Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

• Sponsor: Gen-Probe, Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01733069
• Collaborator: (none)
• Enrollment: 1,912
• Locations: 7
• Duration (Months): 15
• Patients Per Site: 273.1
• Patients Per Site Per Month: 18.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection	Device: APTIMA COMBO 2 Assay (AC2 Assay)

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The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Study Design

• Study Type: Observational
• Actual Enrollment: 1912 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No treatment	Device: APTIMA COMBO 2 Assay (AC2 Assay); APTIMA COMBO 2 Assay (AC2 Assay

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wishard Health Services Department of Pathology Wishard Health Services	Indianapolis	Indiana	United States	46202
2	Louisiana State University Health Center	New Orleans	Louisiana	United States	70122
3	New England Center for Clinical Research	Fall River	Massachusetts	United States	02720
4	University of North Carolina Chapel Hill STD Clinic	Chapel Hill	North Carolina	United States	27599
5	Planned Parenthood Northeast Ohio	Akron	Ohio	United States	44302
6	Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology	Cincinnati	Ohio	United States	45229
7	Planned Parenthood Houston and Southeast Texas	Houston	Texas	United States	77023

Sponsors and Collaborators

• Gen-Probe, Incorporated

Investigators

• Study Director: Jennifer Reid, PhD, Gen-Probe, Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gen-Probe, Incorporated
• ClinicalTrials.gov Identifier: NCT01733069
• Other Study ID Numbers: AC2PS-US11-001; ACTPS-US10-001
• First Posted: Nov 26, 2012
• Last Update Posted: Jan 14, 2014
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Gonorrhea

Study Results

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 Detail	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.

Arm/Group Title	Positive Infected Status	Negative Infected Status
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	264	1598
COMPLETED	264	1598
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Positive Infected Status	Negative Infected Status	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	264	1598	1862
Age (Count of Participants)
<=18 years	30 11.4%	146 9.1%	176 9.5%
Between 18 and 65 years	234 88.6%	1449 90.7%	1683 90.4%
>=65 years	0 0%	3 0.2%	3 0.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.5 (5.5)	28.1 (9.8)	27.4 (9.5)
Sex: Female, Male (Count of Participants)
Female	143 54.2%	1170 73.2%	1313 70.5%
Male	121 45.8%	428 26.8%	549 29.5%
Region of Enrollment (participants) [Number]
United States	264 100%	1598 100%	1862 100%

Outcome Measures

1. Primary Outcome

Title	APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Description	Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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/Group Title	Positive Infected Status	Negative Infected Status
Arm/Group Description	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	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
Measure Participants	264	1598
Vaginal Swab for CT, AC2 pos (females)	104 39.4%	18 1.1%
Vaginal Swab for CT, AC2 neg (females)	3 1.1%	1149 71.9%
PreservCyt for CT, AC2 pos (females)	112 42.4%	0 0%
PreservCyt for CT, AC2 neg (females)	2 0.8%	1197 74.9%
Endocervical Swab for CT, AC2 pos (females)	104 39.4%	8 0.5%
Endocervical Swab for CT, AC2 neg (females)	3 1.1%	1139 71.3%
Urethral Swab for CT, AC2 pos (males)	100 37.9%	4 0.3%
Urethral Swab for CT, AC2 neg (males)	0 0%	445 27.8%
Vaginal Swab for GC, AC2 pos (females)	42 15.9%	5 0.3%
Vaginal Swab for GC, AC2 neg (females)	1 0.4%	1210 75.7%
PreservCyt for GC, AC2 pos (females)	43 16.3%	0 0%
PreservCyt for GC, AC2 neg (females)	0 0%	1250 78.2%
Endocervical Swab for GC, AC2 pos (females)	42 15.9%	2 0.1%
Endocervical Swab for GC, AC2 neg (females)	0 0%	1194 74.7%
Urethral Swab for GC, AC2 pos (males)	34 12.9%	0 0%
Urethral Swab for GC, AC2 neg (males)	0 0%	512 32%

Adverse Events

Arm/Group Title	Positive Infected Status		Negative Infected Status
Arm/Group Description	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		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
All Cause Mortality
	Positive Infected Status		Negative Infected Status
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Positive Infected Status		Negative Infected Status
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/264 (0%)		0/1598 (0%)
Other (Not Including Serious) Adverse Events
	Positive Infected Status		Negative Infected Status
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/264 (0%)		0/1598 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.