Results – basic reportingThe AlfredDiagnostic performance of the...

Results – basic reporting

The Alfred

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.


https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622000570785