SARS-COV-2 Detection From Used Surgical Mask

Not Applicable

Completed

• Conditions: SARS-CoV-2 Virus
• Interventions: Diagnostic Test: SARS-CoV-2 RNA detection

• Registration Number: NCT06027398
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 RNA in masks	SARS-CoV-2 RNA detection	. After the participants had worn the masks for 8 h, the nurse collected the filters and placed each into a viral transport medium (VTM) tube This was placed inside a clean plastic bag, sprayed with alcohol, placed in an icebox and sent to the biomolecular laboratory for real-time RT-PCR SARS-CoV-2 testing.

Primary Outcome Measures

Name	Time	Method
the efficacy of SARS-CoV-2 RNA detection from used surgical masks	3 months	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

Trial Locations

Locations (1)

2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand; 🇹🇭 Bangkok, Thailand