Trial · NCT07909499
BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
NCT07909499, Not applicable, Not yet recruiting, Indiana University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation. Trials, record NCT07909499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909499
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
- NCT number
- NCT07909499
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Indiana University
- Conditions
- Healthy Subjects, HPV
- Interventions
- BD Cor OnClarity Self-Collection, BD Onclarity HPV Assay
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Sensitivity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV | 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. |
| Primary | Overall Agreement Between Self-Collected Vaginal Swabs and Reference Laboratory HPV Results | 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. |
| Primary | Clinical Specificity of Self-Collected Vaginal Swabs for Detection of High-Risk HPV | 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. |
| Secondary | Type-Specific HPV Genotype Agreement | At specimen collection and completion of laboratory testing (up to 30 days) | Agreement for individual HPV genotypes reported by the BD Onclarity HPV Assay between self-collected vaginal swabs and reference laboratory specimens. |
| Secondary | Rate of Invalid or Unsatisfactory Results | At specimen collection and completion of laboratory testing (up to 30 days) | The proportion of self-collected vaginal swabs yielding invalid, indeterminate, or otherwise non-reportable results on the BD Onclarity HPV Assay. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07909499
GET https://conductscience.org/api/trials/v1/NCT07909499/registered