Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection
Conditions
Brief summary
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.
Detailed description
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 The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).
Interventions
DEVICEAPTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay
Sponsors
Gen-Probe, Incorporated
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
•The subject is at least 14 years of age at the time of informed consent and is sexually active * The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort. * If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam * The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRB (institutional review board) approved waiver for parental consent for minors)
Exclusion criteria
•A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following: * The subject took antibiotic medications within the last 21 days * The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors) * The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Baseline | Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity) |
Countries
United States
Participant flow
Recruitment details
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)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 264 |
| 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 | 1,598 |
| Total | 1,862 |
Baseline characteristics
| Characteristic | Negative Infected Status | Positive Infected Status | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 146 Participants | 30 Participants | 176 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1449 Participants | 234 Participants | 1683 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 9.8 | 23.5 years STANDARD_DEVIATION 5.5 | 27.4 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 1598 participants | 264 participants | 1862 participants |
| Sex: Female, Male Female | 1170 Participants | 143 Participants | 1313 Participants |
| Sex: Female, Male Male | 428 Participants | 121 Participants | 549 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 264 | 0 / 1,598 |
| serious Total, serious adverse events | 0 / 264 | 0 / 1,598 |
Outcome results
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)
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for GC, AC2 pos (females) | 42 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for CT, AC2 neg (females) | 2 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for GC, AC2 neg (females) | 1 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for CT, AC2 neg (females) | 3 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for GC, AC2 pos (females) | 43 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for CT, AC2 pos (females) | 104 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for GC, AC2 neg (females) | 0 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for CT, AC2 pos (females) | 104 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for GC, AC2 pos (females) | 42 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for CT, AC2 neg (females) | 3 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for GC, AC2 neg (females) | 0 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for CT, AC2 pos (females) | 112 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for GC, AC2 pos (males) | 34 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for CT, AC2 pos (males) | 100 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for GC, AC2 neg (males) | 0 participants |
| Positive Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for CT, AC2 neg (males) | 0 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for GC, AC2 neg (males) | 512 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for CT, AC2 pos (females) | 18 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for CT, AC2 neg (females) | 1149 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for CT, AC2 pos (females) | 0 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for CT, AC2 neg (females) | 1197 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for CT, AC2 pos (females) | 8 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for CT, AC2 neg (females) | 1139 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for CT, AC2 neg (males) | 445 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for GC, AC2 pos (females) | 5 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Vaginal Swab for GC, AC2 neg (females) | 1210 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for GC, AC2 pos (females) | 0 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | PreservCyt for GC, AC2 neg (females) | 1250 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for GC, AC2 pos (females) | 2 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Endocervical Swab for GC, AC2 neg (females) | 1194 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for GC, AC2 pos (males) | 0 participants |
| Negative Infected Status | APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Urethral Swab for CT, AC2 pos (males) | 4 participants |