels can be caused by anemia due to malabsorption as a consequence of gastrointestinal diseases, or by blood loss as a result of the body’s iron status. The measurement of transferrin and ferritin can provide more detailed information.

6. MULTIGENT ® Iron Methodology
Methodology: Ferene
Chemical Reaction:
Fe - transferrin pH Fe+3 + transferrin
Fe Fe+2
Fe+2 + FERENE Fe – FERENE complex
Hydroxylamine
Hydrochloride

7. MULTIGENT ® Iron Methodology
Description of Chemical Reaction:
In a pH of 4.8 buffer system, iron is released from transferrin to which it is bound, and then quantitatively reduced to a ferrous state.
The iron forms with Ferene-S* a stable colored complex of which the color intensity is proportional to the amount of iron in the sample.
Particular reaction conditions and a specific masking agent almost entirely eliminate the interference from copper.
* Ferene–S = 3-(2-pyridyl)-5,6-bis-[2-(5-furylsulfonic acid)]-1,2,4-triazine

8. MULTIGENT ® Iron Sample Handling
Specimen Requirements:
Serum
Plastic tubes
With or without gel barrier
Plasma
Sodium or Lithium Heparin
Use nonhemolyzed serum collected by standard venipuncture techniques.

9. MULTIGENT ® Iron Sample Handling
Sample Tubes tested and found acceptable:
Vendor
Ref
Tube
BD Europe
369032
Serum tube
367957
Serum with Gel separator
367869
Na - heparin
368884
Li-heparin (17 IU/mL)
367374
Li -heparin with PST II gel barrier

10. MULTIGENT ® Iron Sample Handling
Specimen storage:
Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing.
Sample volume = 20 μg/dL
The system performs a 1:6.55 dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor.
Maximum storage
Temperature
Serum/Plasma
20 to 25°C
7 days
2 to 8°C
3 weeks
-20°C
1 year

11. MULTIGENT ® Iron Reagent Handling
Reagent kit
Reagent is liquid, ready-to-use, two reagent kit.
Storage: 2 to 8°C.
Store reagent in the box.
Unopened kit is stable to the expiration date.
Remove any air bubbles with an applicator stick.
Reagent onboard stability is 30 days.
List Number
Kit Configuration
REF 6K95-50 R1
3 x 90 mL R2
3 x 11 mL
CAL
1 x 10 mL
904 tests/kit

12. MULTIGENT ® Iron Calibration
Iron calibrator is liquid ready-to-use calibrator supplied in the reagent kit.
Opened calibrator is stable for 120 days at 2 to 8°C if contamination is avoided and vials are recapped immediately after use.
Calibration curve is stable for 14 days
Calibrator value is verified using a NIST (National Institute of Standards and Technology), SRM 3126a.

13. MULTIGENT ® Iron Calibration Curve - ARCHITECT ®

14. MULTIGENT ® Iron Calibration Curve -AEROSET ®

15. Quality Control
Abbott control product for Iron Liquid is not available, however BioRad controls are available for both the AEROSET® and ARCHITECT® customers
BioRad peer value information can be found on WWCS webpage
BIO-RAD
Control Product Name
Catalog Number
Configuration
Lyphochek Assayed Chemistry Control
L-1: C-310-5
L-2: C-315-5
12 x 5 mL
Liquid Assayed Multiqual Chemistry Control
L-1: 694
L-2: 695
L-3: 696
12 x 3 mL

16. MULTIGENT ® Iron Reportable Range
Serum and Plasma
Reportable Range = 5 to 1,000 μg/dL*
(0.9 to μmol/L)
Limit of Detection (LOD)= 5 μg/dL*
(0.9 μmol/L)
LOD calculated on 10 replicates of normal saline reported as “mean zero value + 3 SD”
*Note: SI units are μmol/L
To convert results from μg/dL to µmol/L, multiply by

17. MULTIGENT ® Iron Interference
Interfering substances:
MULTIGENT Iron Liquid assay is not affected (less than 10% difference) by the presence of the following interferents up to the concentrations indicated below:
Interferring Substance
Interferent Concentration
Bilirubin
15 mg/dL (256.5 μmol/L)
Hemoglobin
0.5 g/dL (5.0 g/L)
Human triglyceride
1,000 mg/dL (11.3 mmol/L)

