Use of serology immunoassays for predicting SARS-CoV-2 infection: a serology-based diagnostic algorithm (preprint)

Background. Detection of viral RNA by nucleic acid amplification testing (NAAT) remains the gold standard for diagnosis of SARS-CoV-2 infection but is limited by high cost and other factors. Whether serology-based assays can be effectively incorporated into a diagnostic algorithm remains to be determined. Herein we describe the development of a serology-based testing algorithm for SARS-CoV-2 infection. Patients and Methods. Between July 2020 and February 2021, we included symptomatic unvaccinated patients evaluated in the Emergency Department of our institution for suspected SARS-CoV-2. All patients had testing by real-time Reverse Transcription Polymerase Chain Reaction. The performance characteristics of five commercial enzymatic serology assays testing for different antibody isotypes were evaluated in a derivation cohort and the assay with the best performance was further tested on a validation cohort. Optimal cut-off points were determined using receiver operating characteristic (ROC) curves and further tested using logistic regression. Results. The derivation and validations cohorts included 72 and 319 patients, respectively. Based on its initial performance, the Elecsys Anti-SARS-CoV-2 assay (Roche Diagnostics) was further tested in the validation cohort. Using ROC curve analysis, we estimated the diagnostic performance for different cut-off points assuming a prevalence of positive tests of 5%. At any given cut-off point the NPV was over 97%. Discussion. This study suggests that an initial diagnostic strategy using the Elecsys Anti-SARS-CoV-2 serology test in symptomatic unvaccinated patients could help to rule out an acute SARS-CoV2 infection and potentially lead to appropriately tailored infection control measures or rational guidance for further testing with a potential cost reduction and increased availability

Postpartum mood among universally screened high and low socioeconomic status patients during COVID-19 social restrictions in New York City. (preprint)

Introduction: The mental health effects of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the Coronavirus disease 2019 (COVID-19) pandemic on postpartum women is of increasing concern among mental health practitioners. To date only a handful of studies have explored the impact of the pandemic during pregnancy and none have attempted explore the impact of pandemic related social restrictions on postpartum mood. Methods: Postpartum patients appearing to the Mount Sinai Health System for their postpartum appointment between January 2, 2020 and June 30, 2020, corresponding to before and during pandemic imposed social restrictions, were screened for mood symptomatology using the Edinburgh Postnatal Depression Scale (EPDS). Each patient’s socioeconomic status (SES; high/low) was determined by their location of clinical service. Results: 516 postpartum patients were screened. While no differences in EPDS scores were observed by SES prior to social restrictions (t(262)=0.23, p = .82), a significant change in mood symptomatology was observed following COVID-19 restrictions (t(288)=2.32, p < .02), with patients living in lower SES reporting significantly less depression symptomatology (t(321)=4.07, p < .01). There was no change in symptomatology among patients of higher SES (t(191)=0.59, p=0.56). Discussion: Postpartum depression, the most common complication of childbearing, is a prevalent, cross-cultural disorder with significant morbidity. The observed differences in postpartum mood between patients of different SES in the context of temporarily imposed COVID-19 related social restrictions present a unique opportunity to better understand the specific health and social support needs of postpartum patients living in urban poverty. Given that maternal mental illness has negative long-term developmental implications for the offspring, and that poor mental health reinforces the poverty cycle, future policy specifically directed towards supporting urban postpartum women living in low-SES by ameliorating some of the early maternal mental health burdens associated with balancing employment-family-childcare demands may assist in interrupting this cycle while simultaneously improving the long-term outcomes of their offspring.

Safety of Hydroxychloroquine among Outpatient Clinical Trial Participants for COVID-19 (preprint)

IntroductionUse of hydroxychloroquine in hospitalized patients with COVID-19, especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from three outpatient randomized clinical trials. MethodsWe conducted three randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, post-exposure prophylaxis and early treatment for COVID-19. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. ResultsWe enrolled 2,795 participants. The median age of research participants was 40 (IQR 34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2,324 (84%) participants reported side effect data, and 638 (27%) reported at least one medication side effect. Side effects were reported in 29% with daily, 36% with twice weekly, 31% with once weekly hydroxychloroquine compared to 19% with placebo. The most common side effects were upset stomach or nausea (25% with daily, 18% with twice weekly, 16% with weekly, vs. 10% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for daily, 16% twice weekly, 12% weekly, vs. 6% for placebo). Two individuals were hospitalized for atrial arrhythmias, one on placebo and one on twice weekly hydroxychloroquine. No sudden deaths occurred. ConclusionData from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19. Short SummaryData from three randomized clinical trials using hydroxychloroquine for the prevention and treatment of COVID-19 did not suggest significant safety concerns. Gastrointestinal side effects were common but arrhythmias were rare. There were no sudden deaths in any trial.