Novel Coronavirus Infection
Conditions
Interventions
Gold Standard:Comparison reagents, Sanger sequencing
Index test:(ORF1ab/N) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Sponsors
Guangdong Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fever clinic cases presenting respiratory symptoms: Subjects with a temperature exceeding 37.3°C in the fever clinic and/or exhibiting respiratory symptoms who require COVID-19 nucleic acid testing. 2. Cases with suspected infections by other respiratory pathogens: Considering potential interference from cross-reactions, select cases infected with relevant pathogens (e.g., endemic human coronaviruses, influenza B, parainfluenza viruses, adenoviruses, Mycobacterium tuberculosis, etc.). 3. Cases meeting discharge criteria: Must satisfy the following standards outlined in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9): 1. Normalised temperature maintained for =3 days; 2. Significant improvement in respiratory symptoms; 3. Radiological evidence of marked improvement in acute exudative pulmonary lesions; 4. Two consecutive negative nucleic acid tests for the novel coronavirus, with Ct values >=35 for both the N gene and ORF gene (using quantitative real-time PCR with a threshold of 40, with a minimum 24-hour interval between samples), or two consecutive negative nucleic acid tests for the novel coronavirus (using quantitative real-time PCR with a threshold below 35, with a minimum 24-hour interval between samples).
Exclusion criteria
Exclusion criteria: 1.Clinical samples of people who injected novel coronavirus 2019 nCoV vaccine within two weeks; 2.Sample collection time or information is unclear and incomplete; 3.Samples with insufficient sample size due to errors during test operation; 4.Samples whose preservation conditions are not in accordance with the instructions; 5.Samples with leakage, poor sealing, etc; 6.Samples found contaminated during sample storage before test operation; 7.Vulnerable groups (including mental illness, critically ill patients, pregnant women, illiterates, minors, people with cognitive impairment Subordinates of PI or researchers, employees of research units or sponsors, etc.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency statistical analysis;Sensitivity;Specificity;Overall compliance rate;Kappa value; | — |
Countries
China
Contacts
Public ContactYuan runyu
Guangdong Provincial Center for Disease Control and Prevention
Outcome results
None listed