EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 226
研究概览
简要总结
Diagnostic performance of the EuGeni SARS-CoV-2 Ag RDT test has been determined for each arm of the study. Both Arm A and B, recorded a minimum average sensitivity of >80% and a specificity of 100%. Arm B shows a higher average sensitivity (87.76%) than Arm A (80.85%). Similarly, when comparing the data in terms of PCR Ct results of days post-onset of symptoms, Arm B also showed higher sensitivity (100.00%) up to positive results with Ct 25 and 4-7 days post onset of symptoms, when compared to Arm A (86.67%). These results suggest the combined mid turbinate and throat site sampling may improve test performance when diagnosing COVID-19 positive patients. Whole genome sequencing confirmed circulating Omicron variants; BA1.17, BA.1, BA.2 and BA.5.2.1 were detected using the assay. Data also shows that, although the EuGeni SARS-CoV-2 Ag RDT test is targeted at professional use and sample collections, the majority of participants provided suitable self-collections that produced accurate test results when compared to RT-PCR testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria: (participants must meet ‘Yes’ for all)
- •The participant is 18 years or older and capable to provide informed consent.
- •The participant is eligible regardless of whether they have previously received a COVID-19 vaccine.
- •The participant is eligible regardless of whether antiviral medication has been taken.
- •For Positive patients:
- •oThe participant has previously confirmed positive for COVID-19 RT-PCR or RAT test result within 7 days.
- •oThe participant is either symptomatic and within 7 days post onset of symptoms (according to local state guidelines) or is asymptomatic and within 7 days post COVID-19 RT-PCR or RAT confirmed results (time of the test is the time that the swab was collected) or
- •close contact to an individual who has been confirmed COVID-19 positive. (Note: Home COVID-19 tests cannot be used to determine a positive COVID19 result).
- •For Negative patients:
- •oThe participant has recently tested negative (off study) by RT-PCR or RAT, or is likely to test negative.
- •for COVID-19 and they are not displaying symptoms for COVID-19. o The participant last tested negative for COVID-19 five weeks or more from the time of re-consenting to joining the study to donate samples.
- •(Note: A maximum of 25% of the Negative participant collections can be selected under this criteria)
排除标准
- •Exclusion Criteria: (Participants must meet ‘No’ for all)
- •Under 18 years old.
- •The participant has declined to participate in the study.
- •The participant is deemed clinically unsuitable by a treating physician or the Principal Investigator.
- •The participant is incapable of providing informed consent.