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Evaluate the clinical performance of RESpiratory pathogen Point-Of-Care Testing in Emergency Departments (RESPOCT-ED study).

Evaluate the clinical performance of RESpiratory pathogen Point-Of-Care Testing in Emergency Departments (RESPOCT-ED study).

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000123448
Acronym
RESPOCT-ED study
Enrollment
1100
Registered
2025-02-04
Start date
2025-02-10
Completion date
2026-02-10
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The prospective observational study aims to evaluate the clinical performance of the ZiP-CoVx-P2 point-of-care test for detecting the SARS-CoV-2 virus in oro-naso-pharyngeal swab samples from patients presenting to the emergency department with respiratory infection symptoms. Participants will provide combined nose and throat swabs at a single time point, in addition to samples collected as part of routine clinical care (e.g., RT-PCR test and/or RAT test). These samples will be tested using the ZiP-CoVx-P2 point-of-care test within the emergency department. The performance of the ZiP-CoVx-P2 test will be compared to a lab-based RT-PCR test, focusing on clinical sensitivity and specificity. Furthermore, the clinical performance of the ZiP-CoVx-P2 test will be compared to the RAT test, and the study will also assess the potential impact of this test on emergency department care outcomes.

Interventions

This study is a prospective, observational study to assess the clinical performance of the ZiP-CoVx-P2 point-of-care (POC) test for SARS-CoV-2 infection. The ZiP-CoVx-P2 test is performed on the ZiP-P2 instrument and uses isothermal nucleic acid amplification technology to detect SARS-CoV-2 RNA in combined oropharyngeal and bilateral mid-turbinate swabs. It provides results comparable to RT-PCR with a much faster turnaround time of 10-30 minutes for immediate clinical decision-making. The prim

This study is a prospective, observational study to assess the clinical performance of the ZiP-CoVx-P2 point-of-care (POC) test for SARS-CoV-2 infection. The ZiP-CoVx-P2 test is performed on the ZiP-P2 instrument and uses isothermal nucleic acid amplification technology to detect SARS-CoV-2 RNA in combined oropharyngeal and bilateral mid-turbinate swabs. It provides results comparable to RT-PCR with a much faster turnaround time of 10-30 minutes for immediate clinical decision-making. The primary aim is to assess the clinical performance of the ZiP-CoVx-P2 test in detecting SARS-CoV-2 in oro-naso-pharyngeal swab samples from patients presenting to the emergency department with respiratory infection symptoms. Additionally, the study aims to evaluate the potential impact of this test on outcomes related to emergency department care. Participants will be asked to provide two swab samples immediately after in addition to any swabs taken for routine clinical care (i.e. rapid antigen test and RT-PCR). It will take approximately 3-5 minutes to extract additional swabs for the RESPOCT-ED study. Each sample will include oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample and will be collected by healthcare staff. One swab will be tested using the ZiP-CoVx-P2 platform for SARS-CoV-2 detection within the emergency department and second swab will be bio banked. The RT-PCR and RAT test results will be retrieved from the medical records. The ZiP-CoVx-P2 test results are not provided back to the participants or are part of any clinical management. Clinical management will be based on the RT-PCR test results collected as part of routine clinical care.

Sponsors

ZiP Diagnostics Pty Ltd
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults with suggestive of respiratory infections where multiplex polymerase chain reaction (PCR) testing is requested as part of routine clinical care. - Able to provide an additional two combined nose and throat swabs along with samples collected for routine clinical practice. - Medicare eligible - Adults who have decision-making capacity will be included in this study.

Exclusion criteria

Individuals for whom an adequate explanation of the study cannot be provided, or comprehended, preventing them from making an informed decision about participation or formally opting out, will also be excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026