The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology.

Accurate and rapid point-of-care (PoC) diagnostics are critical to the control of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR) assays. Here, a preliminary prospective performance evaluation of the QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay is reported. Between November 2020 and March 2021, 49 longitudinal combined nose/throat (NT) swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 were obtained at St George's Hospital, London. In addition, 101 mid-nasal (MN) swabs were obtained from healthy volunteers in June 2021. These samples were used to evaluate the Q-POC SARS-CoV-2 RT-PCR assay. The primary analysis was to compare the sensitivity and specificity of the Q-POC test against a reference laboratory-based RT-PCR assay. The overall sensitivity of the Q-POC test compared with the reference test was 96.88% (83.78- 99.92% CI) for a cycle threshold (Ct) cut-off value for the reference test of 35 and 80.00% (64.35-90.95% CI) without altering the reference test's Ct cut-off value of 40. The Q-POC test is a sensitive, specific and rapid PoC test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC test provides an accurate option for RT-PCR at PoC without the need for sample pre-processing and laboratory handling, enabling rapid diagnosis and clinical triage in acute care and other settings.

Aerosol jet printing polymer dispersed liquid crystals on highly curved optical surfaces and edges.

We demonstrate a new technique for producing Polymer Dispersed Liquid Crystal (PDLC) devices utilising aerosol jet printing (AJP). PDLCs require two substrates to act as scaffold for the Indium Tin Oxide electrodes, which restricts the device geometries. Our approach precludes the requirement for the second substrate by printing the electrode directly onto the surface of the PDLC, which is also printed. The process has the potential to be precursory to the implementation of non-contact printing techniques for a variety of liquid crystal-based devices on non-planar substrates. We report the demonstration of direct deposition of PDLC films onto non-planar optical surfaces, including a functional device printed over the 90° edge of a prism. Scanning Electron Microscopy is used to inspect surface features of the polymer electrodes and the liquid crystal domains in the host polymer. The minimum relaxation time of the PDLC was measured at 1.3 ms with an 800 Hz, 90 V, peak-to-peak (Vpp) applied AC field. Cross-polarised transmission is reduced by up to a factor of 3.9. A transparent/scattering contrast ratio of 1.4 is reported between 0 and 140 V at 100 Hz.

SARS-CoV-2 enzyme-linked immunosorbent assays as proxies for plaque reduction neutralisation tests.

Severe acute respiratory coronavirus 2 (SARS-CoV-2) has spread globally since its emergence in 2019. Most SARS-CoV-2 infections generate immune responses leading to rising levels of immunoglobulins (Ig) M, A and G which can be detected using diagnostic tests including enzyme-linked immunosorbent assays (ELISA). Whilst implying previous SARS-CoV-2 infection, the detection of Ig by ELISA does not guarantee the presence of neutralising antibodies (NAb) that can prevent the virus infecting cells. Plaque reduction neutralisation tests (PRNT) detect NAb, but are not amenable to mass testing as they take several days and require use of SARS-CoV-2 in high biocontainment laboratories. We evaluated the ability of IgG and IgM ELISAs targeting SARS-CoV-2 spike subunit 1 receptor binding domain (S1-RBD), and spike subunit 2 (S2) and nucleocapsid protein (NP), at predicting the presence and magnitude of NAb determined by PRNT. IgG S2 + NP ELISA was 96.8% [95% CI 83.8-99.9] sensitive and 88.9% [95% CI 51.8-99.7] specific at predicting the presence of NAbs (PRNT80 > 1:40). IgG and IgM S1-RBD ELISAs correlated with PRNT titre, with higher ELISA results increasing the likelihood of a robust neutralising response. The IgM S1-RBD assay can be used as a rapid, high throughput test to approximate the magnitude of NAb titre.

IgG Seroconversion and Pathophysiology in Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

We investigated the dynamics of seroconversion in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. During March 29-May 22, 2020, we collected serum samples and associated clinical data from 177 persons in London, UK, who had SARS-CoV-2 infection. We measured IgG against SARS-CoV-2 and compared antibody levels with patient outcomes, demographic information, and laboratory characteristics. We found that 2.0%-8.5% of persons did not seroconvert 3-6 weeks after infection. Persons who seroconverted were older, were more likely to have concurrent conditions, and had higher levels of inflammatory markers. Non-White persons had higher antibody concentrations than those who identified as White; these concentrations did not decline during follow-up. Serologic assay results correlated with disease outcome, race, and other risk factors for severe SARS-CoV-2 infection. Serologic assays can be used in surveillance to clarify the duration and protective nature of humoral responses to SARS-CoV-2 infection.

Fine needle aspiration cytology (FNAC) of salivary gland tumours: repeat aspiration provides further information in cases with an unclear initial cytological diagnosis.

INTRODUCTION: Fine needle aspiration cytology (FNAC) for salivary gland tumours requires expertise in interpretation. When a diagnosis is not clear (despite a cellular aspirate), published work is lacking on the value of repeating the test. METHODS: A retrospective study of 135 patients who had FNAC followed by definitive excision for a suspected salivary gland tumour. Accuracy was compared among those requiring repeat FNAC on one more occasion because of a non-diagnostic initial cytology report. RESULTS: 33 patients (24% of study group) had repeat FNAC. A definite cytological diagnosis was subsequently made in 27/33 patients (82%). The sensitivity (84%) and specificity (93%) of repeat FNAC in distinguishing benign from malignant tumours was similar to initial FNAC (70% and 95%, respectively). CONCLUSIONS: Repeat FNAC may provide a cytological diagnosis in cases where the initial diagnosis is not clear, although cytology should be used in conjunction with other investigations of salivary tumours, including image-guided biopsy examination where appropriate. Ideally salivary gland FNAC should be interpreted by a specialist pathologist.