1029. Torus Synestia Nucleic Acid Analysis Platform for Fast, High Multiplex Analysis of Nucleic Acids With Single-Nucleotide Discrimination Level

Abstract Background Nucleic acid amplification testing (NAAT) is an essential tool both for biomedical research and for clinical molecular diagnostics. Currently, there are multiple NAAT platforms available, each offering certain performance and utility advantages and disadvantages as compared to each other. Next generation NAAT platforms aim to deliver increased target detection sensitivity and specificity, low limits of target detection, quantitative high multiplex target capacity, rapid time to results, and simple sample-to-answer workflow. Methods Here we describe the Torus Synestia System, a NAAT platform capable of rapid, highly multiplexed amplification and detection of both DNA and RNA targets. The platform comprises a small, portable (~ 2kg) amplification and detection device and a disposable single-use cartridge housing a PCR amplification chamber with an integrated label-free microarray for real-time data acquisition and interpretation. The platform offers a 30-min turnaround time with a detection limit of 10 DNA/RNA molecules per assay and single nucleotide discrimination. Results We demonstrate the Synestia System performance and utility with three distinct molecular applications: 1) detection of 20 genetic loci and 30 single nucleotide polymorphisms in human genomic DNA; 2) detection and genotyping of 43 unique bacterial species associated with human urinary tract infections; and 3) detection and profiling human respiratory viral pathogens including SARS-CoV-1/2, seasonal coronaviruses, Influenza A/B, and human respiratory syncytial viruses. In addition, the single-nucleotide specificity of our label-free microarray probes allowed for robust identification and discrimination of newly emerging SARS-CoV-2 lineages, such as B.1.1.7 (a.k.a. UK), B.1.351 (a.k.a. South African), P.1 (a.k.a. Brazilian), and B.1.617 (a.k.a. Indian). Conclusion The Torus Synestia System has broad applicability in both clinical and research environments. We are confident that the Torus Synestia System will revolutionize syndromic diagnostics at the point of care (PoC) and lead to improved response times during future epidemic and pandemic pathogen outbreaks. Disclosures All Authors: No reported disclosures


1
Johns Hopkins University, Baltimore, Maryland; 2 Johns Hopkins, Baltimore, MD; 3 Johns Hopkins University School of Medicine, Baltimore, MD Session: P-58. New Approaches to Diagnostics Background. Emergency departments (EDs) serve as sentinel settings for diagnosing sexually transmitted infections (STIs), including HIV and syphilis. We aimed to assess performance and patient acceptability of a point-of-care (POC) test, the Chembio Dual Path Platform (DPP®) HIV-Syphilis Assay, in an urban ED in Baltimore.
Methods. 170 patients were enrolled via convenience sampling from Oct 2019 -March 2020 and Jan 2021 -June 2021. Patients eligible were < 70 yrs, men who have sex with men, pregnant without care, had STI concerns, or history of drug use. Subjects received standard of care (SOC) HIV and syphilis testing under institutional laboratory algorithms. Subjects were then tested with the finger-stick POC test and completed a survey, both before and after the POC test to assess subjects' attitudes about the POC test.
The pre-test survey found 67% and 77% of participants were comfortable with a finger-stick test and agreed the POC test result would be as good as the SOC test result, which increased to 96% and 86% in the post-test, respectively, (p< 0.05). At post-test, 86% reported they would feel confident to perform this test at home and 81% would use it at least once per year if it were available. 97% reported they were more likely to seek treatment if receiving a positive result during their ED visit and 91% reported it would reduce their stress/anxiety if receiving a negative test result in the ED.
Conclusion. Our findings demonstrated satisfactory performance and high patient acceptability of the Chembio DPP® HIV-Syphilis Assay. Given the test is FDA approved, implementation studies are needed to determine whether adoption of this POC test will benefit patients and be consistent with ED workflows.

Session: P-58. New Approaches to Diagnostics
Background. Nucleic acid amplification testing (NAAT) is an essential tool both for biomedical research and for clinical molecular diagnostics. Currently, there are multiple NAAT platforms available, each offering certain performance and utility advantages and disadvantages as compared to each other. Next generation NAAT platforms aim to deliver increased target detection sensitivity and specificity, low limits of target detection, quantitative high multiplex target capacity, rapid time to results, and simple sample-to-answer workflow.
Methods. Here we describe the Torus Synestia System, a NAAT platform capable of rapid, highly multiplexed amplification and detection of both DNA and RNA targets. The platform comprises a small, portable (~ 2kg) amplification and detection device and a disposable single-use cartridge housing a PCR amplification chamber with an integrated label-free microarray for real-time data acquisition and interpretation. The platform offers a 30-min turnaround time with a detection limit of 10 DNA/RNA molecules per assay and single nucleotide discrimination.
Results. We demonstrate the Synestia System performance and utility with three distinct molecular applications: 1) detection of 20 genetic loci and 30 single nucleotide polymorphisms in human genomic DNA; 2) detection and genotyping of 43 unique bacterial species associated with human urinary tract infections; and 3) detection and profiling human respiratory viral pathogens including SARS-CoV-1/2, seasonal coronaviruses, Influenza A/B, and human respiratory syncytial viruses. In addition, the single-nucleotide specificity of our label-free microarray probes allowed for robust identification and discrimination of newly emerging SARS-CoV-2 lineages, such as B.1.1.7 (a.k.a. UK), B.1.351 (a.k.a. South African), P.1 (a.k.a. Brazilian), and B.1.617 (a.k.a. Indian).
Conclusion. The Torus Synestia System has broad applicability in both clinical and research environments. We are confident that the Torus Synestia System will revolutionize syndromic diagnostics at the point of care (PoC) and lead to improved response times during future epidemic and pandemic pathogen outbreaks.
Disclosures. All Authors: No reported disclosures