Healthy SubjectsNCT07909499
BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
A study testing BD Cor OnClarity Self-Collection and BD Onclarity HPV Assay in people with Healthy Subjects and HPV, run by Indiana University at 1 site in United States.
Trial summary
This study is being done to help IU Health validate a new method for HPV testing using self-collected vaginal swab samples. Volunteers will collect two vaginal swabs during a single study visit. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, HPV
- What is being tested?
- BD Cor OnClarity Self-Collection and BD Onclarity HPV Assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with a vagina and cervix.
Who cannot join
- Absence of vagina or cervix or refusal to participate in the study, pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University, Department of Pathology
Indianapolis, Indiana, 46202
Ben Shuler, MBA, CT(ASCP), 317-491-6440, bshuler@iuhealth.org
About this study
Official title: BD Onclarity HPV Assay on the BD COR Instrument: a Performance Analysis Comparing Two Self-collected Vaginal Swabs From Volunteer IU Health Pathology Laboratory Team Members for Laboratory Validation
This study is being done to help IU Health validate a new method for HPV testing using self-collected vaginal swab samples. Volunteers will collect two vaginal swabs during a single study visit. The test results from these samples will be compared to results from an already validated collection method to make sure the new testing process performs as expected. The information gathered will be used for laboratory validation and will not be used for medical care or reported back to participants.
Read the detailed description
Human papillomavirus (HPV) testing plays an important role in the prevention and early detection of cervical cancer. The BD Onclarity HPV Assay for self-collected vaginal samples obtained in a healthcare setting has already received FDA approval and has been validated at IU Health. Recently, FDA approval was expanded to include at-home self-collection using the same testing platform, collection devices, and reagents.
The purpose of this study is to support laboratory validation of the BD Onclarity HPV Assay for at-home self-collected vaginal specimens prior to clinical implementation at IU Health. Participants will provide both an in-office self-collected vaginal specimen and a specimen collected using the BD At-Home Self-Collection Kit. Results from the paired specimens will be compared to evaluate assay performance and specimen collection workflow using the collection methods approved for use with the BD Onclarity HPV testing platform.
Data generated through this study will be used to establish the performance characteristics necessary for laboratory implementation of at-home HPV self-collection testing. Expanding access to validated self-collection options may reduce barriers to cervical cancer screening and increase participation among individuals who may not otherwise undergo routine screening. The long-term goal of this work is to support additional approaches for cervical cancer detection, prevention, and monitoring for patients served by IU Health and throughout Indiana.
All study data and specimens will be de-identified before analysis. Results will be used for laboratory validation, quality assurance, regulatory compliance, and potential scientific dissemination, and will not be used for clinical diagnosis or patient management.
- Conditions
- Healthy Subjects, HPV
- Being tested
- BD Cor OnClarity Self-Collection, BD Onclarity HPV Assay
- Keywords
- HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Cor OnClarity Self-CollectionDevice
Participants will self-collect two vaginal specimens during a single study visit, including one specimen using the currently validated in-office self-collection method and one specimen using the BD Onclarity At-Home Self-Collection Kit. Both specimens will undergo HPV testing using the BD Onclarity HPV Assay on the BD COR System. Results will be compared to evaluate the performance of at-home self-collected specimens and support laboratory validation prior to clinical implementation.
BD Onclarity HPV AssayDiagnostic test
HPV testing of paired self-collected vaginal specimens using the BD Onclarity HPV Assay on the BD COR System to support laboratory validation of at-home self-collection for HPV screening.
| Study group | Role | What they receive |
|---|---|---|
| BD Onclarity Self-Collection Validation | Experimental | Participants will provide two self-collected vaginal specimens during a single study encounter: one specimen using the currently validated in-office self-collection method and one specimen using the BD Onclarity At-Home Self-Collection Kit. Both specimens will be tested using the BD Onclarity HPV Assay on the BD COR System. Results from the paired specimens will be compared to support laboratory validation of at-home self-collected HPV testing prior to clinical implementation at IU Health. Receives: Device: BD Cor OnClarity Self-Collection; Diagnostic Test: BD Onclarity HPV Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Sensitivity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV
To evaluate the ability of self-collected vaginal swabs tested using the BD Onclarity HPV Assay on the BD COR Instrument to correctly identify high-risk HPV-positive specimens. Sensitivity will be calculated as the proportion of reference laboratory HPV-positive specimens correctly identified as positive by testing of the self-collected vaginal swabs.
