RecruitingACTRN12620001029987

Negative predictive value of the FebriDx host response point-of-care test in patients presenting to a single Australian Emergency Department with suspected COVID-19.

Sponsor

Planet Innovation

Enrollment

300 participants

Start Date

Oct 8, 2021

Study Type

Observational

Conditions

COVID-19 Infection Acute Respiratory Infections

Summary

During the COVID-19 pandemic of 2020, a large number of patients attending Australian Emergency Departments (EDs) require viral screening to allow appropriate disposition and treatment decision making. Over 1000 tests were performed in Box Hill ED during July 2020. This process is currently hampered by the long turnaround times of laboratory PCR testing, which currently takes up to 8 hours to be available in this setting. This prolonged COVID-19 time-to-result(s) leads to poor patient flow as COVID-19 suspected patients are held in assessment cohort areas until their results are available. Prolonged ED length of stay has been associated with adverse patient outcomes in general. In addition, lack of single occupancy rooms means that COVID-19 negative patients cohorted in these assessment areas are at risk of acquiring infection from positive patients before test results are available. Rapid, accurate diagnostic or screening tests are therefore urgently required. Current ED testing for COVID-19 involves obtaining nasopharyngeal swabs from three sites (oropharynx and both nostrils) and performing viral PCR testing. FebriDx (Lumos diagnostics, Sarasota, Florida, US) is a TGA registered single use point of care testing (POCT) device that detects two host response proteins, Myxovirus resistance protein A (MxA) and C reactive protein (CRP), in finger prick blood samples, and is designed to distinguish viral from bacterial respiratory infection. Results are available after 10 minutes. A recent UK study performed by Clark et al during the pandemic, found the FebriDX test had a high accuracy for the identification of COVID-19 in hospitalised adults and suggested FebriDx could be deployed as a patient triage tool. In this study of 248 patients, the FebriDx test was shown to have a sensitivity of 93% and specificity of 86% for COVID-19 when compared to reference PCR testing. In their population this translated to a negative predictive value for COVID-19 of 93%. Due to different testing criteria and lower population COVID-19 infection rates, Australian data is required to assess applicability of FebriDx test as a first line screening test for suspected COVID-19 patients within Australian hospitals.

Eligibility

Sex: Both males and femalesMin Age: 2 Yearss

Plain Language Summary

Simplified for easier understanding

During the COVID-19 pandemic, hospitals were flooded with patients who needed testing — but waiting many hours for lab PCR results caused significant delays and created risk of spreading infection in waiting areas. This study evaluated a rapid finger-prick blood test called FebriDx, which measures two proteins that the body makes in response to viral infections and gives a result in just 10 minutes. The study took place at Box Hill Emergency Department in Melbourne and aimed to find out how accurately FebriDx could predict a negative COVID-19 PCR result — in other words, how reliably it could rule out COVID-19 quickly so lower-risk patients could be moved more safely and efficiently through the department. Adults and children aged 2 and over who met the criteria for COVID-19 testing at the emergency department were eligible. People who were critically unwell, had symptoms for more than 14 days, had recent antibiotic or antiviral use, or had received certain immunosuppressive treatments were not eligible.

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Interventions

This real-world observational diagnostic accuracy study will compare the FebriDx point of care test result to that of the COVID-19 RT-PCR reference standard with a view to determining whether FebriDx

This real-world observational diagnostic accuracy study will compare the FebriDx point of care test result to that of the COVID-19 RT-PCR reference standard with a view to determining whether FebriDx has a sufficient negative predictive value to screen suspected COVID-19 patients attending the hospital emergency department. Patients who meet the Eastern Health case definition for suspected COVID-19 infection (COVID-S) PCR testing will be invited to have same time point of care testing with the FebriDx device. Patients who consent to participate in the trial will undergo a FebriDx finger prick test. A 5µl capillary blood sample will be taking via a built in lancet and collected into the blood collection tube which is then moved into position on the lateral flow assay component of test. This test will be performed by a healthcare professional e.g. Nurse or Doctor in the Emergency Department. Their treating clinician will be blinded to the result, which will be directly viewed and documented by a member of the research team who is not directly involved in the patient’s clinical care. Neither the participant or the treating doctor will have access to the FebriDx result. We have done this because it is important that the result is not used as part of the management decision while we are still working out how accurate it is. A member of the research team, most likely a research nurse, will be performing the test in one of the dedicated testing areas within the department and not at the patient bedside. All parameters will be observed retrospectively by the study team from review of electronic medical records. They key parameters being observed in patients are: - the COVID-19 PCR result - the FebriDx result - presenting symptoms - ED observations including: - Temperature - Respiratory rate - Heart rate - Blood pressure - Oxygen saturation - White cell count and differential on day of ED presentation (if present) - CRP on day of ED presentation (if present) - Influenza PCR result on day of ED presentation (if present) - Additional subsequent viral PCR or serological results relating to relevant ED presentation (if present) - Blood culture result on day of ED presentation (if present) - Additional subsequent blood culture results relating to relevant ED presentation (if present) Each participant will be observed from the point of ED triage until hospital discharge.