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Clinical Chemistry 53: 1990-1995, 2007. First published September 21, 2007; 10.1373/clinchem.2007.091181
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(Clinical Chemistry. 2007;53:1990-1995.)
© 2007 American Association for Clinical Chemistry, Inc.

Oak Ridge Conference

Ultrasensitive Flow-based Immunoassays Using Single-Molecule Counting

John Todda, Bob Freese, Ann Lu, Douglas Held, Jennifer Morey, Richard Livingston and Philippe Goix

Singulex, Inc., Hayward, CA.

aAddress correspondence to this author at: Singulex, Inc., 3507 Breakwater Ave., Hayward, CA 94545. Fax 510-259-1581; e-mail j.todd{at}singulex.com.


Abstract

Background: Immunoassay (IA) technology has expanded the clinical utility of protein biomarkers, but demands for increased sensitivity, dynamic reporting ranges, and small sample volumes have 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.




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