Measured: At specimen collection and completion of laboratory testing (up to 30 days)
Overall Agreement Between Self-Collected Vaginal Swabs and Reference Laboratory HPV Results
To evaluate concordance between self-collected vaginal swab results obtained using the BD Onclarity HPV Assay on the BD COR Instrument and previously characterized laboratory specimens. Overall agreement will be calculated as the proportion of specimens with concordant HPV results.
Measured: At specimen collection and completion of laboratory testing (up to 30 days)
Clinical Specificity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV
To evaluate the ability of self-collected vaginal swabs tested using the BD Onclarity HPV Assay on the BD COR Instrument to correctly identify HPV-negative specimens. Specificity will be calculated as the proportion of reference laboratory HPV-negative specimens correctly identified as negative by testing of the self-collected vaginal swabs.
Measured: At specimen collection and completion of laboratory testing (up to 30 days)
Secondary outcomes (2)
Type-Specific HPV Genotype Agreement
Agreement for individual HPV genotypes reported by the BD Onclarity HPV Assay between self-collected vaginal swabs and reference laboratory specimens.
Measured: At specimen collection and completion of laboratory testing (up to 30 days)
Rate of Invalid or Unsatisfactory Results
The proportion of self-collected vaginal swabs yielding invalid, indeterminate, or otherwise non-reportable results on the BD Onclarity HPV Assay.
Measured: At specimen collection and completion of laboratory testing (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Segura, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909499
- Sponsor's protocol ID
- 28603
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Latsuzbaia A, Vanden Broeck D, Van Keer S, Weyers S, Donders G, Doyen J, Tjalma W, De Sutter P, Peeters E, Vorsters A, Arbyn M. Validation of BD Onclarity HPV Assay on Vaginal Self-Samples versus Cervical Samples Using the VALHUDES Protocol. Cancer Epidemiol Biomarkers Prev. 2022 Dec 5;31(12):2177-2184. doi: 10.1158/1055-9965.EPI-22-0757.
PubMed 36099441Martinelli M, Latsuzbaia A, Bonde J, Pedersen H, Iacobone AD, Bottari F, Piana AF, Pietri R, Cocuzza CE, Arbyn M; Extended Valhudes Study Group. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiol Spectr. 2024 Mar 5;12(3):e0287223. doi: 10.1128/spectrum.02872-23. Epub 2024 Feb 7.
PubMed 38323823
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BD Onclarity HPV Assay on the BD COR Instrument: a Performance Analysis Comparing Two Self-collected Vaginal Swabs From Volunteer IU Health Pathology Laboratory Team Members for Laboratory Validation
- ClinicalTrials.gov ID
- NCT07909499
- Acronym / sponsor ID
- 28603
- Conditions
- Healthy Subjects, HPV
- Keywords
- HPV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 2 Nov 2026 (actual)
- 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.
This study is being done to help IU Health validate a new method for HPV testing using self-collected vaginal swab samples. Volunteers will collect two vaginal swabs during a single study visit. The test results from these samples will be compared to results from an already validated collection method to make sure the new testing process performs as expected. The information gathered will be used for laboratory validation and will not be used for medical care or reported back to participants.
Detailed description
Human papillomavirus (HPV) testing plays an important role in the prevention and early detection of cervical cancer. The BD Onclarity HPV Assay for self-collected vaginal samples obtained in a healthcare setting has already received FDA approval and has been validated at IU Health. Recently, FDA approval was expanded to include at-home self-collection using the same testing platform, collection devices, and reagents.
The purpose of this study is to support laboratory validation of the BD Onclarity HPV Assay for at-home self-collected vaginal specimens prior to clinical implementation at IU Health. Participants will provide both an in-office self-collected vaginal specimen and a specimen collected using the BD At-Home Self-Collection Kit. Results from the paired specimens will be compared to evaluate assay performance and specimen collection workflow using the collection methods approved for use with the BD Onclarity HPV testing platform.
Data generated through this study will be used to establish the performance characteristics necessary for laboratory implementation of at-home HPV self-collection testing. Expanding access to validated self-collection options may reduce barriers to cervical cancer screening and increase participation among individuals who may not otherwise undergo routine screening. The long-term goal of this work is to support additional approaches for cervical cancer detection, prevention, and monitoring for patients served by IU Health and throughout Indiana.
