This study is currently not recruiting participants.

Clinical Method Comparison Study for the NeuMoDx Group B Streptococcus (GBS) Assay on the NeuMoDx Molecular System

Investigating the Accuracy of an Investigational Test for GBS

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to establish the clinical sensitivity and specificity of the NeuMoDx GBS Test by comparing the results to those produced by the GBS culture processing technique recommended by the published 2010 CDC guidelines to provide data in support of a 510(k) Premarket submission.

Detailed description of study

The purpose of this study is to establish the clinical sensitivity and specificity of the NeuMoDx GBS Test by comparing the results to those produced by the GBS culture processing technique recommended by the published 2010 CDC guidelines to provide data in support of a 510(k) Premarket submission.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Streptococcus
  • Age: 100 years or below
  • Gender: All

The purpose of this study is to investigate the accuracy of an investigational test for Group B Streptococcus (GBS), a type of bacteria that can cause infections in newborns. The study will compare the test results to those obtained using a standard method recommended by health guidelines.

Participants will undergo testing with both the investigational test and the standard method to determine the accuracy of the investigational test. The study will help evaluate the test's ability to correctly identify the presence of GBS.

  • Who can participate: Eligibility criteria are not specified.
  • Study details: Participants will be tested using both the investigational test and the standard GBS culture method. The investigational test's results will be compared to the standard method to determine its accuracy.
Updated on 19 Feb 2024. Study ID: 1703836394

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