This study is currently not recruiting participants.

Portrait Group B Strep (GBS) Clinical Evaluation

Investigation of a Diagnostic Assay for Streptococcus agalactiae Detection

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to evaluate the clinical performance of the Portrait GBS Assay in the identification of Streptococcus agalactiae (GBS) from enriched LIM broth cultures obtained from vaginal and/or rectal swab of women.

Detailed description of study

The purpose of this study is to evaluate the clinical performance of the Portrait GBS Assay in the identification of Streptococcus agalactiae (GBS) from enriched LIM broth cultures obtained from vaginal and/or rectal swab of women.

Eligibility of study

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

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

This study investigates the clinical performance of a diagnostic test in identifying Streptococcus agalactiae, also known as Group B Streptococcus (GBS), from samples collected from women. GBS is a type of bacteria that can be found in the body and may cause infections, particularly in newborns. The study uses enriched LIM broth cultures to enhance the detection of GBS from vaginal and/or rectal swabs.

Participants in the study will undergo procedures to collect vaginal and/or rectal swabs. These samples will then be used to test the effectiveness of the diagnostic assay in identifying the presence of GBS. The study aims to validate the assay's accuracy in a clinical setting.

  • Who can participate: Women aged 18 years and older who are capable of providing informed consent and are willing to undergo vaginal and/or rectal swab collection are eligible to participate. Key eligibility factors include the absence of antibiotic use in the last two weeks and no known allergies to swab materials.
  • Study details: Participants will provide vaginal and/or rectal swabs for testing. The samples will be used to evaluate the diagnostic assay's ability to detect GBS.
Updated on 19 Feb 2024. Study ID: 1408813133

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