Beta Testing Protocol for the Meridian M10 Mrsa/Sa Assay
Study of Nasal Swab Testing for MRSA/SA Detection
Thomas E. Davis
Primary Investigator
Brief description of study
This is a non-interventional method comparison study using prospectively collected nasal swab specimens collected from subjects via the informed consent process. The study is designed to assist MBI in determining the reference method to be used in Meridian M10 MRSA/SA assay clinical study. The objective of this Beta Testing Protocol is to aid Meridian Bioscience Inc. (MBI) in determining the reference method to be used in the Meridian M10 MRSA/SA assay clinical study.
Detailed description of study
Once enrolled, subjects will provide two (2) nasal swab specimens collected with the Copan Elution Swab (Eswab) collection and transport system or Copan Dual Rayon Swab and Liquid Stuart Medium (Dual Transport Swab) from individuals that are in a healthcare setting and at risk of MRSA/SA colonization. These specimens will be tested
fresh on the Meridian M10 MRSA/SA assay and direct and enriched bacteria culture (reference method). Test results in this study will not influence patient management as each sample will be de- identified and no result will be transmitted to either the patient or physician
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Infection
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Age: 18 years or above
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Gender: All
Enrollment Inclusion Criteria
Subject and/or legally authorized representative provides informed consent or assent
prior to study participation.
Subject is willing to provide two (2) nasal swab specimens for study purposes.
Subject is in a healthcare setting and is at risk of nasal colonization.
Enrollment Exclusion Criteria
Subject was previously enrolled in the study
Subject has received systemic or topical nasal antibiotics associated with the treatment
of S. aureus within 7 days prior to enrollment
Subject has received topical nasal antiseptic within 7 days prior to enrollment
Subject has a contraindication to nasal sampling as performed in accordance with the
collection device manufacturer’s instructions and site procedures.
This study investigates a method to compare different ways of testing for MRSA and SA, which are types of bacteria that can live in the nose. MRSA stands for Methicillin-resistant Staphylococcus aureus, and SA stands for Staphylococcus aureus. These bacteria can cause infections, especially in people in healthcare settings. The purpose of this study is to find the best way to test for these bacteria using nasal swabs.
Participants will have two nasal swabs taken. These swabs will be tested using the Meridian M10 MRSA/SA assay and a method called bacteria culture. Bacteria culture is when a sample is placed in a special dish to see if bacteria grow. This study will not affect the treatment of participants because the test results will not be shared with them or their doctors.
- Who can participate: People who are in a healthcare setting and at risk of nasal colonization can participate if they provide informed consent and are willing to give two nasal swab samples.
- Study details: Participants will provide two nasal swab samples for testing.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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