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

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.

Unknown status
COVID-19

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

Eligibility Criteria

Inclusion Criteria:

- Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

- none

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 100 Years
Countries
China
Locations

Huashan Hospital of Fudan University
Shanghai, Shanghai, China

Investigator: Wenhong Zhang, PhD,MD
Contact: +86 21 52889999
zhangwenhong@fudan.edu.cn

Investigator:

Contacts

Wenhong Zhang, Doctor
13801844344
zhangwenhong@fudan.edu.cn

Huashan Hospital
NCT Number
MeSH Terms
Coronavirus Infections