Clinical trial NCT04311398: Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
Official title: Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in 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.

Eligibility criteria: Inclusion Criteria:

* Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

* none

Primary outcomes:
measure: Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
Study officials:
References: