Influenza A virus infection
Conditions
Interventions
Gold Standard:RT-PCR for H1N1 virus detection: The CT values range from 20 to 40, indicating that the patients are positive.
Index test:Influenza A virus antigen
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 80 Years
Inclusion criteria
Inclusion criteria: 1.H1N1 positive samples (for evaluating the possibility of false negative interference): Confirmed as positive for nucleic acid of influenza A virus (H1N1) by clinical standard RT-PCR method. Record their Ct values for subsequent stratified analysis, and do not use them as restrictive inclusion criteria. 2.Disease control samples (for evaluating cross-reaction and the possibility of false positives): Samples of other respiratory infections confirmed by RT-PCR or multiplex respiratory pathogen detection as non-H1N1, including but not limited to single infections of influenza A H3N2, influenza B virus, respiratory syncytial virus, adenovirus, novel coronavirus, and Mycoplasma pneumoniae. 3.Special matrix samples (for evaluating endogenous interference): Respiratory samples with distinctive appearance or physical/chemical characteristics, including samples with high mucus content or visibly bloody samples. 4.Drug-related samples (for evaluating exogenous interference): Samples from patients who are undergoing treatment with antiviral drugs or common cold medications. For the drug concentration verification experiment, de-identified and discarded negative respiratory matrix samples can be used for in vitro addition simulation experiments, without involving new clinical sampling. 5.General conditions: The remaining volume of the sample is >= 200 µL, and the storage conditions comply with laboratory standards, which can meet the testing requirements.
Exclusion criteria
Exclusion criteria: 1.The samples were severely deteriorated or contaminated, which affected the interpretation of the test results. 2.Severe hemolysis or background absorbance exceeds the detection linear range and cannot be corrected. 3.The use of non-standard sampling media containing strong reducing agents or strong chelating agents may affect the stability of the detection system. 4.No clear reference results for RT-PCR could be obtained. 5.In the specific evaluation, if the samples show mixed infections that cannot be distinguished as primary or secondary, they can be excluded from the cross-reaction analysis, but can be included in the overall analysis of H1N1 positive cases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infection with the influenza A virus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Healthy or non-infection control group;Negative interference control group; | — |
Countries
China
Contacts
Public ContactLing Ji
Peking University Shenzhen Hospital
Outcome results
None listed