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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 : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

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. Our team 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. 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.

Condition or disease Intervention/treatment
New Coronavirus Diagnostic Test: Recombinase aided amplification (RAA) assay

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. Our team 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. 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. Patients who were suspected of being infected with 2019-nCoV in the hospital.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RAA assay for 2019-nCoV
a simple, fast and portable recombinase aided amplification (RAA) assay for 2019-nCoV
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.




Primary Outcome Measures :
  1. Detection sensitivity is greater than 95% [ Time Frame: at baseline ]
    Detection sensitivity is greater than 95%

  2. Detection specificity is greater than 95% [ Time Frame: at baseline ]
    Detection specificity is greater than 95%


Secondary Outcome Measures :
  1. Consistent with existing universal reagent detection rates greater than 95% [ Time Frame: at baseline ]
    Consistent with existing universal reagent detection rates greater than 95%



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were suspected of being infected with 2019-nCoV in the hospital.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245631


Contacts
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Contact: Yao Xie, Doctor 8610-84322200 ext 2489 xieyao00120184@sina.com
Contact: Xuejun Ma, phD +86 10 58900810 maxj2004@aliyun.com

Locations
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China, Beijing
Department of Hepatology Division 2, Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, Doctor    8610-84322200 ext 2489    xieyao00120184@sina.com   
Contact: Xuejun Ma, phD    +86 10 58900810    maxj2004@aliyun.com   
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
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Principal Investigator: Yao Xie, Doctor Department of Hepatology, Division 2, Beijing Ditan Hospital

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Responsible Party: Yao Xie, Director of the Second Division of Liver Diseases, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT04245631    
Other Study ID Numbers: DTXY022
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yao Xie, Beijing Ditan Hospital:
recombinase aided amplification assay
2019-nCoV
diagnosis
Specificity
Sensitivity
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases