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

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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:
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
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
Hide 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
Arm/Group Title Positive Infected Status Negative Infected Status Total
Hide 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
Hide 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
1.Primary Outcome
Title APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Hide Description Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Time Frame Baseline
Hide Outcome Measure Data
Hide 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
Hide 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positive Infected Status Negative Infected Status
Hide 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   --/--   --/-- 
Hide Serious Adverse Events
Positive Infected Status Negative Infected Status
Affected / at Risk (%) Affected / at Risk (%)
Total   0/264 (0.00%)   0/1598 (0.00%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Jennifer Reid, Director of Clinical Affairs
Organization: Gen-Probe Incorporated
Phone: 858-731-5985
EMail: jennifer.reid@hologic.com
Layout table for additonal information
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