SARS-COV-2 Detection From Used Surgical Mask

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

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Virus
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 RNA detection

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 Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • 2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the efficacy of SARS-CoV-2 RNA detection from used surgical masks	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	3 months

Collaborators and Investigators

• Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Investigators: Principal Investigator: Thananda Trakarnvanich, M.D., Navamindradhiraj University

Publications and helpful links

General Publications

• Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
• Qian Y, Zeng T, Wang H, Xu M, Chen J, Hu N, Chen D, Liu Y. Safety management of nasopharyngeal specimen collection from suspected cases of coronavirus disease 2019. Int J Nurs Sci. 2020 Apr 4;7(2):153-156. doi: 10.1016/j.ijnss.2020.03.012. eCollection 2020 Apr 10.
• Comber L, Walsh KA, Jordan K, O'Brien KK, Clyne B, Teljeur C, Drummond L, Carty PG, De Gascun CF, Smith SM, Harrington P, Ryan M, O'Neill M. Alternative clinical specimens for the detection of SARS-CoV-2: A rapid review. Rev Med Virol. 2021 Jul;31(4):e2185. doi: 10.1002/rmv.2185. Epub 2020 Oct 22.
• Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3. Erratum In: Nature. 2020 Apr;580(7803):E7. doi: 10.1038/s41586-020-2202-3.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; RT-PCR; Nasopharyngeal swab; surgical mask
• Other Study ID Numbers: 138/64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data underlying this article are available in figshare 10.6084/m9.figshare.24064218
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No