OPTN/SRTR 2020 Annual Data Report: Heart.

As we enter the third year of the new adult heart allocation policy, we are faced with the new challenges of the COVID-19 pandemic. In 2020, new listings (adult and pediatric) decreased slightly, with 4000 new listings in 2020, compared with 4087 in 2019; however, the number of adult heart transplants performed continued to increase, to 3715 in 2020. The number of pediatric heart transplants declined from 509 in 2019 to 465 in 2020. One-year and six-month posttransplant mortality rates in adult recipients have increased slightly since 2015 but have not significantly changed over the past decade. Overall, posttransplant mortality rates for adult recipients were 7.4% at six months and 9.4% at one year for transplants in 2019, 14.0% at three years for transplants in 2017, and 19.1% at five years for transplants in 2015. Although shorter-term posttransplant mortality rates have slightly increased, there has been a steady downward trend in longer-term mortality. Mortality rates for pediatric recipients were 5.7% at six months and 8.1% at one year for transplants in 2019, 11.6% at three years for transplants in 2017, and 15.2% at five years for transplants in 2015.

Neuropsychology consultation to identify learning disorders in children and adolescents: a proposal based on lessons learned during the COVID-19 pandemic.

Learning disorders are common neurodevelopmental conditions, occurring both idiopathically and in the context of other medical conditions. They are frequently comorbid with other neurodevelopmental and psychiatric conditions. Delayed identification and treatment have been associated with significant negative psychosocial consequences. The need for pediatric neuropsychologists to efficiently screen for learning disorders is likely to increase in the months and years following the COVID-19 pandemic, which has severely disrupted access to educational services, especially for children who also face racial and economic disparities. In this paper, we describe a consultation model that can be used to screen for learning disorders and can be completed using both in-person and telemedicine visits. Implementation may result in earlier intervention for struggling children, increase access to neuropsychological services without increasing wait times for comprehensive evaluations, and provide opportunities for collaborations with other health professionals (e.g., pediatricians, therapists, psychiatrists, and neurologists).

Performance of the VITROS® immunodiagnostic products SARS-CoV-2 antigen assay

Background/Case Studies: This study was designed to assess the clinical and analytical performance of the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen assay (VITROS SARS-CoV-2 Antigen) on the VITROS 3600 Immunodiagnostic System and the VITROS 5600/ XT 7600 Integrated Systems. Study Design/Methods: Detection of SARS-CoV-2 nucleocapsid protein in the VITROS SARS-CoV-2 Antigen assay is achieved using monoclonal anti-SARSCoV- 2 nucleocapsid antibodies coated onto the well. Sample is added to the coated well in the first stage of the reaction, and SARS-CoV-2 nucleocapsid antigen from the sample is captured. After washing, HRP conjugated monoclonal anti-SARS-CoV-2 nucleocapsid antibodies are added. Following a final wash, bound HRP conjugates are detected using the VITROS signal reagent. The assay cut-off for VITROS SARS-CoV-2 Antigen is 1.00;values above the cut-off are Reactive for SARS-CoV-2 antigen and values below 1.00 are Non-reactive. All VITROS testing was performed at the Ortho Clinical Diagnostics R&D lab, located in Rochester, NY, USA. RTPCR testing of clinical specimen was performed at an external clinical laboratory. Clinical performance was evaluated using 152 paired nasopharyngeal and nasal specimen that were collected in the United States between September and November 2020. Samples were stored frozen between the time of collection and testing and were from patients suspected of having contracted SARS-CoV-2 within seven days of symptom onset. Data were analyzed to calculate the positive percent agreement (PPA) and negative percent agreement to RT-PCR result. Analytical specificity was assessed by testing patient matrix spiked with inactivated organisms known to cause other respiratory infections. Exogenous compounds with potential to be present in upper respiratory specimen collected from patients suffering from upper respiratory infection were also tested for potential interference with the VITROS assay. Results/Findings: PPA for the VITROS assay in nasopharyngeal specimen was 86.2% overall and 94.8% in samples with RT-PCR cycle threshold (Ct) less than 30. PPA for nasal specimen was 83.1% overall and 92.3% in samples with RT-PCR Ct less than 30. Other respiratory organisms and potentially interfering substances were shown to not impact test results. Conclusions: The VITROS SARS-CoV-2 Antigen assay demonstrates excellent clinical agreement with RT-PCR and can be used as an aid in identifying individuals with active SARS-CoV-2 infection.

