Your browser doesn't support javascript.
Diagnostic Value of a SARS-CoV-2 Rapid Test Kit for Detection of Neutralizing Antibodies as a Point-of-Care Surveillance Test.
Chan, Michele Mun Hei; Leung, Ka-Yi; Zhang, Ricky Rui Qi; Liu, Danlei; Fan, Yujing; Khong, Matthew Ka Wa; Tam, Anthony R; Chen, Honglin; Yuen, Kwok-Yung; Hung, Ivan F N; Chan, Kwok-Hung.
  • Chan MMH; Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Leung KY; Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Zhang RRQ; Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Liu D; Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Fan Y; Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Khong MKW; Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Tam AR; Department of Medicine, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
  • Chen H; Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Yuen KY; State Key Laboratory for Emerging Infectious Diseases, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Hung IFN; Carol Yu Centre for Infection, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
  • Chan KH; Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Konggrid.194645.b, Hong Kong Special Administrative Region, China.
Microbiol Spectr ; 10(2): e0099321, 2022 04 27.
Article in English | MEDLINE | ID: covidwho-1731261
ABSTRACT
Detection and tracking of antibodies play an increasingly prominent role in population surveillance and implementation of public health measures to combat the current coronavirus disease 2019 (COVID-19) pandemic, with much attention placed on developing commercial serological assays as point-of-care diagnostic tools. While many rapid diagnostic tests (RDTs) that detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG and IgM antibodies have been evaluated, there is currently limited insight into detection of neutralizing antibodies (nAbs) by such modalities. Here, we evaluate performance characteristics of an RDT that detects SARS-CoV-2 IgG antibodies and, importantly, nAbs based on both infection- and vaccine-immunized cohorts by direct comparison to known antibody titers obtained from live virus microneutralization (VMN) assays. We further contextualize interpretations of band intensity of the RDT with reference to the World Health Organization (WHO) International Standard. We report a sensitivity of 94.37% and specificity of 92.50% for SARS-CoV-2 IgG detection and a sensitivity of 94.37% and specificity of 92.68% for nAbs. A limit of detection was determined as 3.125 IU/mL and 25.00 IU/mL, respectively, with reference to the WHO International Standard. We confirm that indication of nAb concentration, as elucidated by band intensity on the RDT, correlated with nAb titers defined by VMN assays and surrogate nAb assays. We additionally observe no cross-reactivity of the nAb test line to SARS-CoV-1 but report display of weak seropositivity for one sample on the SARS-CoV-2 IgG test line. Our study reveals promising performance characteristics of the assessed RDT, which implicates its usefulness in a wide range of diagnostic and epidemiological settings. IMPORTANCE In the ongoing coronavirus disease 2019 (COVID-19) pandemic, antibody tests play an increasingly important role in detecting previous infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and monitoring of response to vaccinations. In particular, neutralizing antibodies have recently been demonstrated to be highly predictive of immune protection against symptomatic infection. Our study is the first to evaluate a rapid diagnostic test based on samples acquired from both recovered COVID-19 patients and individuals vaccinated for SARS-CoV-2, which detects neutralizing antibodies in addition to SARS-CoV-2 IgG. We report promising sensitivity, specificity, and cross-reactivity profiles, which implicate its usefulness in a wide range of settings as a diagnostic point-of-care tool to aid in curbing transmission and reducing mortality caused by COVID-19 symptoms.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Microbiol Spectr Year: 2022 Document Type: Article Affiliation country: Spectrum.00993-21

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Microbiol Spectr Year: 2022 Document Type: Article Affiliation country: Spectrum.00993-21