Nasal Swab Objective and Statistical Evaluation (NOSE Study)

Conditions

• SARS Coronavirus 2 RT-PCR Testing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

Supply chain disruptions have led to shortages in test swabs which are used to collect respiratory samples. Lack of these test swabs can reduce a hospital or state's ability to test patients for COVID-19. To address this shortage, many manufacturers, hospitals and individuals have designed non-traditional 3D printed swabs for COVID-19 diagnosis that could potentially meet demands for nasal swabs. However, questions regarding the safety and effectiveness of these swabs remain. This study will provide additional, statistically supported evidence as to the safety and efficacy of novel swabs.

Key Dates

Start date

Apr 5, 2021

Status verified

Mar 2026

Primary completion

Aug 16, 2022

Completion

Aug 16, 2022

Study Design

Enrollment

1,179 participants (actual)

Arms

• Arm: Standard of Care / Standard of Care
  Initial cohort to identify the effect of order on swab result. Swab order (standard of care first) was set to preserve clinical test result in case there was an impact to swab order.
• Arm: 1st Alt Swab / Standard of Care
  Evaluation of 1st alternatively sourced swab to the standard of care swab
• Arm: 2nd Alt Swab / Standard of Care
  Evaluation of 2nd alternatively sourced swab to the standard of care swab

Primary Outcome Measure

Sensitivity [ Time Frame: Day 1 ]

Locations (1)

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