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Development and Evaluation of 2019-nCoV Nucleic Acid Rapid Detection Kit (Isothermal Amplification-Colloidal Gold Method)

Development and Evaluation of 2019-nCoV Nucleic Acid Rapid Detection Kit (Isothermal Amplification-Colloidal Gold Method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060495
Enrollment
Unknown
Registered
2022-06-03
Start date
2022-05-23
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Gold Standard:2019-nCoV nucleic acid detection (Fluorometric real-time PCR)
Index test:2019-nCoV Nucleic Acid Rapid Detection Kit (Isothermal Amplification-Colloidal Gold Method)

Sponsors

The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Positive group: (1) Subjects who have recently (within 24 hours is recommended) tested positive for novel coronavirus nucleic acid and signed informed consent. (2) Ct value can be detected by fluorescence PCR. (3) Aged 18-80 years. 2. Negative group: (1) Subjects who have been clinically confirmed to exclude novel coronavirus infection and signed informed consent. (2) Aged 18-80 years.

Exclusion criteria

Exclusion criteria: 1. For subjects who have recently tested positive or negative for the novel coronavirus by fluorescent PCR, the results of the secondary fluorescent PCR test are inconsistent with them, and the results of the repeated fluorescent PCR test are still inconsistent. 2. Pregnant subjects.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactHuang Weifeng

The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

breeze-huang@hotmail.com+86 18930173670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026