Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants.

BACKGROUND AND OBJECTIVES: Timely detection of SARS-CoV-2 infection with subsequent contact tracing and rapid isolation are considered critical to containing the pandemic, which continues with the emergence of new variants. Hence, there is an ongoing need for reliable point-of-care antigen rapid diagnostic tests (Ag-RDT). This report describes the development, evaluation, and analytical sensitivity of the diagnostic performance of the InteliSwab® COVID-19 Rapid Test. Methods: Samples from 165 symptomatic subjects were tested with InteliSwab® and the results were compared to RT-PCR to determine the antigen test performance. The analytical sensitivity of InteliSwab® for the detection of different variants was assessed by limit of detection (LOD) determination using recombinant nucleocapsid proteins (NPs) and testing with virus isolates. Western immunoblot independently confirmed that each monoclonal Ab is capable of binding to all variants tested thus far. RESULTS: The overall positivity rate by RT-PCR was 37% for the 165 symptomatic subjects. Based on RT-PCR results as the reference standard, InteliSwab® showed clinical sensitivity and specificity of 85.2% (95% CI, 74.3-92.0%) and 98.1% (95% CI, 93.3-99.7%), respectively. The overall agreement was 93.3% (Kappa index value 0.85; 95% CI, 0.77-0.74) between RT-PCR and InteliSwab® test results. Furthermore, the evaluation of analytical sensitivity for different SARS-CoV-2 variants by InteliSwab® was comparable in the detection of all the variants tested, including Omicron subvariants, BA.4, BA.5, and BQ.1. CONCLUSIONS: Due to the surge of infections caused by different variants from time to time, there is a critical need to evaluate the sensitivity of rapid antigen-detecting tests for new variants. The study findings showed the robust diagnostic performance of InteliSwab® and analytical sensitivity in detecting different SARS-CoV-2 variants, including the Omicron subvariants. With the integrated swab and excellent sensitivity and variant detection, this test has high potential as a point-of-care Ag-RDT in various settings when molecular assays are in limited supply and rapid diagnosis of SARS-CoV-2 is necessary.

Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista).

PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. METHODS: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. RESULTS: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. CONCLUSION: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.

Patients' vs. Physicians' Assessments of Emergencies: The Prudent Layperson Standard.

OBJECTIVE: To compare perception of the need for emergency care by emergency department (ED) patients vs. emergency physicians (EPs). METHODS: Mailed survey to EPs and a convenience sample of ED patients. Survey rated urgency of acute sore throat, ankle injury, abdominal pain, and hemiparesis, as well as the best definition of "emergency." Responses were compared with chi-square (p < .05). RESULTS: 119/140 (85%) of EPs and 1453 ED patients responded. EPs were more likely to judge acute abdominal pain (79.8% vs. 43.4%, p < 0.001, odds ratio (OR) 5.16, 95% confidence interval (CI) 3.19-8.40) and hemiparesis (100% vs. 82.6%, p < 0.001, OR 24.9, 95% CI 3.75-94.4) as an emergency. Similar proportions of ED patients and EPs considered sore throat (12.2% vs. 7.6%, p = 0.18, OR 0.59, CI 0.27-1.23) and ankle injury (46.9% vs. 38.6%, p = 0.10, OR 0.71, CI 0.48-1.06) an emergency. EPs (35%) and ED patients (40%) agreed to a similar degree with the "prudent layperson" definition, "a condition that may result in death, permanent disability, or severe pain." (p = .36, OR 1.22, CI 0.81-1.84). EPs were more likely to add, "the condition prevented work," (27% vs. 16%, p = 0.003, OR 0.51, CI 0.33-0.81). Patients more often added, "occurred outside business hours" (15% vs. 4%, p = 0.002, OR 4.0, CI = 1.5-11.3). CONCLUSION: For serious complaints, ED patients' thresholds for seeking care are higher than judged appropriate by EPs. Stroke is not uniformly recognized as an emergency. Absent consensus for the "correct" threshold, the prudent layperson standard is appropriate.