Quantum-enhanced nanodiamond rapid test advances early SARS-CoV-2 antigen detection in clinical diagnostics
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Abstract
Worldwide, the urgent need for more sensitive rapid lateral flow tests (LFTs) for early disease diagnosis is driving advances in quantum technologies. Spin-enhanced nanodiamond LFTs offer the potential for a sensitivity step change, yet to date only model systems have been studied with few clinical samples. Herein, we report the largest spin-enhanced LFT clinical evaluation, focusing on SARS-CoV-2 antigen as an exemplar. The limit of detection for recombinant antigens was 0.67 pg/ml, and inactivated whole virus wild-type and Omicron variants were 13 TCID 50 /mL and 8.8 TCID 50 /mL, respectively. Our blinded clinical study with 103 patient upper respiratory tract swab samples showed 95.1% sensitivity (Ct ≤ 30) and 100% specificity benchmarked to RT-qPCR, with no cross-reactivity to influenza A, RSV, and Rhinovirus. Analysis of trial data indicates spin-enhanced LFTs could diagnose SARS-CoV-2 on average 2.0 days earlier than conventional gold nanoparticle LFTs with identical antibodies, and just 0.6 days after RT-qPCR. Quantum-enhanced LFT sensitivity would have detected ~69,400 more patients in a single day at the peak of Omicron, reducing the transmission risk and protecting populations. Our findings mark an important milestone in the emerging field of quantum-enhanced diagnostics, with the potential for significant health-economic benefits to patients, populations, health systems and society.
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Strength of evidence
Reviewer(s): S Ramanathan (Universiti Malaya) | 📒📒📒 ◻️◻️
V Knight (Children's Hospital Colorado) | 📗📗📗📗◻️ -
Vijaya Knight
Review 2: "Quantum-enhanced Nanodiamond Rapid Test Advances Early SARS-CoV-2 Antigen Detection in Clinical Diagnostics"
Peer reviewers praised the rigor of the study noting it as the first large-scale blinded clinical evaluation of spin-enhanced nanodiamond LFTs, moving beyond proof-of-concept to a performance assessment with real clinical samples.
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Santheraleka Ramanathan
Review 1: "Quantum-enhanced Nanodiamond Rapid Test Advances Early SARS-CoV-2 Antigen Detection in Clinical Diagnostics"
Peer reviewers praised the rigor of the study noting it as the first large-scale blinded clinical evaluation of spin-enhanced nanodiamond LFTs, moving beyond proof-of-concept to a performance assessment with real clinical samples.
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