Clinical Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) Utilizing Vaginal Swabs: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) Utilizing Vaginal Swabs (NCT03596151), a na na study. The primary outcome is The Percent Sensitivity and Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to Patient Infection Status (PIS) Using Vaginal Specimens Collected by a Qualified HCP.

2. Clinical Question

This is a diagnostic-performance question, not a treatment comparison. The central issue is how closely a device result agrees with a reference classification for each infection-status category. Sensitivity and specificity describe different aspects of that agreement, so neither measure alone conveys the complete pattern of results. A valid comparison also depends on how evaluable specimens and PIS classifications were determined. The record defines evaluability as having valid positive or negative results from both the Click Device and PIS for CT, but does not report how many participants met that definition. The stated study objective also includes NG and TV, while the primary endpoint description is specific to CT. Numerical findings for CT, NG, or TV are not reported in the registry record.

3. Trial Design

The registry describes a multicenter, single-group device study. Its stated intervention was the Click Device, and the arm description specifies a self-collected vaginal swab for device testing alongside three health care provider-collected swabs for comparator testing. Participants were to complete the study in a single visit and were managed according to standard of care as applicable. The design therefore evaluates diagnostic performance within participants rather than comparing randomized treatment groups.

Allocation is recorded as not applicable, and masking is recorded as none. The study is not a randomized comparison, and its single group should not be interpreted as a treatment arm with a like-for-like control arm. The comparator assays contribute to PIS, the reference classification against which device performance is assessed; they are not a separately assigned participant group.

The brief description states that the study was planned for a minimum of three United States sites, approximately 1750 female subjects, and an approximate duration of 9 months after enrollment of the first subject. Actual enrollment is recorded as 295. The study status is terminated. The registry lists a start date of 2018-07-09 and a primary completion date of 2018-08-20. The reason for termination is not reported in the registry record, and the record does not explain the difference between planned and recorded enrollment.

The sponsor is the National Institute of Allergy and Infectious Diseases (NIAID). The study is listed as phase NA, which is consistent with its device-evaluation focus rather than a drug-phase designation. The broad objective was to assess Click Device performance for CT, NG, and TV using self-collected specimens against PIS based on approved comparator assays. The primary endpoint specifically describes CT sensitivity and specificity on Day 1. No numerical diagnostic results or analysis outputs are reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This population includes all participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: The baseline analysis population includes all participants who were enrolled in the study.

6. Primary Endpoint

The registry lists the primary outcome as The Percent Sensitivity and Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to Patient Infection Status (PIS) Using Vaginal Specimens Collected by a Qualified HCP, measured over Day 1.

The primary endpoint is the percent sensitivity and percent specificity of the Click Device for detecting CT in self-collected vaginal specimens, compared with PIS determined using vaginal specimens collected by a qualified health care provider. The timeframe is Day 1. The endpoint is restricted to participants with evaluable device and PIS results: each had to be a valid positive or negative result.

Sensitivity is the proportion of PIS-positive specimens for which the Click Device also returns a positive result. In the registry’s definition, true positives are positive by both methods, while false negatives are device-negative but PIS-positive. Specificity is the proportion of PIS-negative specimens for which the device returns a negative result. True negatives are negative by both methods, while false positives are device-positive but PIS-negative.

These measures are used because they distinguish performance among specimens classified as infected from performance among specimens classified as not infected by the reference approach. They are not interchangeable: one describes detection within the PIS-positive group, and the other describes negative classification within the PIS-negative group. Neither measure, by itself, gives the number of evaluable participants, the underlying prevalence in the enrolled population, or the full pattern of agreement.

The registry record does not report the endpoint estimates, their confidence intervals, or the evaluable participant count. It also does not report detailed results for NG or TV in the primary endpoint description.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General: what sensitivity and specificity measure. Sensitivity and specificity are conditional proportions. Sensitivity uses the PIS-positive specimens as its denominator and asks what proportion the device calls positive. Specificity uses the PIS-negative specimens as its denominator and asks what proportion the device calls negative. The registry definitions express these proportions through true-positive, false-negative, true-negative, and false-positive classifications. The two results answer complementary questions; one cannot be substituted for the other.

General: why the reference definition matters. A diagnostic evaluation needs a reference classification against which the test under study is assessed. In this study, the reference is called PIS and is determined using three approved comparator assays on health care provider-collected vaginal specimens. The record does not report the exact rule used to assign PIS from those assays. Since the calculated diagnostic measures are relative to that reference classification, the rule is relevant to interpretation. This is a general methodological point and does not imply that the reference is right or wrong.

General: evaluability and denominators. A valid paired result is required for the primary endpoint population: the Click Device and PIS must each return a valid positive or negative CT result. If one or both results are not evaluable, the participant is outside the stated endpoint population. The registry gives this definition, but does not report the number excluded, the number with paired evaluable results, or the reasons for any non-evaluable results. As a result, the enrollment count cannot be assumed to equal the denominator used for either measure.

