Sample Collection Methods for Respiratory Infection Testing
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing methods rather than medication use.
What data supports the effectiveness of the treatment COVID-19 antibody test and Respiratory pathogen panel PCR test?
The Respiratory Pathogen Panel (RPP) is a rapid and sensitive test for detecting viruses and bacteria causing respiratory infections, which can help in diagnosing and managing respiratory conditions. However, its use in outpatient settings, like oncology patients, showed limited impact on changing treatment plans, suggesting it may be more beneficial in specific clinical scenarios such as critical care.12345
Is it safe to use home sample collection kits for respiratory infection testing?
How does the sample collection method for respiratory infection testing differ from other treatments?
This method is unique because it allows patients to self-collect samples like saliva, nasal, and oral swabs, which can be as effective as those collected by healthcare professionals. This reduces the need for protective equipment and minimizes the risk of virus transmission to healthcare workers.1112131415
What is the purpose of this trial?
Respiratory tract infections (RTIs) are prevalence community diseases and is the third leading cause of death worldwide. Rapid diagnosis of RTIs is essential as it drives decision points such as treatment, disposition, and containment. According to recent CDC (The Centers for Disease Control and Prevention) updates, nasopharyngeal swabbing is the preferred method of specimen collection for most RTIs such as SARS-COV-2. This process is invasive and traumatizing for patients as it requires probing (20 seconds) of the posterior nasopharynx with swab applicator. In some cases, this procedure has resulted in pain and injury. Because of the invasive nature of the procedure, patients often refuse testing or withdraw during the collection process resulting in inadequate specimen procurement. The study principle investigators (PI) have developed 2 novel specimen collection devices: 1) nasopharyngeal wash collection device (NP wash device) and 2) saliva collection device (the Oral Capsule). Both devices are designed for ease of use either by a healthcare professional or a patient. The benefits of such collection devices include 1) minimizing the invasive nature of the procedure because a swab applicator is not utilized and 2) minimizing infection risk to healthcare professional because the study devices can be self-administered when applicable. The study will enroll 1000 participants from a pool of patients presenting to the Nebraska Medicine Emergency Department (ED) who received a nasopharyngeal (NP) swab viral PCR test as part of their ED work up. Enrolled patients will be asked to provide four total specimens: 1) a saliva drool specimen, 2) a saliva Oral Capsule specimen, 3) a NP wash specimen, and 4) a finger stick serum specimen. Patients are able to opt out of any specimen collection method. Study specimens 1, 2, 3 will undergo a respiratory pathogen panel (RPP) PCR test and COVID-19 antibody testing. Study specimen 4 will undergo COVID-19 antibody testing and will function as a serum control for antibody detection.
Research Team
Thanh Nguyen, PhD
Principal Investigator
University of Nebraska
Eligibility Criteria
This trial is for individuals aged 19 or older who are being seen at the UNMC Emergency Department and have a non-research nasopharyngeal swab ordered. There are no other exclusion criteria, so anyone meeting the age requirement in this setting can participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Specimen Collection
Participants provide four specimens: saliva drool, Oral Capsule saliva, NP wash, and finger stick serum for testing
Testing and Analysis
Specimens undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing
Follow-up
Participants are monitored for safety and effectiveness after specimen collection
Treatment Details
Interventions
- COVID-19 antibody test
- Respiratory pathogen panel PCR test
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor