Hepatitis B virus
Conditions
Interventions
Index test:Nucleic acid detection system based on CRISPR isothermal amplification technology
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Target Pathogen Positive Group (to evaluate false negative interference) (1) Positive samples confirmed by the clinical standard RT-PCR method as infected with hepatitis B virus, novel coronavirus, or Mycobacterium tuberculosis, etc.; (2) Samples with Ct values between 20-35 (representing medium to high viral load, which facilitates observation of the inhibitory effect of interfering substances on the signal). 2. Disease Control Group (to evaluate biological cross-reactivity/false positives) Samples confirmed by RT-PCR or multiplex pathogen detection as infected with other related respiratory or systemic infections, including: (1) Influenza virus (type A influenza, type B influenza); (2) Novel coronavirus (SARS-CoV-2) or other respiratory viruses (such as RSV, adenovirus, Mycoplasma pneumoniae); (3) Other common bacterial infections (such as Mycobacterium tuberculosis). 3. Special matrix interference group (to evaluate endogenous interference) Clinical appearance inspection shows samples with specific characteristics, including: (1) Highly viscous samples: samples containing a large amount of mucin; (2) Hematic samples: samples containing medium concentrations of whole blood, either visible to the naked eye or confirmed by occult blood test. 4. Drug interference group (to evaluate exogenous interference) Samples derived from patients undergoing treatment with antiviral drugs (such as oseltamivir), commonly used cold medications (such as acetaminophen), or nasal sprays, or samples in healthy individual matrices artificially spiked with drugs to simulate therapeutic peak concentrations (Cmax). 5. General conditions (1) Age between 1 and 85 years (covering high-risk populations, including children and the elderly), any gender; (2) Remaining sample volume >=200 µL, sufficient to complete study review and testing; (3) Patients (or guardians) from whom samples are sourced have signed informed consent, allowing residual samples to be used for scientific research.
Exclusion criteria
Exclusion criteria: 1. Severely degraded or contaminated samples Improperly stored samples that are visibly turbid, moldy, or have an unusual odor may contain large amounts of bacteria or chemical contaminants, interfering with the CRISPR system's reaction. 2. Severe hemolysis or dark-colored samples Samples with overly dark colors (such as deep red hemo-concentrated blood or dark yellow high-bilirubin samples) may have background absorbance exceeding the detection linear range, affecting signal measurement. 3. Incompatible sampling media Using non-standard viral transport media (VTM) containing strong reducing agents (such as high-concentration vitamin C or dithiothreitol) or strong chelating agents. These chemicals may damage the integrity of the sample, leading to false negatives or signal loss. 4. Missing Clinical Information Unable to provide accurate RT-PCR reference results, or unable to trace the type of infection in the sample. 5. Mixed Infections Cannot Distinguish Primary and Secondary (Only for Specificity Evaluation) When a sample contains multiple viruses or pathogens simultaneously (such as double positives), this can interfere with specificity judgment and should be excluded from the cross-reactivity group, but can be included in the target pathogen positive group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ROC curve analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactLing Ji
Peking University Shenzhen Hospital
Outcome results
None listed