Trial Outcomes & Findings for Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System (NCT NCT01733069)
NCT ID: NCT01733069
Last Updated: 2014-01-14
Results Overview
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Recruitment status
COMPLETED
Target enrollment
1912 participants
Primary outcome timeframe
Baseline
Results posted on
2014-01-14
Participant Flow
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)
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
264
|
1598
|
|
Overall Study
COMPLETED
|
264
|
1598
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
Baseline characteristics by cohort
| Measure |
Positive Infected Status
n=264 Participants
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
|
Negative Infected Status
n=1598 Participants
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
|
Total
n=1862 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=39 Participants
|
146 Participants
n=41 Participants
|
176 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
234 Participants
n=39 Participants
|
1449 Participants
n=41 Participants
|
1683 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Continuous
|
23.5 years
STANDARD_DEVIATION 5.5 • n=39 Participants
|
28.1 years
STANDARD_DEVIATION 9.8 • n=41 Participants
|
27.4 years
STANDARD_DEVIATION 9.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=39 Participants
|
1170 Participants
n=41 Participants
|
1313 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=39 Participants
|
428 Participants
n=41 Participants
|
549 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
264 participants
n=39 Participants
|
1598 participants
n=41 Participants
|
1862 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Outcome measures
| Measure |
Positive Infected Status
n=264 Participants
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
|
Negative Infected Status
n=1598 Participants
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
|
|---|---|---|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Urethral Swab for GC, AC2 neg (males)
|
0 participants
|
512 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Vaginal Swab for CT, AC2 pos (females)
|
104 participants
|
18 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Vaginal Swab for CT, AC2 neg (females)
|
3 participants
|
1149 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
PreservCyt for CT, AC2 pos (females)
|
112 participants
|
0 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
PreservCyt for CT, AC2 neg (females)
|
2 participants
|
1197 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Endocervical Swab for CT, AC2 pos (females)
|
104 participants
|
8 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Endocervical Swab for CT, AC2 neg (females)
|
3 participants
|
1139 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Urethral Swab for CT, AC2 pos (males)
|
100 participants
|
4 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Urethral Swab for CT, AC2 neg (males)
|
0 participants
|
445 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Vaginal Swab for GC, AC2 pos (females)
|
42 participants
|
5 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Vaginal Swab for GC, AC2 neg (females)
|
1 participants
|
1210 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
PreservCyt for GC, AC2 pos (females)
|
43 participants
|
0 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
PreservCyt for GC, AC2 neg (females)
|
0 participants
|
1250 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Endocervical Swab for GC, AC2 pos (females)
|
42 participants
|
2 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Endocervical Swab for GC, AC2 neg (females)
|
0 participants
|
1194 participants
|
|
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Urethral Swab for GC, AC2 pos (males)
|
34 participants
|
0 participants
|
Adverse Events
Positive Infected Status
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Infected Status
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Reid, Director of Clinical Affairs
Gen-Probe Incorporated
Phone: 858-731-5985
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60