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Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV

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ClinicalTrials.gov Identifier: NCT04245631
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Tracking Information
First Submitted Date January 26, 2020
First Posted Date January 29, 2020
Last Update Posted Date April 10, 2020
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2020)
  • Detection sensitivity is greater than 95% [ Time Frame: at baseline ]
    Detection sensitivity is greater than 95%
  • Detection specificity is greater than 95% [ Time Frame: at baseline ]
    Detection specificity is greater than 95%
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 26, 2020)
Consistent with existing universal reagent detection rates greater than 95% [ Time Frame: at baseline ]
Consistent with existing universal reagent detection rates greater than 95%
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV
Official Title Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV
Brief Summary In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference.
Detailed Description In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The investigators has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference. Patients who were suspected of being infected with 2019-nCoV in the hospital.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who were suspected of being infected with 2019-nCoV in the hospital.
Condition New Coronavirus
Intervention Diagnostic Test: Recombinase aided amplification (RAA) assay
We established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, we also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference. Sample types include either of nasal swab, oral swab, bronchoalveolar-lavage fluid, urea, blood, fecal.
Study Groups/Cohorts RAA assay for 2019-nCoV
a simple, fast and portable recombinase aided amplification (RAA) assay for 2019-nCoV
Intervention: Diagnostic Test: Recombinase aided amplification (RAA) assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 26, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1. Suspected cases (formerly observed cases)

Meet the following 2 at the same time:

Epidemiological history There was a history of travel or residence in Wuhan within two weeks before the onset of illness; or patients who had had fever from Wuhan with respiratory symptoms within 14 days before the onset of illness, or had clustered onset.

Clinical manifestations

  1. fever;
  2. It has the imaging characteristics of pneumonia mentioned above;
  3. The total number of white blood cells is normal or decreased, or the lymphocyte count is decreased in the early stage of onset.

    • 2. confirmed cases On the basis of meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory tract secretions, and other specimens were tested by real-time fluorescent RT-PCR for positive nucleic acid detection of new coronavirus; or viral gene sequencing was highly homologous with known new coronaviruses.

Exclusion Criteria:

  • 1. Influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, SARS coronavirus, and other known other viral pneumonia;
  • 2. Mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia; non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yao Xie, Doctor 8610-84322200 ext 2489 xieyao00120184@sina.com
Contact: Xuejun Ma, phD +86 10 58900810 maxj2004@aliyun.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04245631
Other Study ID Numbers DTXY022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yao Xie, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yao Xie, Doctor Department of Hepatology, Division 2, Beijing Ditan Hospital
PRS Account Beijing Ditan Hospital
Verification Date April 2020