Sample Collection Methods for Respiratory Infection Testing

Overseen By Brooklin K Zimmerman, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Who Is on the Research Team?

Thanh Nguyen, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Saliva passive drool Experimental Treatment 2 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 saliva Experimental Treatment 2 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 device Experimental Treatment 2 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 method Experimental Treatment 1 Intervention

Participant is asked to provide approximately 60 uL of blood via a capillary finger stick. This specimen will undergo COVID-19 antibody testing.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Respiratory Pathogen Panels in the Outpatient Oncology Setting. Gripp, EW., Hess, BD., Binder, AF.[2023]

The use of the FilmArray® Respiratory Panel (FA RP) significantly improved the etiological diagnosis of acute lower respiratory infections (ALRI) in pediatric patients, confirming the cause in 94.6% of samples compared to 55.4% with standard microbiological assays.

FA RP also enhanced antimicrobial stewardship by influencing treatment decisions in 8.4% of cases, leading to more targeted use of antibiotics and antivirals, which is crucial for preventing unnecessary antibiotic use in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. Brotons, P., Villaronga, M., Henares, D., et al.[2021]

The FilmArray® Respiratory Panel (FA RP) significantly improved the etiological diagnosis of acute lower respiratory infections (ALRI) in pediatric patients, confirming the cause in 94.6% of samples compared to only 55.4% with standard microbiological assays, based on a study of 130 children.

The use of FA RP also enhanced antimicrobial stewardship, influencing treatment decisions in 8.4% of cases, which included discontinuing unnecessary antiviral drugs and starting targeted antibiotics, demonstrating its potential to optimize patient care in critical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. Brotons, P., Villaronga, M., Henares, D., et al.[2023]

The development of an at-home finger-prick dried blood spot collection kit for COVID-19 testing has shown 100% sensitivity and specificity, making it a reliable alternative to traditional testing methods.

This innovative approach allows for easier access to testing for hard-to-reach populations, reducing the burden on healthcare systems and minimizing exposure risks for both patients and healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots. Karp, DG., Danh, K., Seftel, D., et al.[2023]

Dried blood spot (DBS) specimens collected at home can effectively detect anti-SARS-CoV-2 antibodies, showing consistent results compared to traditional venous blood samples, which enhances accessibility for testing.

The stability of anti-SARS-CoV-2 antibody levels in DBS samples was maintained for over 200 days, indicating that this method is reliable for long-term monitoring of antibody presence post-infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of anti-SARS-CoV-2 antibodies in dried blood spots utilizing manual or automated spot extraction and electrochemiluminescence immunoassay (ECLIA). Knoop, A., Geyer, H., Lerch, O., et al.[2022]

Self-collection kits for COVID-19 testing, like those approved by the FDA from LapCorp and Everlywell, offer a convenient and effective screening method for mild or asymptomatic patients, helping to alleviate the burden on healthcare systems.

While these home-based kits are user-friendly and conserve resources, their efficacy can be impacted by issues such as improper sampling techniques and lack of clinical oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Sample Self-Collection for COVID-19 Patients. Liao, WT., Hsu, MY., Shen, CF., et al.[2022]

A diagnostic panel with 3 real-time reverse transcription PCR assays was developed to detect SARS-CoV-2, showing a high sensitivity with a limit of detection as low as 5 copies per reaction.

The assays demonstrated no false positives with other coronaviruses or common respiratory pathogens, ensuring specificity, and were authorized for emergency use by the FDA on February 4, 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2. Lu, X., Wang, L., Sakthivel, SK., et al.[2023]

A new PCR test for COVID-19 was developed that can process approximately 180 samples per day without needing robotics, making it more accessible for widespread testing.

