LIAISON NES Flu A/B & COVID-19 Clinical Agreement in Australia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
The DiaSorin Molecular LIAISON® NES FLU A/B & COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.
The LIAISON® NES FLU A/B & COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting.
Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Participants are not provided investigational results and will only be provided with routine standard of care diagnostics results.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Human patients with active signs and symptoms of respiratory tract infection at time of collection
- •Specimens collected within 7 days of symptom onset for the initial collection
- •Availability of age, gender, race, ethnicity, collection dates, collection time, routine respiratory testing method, routine respiratory result, signs and symptoms (e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and COVID-19, as applicable), pre-existing medical conditions (as applicable), medications (e.g., COVID-19 antivirals), etc. for each subject
排除标准
- •Incorrect swab type
- •Incorrect transport media
- •Incorrect specimen handling (specimens not stored at recommended temperature)
- •Samples collected >7 days from symptom onset
- •Subjects not consented
结局指标
主要结局
Diagnostic accuracy
时间窗: Samples will be tested on LIAISON NES within one hour of collection.
Estimates of Sensitivity/percent positive agreement (PPA) and Specificity/percent negative agreement (NPA) will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV \& COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of-care and molecular comparator result, will be presented in a separate 2 x 2 table.
次要结局
未报告次要终点