Clinical Validation of a Novel T-Cell Receptor Sequencing Assay for Identification of Recent or Prior Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

BACKGROUND: While diagnostic, therapeutic, and vaccine development in the coronavirus disease 2019 (COVID-19) pandemic has proceeded at unprecedented speed, critical gaps in our understanding of the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain unaddressed by current diagnostic strategies. METHODS: A statistical classifier for identifying prior SARS-CoV-2 infection was trained using >4000 SARS-CoV-2-associated T-cell receptor (TCR) ß sequences identified by comparing 784 cases and 2447 controls from 5 independent cohorts. The T-Detect COVID (Adaptive Biotechnologies) assay applies this classifier to TCR repertoires sequenced from blood samples to yield a binary assessment of past infection. Assay performance was assessed in 2 retrospective (n = 346; n = 69) and 1 prospective cohort (n = 87) to determine positive percent agreement (PPA) and negative percent agreement (NPA). PPA was compared with 2 commercial serology assays, and pathogen cross-reactivity was evaluated. RESULTS: T-Detect COVID demonstrated high PPA in individuals with prior reverse transcription-polymerase chain reaction (RT-PCR)-confirmed SARS-CoV-2 infection (97.1% 15+ days from diagnosis; 94.5% 15+ days from symptom onset), high NPA (∼100%) in presumed or confirmed SARS-CoV-2 negative cases, equivalent or higher PPA than 2 commercial serology tests, and no evidence of pathogen cross-reactivity. CONCLUSIONS: T-Detect COVID is a novel T-cell immunosequencing assay demonstrating high clinical performance for identification of recent or prior SARS-CoV-2 infection from blood samples, with implications for clinical management, risk stratification, surveillance, and understanding of protective immunity and long-term sequelae.

Adjusting to a Diagnosis of Cancer: Processes for Building Patient Capacity for Decision-Making.

This short report contributes to the expanding body of qualitative research literature about the cognitive processes of newly diagnosed cancer patients as they adjust to a diagnosis of cancer. The study is based on secondary qualitative analysis of audio records collected as part of a larger NIH study (RO1D: An Interdisciplinary Perspective: A Social Science Examination of Oncofertility RL1 HD058296). Core categories illustrate the processes of "naming it," "dealing with dealing with it," and finding the "new norm" and were based on nine patient experiences. We observe that our substantive conceptual categories have equivalents in bereavement and grief literature where researchers have posited the theory that processing the diagnosis of a terminal illness is the equivalent to adjusting to a bereavement. These findings emphasize the importance of understanding real-time patient thoughts and feelings as soon after diagnosis as was possible with full patient consent.

Association of screen time use and language development in Hispanic toddlers: a cross-sectional and longitudinal study.

This study examined the association between screen media use, media content, and language development among 119 Hispanic infants and toddlers. Children and their caregivers were recruited through an urban, Early Head Start program. Duration and content of screen media exposure was measured through a 24-hour recall questionnaire, and language development was measured at baseline and at 1-year follow up. Children in the sample spent an average of 3.29 hours engaged with screen media (median 2.5 hours per day). In both cross-sectional and longitudinal analyses, children who watched over 2 hours of television per day had increased odds of low communication scores. Whereas child-directed media was associated with low language scores, adult-directed media was not. Our findings support the mounting literature on the deleterious impacts of screen media in toddler's language development. Guidance and alternatives to screen media use should be available to families in pediatric practices and early childhood centers.