The test demonstrated high sensitivity and accuracy, comparable to existing clinical diagnostic protocols, and includes a novel internal control that simplifies the testing process by eliminating the need for DNA digestion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processing Hundreds of SARS-CoV-2 Samples with an In-House PCR-Based Method without Robotics. Mair, T., Ivankovic, M., Paar, C., et al.[2021]

Self-sampling techniques for COVID-19 testing, specifically multi-swab (MS) and saliva sponge combined with nasal vestibula (SN), demonstrated high sensitivity (95.2%) compared to professionally collected samples, making them effective alternatives for early symptomatic patients.

Gargled water (GW) samples showed lower sensitivity (88.7%) and the effectiveness of self-sampling decreased significantly if samples were collected more than 8 days after symptom onset, highlighting the importance of timing and proper technique in sample collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-collected oral, nasal and saliva samples yield sensitivity comparable to professionally collected oro-nasopharyngeal swabs in SARS-CoV-2 diagnosis among symptomatic outpatients. Gertler, M., Krause, E., van Loon, W., et al.[2021]

Self-collected sputum samples showed higher SARS-CoV-2 RNA concentrations and longer detection times, making them more effective for diagnosing and monitoring COVID-19 pneumonia compared to nasopharyngeal and throat swabs.

Using self-collected sputum can reduce the risk of exposure for healthcare workers, conserve personal protective equipment, and help limit the spread of the virus in the environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Change of SARS-CoV-2 in Clinical Specimens of COVID-19 Pneumonia Patients. Luvira, V., Jittmittraphap, A., Muangnoicharoen, S., et al.[2022]

Exhaled breath condensate (EBC) as a method for collecting respiratory samples for COVID-19 diagnosis showed a pooled sensitivity of 69.5% and a specificity of 98.3%, indicating it may not be reliable enough compared to the gold standard of nasal swabs.

The study, which included 4 studies with a total of 205 specimens, highlighted significant variability in results and called for more research to better understand the effectiveness of EBC for COVID-19 diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis. Riccò, M., Zaniboni, A., Satta, E., et al.[2022]

A pooling strategy using rRT-PCR testing for SARS-CoV-2 can effectively detect the virus in samples, even when the viral load is low, making it a reliable method for monitoring infections.

This approach allows for faster and less invasive testing, which is particularly beneficial for routine monitoring in areas with low COVID-19 prevalence, helping to identify and isolate infected individuals more efficiently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe acute respiratory syndrome coronavirus 2 detection by real time polymerase chain reaction using pooling strategy of nasal samples. Pratelli, A., Pellegrini, F., Ceci, L., et al.[2022]

In a study of mechanically ventilated patients during the COVID-19 pandemic, paired testing of upper respiratory tract (URT) and lower respiratory tract (LRT) samples showed high concordance, indicating that URT testing alone was sufficient for diagnosing SARS-CoV-2 in children.

The findings led to a change in testing protocol at the institution, allowing for URT sampling to be the primary method, reserving LRT testing only for cases with continued clinical suspicion after a negative URT result, thus streamlining the testing process.

NCBI (Pubmed)

pubmed.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. Kitt, EM., Davis, DH., Kerman, C., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Diagnostic stewardship to support optimal use of multiplex molecular respiratory panels: A survey from the Society for Healthcare Epidemiology of America Research Network. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Utility of Respiratory Pathogen Panels in the Outpatient Oncology Setting. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

Clinical impact of rapid viral respiratory panel testing on pediatric critical care of patients with acute lower respiratory infection. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Detection of anti-SARS-CoV-2 antibodies in dried blood spots utilizing manual or automated spot extraction and electrochemiluminescence immunoassay (ECLIA). [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Home Sample Self-Collection for COVID-19 Patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Processing Hundreds of SARS-CoV-2 Samples with an In-House PCR-Based Method without Robotics. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Temporal Change of SARS-CoV-2 in Clinical Specimens of COVID-19 Pneumonia Patients. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Severe acute respiratory syndrome coronavirus 2 detection by real time polymerase chain reaction using pooling strategy of nasal samples. [2022]

15. United States pubmed.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]