Quanterix’ Simoa Technology Demonstrates Advancements in COVID-19 Research through Viral Antigen Measurements in Blood and Saliva Samples
Company’s SARS-CoV-2 N-Protein Assay measures viral antigen in plasma, dried blood spots and saliva in more than 90 percent of COVID-19 PCR+ positive donors, including those without symptoms
“Despite the rapid proliferation of COVID-19 testing, the global community continues to struggle to overcome critical challenges with the accuracy, cost and availability of diagnostic tests, and with access to research tools that could help to enable a highly tailored approach to COVID-19 patient care,” said
While current PCR-based testing remains the gold standard for COVID-19 detection, concerns have been raised with respect to false negatives associated with nasal and NP swabs, particularly in asymptomatic and pre-symptomatic patients. According to data published in the Annals of Internal Medicine, on day five of infection – the median time for symptom onset and the peak of viral transmission – molecular tests show a 38 percent probability of producing a false result. Moreover, PCR-based supply chains have been strained by increased testing demands, requiring the need to evaluate new testing paradigms.
Harnessing the high-sensitivity and specificity of the Simoa HD-X AnalyzerTM to quantitate the SARS-CoV-2 nucleocapsid protein and anti-SARS-CoV-2 spike IgG directly in the various sample matrices in this research test, which is authorized for use with NP swabs, but not yet authorized by the FDA for emergency use with saliva or DBS samples, the research team observed a more than 90 percent positive percentage agreement (PPA) of COVID-19 positive patients and a more than 98 percent negative percent agreement (NPA) in all matrices within seven days of a positive PCR test, using sample cohorts which included both asymptomatic and symptomatic patients. The research also demonstrates an inverse correlation between nucleocapsid protein clearance and an increase in SARS-CoV-2 anti-spike IgG in all matrices, suggesting that an early and robust IgG response alleviates severe disease outcomes, even when high levels of viral nucleocapsid protein are initially present.
“The impact of the COVID-19 pandemic will continue to reverberate globally in the months and years ahead.” continued Hrusovsky. “With technologies like Simoa, which can measure the concentration of viral proteins in blood and saliva samples obtained non-invasively, new pathways may become available to expand access to accurate and reliable testing, and to extend our understanding of COVID-19 biology. When combined with highly sensitive Simoa assays to measure biomarkers of inflammation and neurodegeneration, we can begin to unravel the mysteries of COVID-19 infection, including the estimated 30% of infections that progress to 'Long COVID', and accelerate development of effective treatment paradigms. We’re elated by the results of this research and continue to support the global scientific community in their tireless efforts to address the pandemic.”
The results presented in the
To learn more about Quanterix’ technology, visit https://www.quanterix.com/simoa-technology/.
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