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Quanterix’s Ultrasensitive Single Molecule Measurement Technology Featured In Clinical Chemistry

Lexington, MA – Quanterix Corporation, a leader in high definition diagnostics, delivering ultrasensitive single molecule measurement for the benefit of human health, today announced that the paper, “Rapid, Fully Automated Digital Immunoassay for p24 Protein with the Sensitivity of Nucleic Acid Amplification for Detecting Acute HIV Infection,” which prominently features Simoa’s unprecedented sensitivity, has been published in Clinical Chemistry, the highest-impact journal serving the clinical laboratory. The paper describes development of the assay p24, a capsid protein of HIV, and demonstrates analytical and clinical efficacy by measurement of HIV in the earliest infections detectable by nucleic acid testing (NAT), the current gold standard for sensitivity.  

While NAT has become the standard for high-sensitivity in detecting low levels of the virus, the adoption of NAT can be cost prohibitive in low-resource settings where access to extreme sensitivity could be clinically advantageous for early detection of infection. With Simoa, researchers found a low-cost, fully- automated digital p24 antigen immunoassay with the sensitivity of quantitative NAT viral load methods for detection of acute HIV infection. The digital immunoassay exhibited >4000-fold greater sensitivity than contemporary immunoassays for p24 and sensitivity equivalent to that of NAT methods for early detection of HIV. 

“It is very exciting to see such impressive results with an immunoassay for HIV p24 Ag, with the Simoa digital immunoassay exhibiting the sensitivity of state-of-the-art viral load assays and approaching the sensitivity of blood screening NAT assays,” said Dr. Michael Busch, Co-Director, BSRI, and Senior Vice President, Research and Scientific Affairs, Blood Systems Inc. “I am encouraged by the potential of Simoa and look forward to further evaluate the utility of this and other next-generation immunoassays from Quanterix for diagnostic and blood screening applications.”

“This study is a significant advancement in early detection and treatment of infectious disease. The unique sensitivity of our technology to detect acute HIV infection early on can help limit the spread of the disease by offering a rapid, accurate and low-cost alternative to existing tools,” said Kevin Hrusovsky, CEO and Executive Chairman, Quanterix. “We’re excited about the possibilities associated with Simoa to detect acute infectious disease and hope to eventually transform today’s sick care to true, preventative healthcare through these advanced detection screenings.” 

Additional information on this paper can be found at:

About Quanterix

Quanterix is a developer of ground-breaking tools in high definition diagnostics. Its Simoa platform uses single molecule measurements to access previously undetectable proteins. With this unprecedented sensitivity and full automation, Simoa offers significant benefits to both research and clinical testing applications. Quanterix was established in 2007 and is located in Lexington, Massachusetts. To learn more about Quanterix and Simoa, please visit

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Nikki Festa & Caitlyn Keating
PAN Communications