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Received on May 3, 2007
Accepted on August 29, 2007
General Clinical Chemistry |
1 Singulex, Inc., Hayward, CA
* To whom correspondence should be addressed. E-mail: j.todd{at}singulex.com.
Background: Immunoassay (IA) technology has expanded the clinical utility of protein biomarkers, but demands for increased sensitivity, dynamic reporting ranges, and small sample volumes has limited the potential clinical usefulness of many biomarkers. We assessed the performance, including limits of detection (LODs) and the dynamic reporting range of an IA-based technology, Erenna Immunoassay System, for a series of biomarkers, including cardiac troponin I (cTnI).
Methods: Erenna IAs were used with 10 different and clinically important biomarkers to ascertain the LOD with various sample sizes (10 µL to 200 µL).
Results: The Erenna Immunoassay System generated LODs of 10–100 pg/L using 100 µL of sample. For cTnI, the LOD was 0.2 ng/L and a 10% CV was seen between 0.78 and 1.6 ng/L.
Conclusions: The Erenna IA-based technology reproducibly measures protein biomarkers with detection limits of 10–100 pg/L, with a dynamic range of >4.5 logs in sample volumes of 50–150 µL.
The following articles in journals at HighWire Press have cited this article:
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  A. E. Schultze, K. H. Carpenter, F. H. Wians, S. J. Agee, J. Minyard, Q. A. Lu, J. Todd, and R. J. Konrad Longitudinal Studies of Cardiac Troponin-I Concentrations in Serum from Male Sprague Dawley Rats: Baseline Reference Ranges and Effects of Handling and Placebo Dosing on Biological Variability Toxicol Pathol, October 1, 2009; 37(6): 754 - 760. [Abstract] [Full Text] [PDF]
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 K. Pettersson, S. Eriksson, S. Wittfooth, E. Engstrom, M. Nieminen, and J. Sinisalo Autoantibodies to Cardiac Troponin Associate with Higher Initial Concentrations and Longer Release of Troponin I in Acute Coronary Syndrome Patients Clin. Chem., May 1, 2009; 55(5): 938 - 945. [Abstract] [Full Text] [PDF]
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 R. Shave, K. George, and D. Gaze Reply J. Am. Coll. Cardiol., April 14, 2009; 53(15): 1341 - 1342. [Full Text] [PDF]
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 M. S. Sabatine, D. A. Morrow, J. A. de Lemos, P. Jarolim, and E. Braunwald Detection of acute changes in circulating troponin in the setting of transient stress test-induced myocardial ischaemia using an ultrasensitive assay: results from TIMI 35 Eur. Heart J., January 2, 2009; 30(2): 162 - 169. [Abstract] [Full Text] [PDF]
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A. H.B. Wu, S. J. Agee, Q. A. Lu, J. Todd, and A. S. Jaffe Specificity of a High-Sensitivity Cardiac Troponin I Assay Using Single-Molecule-Counting Technology Clin. Chem., January 1, 2009; 55(1): 196 - 198. [Full Text] [PDF]
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A. H.B. Wu, Q. A. Lu, J. Todd, J. Moecks, and F. Wians Short- and Long-Term Biological Variation in Cardiac Troponin I Measured with a High-Sensitivity Assay: Implications for Clinical Practice Clin. Chem., January 1, 2009; 55(1): 52 - 58. [Abstract] [Full Text] [PDF]
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A. Mingels, L. Jacobs, E. Michielsen, J. Swaanenburg, W. Wodzig, and M. van Dieijen-Visser Reference Population and Marathon Runner Sera Assessed by Highly Sensitive Cardiac Troponin T and Commercial Cardiac Troponin T and I Assays Clin. Chem., January 1, 2009; 55(1): 101 - 108. [Abstract] [Full Text] [PDF]
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A. E. Schultze, R. J. Konrad, K. M. Credille, Q. A. Lu, and J. Todd Ultrasensitive Cross-species Measurement of Cardiac Troponin-I Using the Erenna Immunoassay System Toxicol Pathol, October 1, 2008; 36(6): 777 - 782. [Abstract] [Full Text] [PDF]
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 E. M. Antman and D. A. Morrow Biomarker Release After Percutaneous Coronary Intervention: A Message From the Heart Circ Cardiovasc Interv, August 1, 2008; 1(1): 3 - 6. [Full Text] [PDF]
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