thermo scientific cedia tacrolimus immunoassay.pdf · clinical chemistry analyzers. complementing...
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Thermo ScientificCEDIA Tacrolimus Immunoassay
This CEDIA® assay uses a recombinant DNA technology to produce a unique homogeneous enzyme immunoassay
system. Our CEDIA assays are recognized worldwide for their ease-of-use, performance and lot-to-lot
consistency. These test kits can be used on a variety of clinical chemistry analyzers.
Complementing this assay, is a multiconstituent More Diagnostics® Immunosuppressant control. This
liquid, whole blood control can be used with CEDIA Cyclosporine PLUS, and Tacrolimus assays.
Part of Thermo Fisher Scientific
Thermo ScientificCEDIA Tacrolimus Immunoassay
© 2011 Thermo Fisher Scientific Inc. All rights reserved. CEDIA is a registered trademark of Roche Diagnostics. All other trademarks are the property of Thermo Fisher Scientific and its subsidiaries.
PrecisionWith-in run CV was less than 7%. Total CV was less than 10%.
WITHIN RUN
n=126 Avg. With-in Run SD With-in Run % CV
Patient 1 6.30 0.43 6.80
Patient 2 9.23 0.43 4.68
Patient 3 15.18 0.47 3.12
Spike 1 5.33 0.32 5.97
Spike 2 10.54 0.35 3.28
Spike 3 21.01 0.43 2.04
Interference
Unconjugated Bilirubin 60 mg/dL
Triglycerides 1500 mg/dL
Cholesterol 500 mg/dL
Albumin 12 g/dL
g-Globulin 12 g/dL
Rheumatoid Factor 573 IU/mL
Hematocrit 15% - 60%
Method Comparison
CEDIA vs. n Slope Intercept Correlation (r)
LC-MS/MS 187 1.190 0.70 0.964
MEIA 91 1.117 0.99 0.874
Ordering Information
Cat # Description Size
10008656 Tacrolimus Reagent Kit 26, 11 mL
10008666 Tacrolimus Calibrator Kit 2 x 4, 2 x 2 mL
280-1 More Diagnostics Immunosuppressant Control Level 1 4 x 4 mL
280-2 More Diagnostics Immunosuppressant Control Level 2 4 x 4 mL
280-3 More Diagnostics Immunosuppressant Control Level 3 4 x 4 mL
Reportable RangeThe reportable range for the CEDIA Tacrolimus Assay is 2 - 30 ng/mL.The functional sensitivity of the CEDIA Tacrolimus assay in whole blood is 2 ng/mL. The lowest detectable dose (LDD) is 2 ng/mL.
LinearityThe CEDIA® Tacrolimus assay quantitates samples from 2 - 30 ng/mL. The assay is linear from 0 - 30 ng/mL.
40
30
20
10
00 10 20 30 40
Mea
sure
d (n
g/m
L)
Assigned (ng/mL)
Slope: 0.92
Intercept: -0.07
TOTAL RUN
n=126 Avg. Total SD Total % CV
Patient 1 6.30 0.49 7.80
Patient 2 9.23 0.56 6.06
Patient 3 15.18 0.65 4.26
Spike 1 5.33 0.48 8.90
Spike 2 10.54 0.49 4.69
Spike 3 21.01 0.72 3.40
Accurate• Correlation with gold standard methods• Precise throughout standard curve assay range• Lot-to-lot consistency
Efficient• 2-point linear calibration• Bar-coded reagents for Hitachi systems• Applications for a variety of chemistry analyzers
Convenient• Mix and Run reagent systems• More Diagnostics multi-analyte ISD controls available
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2011 01-1