Streptococcus Agalactiae InfectionNCT02718157
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
A study testing Comparison between GenePOC PCR and Reference Method in people with Streptococcus Agalactiae Infection, run by Meridian Bioscience, Inc. at 4 sites in 2 countries.
Trial summary
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Streptococcus Agalactiae Infection
- What is being tested?
- Comparison between GenePOC PCR and Reference Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 771 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Aug 2016to 7 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Antepartum pregnant women
- 18 years old and more
- Being at a gestation period of 35 to 37 weeks.
- Vaginal/rectal swab specimen
- Transport and storage times, and conditions (e.g. room temperature and/or refrigerated) within the labeled indications.
- Fresh specimens available to be tested with the GenePOC GBS System within 96 hours (4 days) of collection if kept at 2-25°C
Show all 9Show fewer
- Fresh specimens must be tested with the Reference Method within 96 hours (4 days) of collection if kept at 2-25°C
- The GenePOC GBS System and the Reference Method will be performed according to the GenePOC GBS Investigation Documents.
- Materials use within their expiration date
Who cannot join
- Non pregnant women
- Less than 18 years old
- Gestation not between 35-37 weeks
- Transport and storage times and conditions that exceed these Study Protocol requirements
- The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents
- Materials used beyond their expiration date
- Specimens without all test results required by this Study Protocol. Specimens that are inadvertently entered into the study that do not meet the specimen inclusion criteria will be made non-compliant.
- The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Tricore Laboratory University of New Mexico
Albuquerque, New Mexico, 87102
Detroit Medical Center University Laboratories
Detroit, Michigan, 48201
Canada2 sites
CHU de Québec - Université Laval
Québec, G1V 4G2
Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
Toronto, Ontario, M5G 1X5
About this study
Official title: Prospective Study for Clinical Validation of the Molecular-Based GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains in Vaginal/Rectal Swab Specimens, After Lim Broth Enrichment, From Pregnant Women
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women.
Read the detailed description
The GenePOC GBS Test performed on the GenePOC System is a qualitative in vitro diagnostic (IVD) test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women following enrichment in Lim broth for 18-24 hours.
The GenePOC GBS Test utilizes automated sample preparation and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC GBS Test is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
The GenePOC GBS is an IVD system is comprised of the GenePOC Diagnostics System and the GenePOC Group B Step [GBS] Test, the components of which are:
- Instrument
- GBS disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- GBS Sample Buffer Tube (SBT)
- Sample Transfer Device (STD).
The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.
Lim Broth is used for the selective enrichment of group B streptococci (Streptococcus agalactiae). An aliquot of the broth is mixed with GenePOC Sample Buffer Tube Reagent (SBT), after which a sample is transferred to the GenePOC GBS PIE. The GenePOC GBS PIE is then automatically processed by the GenePOC Instrument.
On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.
One GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from four (4) Clinical Centers to obtain a total of 150 specimens positive for GBS based on the Reference Method final result.
Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.
- Conditions
- Streptococcus Agalactiae Infection
- Being tested
- Comparison between GenePOC PCR and Reference Method
- Keywords
- Polymerase Chain Reaction (PCR), GBS, Streptococcus agalactiae, Antepartum women
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between GenePOC PCR and Reference MethodDevice
Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain.
| Study group | Role | What they receive |
|---|---|---|
| Accuracy Testing | Experimental | Comparison between GenePOC PCR and Reference Method Receives: Device: Comparison between GenePOC PCR and Reference Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Characteristics
To establish the performance characteristics of the GenePOC GBS System for its use in determining the presence of GBS in vaginal/rectal swab, after Lim Broth enrichment, specimens from antepartum pregnant women. Sensitivity and specificity will be established in comparison to the Reference Method.
Sensitivity performance results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Reference Method only. Sensitivity is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive ([False Negative]).
Specificity performance results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Reference Method only. Specificity is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives ([False Positive]).
Measured: At the time of the results with Reference Method is confirmed, up to 6 months
Secondary outcomes (3)
Positive and Negative Predictive Values
To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC GBS System.
PPV results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Investigational test only. PPV is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive ([False Positive]).
NPV results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Investigational test only. NPV is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives ([False Negative]).
