Background Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in blood, also known as RNAemia, has been reported, but its prognostic implications are poorly understood. This study aimed to determine the frequency of SARS-CoV-2 RNA in plasma and its association with coronavirus disease 2019 (COVID-19) clinical severity. Methods An analytical cross-sectional study was performed in a single-center tertiary care institution and included consecutive inpatients and outpatients with confirmed COVID-19. The prevalence of SARS CoV-2 RNAemia and the strength of its association with clinical severity variables were examined and included intensive care unit (ICU) admission, invasive mechanical ventilation, and 30-day all-cause mortality. Results Paired nasopharyngeal and plasma samples were included from 85 patients. The median age was 55 years, and individuals with RNAemia were older than those with undetectable SARS-CoV-2 RNA in plasma (63 vs 50 years; P = .04). Comorbidities were frequent including obesity (37.6%), hypertension (30.6%), and diabetes mellitus (22.4%). RNAemia was detected in 28/85 (32.9%) of patients, including 22/28 (78.6%) who required hospitalization. In models adjusted for age, RNAemia was detected more frequently in individuals who developed severe disease including ICU admission (32.1 vs 14.0%; P = .04) and invasive mechanical ventilation (21.4% vs 3.5%; P = .02). All 4 deaths occurred in individuals with detectable RNAemia. An additional 121 plasma samples from 28 individuals with RNAemia were assessed longitudinally, and RNA was detected for a maximum duration of 10 days. Conclusions This study demonstrated a high proportion of SARS-CoV-2 RNAemia, and an association between RNAemia and clinical severity suggesting the potential utility of plasma viral testing as a prognostic indicator for COVID-19.

Background: Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for diagnosis of SARS-CoV-2. The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. Objectives: The aim of this study was to assess test performance of the Accula SARS-CoV-2 test. Study design: The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT) targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Results: Overall percent agreement between the assays was 84.0% (95% confidence interval [CI] 75.3 to 90.6%), PPA was 68.0% (95% CI 53.3 to 80.5%) and the kappa coefficient was 0.68 (95% CI 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test, and showed low viral load burden with a median cycle threshold value of 37.7. NPA was 100% (95% CI 94.2 to 100%). Conclusion: Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings, and for confirmatory testing in individuals with moderate to high pre-test probability of SARS-CoV-2 who test negative on Accula.

Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

24Background: Detection of SARS-CoV-2 RNA in the blood, also known as RNAemia, has been 25 reported, but its prognostic implications are not well understood. This study aimed to determine 26 the frequency of SARS-CoV-2 RNA in plasma and its association with the clinical severity of 27 Methods: An analytical cross-sectional study was performed in a single-center tertiary care 29 institution in northern California and included consecutive inpatients and outpatients with COVID-30 19 confirmed by detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens. The 31 prevalence of SARS CoV-2 RNAemia and the strength of its association with clinical severity 32 variables were examined and included the need for transfer to an intensive care unit (ICU), 33 mechanical ventilation and 30-day all-cause mortality. 34 Results: Paired nasopharyngeal and plasma samples were included from 85 patients. The overall 35 median age was 55 years, and individuals with RNAemia were older than those with undetectable 36 SARS-CoV-2 RNA in plasma (63 vs 50 years; p=0.001). Comorbidities were frequent including 37 obesity (37.7%), hypertension (30.6%) and diabetes mellitus (22.4%). RNAemia was detected in 38 a total of 28/85 (32.9%) individual patients, including 22/28 (78.6%) who required hospital 39 admission. RNAemia was detected more frequently in individuals who developed severe disease 40 including the need for ICU transfer (32.1% vs 14.0%; p=0.05), mechanical ventilation (21.4% vs 41 3.5%; p=0.01) and 30-day all-cause mortality (14.3% vs 0%; p=0.01). No association was detected 42 between RNAemia and estimated levels of viral RNA in the nasopharynx. An additional 121 43 plasma samples from 28 individuals with RNAemia were assessed longitudinally, and RNA was 44 detected for a maximum duration of 10 days.45 All rights reserved. No reuse allowed without permission.was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. Conclusion:This study demonstrated a high proportion of SARS-CoV-2 RNAemia, and an 46 association between RNAemia and clinical severity suggesting the potential utility of plasma viral 47 testing as a prognostic indicator for COVID-19. 48All rights reserved. No reuse allowed without permission.was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.(NP) swab samples. Preliminary data suggest that severe acute respiratory syndrome coronavirus 51 2 (SARS-CoV-2) RNA may also be detected in plasma and serum. 1,2 However, the frequency and 52 prognostic implication of viral RNA detection in these sample types is not fully understood. We 53 aim to investigate the association between detectable SARS-CoV-2 RNA in nasopharyngeal swab 54 and plasma samples, and to describe clinical implications of viral RNA detection in plasma. 55 56 Methods 57 We performed a cross-sectional study at the Stanford Health Care (SHC) Clinical Virology 58 Laboratory, which serves adult and pediatric tertiar...

Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.