CovidNudge: diagnostic accuracy of a novel lab-free point-of-care diagnostic for SARS-CoV-2

3.BackgroundAccess to rapid diagnosis is key to the control and management of SARS-CoV-2. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) testing usually requires a centralised laboratory and significant infrastructure. We describe the development and diagnostic accuracy assessment of a novel, rapid point-of-care RT-PCR test, the DnaNudge(R) platform CovidNudge test, which requires no laboratory handling or sample pre-processing.

MethodsNasopharyngeal swabs are inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as positive control. Between April and May 2020, swab samples were tested in parallel using the CovidNudge direct-to-cartridge platform and standard laboratory RT-PCR using swabs in viral transport medium. Samples were collected from three groups: self-referred healthcare workers with suspected COVID-19 (Group 1, n=280/386; 73%); patients attending the emergency department with suspected COVID-19 (Group 2, n=15/386; 4%) and hospital inpatient admissions with or without suspected COVID-19 (Group 3, n=91/386; 23%).

ResultsOf 386 paired samples tested across all groups, 67 tested positive on the CovidNudge platform and 71 with standard laboratory RT-PCR. The sensitivity of the test varied by group (Group 1 93% [84-98%], Group 2 100% [48-100%] and Group 3 100% [29-100%], giving an average sensitivity of 94.4% (95% confidence interval 86-98%) and an overall specificity of 100% (95%CI 99-100%; Group 1 100% [98-100%]; Group 2 100% [69-100%] and Group 3 100% [96-100%]). Point of care testing performance was comparable during a period of high (25%) and low (3%) background prevalence. Amplification of the viral nucleocapsid (n1, n2, n3) targets were most sensitive for detection of SARS-CoV2, with the assay able to detect 1x104 viral particles in a single swab.

ConclusionsThe CovidNudge platform offers a sensitive, specific and rapid point of care test for the presence of SARS-CoV-2 without laboratory handling or sample pre-processing. The implementation of such a device could be used to enable rapid decisions for clinical care and testing programs.

4. RESEARCH IN CONTEXTO_ST_ABSEvidence before this studyC_ST_ABSThe WHO has highlighted the development of rapid, point-of-care diagnostics for detection of SARS-CoV-2 as a key priority to tackle COVID-19. The Foundation for Innovative Diagnostics (FIND) has identified over 90 point-of-care, near patient or mobile tests for viral detection of SARS-CoV-2. However, the most widely available rapid tests to date require some sample handling which limits their use at point-of-care. In addition, pressure on supply chains is restricting access to current diagnostics and alternatives are needed urgently.

Added value of this studyWe describe the development and clinical validation of COVID nudge, a novel point-of-care RT-PCR diagnostic, evaluated during the first wave of the SARS-CoV-2 epidemic. The platform is able to achieve high analytic sensitivity and specificity from dry swabs within a self-contained cartridge. The lack of downstream sample handling makes it suitable for use in a range of clinical settings, without need for a laboratory or specialized operator. Multiplexed assays within the cartridge allow inclusion of a positive human control, which reduces the false negative testing rate due to insufficient sampling.

Implication of the available evidencePoint-of-care testing can relieve pressure on centralized laboratories and increase overall testing capacity, complementing existing approaches. These findings support a role for COVID Nudge as part of strategies to improve access to rapid diagnostics to SARS-CoV-2. Since May 2020, the system has been implemented in UK hospitals and is being rolled out nationwide.