Clinical trial NCT06027398: SARS-COV-2 Detection From Used Surgical Mask
Official title: Efficacy of SARS-COV-2 Detection From Used Surgical Mask Compared to Standard Detection Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Virus
Keywords: Nasopharyngeal swab
RT-PCR
SARS-CoV-2
surgical mask
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-07
Enrollment: 269
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: the efficacy of SARS-CoV-2 RNA detection from used surgical masks
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: 2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
Study officials:
affiliation: Navamindradhiraj University
name: Thananda Trakarnvanich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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