Impact of Rapid Flu Testing in BMC ED (FluProcess)

Boston Medical Center (BMC)

Status: Completed

Conditions: Influenza; Influenza-Like Illness

Treatments: Other: Core Lab Test; Other: ED Point of Care Test

Study type: Interventional

Funder types: Other

Identifiers

NCT02979730

H-35841

Details and patient eligibility

About

The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing

Enrollment: 233 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients 21 years of age or older
• Presenting to the BMC main ED or Urgent Care area with influenza-like illness
• Physician ordered an influenza A/B diagnostic test

Exclusion criteria

• Previously enrolled in the study
• Any Influenza test result already available at the time approached by the ED RA
• Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
• Unable to give informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 2 patient groups

Core Lab Testing Arm

Active Comparator group

Description:

For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B.

Treatment:

Other: Core Lab Test

ED Point of Care Testing Arm

Experimental group

Description:

Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B.

Treatment:

Other: ED Point of Care Test