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Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

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ClinicalTrials.gov Identifier: NCT04311398
Recruitment Status : Not yet recruiting
First Posted : March 17, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Brief Summary:
Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform

Detailed Description:

COVID-19 has not been well suppressed, and became a pandemic within 3 months globally is mainly because of the virus characteristic in the following aspects:

  1. Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious
  2. Strong transmissibility, virus can be transmitted through aerosol
  3. Difficulty distinguishing infected patients from other pathogenic infections
  4. High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.

Therefore, this project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
Estimated Study Start Date : May 13, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Respiratory infection group
Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University
Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform
We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients




Primary Outcome Measures :
  1. Sensitivity, spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in Huashan Hospital
Criteria

Inclusion Criteria:

  • Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

  • none

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): NCT04311398


Contacts
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Contact: Wenhong Zhang, Doctor 13801844344 zhangwenhong@fudan.edu.cn

Locations
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China, Shanghai
Huashan Hospital of Fudan University
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, PhD,MD    +86 21 52889999 ext 8123    zhangwenhong@fudan.edu.cn   
Sub-Investigator: Jiazhen Chen         
Sub-Investigator: Chao Qiu         
Sub-Investigator: Yanmin Wan         
Sub-Investigator: Jingwen Ai         
Sub-Investigator: Jing Wu         
Sub-Investigator: Mengqi Zhu         
Sub-Investigator: Zhongliang Shen         
Sponsors and Collaborators
Huashan Hospital
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Responsible Party: Wen-hong Zhang, Chief of dpartment of infectious disease, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04311398    
Other Study ID Numbers: KY2020-COVID-19
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases