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

• Conditions: COVID-19
• Interventions: Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform

• Registration Number: NCT04311398
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-14
• Study First Posted: 2020-03-17
• Status Verified: 2020-05
• Study Start: 2020-05-13
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-14
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory infection group	New QIAstat-Dx fully automatic multiple PCR detection platform	Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University

Primary Outcome Measures

Name	Time	Method
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform	3 months

Trial Locations

Locations (1)

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China