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

Fudan University

Status: Unknown

Conditions: COVID-19

Treatments: Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform

Study type: Observational

Funder types: Other

Identifiers

NCT04311398

KY2020-COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients went to the fever clinic with respiratory infectious symptoms

Exclusion criteria

• none

Trial design

100 participants in 1 patient group

Respiratory infection group

Description:

Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University

Treatment:

Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform