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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04311398
Enrollment
100
Registered
2020-03-17
Start date
2020-05-13
Completion date
2020-12-01
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Interventions

DIAGNOSTIC_TESTNew 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

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients went to the fever clinic with respiratory infectious symptoms

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
Sensitivity, spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform3 months

Countries

China

Contacts

Primary ContactWenhong Zhang, Doctor
zhangwenhong@fudan.edu.cn13801844344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026