All study data and specimens will be de-identified before analysis. Results will be used for laboratory validation, quality assurance, regulatory compliance, and potential scientific dissemination, and will not be used for clinical diagnosis or patient management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD Onclarity Self-Collection Validation | Experimental | Device: BD Cor OnClarity Self-Collection, Diagnostic Test: BD Onclarity HPV AssayParticipants will provide two self-collected vaginal specimens during a single study encounter: one specimen using the currently validated in-office self-collection method and one specimen using the BD Onclarity At-Home Self-Collection Kit. Both specimens will be tested using the BD Onclarity HPV Assay on the BD COR System. Results from the paired specimens will be compared to support laboratory validation of at-home self-collected HPV testing prior to clinical implementation at IU Health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with a vagina and cervix.
Key exclusion criteria (1 listed)
- Absence of vagina or cervix or refusal to participate in the study, pregnancy.
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 |
|---|---|---|
| BD Cor OnClarity Self-CollectionParticipants will self-collect two vaginal specimens during a single study visit, including one specimen using the currently validated in-office self-collection method and one specimen using the BD Onclarity At-Home Self-Collection Kit. Both specimens will undergo HPV testing using the BD Onclarity HPV Assay on the BD COR System. Results will be compared to evaluate the performance of at-home self-collected specimens and support laboratory validation prior to clinical implementation. | Device | BD Onclarity Self-Collection Validation |
| BD Onclarity HPV AssayHPV testing of paired self-collected vaginal specimens using the BD Onclarity HPV Assay on the BD COR System to support laboratory validation of at-home self-collection for HPV screening. | Diagnostic test | BD Onclarity Self-Collection Validation |
Primary outcome
Clinical Sensitivity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV
Time frame: At specimen collection and completion of laboratory testing (up to 30 days)
To evaluate the ability of self-collected vaginal swabs tested using the BD Onclarity HPV Assay on the BD COR Instrument to correctly identify high-risk HPV-positive specimens. Sensitivity will be calculated as the proportion of reference laboratory HPV-positive specimens correctly identified as positive by testing of the self-collected vaginal swabs.
Overall Agreement Between Self-Collected Vaginal Swabs and Reference Laboratory HPV Results
Time frame: At specimen collection and completion of laboratory testing (up to 30 days)
To evaluate concordance between self-collected vaginal swab results obtained using the BD Onclarity HPV Assay on the BD COR Instrument and previously characterized laboratory specimens. Overall agreement will be calculated as the proportion of specimens with concordant HPV results.
Clinical Specificity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV
Time frame: At specimen collection and completion of laboratory testing (up to 30 days)
To evaluate the ability of self-collected vaginal swabs tested using the BD Onclarity HPV Assay on the BD COR Instrument to correctly identify HPV-negative specimens. Specificity will be calculated as the proportion of reference laboratory HPV-negative specimens correctly identified as negative by testing of the self-collected vaginal swabs.
2 secondary outcomes
Type-Specific HPV Genotype Agreement
Time frame: At specimen collection and completion of laboratory testing (up to 30 days)
Rate of Invalid or Unsatisfactory Results
Time frame: At specimen collection and completion of laboratory testing (up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 36099441Latsuzbaia A, Vanden Broeck D, Van Keer S, Weyers S, Donders G, Doyen J, Tjalma W, De Sutter P, Peeters E, Vorsters A, Arbyn M. Validation of BD Onclarity HPV Assay on Vaginal Self-Samples versus Cervical Samples Using the VALHUDES Protocol. Cancer Epidemiol Biomarkers Prev. 2022 Dec 5;31(12):2177-2184. doi: 10.1158/1055-9965.EPI-22-0757.
- Background: PubMed 38323823Martinelli M, Latsuzbaia A, Bonde J, Pedersen H, Iacobone AD, Bottari F, Piana AF, Pietri R, Cocuzza CE, Arbyn M; Extended Valhudes Study Group. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiol Spectr. 2024 Mar 5;12(3):e0287223. doi: 10.1128/spectrum.02872-23. Epub 2024 Feb 7.
- 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.
Indiana University, Department of Pathology
Indianapolis, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD Cor OnClarity Self-Collection and BD Onclarity HPV Assay in people with Healthy Subjects and HPV, run by Indiana University at 1 site 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Sensitivity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV (time frame: At specimen collection and completion of laboratory testing (up to 30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07909499, which also lists 2 linked publications.
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 2 Nov 2026.