Measured: At the time of the results with Reference Method is confirmed, up to 6 months
Unresolved Sample Results
To estimate the rate of unresolved results for the GenePOC GBS System due to Sample Processing control failure (unresolved sample results).
Measured: At the time of the results with Reference Method is confirmed, up to 6 months
Indeterminate Sample Results
To estimate the rate of indeterminate results for the GenePOC GBS Test due to an Instrument failure (indeterminate sample results).
Measured: At the time of the results with Reference Method is confirmed, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start10 Aug 2016
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Streptococcus Agalactiae InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Allibert, Study director, Meridian Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718157
- Sponsor's protocol ID
- GenePOC-GBS_clinical-01
- Status last verified
- Nov 2018
- First submitted
- 15 Mar 2016
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Clinical Validation of the Molecular-Based GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains in Vaginal/Rectal Swab Specimens, After Lim Broth Enrichment, From Pregnant Women
- ClinicalTrials.gov ID
- NCT02718157
- Acronym / sponsor ID
- GenePOC-GBS_clinical-01
- Conditions
- Streptococcus Agalactiae Infection
- Keywords
- Polymerase Chain Reaction (PCR), GBS, Streptococcus agalactiae, Antepartum women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women.
Detailed description
The GenePOC GBS Test performed on the GenePOC System is a qualitative in vitro diagnostic (IVD) test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women following enrichment in Lim broth for 18-24 hours.
The GenePOC GBS Test utilizes automated sample preparation and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC GBS Test is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
The GenePOC GBS is an IVD system is comprised of the GenePOC Diagnostics System and the GenePOC Group B Step [GBS] Test, the components of which are:
- Instrument
- GBS disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- GBS Sample Buffer Tube (SBT)
- Sample Transfer Device (STD).
The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.
Lim Broth is used for the selective enrichment of group B streptococci (Streptococcus agalactiae). An aliquot of the broth is mixed with GenePOC Sample Buffer Tube Reagent (SBT), after which a sample is transferred to the GenePOC GBS PIE. The GenePOC GBS PIE is then automatically processed by the GenePOC Instrument.
On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.
One GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from four (4) Clinical Centers to obtain a total of 150 specimens positive for GBS based on the Reference Method final result.
Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuracy Testing | Experimental | Device: Comparison between GenePOC PCR and Reference MethodComparison between GenePOC PCR and Reference Method |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Antepartum pregnant women
- 18 years old and more
- Being at a gestation period of 35 to 37 weeks.
- Vaginal/rectal swab specimen
- Transport and storage times, and conditions (e.g. room temperature and/or refrigerated) within the labeled indications.
Key exclusion criteria (8 listed)
- Non pregnant women
- Less than 18 years old
- Gestation not between 35-37 weeks
- Transport and storage times and conditions that exceed these Study Protocol requirements
- The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison between GenePOC PCR and Reference MethodAntepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain. | Device | Accuracy Testing |
Primary outcome
Performance Characteristics
Time frame: At the time of the results with Reference Method is confirmed, up to 6 months
To establish the performance characteristics of the GenePOC GBS System for its use in determining the presence of GBS in vaginal/rectal swab, after Lim Broth enrichment, specimens from antepartum pregnant women. Sensitivity and specificity will be established in comparison to the Reference Method. Sensitivity performance results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Reference Method only. Sensitivity is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive ([False Negative]). Specificity performance results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Reference Method only. Specificity is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives ([False Positive]).
3 secondary outcomes
Positive and Negative Predictive Values
Time frame: At the time of the results with Reference Method is confirmed, up to 6 months
Unresolved Sample Results
Time frame: At the time of the results with Reference Method is confirmed, up to 6 months
Indeterminate Sample Results
Time frame: At the time of the results with Reference Method is confirmed, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Patrice Allibert study director
Meridian Bioscience, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison between GenePOC PCR and Reference Method in people with Streptococcus Agalactiae Infection, run by Meridian Bioscience, Inc. at 4 sites in 2 countries.
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 9 inclusion and 8 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Performance Characteristics (time frame: At the time of the results with Reference Method is confirmed, up to 6 months). 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 3 May 2021.