Characterization of SARS-CoV-2 in saliva of healthcare workers in high-risk settings and evaluation of the use of Cepheid's Xpert®Xpress SARS CoV-2 test kit

  • Funded by Oxford University Clinical Research Unit (OUCRU)
  • Total publications:0 publications

Grant number: unknown

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Key facts

  • Disease

    COVID-19
  • start year

    -99
  • Known Financial Commitments (USD)

    $0
  • Funder

    Oxford University Clinical Research Unit (OUCRU)
  • Principal Investigator

    N/A

  • Research Location

    Nepal
  • Lead Research Institution

    N/A
  • Research Priority Alignment

    N/A
  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Diagnostics

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Unspecified

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Health Personnel

Abstract

Group description The laboratory team of Patan Hospital (PH), Institute of Medicine: Teaching Hospital (IOM) and CMDN/Intrepid laboratory are all involved in this project. All three centers are located in Kathmandu. PH and IOM are the central public hospitals for COVID-19 while ID/INPL is the center for molecular diagnostics. Diagnostic testing to identify people with severe acute respiratory syndrome associated with SARS-CoV-2 infection is central to the control of the global COVID-19 pandemic. In some countries, the large-scale use of diagnostic testing has been the cornerstone of successful epidemic control strategies. In contrast, Nepal has been hampered by limited testing capacity in the country. However, a variety of bedside rapid testing technologies are emerging, and the GenXpertXpert® Xpress SARS-CoV-2 test kit is receiving particular attention as it fits our context. The Cepheid company has developed an automated molecular test for the qualitative detection of SARS-CoV-2. The test utilizes design principles that target multiple regions of the viral genome. The test can quickly detect the current pandemic corona virus and can give a positive result within 30 minutes. GenXpert machines have been massively rolled out across Nepal since 2018. Therefore, providing evidence that the test kits work effectively will be a vantage point for successful containment. As rapid diagnostic tests have so far been very unreliable and PCR capabilities in the country are severely lacking, the use of existing GenXpert machines would be a cost-effective and efficient method. for screening and diagnosis. The Xpert® Xpress SARS-CoV-2 test kits have also received urgent FDA approval. Providing evidence that the test kits work effectively will be a vantage point for successful containment. As rapid diagnostic tests have so far been very unreliable and PCR capabilities in the country are severely lacking, the use of existing GenXpert machines would be a cost-effective and efficient method. for screening and diagnosis. The Xpert® Xpress SARS-CoV-2 test kits have also received urgent FDA approval. Providing evidence that the test kits work effectively will be a vantage point for successful containment. As rapid diagnostic tests have so far been very unreliable and PCR capabilities in the country are severely lacking, the use of existing GenXpert machines would be a cost-effective and efficient method. for screening and diagnosis. The Xpert® Xpress SARS-CoV-2 test kits have also received urgent FDA approval. - Target To provide evidence for the national recommendation for the use of Cepheid's Xpert®Xpress SARS CoV-2 test kit on GenXpert machines; To determine the frequency and characteristics of asymptomatic SARS-CoV-2 infection among healthcare workers caring for COVID-19 patients; To determine the frequency of SARS-CoV-2 infection among healthcare workers caring for COVID-19 patients; To determine how long SARS-CoV-2 is detected in healthcare workers before symptoms develop; To determine whether transmission of SARS-CoV-2 occurs from healthcare workers (asymptomatic and forewarned) to community contacts; To demonstrate the utility of filter paper collection of saliva as a surveillance tool for SARS-CoV-2 infection; To study the molecular epidemiology, diversity and evolution of SARS-CoV-2 in the host organism during symptomatic and asymptomatic SARS-CoV-2 infection in healthcare workers. - Importance Providing evidence for the use of Cepheid's SARS CoV-2 test kit would be a cost-effective method to deploy testing for the current coronavirus situation in Nepal. Understanding the risk of carrying and transmitting the virus to and by healthcare workers will allow the design of interventions to reduce this risk. - Main target Early identification and understanding of the incidence of symptomatic and asymptomatic viral infections among healthcare workers; Sequence and epidemiological analysis of transmission from infected patients (together with data collected in Vietnam); Evaluation of the collection of saliva samples on filter paper for the diagnosis and sequencing of SARS-CoV-2; Evaluate the time from sample receipt to result delivery and the effectiveness of the Xpert®Xpress SARS CoV-2 test kit for nationwide deployment.