EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria

Not Applicable

Completed

• Conditions: SARS-CoV-2 antigen; Infection - Other infectious diseases

• Registration Number: ACTRN12622000570785
• Lead Sponsor: Anteotech Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-13
• Study Completion: 2022-06-01
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the overall (composite) specificity and sensitivity of EuGeni SARS-CoV-2 Ag RDT assay using bilateral nasal swabs against data obtained from COVID-19 RT-PCR standard of care mid-turbinate and throat samples. [Once 100 positive and 200 negative participant results have been obtained.]

Secondary Outcome Measures

Name	Time	Method
Clinical performance of sensitivity and specificity produced across different viral loads and participant demographics. This will be assessed by comparing bilateral nasal swabs data against data obtained from COVID-19 RT-PCR standard of care mid-turbinate and throat samples.[Once the primary timepoint has been reached]