SARS-COV-2 Detection From Used Surgical Mask

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06027398

Collaborator

(none)

269

Enrollment

Location

Arm

Actual Duration (Months)

53.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Virus	Diagnostic Test: SARS-CoV-2 RNA detection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

269 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SARS-CoV-2 RNA in masks . 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.	Diagnostic Test: SARS-CoV-2 RNA detection SARS-CoV-2 RNA detection in used mask filters

Arm

Intervention/Treatment

Experimental: SARS-CoV-2 RNA in masks

. 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.

Diagnostic Test: SARS-CoV-2 RNA detection

SARS-CoV-2 RNA detection in used mask filters

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand	Bangkok		Thailand	10400

Sponsors and Collaborators

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Investigators

Principal Investigator: Thananda Trakarnvanich, M.D., Navamindradhiraj University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital

ClinicalTrials.gov Identifier:

NCT06027398

Other Study ID Numbers:

138/64

First Posted:

Sep 7, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Study Results

No Results Posted as of Sep 7, 2023