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SARS-COV-2 Detection From Used Surgical Mask

Efficacy of SARS-COV-2 Detection From Used Surgical Mask Compared to Standard Detection Method

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06027398
Enrollment
269
Registered
2023-09-07
Start date
2021-05-01
Completion date
2021-09-30
Last updated
2024-11-15

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

Conditions

SARS-CoV-2 Virus

Keywords

Nasopharyngeal swab, RT-PCR, SARS-CoV-2, surgical mask

Brief summary

The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a sufficient sample are the most important steps for laboratory diagnosis. The nasopharyngeal (NP) swab is recommended as the reference collection method. However, NP swab collection is invasive and uncomfortable for patients and poses some risk to healthcare workers. This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with the NP swab method using RT-PCR testing

Detailed description

Proper specimen collection and obtaining sufficient samples are the most important steps for laboratory diagnosis of an infectious disease. Improper collection may lead to false or inconclusive test results. During the early stages of the COVID-19 outbreak, the Center for Disease Prevention and Control recommended collecting and testing an upper respiratory specimen \[4\]. Nasopharyngeal (NP) and oropharyngeal (OP) swabs are the preferred choice for initial SARS-CoV-2 diagnostic testing. This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods. We tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing. Hospitalized patients with laboratory-confirmed COVID-19 were recruited to provide surgical masks. Collection of used surgical mask samples by patients themselves is easy, convenient, requires no sampling equipment and decreases the risk of healthcare personnel exposure to COVID-19. If SARS-CoV-2 RNA can be detected on used surgical mask samples, this may encourage patients to provide specimens for testing and help in early detection and transmission prevention. As an alternative method to NP swabs, it may facilitate timely diagnosis and treatment.

Interventions

DIAGNOSTIC_TESTSARS-CoV-2 RNA detection

SARS-CoV-2 RNA detection in used mask filters

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

* Newly confirmed SARS-CoV-2 positive cases admitted to a field hospital within 48 hours or outpatient with a positive result for SARS-CoV-2 * Should be able to wear a mask for 8 h according to the protocol

Exclusion criteria

* require oxygen intubation or any breathing support devices

Design outcomes

Primary

MeasureTime frameDescription
the efficacy of SARS-CoV-2 RNA detection from used surgical masks3 monthstested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026