18. MULTIGENT ® Iron Precision
Representative data from a 10 day study with two runs and two
replicates of each control per day are summarized below.
Control
Level 1
Level 2 N
Mean (μg/dL) 40
112.4
188.4
Within Run SD
%CV
0.92
0.82
1.28
0.68
Between Run SD
1.53
1.36
3.64
1.93
Total SD
2.34
2.08
3.78
2.01

19. MULTIGENT ® Iron Method Comparison
Serum results from the MULTIGENT Iron Liquid assay on an ARCHITECT
c System and the AEROSET System were compared with results from the MULTIGENT Iron Liquid assay on a commercially available analyzer.
c System were compared with the results on the AEROSET system.
ARCHITECT vs.
Comparative Method
AEROSET vs.
Comparative
Method
ARCHITECT
vs. AEROSET N 58 60 40
Y – Intercept
-0.40
2.89
1.65
Correlation Coefficient
0.9998
0.9996
0.9971
Slope
1.002
0.9584
0.9938
Range (μg/dL)
16 to 137
14 to 247
12 to 196

20. MULTIGENT ® Iron method comparison internal study
An internal study was performed to determine the potential bias customers may observe when converting from the Abbott Iron assay (LN 7D68) to the MULTIGENT Iron assay.
The study data and conclusions follow.
MULTIGENT Iron Serum vs. Abbott Iron Serum Samples

21. MULTIGENT ® Iron method comparison internal study
MULTIGENT Iron Plasma vs. Abbott Serum Samples
Conclusion: Customers that convert to MULTIGENT Iron liquid from
Abbott Iron may observe an average of 8.7% higher results when using serum samples.

22. MULTIGENT ® Iron CAP Performance
CAP Proficiency Testing (PT) for MULTIGENT Iron assay was performed in-house on the Architect c8000 analyzer using CAP PT materials : CHM-01, CHM-02, CHM-03, CHM-04 and CHM-05.
2008 CZ-A CAP Survey Results (Information Only) MULTIGENT All Method Mean
CHM
CHM CHM
CHM
CHM
NOTE: results units = μg/dl

23. MULTIGENT ® Iron CAP Performance
CAP Proficiency Testing (PT) for MULTIGENT Iron assay was performed in-house on the Architect c8000 analyzer using CAP PT materials : CHM-06, CHM-07, CHM-08, CHM-09 and CHM-10.
2008 CZ-B CAP Survey Results (Information Only) MULTIGENT All Method Mean
CHM
CHM CHM
CHM
CHM
NOTE: results units = μg/dl

24. Troubleshooting Tips AEROSET® system:
Iron must be configured on a separate line
from Creatinine.
If running Microalbumin, you must configure
Microalbumin assay parameters with the following
SmartWashes:
Component
Reagent/Assay
Wash
Volume (μl)
Reagent probe
FEP0S61
AlkW
345
FEP0S62

25. Questions and Answers
Why am I getting a No Assay reagent status? (ARCHITECT)
Answer:
The reagent is not used by any assay installed on the system.
Ensure the reagent parameters are entered correctly.
Enter the reagent name exactly as displayed in the reagent application sheet FEP0S. The reagent name contains a zero (0) not an alpha character.

26. Questions and Answers
Package insert sample requirements state heparin salt is acceptable. Does this mean that all heparin is OK?
Answer:
Yes, all types of heparin (ammonium, lithium, and sodium) are acceptable.

27. Does copper interfere with the MULTIGENT Iron Liquid assay?
Questions and Answers
Does copper interfere with the MULTIGENT Iron Liquid assay?
Answer:
Particular reaction conditions and a specific masking agent almost entirely eliminate the interference from copper. In the MULTIGENT Iron package insert, the specific masking agent is identified as thiourea.
Cited article statement: “The effects of copper interference can be almost entirely eliminated by the addition of thiourea, which preferentially binds the copper in a copper (1) complex.
Reference: Gaudin, J. The determination of serum iron and total iron binding capacity. Diagnostic Chemicals LTD, Charlottetown, P.E.I., Canada.
End of Document