1000 Participants Needed

Sample Collection Methods for Respiratory Infection Testing

TN
BZ
BK
Overseen ByBrooklin K Zimmerman, MSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Home sample collection kits for COVID-19 testing, like those approved by the FDA, are generally considered safe for use by individuals at home. These kits are designed to be easy to use and reduce the risk of exposure to infection for both patients and healthcare workers.678910

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

TN

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

I am 19 or older and had a nasopharyngeal swab test at UNMC.

Exclusion Criteria

None, if the inclusion criterion is met.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Specimen Collection

Participants provide four specimens: saliva drool, Oral Capsule saliva, NP wash, and finger stick serum for testing

1 day
1 visit (in-person)

Testing and Analysis

Specimens undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing

1 year

Follow-up

Participants are monitored for safety and effectiveness after specimen collection

4 weeks

Treatment Details

Interventions

  • COVID-19 antibody test
  • Respiratory pathogen panel PCR test
Trial Overview The study is testing two new devices for collecting samples to diagnose respiratory infections: a nasopharyngeal wash device and a saliva collection device called the Oral Capsule. These will be compared with traditional swabbing methods to see if they're easier for patients and safer for healthcare workers.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Saliva passive droolExperimental Treatment2 Interventions
Participant is asked to spit saliva, through a straw, into a micro centrifuge tube. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.
Group II: Oral Capsule salivaExperimental Treatment2 Interventions
Participant is asked to chew on a study device (Oral Capsule) with their molar teeth which will draw saliva into the device's internal specimen chamber. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.
Group III: NP saline wash by study deviceExperimental Treatment2 Interventions
Participant will receive a nasopharyngeal wash with sterile saline. The irrigation saline is recollected into the device's internal specimen chamber. This specimen will undergo respiratory pathogen panel PCR testing and COVID-19 antibody testing.
Group IV: Blood by standard finger stick methodExperimental Treatment1 Intervention
Participant is asked to provide approximately 60 uL of blood via a capillary finger stick. This specimen will undergo COVID-19 antibody testing.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Findings from Research

Multiplex PCR respiratory panels are viewed positively by healthcare experts, with 85% of surveyed sites believing they support accurate diagnoses and 80% indicating they enhance patient care.
Many institutions implement diagnostic stewardship practices, such as structured order sets and restrictions on test ordering, to optimize the use of these panels, suggesting a proactive approach to improve testing effectiveness.
Diagnostic stewardship to support optimal use of multiplex molecular respiratory panels: A survey from the Society for Healthcare Epidemiology of America Research Network.Baghdadi, JD., O'Hara, LM., Johnson, JK., et al.[2023]
The FilmArray Pneumonia Panel is effective for the rapid detection of key respiratory pathogens, which is crucial for managing critically ill patients, especially those on ventilation due to COVID-19.
Proper knowledge and understanding of the panel's indications and interpretation are essential for its successful daily use in clinical settings.
Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients.Novy, E., Goury, A., Thivilier, C., et al.[2022]
In a study of 183 outpatient oncology patients with respiratory tract infections, only 16.9% tested positive for a respiratory virus using a respiratory pathogen panel, indicating limited effectiveness of this broad testing approach.
Only 1.6% of patients had a change in medication management based on the RPP results, suggesting that targeted testing for specific viruses like influenza, RSV, and SARS-CoV-2 may be more beneficial and less burdensome for patients.
Utility of Respiratory Pathogen Panels in the Outpatient Oncology Setting.Gripp, EW., Hess, BD., Binder, AF.[2023]

References

Diagnostic stewardship to support optimal use of multiplex molecular respiratory panels: A survey from the Society for Healthcare Epidemiology of America Research Network. [2023]
Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. [2022]
Utility of Respiratory Pathogen Panels in the Outpatient Oncology Setting. [2023]
Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. [2021]
Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. [2023]
A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots. [2023]
Detection of anti-SARS-CoV-2 antibodies in dried blood spots utilizing manual or automated spot extraction and electrochemiluminescence immunoassay (ECLIA). [2022]
Home Sample Self-Collection for COVID-19 Patients. [2022]
US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2. [2023]
Processing Hundreds of SARS-CoV-2 Samples with an In-House PCR-Based Method without Robotics. [2021]
Self-collected oral, nasal and saliva samples yield sensitivity comparable to professionally collected oro-nasopharyngeal swabs in SARS-CoV-2 diagnosis among symptomatic outpatients. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Temporal Change of SARS-CoV-2 in Clinical Specimens of COVID-19 Pneumonia Patients. [2022]
Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis. [2022]
Severe acute respiratory syndrome coronavirus 2 detection by real time polymerase chain reaction using pooling strategy of nasal samples. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
The utility of paired upper and lower respiratory tract sampling for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing in patients with artificial airways. [2022]
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