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SARS-CoV-2 Antigen Rapid Test Kit for medical use
SARS-CoV-2 Antigen Rapid Test Kit for medical use
Consistency Evaluation Results
The document presents the evaluation of a colloidal gold detection reagent compared to a reference RT-PCR detection reagent. The evaluation is based on sampling and testing conducted within seven days of symptom onset.
Key Performance Metrics
- Positive Coincidence Rate: 97.46% (Confidence Interval: 92.19% to 99.34%)
- Negative Coincidence Rate: 99.45% (Confidence Interval: 96.53% to 99.97%)
- Total Coincidence Rate: 98.46%
Components and Specifications
The document references a section on kit components and their specifications, including quantities, but detailed information is not provided in the excerpt.
Summary
The colloidal gold detection reagent demonstrates high consistency with the RT-PCR method, showing excellent positive and negative agreement rates. This suggests it is a reliable alternative for detection within the first week of symptom onset.
Catalog excerpts
Consistency evaluation results: Based on the comparison results of sampling and testing within seven days of onset, our colloidal gold detection reagent is compared with the contrast RT-PCR detection reagent. The positive coincidence rate is 97.46% (92.19%~99.34%), and the negative coincidence rate is 99.45% (96.53%). ~99.97%), the total coincidence rate is 98.46%.
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Components Specification
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