Clinical performance of the VITROS® Immunodiagnostic products anti-SARS-CoV-2 total antibody assay

Background/Case Studies: This study was designed to assess the analytical and clinical performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total assay (VITROS SARS-CoV-2 Total) on the VITROS ECi/ECiQ/ 3600 Immunodiagnostic Systems and the VITROS 5600/ XT 7600 Integrated Systems. Study Design/Methods: Antibody detection in VITROS SARS-CoV-2 Total assay is achieved using SARS-CoV-2 spike S1 protein antigen coated onto the well. Sample is added to the coated wells in the first stage of the reaction, and SARS-CoV-2 antibody from the sample is captured. After washing, HRP conjugated SARS-CoV-2 spike S1 protein antigens are added. Following a final wash, bound HRP conjugates are detected using the VITROS signal reagent. The assay cut-off for VITROS SARS-CoV-2 Total is 1.00;values equal to or above the cut-off are Reactive for SARSCoV- 2 antibodies and values below 1.00 are Non-reactive. Clinical testing was performed at the Ortho Clinical Diagnostics R&D lab located in Rochester, NY, USA. Clinical sensitivity was evaluated using 86 samples from 86 individuals diagnosed as SARS-CoV-2 positive by PCR, frozen and then sent to the R&D lab for evaluation. Date of reported onset of symptoms were reported for 69 of the 86 samples. Clinical specificity was evaluated using frozen serum and EDTA plasma samples from 400 healthy blood donors collected prior to 2019 and the COVID-19 pandemic. Data were analyzed to calculate the positive percent agreement (PPA) to PCR positivity and the clinical specificity of the assay. A five-day precision study was performed on a 12-member panel including 4 non-reactive, 1 cutoff, 3 weakly reactive and 3 moderately reactive samples using one reagent kit lot and one analyzer. Analytical specificity was assessed by testing patient samples known to include potentially interfering substances and potentially cross-reacting subgroups. Results/Findings: The sensitivity of VITROS SARSCoV- 2 Total was 100.0% (49/49, 95% CI: 92.7-100.0%) for samples collected >8 days after onset of symptoms were reported. Specificity in the blood donor population for VITROS SARS-CoV-2 Total was 100% (400/400, 95% CI: 99.1-100.0%). The 5-day precision study demonstrated within calibration precision in samples with results ≥ 0.50 S/C ranging from 3.1% to 6.1%. Other disease states and potentially interfering substances were shown to not impact test results. Conclusions: The VITROS Anti-SARS-CoV-2 Total assay demonstrates excellent clinical sensitivity and specificity.

COVID-19 outcomes among solid organ transplant recipients: A matched case-control study

Background: Solid organ transplant (SOT) recipients are considered to be 'vulnerable' to COVID-19 infection due to immunosuppression To date, there are no studies that compared the disease severity of COVID-19 in SOT recipients with non-SOT COVID-19 patients We characterized COVID-19 illness and clinical course among SOT recipients and compared the COVID-19 outcomes between SOT recipients and matched non-SOT patients Methods: In this case-control study, we compared the outcomes of COVID-19 between SOT recipients (cases: N=41) and their matched non-SOT (controls: N=121) patients from our center between 3/10/20 and 5/15/20 SOT recipients with COVID-19 were matched with up to three non-SOT COVID-19 controls on age (±5years), race, and admission status Patients were followed up until death or June 10, 2020 The primary outcome was death and secondary outcomes were severe diseasedefined as transfer to the intensive care unit and requiring at least humidified high flow oxygen), intubation and renal replacement therapy (RRT) use Results: The SOT recipients had the following transplants: 9 heart, 3 lung, 16 kidney, 8 liver and 5 dual organ (2 kidney-pancreas,1 heart-kidney, 1 liver-kidney, 1 kidney after liver) with a median age of 60 years (54-69), 80% male, 67% Black, 92% hypertension, 51% diabetes and 80% chronic kidney disease (CKD) Median time from transplant to COVID-19 was 9 years (5-16) Fortyfour percent of SOT COVID-19 had severe disease (61% renal replacement therapy [RRT], 61% intubation and 11% ECMO) The overall (14 6% vs 11 4%, P=NS) and severe disease (33% vs 29%;p=NS) case fatality rates were similar in SOT and non-SOT with COVID-19 Organ type did not predict the severe disease or death in SOT-recipients Risk of death was similar between SOT and non-SOT matched COVID-19 patients (HR=0 84[0 32, 2 20]) after adjusting for disease severity RRT use was higher in SOT recipients than matched non-SOT with COVID-19 (adjusted OR=5 32 [1 26, 22 42]) after adjusting for baseline CKD Tocilizumab use was higher in SOT than non-SOT COVID-19 patients (27% vs 9%, P=0 01) Hydroxychloroquine (HCQ) use for COVID-19 was similar (28% vs 29%;p=0 89) in both the groups Among SOT recipients, those treated with HCQ for COVID-19 had a ten-fold higher hazard of death compared to those who did not receive HCQ (HR=10 62[1 24, 91 09]) (Figure 1) This effect was not seen in non-SOT matched controls with COVID-19 Conclusion: Blacks and Males SOT recipients affected disproportionately with COVID-19 Black constitute one-tenth of all SOT in our center yet they represented two-thirds of COVID-19 cases Despite high RRT use in SOT recipients, the severe disease and short-term death were similar in both groups HCQ for the treatment of COVID-19 among SOT recipients was associated with high mortality and therefore, its role as a treatment modality requires further scrutiny(Figure Presented).