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?

This trial tests new, less invasive methods for collecting samples to diagnose respiratory infections like COVID-19. Researchers compare two new devices to the traditional nasopharyngeal swab, which can be uncomfortable and painful. Participants will provide samples using a saliva collection device, a nasopharyngeal wash, and a finger stick for blood (for a COVID-19 antibody test). Those who have already had a nasopharyngeal swab during an emergency department visit might be a good fit for this study. As an unphased trial, this study offers participants the chance to contribute to innovative diagnostic methods that could improve patient comfort and care.

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 prior data suggests that these sample collection methods are safe for respiratory infection testing?

In a previous study, saliva tests, such as those using the Oral Capsule, showed potential for diagnosing COVID-19. However, more research is needed to improve their accuracy. Collecting saliva is generally safe and less uncomfortable than traditional methods.

Research has shown that the finger stick blood method is easy to handle. It requires only a small drop of blood and is commonly used to detect COVID-19 antibodies. This method is popular in at-home test kits and is considered safe.

The passive drool method for collecting saliva is another safe option. Studies suggest that saliva collection effectively checks for COVID-19 antibodies, avoiding the discomfort of deeper nasal swabs.

Lastly, the nasopharyngeal (NP) saline wash is less uncomfortable than traditional swabs. It uses a gentle saline rinse to collect samples. CDC guidelines recommend NP specimen collection as a reliable way to test for respiratory infections.

Overall, these methods are designed to be safer and more comfortable than older techniques, aiming to reduce pain and injury during sample collection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to collect samples for testing respiratory infections like COVID-19. Unlike traditional methods that often involve deep nasal swabs, these new techniques focus on less invasive options. For example, the Oral Capsule allows saliva collection through chewing, and the passive drool method utilizes a simple straw to collect saliva. Additionally, the NP saline wash uses a gentle saline rinse for sample collection. These methods could make testing more comfortable and accessible, potentially increasing the willingness of individuals to get tested and improving early detection of infections.

What evidence suggests that these sample collection methods are effective for respiratory infection testing?

This trial will compare different sample collection methods for respiratory infection testing. Research has shown that saliva tests are promising for detecting respiratory infections like COVID-19. One study found that saliva tests can serve as a good alternative to the usual nose swabs, which are more uncomfortable. Participants in this trial may use the Oral Capsule, a saliva-based method, which appears effective for accurate detection, though further research is needed for confirmation.

For blood tests, participants may undergo the fingerstick method, which accurately detects COVID-19 antibodies. Studies have found it easy to use and effective in indicating exposure to COVID-19.

The NP saline wash is another method tested in this trial. It uses a gentle saltwater solution to collect samples from the nose. This technique aims to be less uncomfortable while still effectively identifying respiratory viruses. ^{2 6 7 8 9}

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

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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-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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8745372/

A new testing platform using fingerstick blood for quantitative ... The data presented here demonstrate the efficacy of an easy-to-use fingerstick blood collection method for detecting and monitoring anti-SARS- ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0245848

Evaluation of the practicability of a finger-stick whole-blood ... Data are scarce regarding the performance of the existing serological COVID-19 tests, and to our knowledge this is the first practicability ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023098201

Evaluation of the Panbio™ COVID-19 IgG rapid test device ... In conclusion, the sensitivity, specificity and accuracy of the Panbio™ test from fingerstick capillary whole blood were high. Testing between 22 and 180 days ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05379478

Immune Responses to COVID-19 Infection or Vaccination Participants will be asked to provide blood samples (either a normal venous blood draw, a few drops of blood obtained with a small finger-stick device, or both) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7842899/

Evaluation of the practicability of a finger-stick whole-blood ... A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO ® POC test and the results were recently published.

6. fda.gov fda.gov/media/147368/download

COVID-19 Self-Collected Antibody Test System The COVID-19 Self-Collected Antibody Test System is an enzyme-linked immunosorbent assay. (ELISA) and a blood collection kit intended for qualitative detection ...

7. fda.gov fda.gov/media/138438/download

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ ... The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunoassay intended for the qualitative detection and differentiation.

8. archive.cdc.gov archive.cdc.gov/www_cdc_gov/coronavirus/2019-ncov/hcp/testing/antibody-tests-guidelines.html

Interim Guidelines for COVID-19 Antibody Testing Antibody POC tests generally are lateral flow devices that detect IgG, IgM, or total antibody in fingerstick whole blood. Laboratory tests use lateral flow, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7184973/

Understanding Antibody Testing for COVID-19 - PMC More traditional laboratory-based tests may require traditional blood draws, whereas newer systems require only finger prick blood samples.