Diagnostic accuracy of a new COVID-19 antigen test obtained by mid-turbinate swab.

Context: At the mid-point of the COVID-19 pandemic, polymerase chain reaction (PCR) testing for SARS-CoV-2 was difficult to obtain and took several days to return a result. Our health system wished to explore the use of the Quidel Sofia™ antigen test to diagnose COVID-19 in our primary care clinics, but the test was approved for emergency use authorization by the US Food and Drug Administration with only 250 test subjects. In addition, because it was important to avoid aerosol generating procedures in primary care clinics, it was necessary to test the diagnostic performance of the antigen test using mid-turbinate (MT) swabs rather than the approved nasopharyngeal (NP) swab technique. Objective: To assess the diagnostic test characteristics of a SARS-CoV-2 antigen test performed using mid-turbinate nasal swabs compared with the presumed reference standard PCR test by NP swab. Study Design: Prospective cohort study. Setting or Dataset: Outpatient. Population studied: Adults with symptoms consistent with mild-moderate COVID-19. We attempted to recruit 800 subjects to provide statistical assurance that the test sensitivity was at least 90%. Intervention/Instrument: After informed consent, subjects underwent MT nasal swab for antigen testing followed by NP swabbing for PCR testing. Outcome Measures: Sensitivity, specificity, positive and negative predictive values, and likelihood ratios, all with associated 95% confidence intervals. Results: Due to recruitment difficulty (subject reluctance and staffing issues at the testing centers), we recruited only 117 subjects. Sensitivity was 0.750 (95% CI 0.566, 0.885), and specificity was 0.988 (95% CI 0.936, 1.000). Positive Predictive Value was 0.960 (95% CI 0.796, 0.999) and Negative Predictive Value was 0.913 (95% CI 0.836, 0.962). The likelihood ratio for a positive test was 63.75 (95% CI 8.99, 451.97) and the likelihood ratio for a negative test was 0.25 (95% CI 0.14, 0.46). Conclusions: This antigen test for SARS-CoV-2 was of reasonable clinical utility in a low prevalence environment but concerns about the actual prevalence of COVID-19 and the ramifications of false negatives limited its use. Difficulty recruiting subjects and the resultant delay in the results made it impossible to implement this antigen testing in primary care practices, but it is hoped that these data will contribute to the accumulation of evidence about diagnostic testing for COVID-19.

Effects of COVID-19 on Patients in Adult Ambulatory Psychiatry: Using Patient-Rated Outcome Measures and Telemedicine.

Introduction: To examine the effects of coronavirus disease 2019 (COVID-19) on patients in an academic psychiatric ambulatory clinic, data from a measurement-based care (MBC) system were analyzed to evaluate impacts on psychiatric functioning in patients using telemedicine. Psychiatric functioning was evaluated for psychological distress (brief adjustment scale [BASE]-6), depression (patient health questionnaire [PHQ]-9), and anxiety (generalized anxiety disorder [GAD]-7), including initial alcohol (U.S. alcohol use disorders identification test) and substance use (drug abuse screening test-10) screening. Methods: This observational study included MBC data collected from November 2019 to March 2021. Patient-Reported Outcome Measures (PROMs) were examined to determine changes in symptomatology over the course of treatment, as well as symptom changes resulting from the pandemic. Patients were included in analyses if they completed at least one PROM in the MBC system. Results: A total of 2,145 patients actively participated in the MBC system completing at least one PROM, with engagement ranging from 35.07% to 83.50% depending on demographic factors, where completion rates were significantly different for age, payor status, and diagnostic group. Average baseline scores for new patients varied for the GAD-7, PHQ-9, and BASE-6. Within-person improvements in mental health before and after the pandemic were statistically significant for anxiety, depression, and psychological adjustment. Discussion: MBC is a helpful tool in determining treatment progress for patients engaging in telemedicine. This study showed that patients who engaged in psychiatric services incorporating PROMs had improvements in mental health during the COVID-19 pandemic. Additional research is needed exploring whether PROMs might serve as a protective or facilitative factor for those with mental illness during a crisis when in-person visits are not possible.