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| ID | Type | Description | Link |
|---|---|---|---|
| ACTPS-US10-001 | Other Identifier | Gen-Probe |
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The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.
The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).
The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APTIMA COMBO 2 Assay (AC2 Assay) | Device | APTIMA COMBO 2 Assay (AC2 Assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity) | Baseline |
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Inclusion Criteria:
•The subject is at least 14 years of age at the time of informed consent and is sexually active
Exclusion Criteria:
•A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
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Male and Females at least 14 years of age at the time of informed consent and sexually active.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Reid, PhD | Gen-Probe, Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wishard Health Services Department of Pathology Wishard Health Services | Indianapolis | Indiana | 46202 | United States | ||
Fifty (50) of the 1912 eligible subjects did not have a conclusive infected status or a valid Panther Combo 2 Assay result and are not included in the results below.
A total of 1912 male and female subjects were enrolled under this protocol. Of the 1912 subjects, 1862 were evaluable for analysis of CT or GC performance (conclusive infected status and at least one valid PANTHER Combo 2 Assay result)
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses. |
| FG001 | Negative Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Symptomatic and asymptomatic men (n=549) and women (n=1313) enrolled from seven geographically and ethnically diverse US clinical sites, including obstetrics and gynecology, family planning, public health, and STD clinics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity) | Results for 4 gender-specific sample types were reported for 2 targets (CT, Chlamydia trachomatis; and GC, Neisseria gonorrhoeae infection). In this observational study, 1313 females (143 CT and/or GC-infected) and 549 males (121 CT and/or GC infected) contributed to one or more analyses. | Posted | Number | participants | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Reid, Director of Clinical Affairs | Gen-Probe Incorporated | 858-731-5985 | jennifer.reid@hologic.com |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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4 specimens will be collected from each female subject in the following order: 1 first-catch urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab specimen. An additional cervical specimen may be collected from female subjects for other clinical trial purposes or research studies. Up to 2 specimens will be collected from each male subject in the following order: 1 urethral swab specimen and 1 first-catch urine specimen
| Louisiana State University Health Center |
| New Orleans |
| Louisiana |
| 70122 |
| United States |
| New England Center for Clinical Research | Fall River | Massachusetts | 02720 | United States |
| University of North Carolina Chapel Hill STD Clinic | Chapel Hill | North Carolina | 27599 | United States |
| Planned Parenthood Northeast Ohio | Akron | Ohio | 44302 | United States |
| Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology | Cincinnati | Ohio | 45229 | United States |
| Planned Parenthood Houston and Southeast Texas | Houston | Texas | 77023 | United States |
| BG001 | Negative Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Negative Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses |
|
|
| 0 |
| 264 |
| 0 |
| 264 |
| EG001 | Negative Infected Status | The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses | 0 | 1,598 | 0 | 1,598 |
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| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |