Usability of a novel Mouthwash sampling Kit for SARS-CoV-2 antigen Measurements – Comparison of samples taken at the site and samples taken at home and shipped to the site

Usability of a novel Mouthwash sampling Kit for SARS-CoV-2 antigen Measurements – Comparison of samples taken at the site and samples taken at home and shipped to the site - PRO-USA-001

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025397

Enrollment

120

Registered

2021-05-21

Start date

2021-08-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV-2

Interventions

Group 1: Participants with unknown SARS-CoV-2 infection status will collect 2 samples (first in the practice and then at home) using the mouthwash sample kit to be tested, then both samples will be t

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 – 80 years. 2. Subjects who agree to the utilization of their samples in terms of sample processing, storage, analysis, documentation, optional shipment as required by the applied SARS-CoV-2 antigen test and publication of study results.

Exclusion criteria

Exclusion criteria: 1. Lack of compliance or other justifications that precludes satisfactory participation in the study in the opinion of the Investigator. 2. Inability to understand the nature and the extent of the study and the procedures required. 3. Participation without legal capacity.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to determine the diagnostic accuracy of the Procuras Corona Test Sampling Kit with mouthwash samples taken at home for the RT-PCR measurement of SARS-CoV-2 Antigen. The reference is given by the RT-PCR measurement of SARS-CoV-2 Antigen using the Procuras Corona Test Sampling Kit with mouthwash samples taken at the study site. The expected sensitivity for detecting SARS-CoV-2 antigen with the proposed method is 90% and the expected specificity is 95%. These parameters will be determined with the respective 95% confidence intervals of prespecified length, namely ±10% for sensitivity and ±5% for specificity.	—

Measure

Time frame

The primary objective of the study is to determine the diagnostic accuracy of the Procuras Corona Test Sampling Kit with mouthwash samples taken at home for the RT-PCR measurement of SARS-CoV-2 Antigen. The reference is given by the RT-PCR measurement of SARS-CoV-2 Antigen using the Procuras Corona Test Sampling Kit with mouthwash samples taken at the study site. The expected sensitivity for detecting SARS-CoV-2 antigen with the proposed method is 90% and the expected specificity is 95%. These parameters will be determined with the respective 95% confidence intervals of prespecified length, namely ±10% for sensitivity and ±5% for specificity.

—

Secondary

Measure	Time frame
Robustness to shipment of the applied mouthwash collection solution for RT-PCR measurement of SARS-CoV-2 antigen. Comparison of mouthwash collection samples taken at the study site with mouthwash collection samples taken at home and following shipment per standard mail in the subsequent RT-PCR measurement of SARS-CoV-2 antigen. The expected sensitivity for detecting SARS-CoV-2 antigen with the proposed method is 90% and the expected specificity is 95%. These parameters will be determined with the respective 95% confidence intervals of prespecified length, namely ±10% for sensitivity and ±5% for specificity.	—

Measure

Time frame

Robustness to shipment of the applied mouthwash collection solution for RT-PCR measurement of SARS-CoV-2 antigen. Comparison of mouthwash collection samples taken at the study site with mouthwash collection samples taken at home and following shipment per standard mail in the subsequent RT-PCR measurement of SARS-CoV-2 antigen. The expected sensitivity for detecting SARS-CoV-2 antigen with the proposed method is 90% and the expected specificity is 95%. These parameters will be determined with the respective 95% confidence intervals of prespecified length, namely ±10% for sensitivity and ±5% for specificity.

—

Countries

Germany

Contacts

Public ContactAndreas Pfützner

Pfützner Science & Health GmbH

andreas.pfuetzner@pfuetzner-mainz.com+49 6131 5884640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026