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

Study Overview
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Brief Summary
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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
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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: Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious Strong transmissibility, virus can be transmitted through aerosol Difficulty distinguishing infected patients from other pathogenic infections 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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients went to the fever clinic with respiratory infectious symptoms Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Respiratory infection group<br>Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University | Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform<br>* We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform |  | 3 months |