Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Iglὁi, Zsὁfia ; Velzing, Jans ; van Beek, Janko ; van de Vijver, David ; Aron, Georgina ; Ensing, Roel ; Benschop, Kimberley ; Han, Wanda ; Boelsums, Timo ; Koopmans, Marion ; Geurtsvankessel, Corine ; Molenkamp, Richard
• Description:
  Rapid detection of infection is essential for stopping the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Roche SD Biosensor rapid antigen test for SARS-CoV-2 was evaluated in a nonhospitalized symptomatic population. We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. We analyzed date of onset and symptoms using data from a clinical questionnaire. Overall test sensitivity was 84.9% (95% CI 79.1-89.4) and specificity was 99.5% (95% CI 98.7-99.8). Sensitivity increased to 95.8% (95% CI 90.5-98.2) for persons who sought care within 7 days of symptom onset. Test band intensity and time to result correlated strongly with viral load; thus, strong positive results could be read before the recommended time. Approximately 98% of all viable specimens with cycle threshold <30 were detected. Rapid antigen tests can detect symptomatic SARS-CoV-2 infections in the early phase of disease, thereby identifying the most infectious persons.
• Subjects:
  Clinical Evaluation Clinical Evaluation Of Roche Sd Biosensor Rapid Antigen Test For Sars-Cov-2 In Municipal Health Service Testing Site, The Netherlands Coronavirus Disease Coronavirus Infections Covid-19 Diagnostics Rapid Antigen Test Research Respiratory Infections Roche Sars-Cov-2 Severe Acute Respiratory Syndrome Coronavirus 2 Viruses Zoonoses

  More +
• Source:
  Emerg Infect Dis. 27(5):1323-1329
• Pubmed ID:
  33724916
• Pubmed Central ID:
  PMC8084500
• Document Type:
  Journal Article
• Place as Subject:
  Netherlands
• Volume:
  27
• Issue:
  5
• Collection(s):
  Emerging Infectious Diseases
• Main Document Checksum:
  urn:sha256:0ac865212975cee631156a098639cb201922a3a49f12d50dff6d30d4f919be8b
• Download URL:
  https://stacks.cdc.gov/view/cdc/106030/cdc_106030_DS1.pdf
• File Type:
  [PDF - 3.90 MB ]