General: uncertainty and confidence intervals. A point estimate describes the observed proportion in the analysis sample, while a confidence interval expresses sampling uncertainty around that estimate under the method used to construct it. Greater precision generally corresponds to a narrower interval, and smaller or less informative samples can yield wider intervals. These are general statistical concepts. The registry record does not report point estimates, confidence intervals, or the method used to calculate interval estimates for this endpoint, so the uncertainty around the diagnostic measures cannot be assessed from the reported record.

General: paired diagnostic results. Because each participant contributes a self-collected device specimen and health care provider-collected comparator specimens, the comparison is organized around classifications within the participant’s testing episode rather than independent randomized groups. The endpoint definitions classify results as positive or negative relative to PIS. The record does not report a complete classification count or describe any additional statistical model. Without those results, it is not possible to reconstruct the observed sensitivity or specificity from the registry information.

General: interpretation of agreement. Sensitivity and specificity summarize particular dimensions of agreement with a reference, not all aspects of test performance. They do not by themselves describe the number of positive or negative results in the tested population, the prevalence of infection in that population, or how a result would perform in a different setting. In general, measures tied to a study sample and reference definition should be interpreted in light of who was enrolled, which results were evaluable, and how the reference status was assigned. The registry provides some of that design context, but not all the required results and procedures.

General: multiplicity. When a study evaluates multiple outcomes or organisms, there can be multiple opportunities for a nominally notable result. Statistical plans may address this through a prespecified hierarchy or an adjustment, but no such approach is described in the registry record. The registry lists nine outcome measures and zero analyses. These registry counts do not establish whether investigators conducted analyses or how they handled multiple endpoints; a multiplicity strategy is not reported in the registry record.

General: sample-size planning versus observed power. The stated sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. The assumptions also distinguish total events for time-to-event outcomes from participants per arm for other outcomes. These are planning conventions, not observed study results. A planning illustration based on an observed effect is not observed power, and the stated two-arm assumptions do not match the registry’s single-group diagnostic design. Numerical illustration results and the trial’s own sample-size justification are not reported in the registry record.

General: no randomized treatment contrast. Allocation is recorded as NA, masking as none, and the model as a single group. Thus, the design does not assign participants to competing treatments or provide randomized treatment groups for a comparative-effect estimate. The comparator assays serve to define PIS for diagnostic assessment. This distinction prevents interpreting diagnostic agreement as evidence from a randomized comparison. It also means that treatment-effect methods designed for parallel randomized groups would not directly describe the primary endpoint as defined.

General: analysis-plan transparency. A statistical analysis plan can specify endpoint estimators, confidence-interval methods, missing-result handling, subgroup analyses, and any multiplicity control. The registry record defines the basic sensitivity and specificity formulas, but does not report a fuller statistical plan. Therefore, no unreported estimator, adjustment, subgroup procedure, or interim analysis should be assumed. The registry also does not report the study’s sample-size justification or explain whether the termination affected planned analyses.

10. Multiplicity, Missing Data and Analysis Populations

The registry describes a primary CT endpoint and a broader objective involving CT, NG, and TV. It lists nine outcome measures, but does not report a multiplicity procedure or an endpoint hierarchy beyond identifying the CT sensitivity and specificity measure as primary. If several outcomes or organisms are tested, the chance of obtaining at least one apparently notable finding can differ from the chance associated with a single prespecified test. This is a general statistical concern, not evidence that any particular adjustment was or was not performed. The registry record does not report the statistical plan for controlling multiplicity.

The CT endpoint population requires evaluable results from both the Click Device and PIS. The record defines a valid result as positive or negative from each method, but does not state how missing, invalid, or indeterminate results were handled in analysis. Counts of missing or non-evaluable samples and reasons for their absence are not reported in the registry record. Nor are sensitivity analyses for missing results reported.

The record reports enrollment of 295 and defines the primary analysis population by paired evaluability, but does not report the number entering that population. It also lists zero analyses, which is a registry-record count rather than evidence about whether analyses occurred outside the posted entry. The approach to analysis populations, protocol deviations, exclusions, or other data-cleaning decisions is not reported in the registry record.

These omissions prevent assessment of how complete the primary endpoint data were, whether outcome reporting followed a prespecified hierarchy, and how uncertainty was handled across the outcomes. They do not establish that missing data or multiplicity altered any result; the relevant analysis details and numerical findings are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry’s adverse-event group is Click Device. It lists 294 participants at risk for serious adverse events and 0 participants affected by serious adverse events. It also lists 294 participants at risk for other adverse events and 0 participants affected by other adverse events, with 0 deaths. No top serious adverse-event terms are listed.

These figures are counts in the registry record, not a measure of diagnostic performance. The reported at-risk count is 294, while total enrollment is 295; the record does not explain that difference. The adverse-event observation period and the methods used to collect or classify events are not reported in the registry record, so the counts should be interpreted only within the information recorded.

A zero count in a posted category means that no affected participants are recorded for that category in this entry. It does not establish that no event could occur, nor does it resolve whether all participants had complete safety follow-up. The record does not report event-level descriptions, severity grading beyond the serious and other categories, or a detailed safety analysis. These counts should not be read as proof of absence of risk or as a comparison against another device or group.

