Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 14, 2020
May 1, 2020
19 days
March 14, 2020
May 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform
3 months
Study Arms (1)
Respiratory infection group
Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University
Interventions
We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients
Eligibility Criteria
We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in Huashan Hospital
You may qualify if:
- Patients went to the fever clinic with respiratory infectious symptoms
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (1)
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of dpartment of infectious disease
Study Record Dates
First Submitted
March 14, 2020
First Posted
March 17, 2020
Study Start
May 13, 2020
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share