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Related Experiment Video

Updated: Jul 11, 2026

Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α

Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α

Published on: June 14, 2018

Ultrasensitive flow-based immunoassays using single-molecule counting.

John Todd¹, Bob Freese, Ann Lu

¹Singulex, Inc., Hayward, CA 94545, USA. j.todd@singulex.com

Clinical Chemistry

|September 25, 2007

Summary

The Erenna Immunoassay System achieves low detection limits for protein biomarkers, enabling sensitive measurements crucial for clinical diagnostics. This technology offers a wide dynamic range, enhancing its utility with small sample volumes.

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Published on: April 16, 2016

Area of Science:

Biochemistry
Analytical Chemistry
Clinical Diagnostics

Background:

Immunoassay (IA) technology advances protein biomarker analysis.
Increased sensitivity, dynamic range, and small sample volumes are critical for clinical utility.
Limitations exist in current IA technologies for certain biomarkers.

Purpose of the Study:

Assess the performance of the Erenna Immunoassay System.
Evaluate limits of detection (LODs) and dynamic reporting range.
Determine suitability for various clinically important biomarkers, including cardiac troponin I (cTnI).

Main Methods:

Utilized Erenna Immunoassays for 10 different biomarkers.
Determined LODs across various sample volumes (10 microL to 200 microL).
Assessed performance metrics including precision (CV).

Main Results:

Erenna Immunoassay System achieved LODs of 10-100 pg/L with 100 microL samples.
Cardiac troponin I (cTnI) LOD was 0.2 ng/L.
A 10% coefficient of variation (CV) was observed between 0.78 and 1.6 ng/L for cTnI.

Conclusions:

Erenna IA technology reproducibly measures protein biomarkers.
Achieved detection limits of 10-100 pg/L.
Demonstrated a dynamic range exceeding 4.5 logs using 50-150 microL sample volumes.