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

• ClinicalTrials.gov Identifier: NCT01733069
• Recruitment Status: Completed
• First Posted: November 26, 2012
• Results First Posted: April 24, 2013
• Last Update Posted: January 14, 2014
• Sponsor: Gen-Probe, Incorporated
• Information provided by (Responsible Party): Gen-Probe, Incorporated

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Conditions: Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection
• Intervention: Device: APTIMA COMBO 2 Assay (AC2 Assay)
• Enrollment: 1912

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.

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 Number of Baseline Participants		264	1598	1862
Baseline Analysis Population Description		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.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	264 participants	1598 participants	1862 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 0.0%	3 0.2%	3 0.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	264 participants	1598 participants	1862 participants
		23.5 (5.5)	28.1 (9.8)	27.4 (9.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	264 participants	1598 participants	1862 participants
	Female	143 54.2%	1170 73.2%	1313 70.5%
	Male	121 45.8%	428 26.8%	549 29.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	264 participants	1598 participants	1862 participants
		264	1598	1862

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
Overall Number of Participants Analyzed	264	1598
Measure Type: Number; Unit of Measure: participants
Vaginal Swab for CT, AC2 pos (females)	104	18
Vaginal Swab for CT, AC2 neg (females)	3	1149
PreservCyt for CT, AC2 pos (females)	112	0
PreservCyt for CT, AC2 neg (females)	2	1197
Endocervical Swab for CT, AC2 pos (females)	104	8
Endocervical Swab for CT, AC2 neg (females)	3	1139
Urethral Swab for CT, AC2 pos (males)	100	4
Urethral Swab for CT, AC2 neg (males)	0	445
Vaginal Swab for GC, AC2 pos (females)	42	5
Vaginal Swab for GC, AC2 neg (females)	1	1210
PreservCyt for GC, AC2 pos (females)	43	0
PreservCyt for GC, AC2 neg (females)	0	1250
Endocervical Swab for GC, AC2 pos (females)	42	2
Endocervical Swab for GC, AC2 neg (females)	0	1194
Urethral Swab for GC, AC2 pos (males)	34	0
Urethral Swab for GC, AC2 neg (males)	0	512

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Positive Infected Status	Negative Infected Status
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/264 (0.00%)	0/1598 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Positive Infected Status	Negative Infected Status
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/264 (0.00%)	0/1598 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jennifer Reid, Director of Clinical Affairs
• Organization: Gen-Probe Incorporated
• Phone: 858-731-5985
• EMail: jennifer.reid@hologic.com

• Responsible Party: Gen-Probe, Incorporated
• ClinicalTrials.gov Identifier: NCT01733069
• Other Study ID Numbers: AC2PS-US11-001; ACTPS-US10-001 ( Other Identifier: Gen-Probe )
• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Results First Submitted: March 7, 2013
• Results First Posted: April 24, 2013
• Last Update Posted: January 14, 2014