12. What the Result Does, and Does Not, Mean

The record supports a clear description of the study question: assess the Click Device’s CT sensitivity and specificity for self-collected vaginal specimens relative to PIS based on comparator assays. It also identifies the enrollment, single-group design, evaluability rule, and selected adverse-event counts. These are useful elements for understanding what the study was intended to assess and how the primary endpoint was defined.

However, numerical sensitivity and specificity estimates are not reported in the registry record. The evaluable CT population size, classification counts, and precision estimates are also not reported. Without these results, the posted record does not show how closely device classifications matched PIS, nor how uncertain any such estimate would be. It cannot support a conclusion that the device performed well or poorly.

The study objective includes CT, NG, and TV, while the named primary endpoint is CT-specific. Numerical results for the organisms are not reported in the registry record. The comparator approach is described at a high level, but the precise PIS combination rule is not reported. These limits matter because diagnostic accuracy is defined relative to the reference status and the participants whose paired results can be analyzed.

The trial was terminated and enrolled 295 participants, whereas its brief summary describes a plan for approximately 1750 female subjects. The reason for termination and the explanation for the difference are not reported in the registry record. These registry entries describe the record but do not reveal the cause or establish how the difference affected performance estimates.

Accordingly, the record should be read as describing a diagnostic study and its endpoint definitions, not as a complete quantitative account of its findings. The available safety counts are also limited to the categories and participants recorded. Nothing in the posted information establishes comparative clinical benefit, treatment effectiveness, or the performance of the device in populations beyond the stated study context.

13. Why This Trial Matters Statistically

This study is statistically notable because it asks a diagnostic-accuracy question rather than a treatment-effect question. Its primary measures condition on the PIS classification: sensitivity is evaluated among PIS-positive results, and specificity among PIS-negative results. Understanding those denominators is essential to interpreting any future or separately reported estimate. The registry defines the measures and the evaluable-result requirement, making the intended comparison understandable even though the numerical results are not reported.

The specimen pathways also matter to the design. The device result comes from a self-collected vaginal swab, while PIS is based on comparator testing using health care provider-collected specimens. The study therefore evaluates the device against a reference classification formed through a distinct specimen-collection process. This is directly relevant to the study objective, but the record does not report the detailed PIS assignment rule or the paired outcome counts needed to quantify agreement.

There is a meaningful distinction between the intended scale and recorded enrollment: the brief summary describes approximately 1750 female subjects, while actual enrollment is 295. The study is marked terminated. Because the record does not state why it ended or give endpoint results, neither the reason for termination nor the consequences for estimate precision can be inferred from these registry entries alone.

Finally, statistical transparency is part of interpreting a diagnostic study. The registry identifies nine outcome measures and zero analyses, while a full account of the multiplicity plan, missing-result handling, interval estimation, and sample-size justification is not reported. These gaps limit independent assessment of the evidence. They do not replace the need for numerical findings; the essential CT sensitivity and specificity results remain not reported in the registry record.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most consequential limitation for interpreting the primary question is the absence of numerical diagnostic results. Sensitivity, specificity, confidence intervals, evaluable sample counts, and the underlying classification counts are not reported in the registry record. The stated endpoint definitions therefore cannot be checked against observed results or used to assess precision.

The intended enrollment was approximately 1750 female subjects, while recorded enrollment is 295, and the status is terminated. The reason for termination, the explanation for the enrollment difference, and any resulting changes to the analysis are not reported in the registry record. Planned study duration is described as approximately 9 months after the first enrollment, but the record does not explain how actual conduct related to that plan.

The primary analysis population excludes participants without valid paired device and PIS results by definition. The number of such participants, reasons for non-evaluability, and handling of missing or invalid results are not reported. The exact process for deriving PIS from the three approved comparator assays is also not reported, limiting assessment of the reference classification.

The record identifies CT as the primary endpoint, while the broader study objective includes NG and TV. It lists nine outcome measures but gives no multiplicity strategy, complete analysis plan, or numerical results for the additional organisms. Allocation is not applicable, masking is none, and the design is single-group, so it does not provide a randomized treatment comparison. Safety reporting lists 294 at risk and zero affected in the serious and other adverse-event categories, but the observation period and explanation for the difference from total enrollment are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) Utilizing Vaginal Swabs — NCT03596151.
• Registry record last updated 2021-08-24; status last verified 2018-06-22.
• Results first posted 2021-08-24.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

This is a terminated, single-group diagnostic device study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The Click Device was evaluated using self-collected vaginal swabs, with health care provider-collected specimens used for comparator testing and PIS. The stated primary endpoint is CT sensitivity and specificity on Day 1 among participants with valid device and PIS results. The broader objective includes CT, NG, and TV.

The registry records enrollment of 295, a start date of 2018-07-09, and a primary completion date of 2018-08-20. The brief summary describes planned enrollment of approximately 1750 female subjects and an approximate duration of 9 months after the first enrollment. The reason for termination and the difference between planned and actual enrollment are not reported in the registry record.

Numerical primary endpoint results, evaluable counts, confidence intervals, and the detailed statistical plan are not reported in the registry record. The adverse-event entry lists 294 at risk, zero affected in serious and other categories, and zero deaths.