Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses

NCT05864118 | Active Not Recruiting FDA Device

• 1 other identifier: 0777-22-EP
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infections

Keywords

Adenovirus; Coronavirus 229E; Coronavirus HKU1; Coronavirus NL63; Coronavirus OC43; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Human Metapneumovirus; Human Rhinovirus/Enterovirus; Influenza A virus; Influenza A virus A/H1; Influenza A virus A/H3; Influenza A virus A/H1-2009; Influenza B virus; Parainfluenza virus 1; Parainfluenza virus 2; Parainfluenza virus 3; Parainfluenza virus 4; Respiratory syncytial virus; Bordetella parapertussis; Bordetella pertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae

Outcome Measures

Primary Outcomes (3)

• Incidence of respiratory pathogen infections in emergency department patients-nasophayngeal wash

  Determine the incidence rate of respiratory pathogen infections in emergency department patients using a nasopharyngeal wash specimen by means of a polymerase chain reaction (PCR).

  1 year

• Incidence rate of respiratory pathogen infections in emergency department patients -saliva drool specimen

  Determine the incidence rate of respiratory pathogen infections in emergency department patients using a saliva drool specimen by means of a polymerase chain reaction (PCR).

  1 year

• Incidence rate of respiratory pathogen infections in emergency department patients-oral capsule saliva specimen

  Determine the incidence rate of respiratory pathogen infections in emergency department patients using an oral capsule saliva specimen by means of a polymerase chain reaction (PCR).

  1 year

Secondary Outcomes (3)

• Study survey and pain rating-nose swab procedure

  1 year

• Study survey and pain rating-nasopharyngeal wash procedure

  1 year

• Study survey and pain rating-oral capsule saliva collection procedure

  1 year

Study Arms (4)

Saliva passive drool

EXPERIMENTAL

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.

Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test

Oral Capsule saliva

EXPERIMENTAL

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.

Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test

NP saline wash by study device

EXPERIMENTAL

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.

Diagnostic Test: Respiratory pathogen panel PCR test; Diagnostic Test: COVID-19 antibody test

Blood by standard finger stick method

EXPERIMENTAL

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

Diagnostic Test: COVID-19 antibody test

Interventions

Respiratory pathogen panel PCR test DIAGNOSTIC_TEST

Respiratory pathogen panel PCR test and COVID-19 antibody test.

NP saline wash by study device; Oral Capsule saliva; Saliva passive drool

COVID-19 antibody test DIAGNOSTIC_TEST

COVID-19 antibody test

Blood by standard finger stick method; NP saline wash by study device; Oral Capsule saliva; Saliva passive drool

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older presenting to the UNMC ED, or admitted from the UNMC ED with a non-research nasopharyngeal swab ordered.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Thanh Nguyen

Omaha, Nebraska, 68198-1150, United States

Location

Related Publications (8)

• Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, Ewings S, Lillie PJ, Clark TW. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 2017 May;5(5):401-411. doi: 10.1016/S2213-2600(17)30120-0. Epub 2017 Apr 6.

  PMID: 28392237 BACKGROUND

• Zumla A, Al-Tawfiq JA, Enne VI, Kidd M, Drosten C, Breuer J, Muller MA, Hui D, Maeurer M, Bates M, Mwaba P, Al-Hakeem R, Gray G, Gautret P, Al-Rabeeah AA, Memish ZA, Gant V. Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections--needs, advances, and future prospects. Lancet Infect Dis. 2014 Nov;14(11):1123-1135. doi: 10.1016/S1473-3099(14)70827-8. Epub 2014 Sep 1.

  PMID: 25189349 BACKGROUND

• Abad, X. Biocontainment in low income countries: a short discussion. Medical Safety & Global Health. 2018. 7(1), 1-3. DOI: 10.4172/2574-0407/1000139.

  BACKGROUND

• Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). Center for Disease Control and Prevention. 2020. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html.

  BACKGROUND

• Daley P, Castriciano S, Chernesky M, Smieja M. Comparison of flocked and rayon swabs for collection of respiratory epithelial cells from uninfected volunteers and symptomatic patients. J Clin Microbiol. 2006 Jun;44(6):2265-7. doi: 10.1128/JCM.02055-05.

  PMID: 16757636 BACKGROUND

• Fry DE. Pressure Irrigation of Surgical Incisions and Traumatic Wounds. Surg Infect (Larchmt). 2017 May/Jun;18(4):424-430. doi: 10.1089/sur.2016.252. Epub 2017 Mar 1.

  PMID: 28437197 BACKGROUND

• Ball, S. Optimal pressures and irrigation techniques in small-animal wound management. Veterinary Nursing Journal. 2017. 32(11). 325-328.

  BACKGROUND

• Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012.

  PMID: 24773788 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Adenoviridae Infections; Enterovirus Infections

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; DNA Virus Infections; Virus Diseases; Picornaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Officials

• Thanh Nguyen, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult emergency department patients receiving nasopharyngeal swab for respiratory viral testing meet inclusion criteria and will be asked to provide up to 4 study specimens.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)