Novel Coronavirus (SARS-CoV-2)
Conditions
Interventions
Gold Standard:The currently listed Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection kit
Index test:Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unlimited gender and age; 2. The sample volume shall not be less than 0.8 mL; 3. Suspected cases were diagnosed according to the current version of diagnosis and treatment plan for novel coronavirus pneumonia at that time; 4. In the early stage, the confirmed cases that have passed the detection of the listed novel coronavirus 2019 ncov nucleic acid detection reagent are negative. The retrospective study is adopted for this part of the cases. The samples for clinical verification include: the remaining samples of the early stage nucleic acid detection and the samples used for case confirmation; 5. For the cases that have been released from isolation and meet the discharge criteria, the confirmation of the negative cases in this part of the cases meets the requirements of the current diagnosis and treatment scheme for novel coronavirus pneumonia on the release of isolation and discharge criteria.
Exclusion criteria
Exclusion criteria: 1. Samples not kept as required; 2. The basic information of the sample is incomplete and cannot be traced; 3. Contaminated samples; 4. Samples with insufficient sample size; 5. The sample collection time is not clear.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive coincidence rate;Positive coincidence rate;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under curve;ROC curve; | — |
Countries
China
Contacts
Public ContactYin Shankai
Shanghai Sixth People's Hospital
Outcome results
None listed