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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04311398
• Other study ID #: KY2020-COVID-19
• Status: Not yet recruiting
• Start date: May 13, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2020
• Source: Huashan Hospital
• Contact: Wenhong Zhang, Doctor
• Phone: 13801844344
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform		3 months