PregnancyNCT02497430
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
An observational study of Pregnancy and GBS, run by Luminex Corporation at 5 sites in United States.
Trial summary
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- How many people
- 918 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All comers
Who may be able to join
- An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
- Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
- The specimen is from a female patient who is at 35 - 37 weeks gestation.
- The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
- Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
- The specimen is received in good condition (no leakage or drying of the specimen) and was accepted for testing by the site in accordance with established laboratory procedures.
- The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.
Who cannot join
- The specimen was collected at a site which is not covered under the study IRB.
- The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
- The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
- The specimen was enriched in Lim broth for <18 hrs or >24 hrs.
- A swab specimen that cannot be placed in Lim broth within 4 days of collection.
- Inconclusive latex agglutination results - weak agglutination, agglutination that occurs in more than one latex reagent or the results are otherwise considered inconclusive based on established laboratory procedures or the instructions included with the latex agglutination test kit.
- Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
TriCore Reference Laboratories
Albuquerque, New Mexico, 87102
Geisinger Medical Laboratories
Danville, Pennsylvania, 17822-0131
Detroit Medical Center University Laboratories
Detroit, Michigan, 48201
Sacred Heart Health System
Pensacola, Florida, 32504
Baylor Scott & White
Temple, Texas, 76508
About this study
Official title: A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.
Read the detailed description
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay through a multi-site, method comparison on prospectively collected, left-over enriched Lim broth specimens.
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity
Measured: Within the first year of sample collection
Secondary outcomes (1)
Comparison of clinical performance per clinical site and per age group
Measured: Within the first year of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald D Dunn, Study director, Luminex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497430
- Sponsor's protocol ID
- LMA-GBS-01-CS-001
- Status last verified
- Sep 2016
- First submitted
- 9 Jul 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women
- ClinicalTrials.gov ID
- NCT02497430
- Acronym / sponsor ID
- LMA-GBS-01-CS-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Luminex CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.
Detailed description
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay through a multi-site, method comparison on prospectively collected, left-over enriched Lim broth specimens.
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comers
Key inclusion criteria (7 listed)
- An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
- Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
- The specimen is from a female patient who is at 35 - 37 weeks gestation.
- The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
- Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
Key exclusion criteria (7 listed)
- The specimen was collected at a site which is not covered under the study IRB.
- The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
- The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
- The specimen was enriched in Lim broth for <18 hrs or >24 hrs.
- A swab specimen that cannot be placed in Lim broth within 4 days of collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity
Time frame: Within the first year of sample collection
1 secondary outcome
Comparison of clinical performance per clinical site and per age group
Time frame: Within the first year of sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald D Dunn study director
Luminex Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and GBS, run by Luminex Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity (time frame: Within the first year of sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.