Your browser doesn't support javascript.
Development of the RealTime SARS-CoV-2 quantitative Laboratory Developed Test and correlation with viral culture as a measure of infectivity.
Berg, Michael G; Zhen, Wei; Lucic, Danijela; Degli-Angeli, Emily J; Anderson, Mark; Forberg, Kenn; Olivo, Ana; Sheikh, Farah; Toolsie, Dan; Greninger, Alexander L; Cloherty, Gavin A; Coombs, Robert W; Berry, Gregory J.
  • Berg MG; Abbott Laboratories, Abbott Park, IL, United States. Electronic address: michael.berg@abbott.com.
  • Zhen W; Northwell Health Laboratories, Lake Success, NY, United States.
  • Lucic D; Abbott Molecular, Des Plaines, IL, United States.
  • Degli-Angeli EJ; Department of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle, WA, United States.
  • Anderson M; Abbott Laboratories, Abbott Park, IL, United States.
  • Forberg K; Abbott Laboratories, Abbott Park, IL, United States.
  • Olivo A; Abbott Laboratories, Abbott Park, IL, United States.
  • Sheikh F; Northwell Health Laboratories, Lake Success, NY, United States.
  • Toolsie D; Abbott Molecular, Des Plaines, IL, United States.
  • Greninger AL; Department of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle, WA, United States.
  • Cloherty GA; Abbott Laboratories, Abbott Park, IL, United States.
  • Coombs RW; Department of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle, WA, United States.
  • Berry GJ; Northwell Health Laboratories, Lake Success, NY, United States.
J Clin Virol ; 143: 104945, 2021 10.
Article in English | MEDLINE | ID: covidwho-1364216
ABSTRACT
While diagnosis of COVID-19 relies on qualitative molecular testing for the absence or presence of SARS-CoV-2 RNA, quantitative viral load determination for SARS-CoV-2 has many potential applications in antiviral therapy and vaccine trials as well as implications for public health and quarantine guidance. To date, no quantitative SARS-CoV-2 viral load tests have been authorized for clinical use by the FDA. In this study, we modified the FDA emergency use authorized qualitative RealTime SARS-CoV-2 assay into a quantitative SARS-CoV-2 Laboratory Developed Test (LDT) using newly developed Abbott SARS-CoV-2 calibration standards. Both analytical and clinical performance of this SARS-CoV-2 quantitative LDT was evaluated using nasopharyngeal swabs (NPS). We further assessed the correlation between Ct and the ability to culture virus on Vero CCL81 cells. The SARS-CoV-2 quantitative LDT demonstrated high linearity with R2 value of 0.992, high inter- and intra-assay reproducibility across the dynamic range (SDs ± 0.08-0.14 log10 copies/mL for inter-assay reproducibility and ± 0.09 to 0.19 log10 copies/mL for intra-assay reproducibility). Lower limit of detection was determined as 1.90 log10 copies/mL. The highest Ct at which CPE was detected ranged between 28.21-28.49, corresponding to approximately 4.2 log10 copies/mL. Quantitative tests, validated against viral culture capacity, may allow more accurate identification of individuals with and without infectious viral shedding from the respiratory tract.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article