An interventional study of Comparison between GenePOC CR and Reference Method in Pharyngitis, Infective, sponsored by Meridian Bioscience, Inc.. Completed at 8 sites in 2 countries. Open to participants aged 25 Months and older. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by Meridian Bioscience, Inc. (part of SD Biosensor) · Not applicable, Interventional, and Diagnostic
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
The GenePOC Strep A, C/G assay will be performed using the revogene™ instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.
A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 497 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Meridian Bioscience, Inc. is the lead sponsor of 27 studies on the registry; none are open to participants now.
First submitted before Meridian Bioscience, Inc. became part of SD Biosensor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay. Intervention will be the Comparison between GenePOC CR and Reference Method.
Device: Comparison between GenePOC CR and Reference Method
The swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method. Intervention will be the Comparison between GenePOC CR and Reference Method.
Device: Comparison between GenePOC CR and Reference Method
The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.
Performance characteristics of the GenePOC Streap A, C/G assay
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
Time frame: Up to 14 months
Positive and Negative Predictive Values (PPV and NPV)
To establish the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC Strep A, C/G assay. PPV will be calculated as the proportion of positive results with the GenePOC Strep A, C/G assay that are true positive results when compared to the Reference Method. NPV will be calculated as the proportion of negative results with the GenePOC Strep A, C/G assay that are true negative results when compared to the Reference Method.
Time frame: Up to 14 months
Unresolved sample results
To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).
Time frame: Up to 14 months
Indeterminate sample results
To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).
Time frame: Up to 14 months
Plan to share: No
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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