<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01733069</url>
  </required_header>
  <id_info>
    <org_study_id>AC2PS-US11-001</org_study_id>
    <secondary_id>ACTPS-US10-001</secondary_id>
    <nct_id>NCT01733069</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System</brief_title>
  <official_title>Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gen-Probe, Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gen-Probe, Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to establish the performance characteristics of the AC2&#xD;
      (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the&#xD;
      TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and&#xD;
      reproducibility of the AC2 Assay on the PANTHER System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from&#xD;
      protocol ACTPS-US10-001(NCT01358799).&#xD;
&#xD;
      The registration for NCT01358799 was withdrawn because the samples were not tested under&#xD;
      protocol ACTPS-US10-001, instead they were tested under the protocol registered here&#xD;
      AC2PS-US11-001 (NCT01733069).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type</measure>
    <time_frame>Baseline</time_frame>
    <description>Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1912</enrollment>
  <condition>Chlamydia Trachomatis</condition>
  <condition>Neisseria Gonorrhoeae Infection</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APTIMA COMBO 2 Assay (AC2 Assay)</intervention_name>
    <description>APTIMA COMBO 2 Assay (AC2 Assay</description>
    <arm_group_label>No treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      4 specimens will be collected from each female subject in the following order: 1 first-catch&#xD;
      urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen&#xD;
      (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab&#xD;
      specimen. An additional cervical specimen may be collected from female subjects for other&#xD;
      clinical trial purposes or research studies. Up to 2 specimens will be collected from each&#xD;
      male subject in the following order: 1 urethral swab specimen and 1 first-catch urine&#xD;
      specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and Females at least 14 years of age at the time of informed consent and sexually&#xD;
        active.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •The subject is at least 14 years of age at the time of informed consent and is sexually&#xD;
        active&#xD;
&#xD;
          -  The subject reports symptoms consistent with a suspected STD (sexually transmitted&#xD;
             disease) such as abnormal discharge, genital itching, pain/discomfort during sexual&#xD;
             intercourse or urination, and/or lower abdominal discomfort.&#xD;
&#xD;
          -  If the subject is asymptomatic, the subject is known to be partners with, or a contact&#xD;
             of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation&#xD;
             for a possible STD(s), and/or is scheduled for a routine exam that may include a&#xD;
             pelvic exam&#xD;
&#xD;
          -  The subject and/or legally authorized representative is willing to undergo the&#xD;
             informed consent process prior to study participation (a minor will need the&#xD;
             documented consent of his/her parent or legal guardian, unless the site has an IRB&#xD;
             (institutional review board) approved waiver for parental consent for minors)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •A potential subject will be ineligible for clinical trial enrollment if the subject,&#xD;
        clinician, or medical record reports any of the following:&#xD;
&#xD;
          -  The subject took antibiotic medications within the last 21 days&#xD;
&#xD;
          -  The subject is underage (as defined by the IRB (institutional review board) or state&#xD;
             law), without the documented consent of her/his parent or legal guardian (exception:&#xD;
             sites that have an IRBapproved waiver for parental consent for minors)&#xD;
&#xD;
          -  The subject is determined by the investigator to be medically unsuitable for&#xD;
             participation in this study (eg, medical history of concurrent illness that could&#xD;
             result in an unacceptable risk to the subject) Concurrent participation in other&#xD;
             clinical study(ies) may be acceptable, with approval by the investigator and sponsor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Reid, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gen-Probe, Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wishard Health Services Department of Pathology Wishard Health Services</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University Health Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Center for Clinical Research</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Chapel Hill STD Clinic</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood Northeast Ohio</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center Division of Pediatric &amp; Adolescent Gynecology</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood Houston and Southeast Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>March 7, 2013</results_first_submitted>
  <results_first_submitted_qc>March 7, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 24, 2013</results_first_posted>
  <last_update_submitted>November 26, 2013</last_update_submitted>
  <last_update_submitted_qc>November 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gonorrhea</mesh_term>
  </condition_browse>

  <clinical_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)</recruitment_details>
      <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.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Positive Infected Status</title>
          <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.</description>
        </group>
        <group group_id="P2">
          <title>Negative Infected Status</title>
          <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</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="264"/>
                <participants group_id="P2" count="1598"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="264"/>
                <participants group_id="P2" count="1598"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>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.</population>
      <group_list>
        <group group_id="B1">
          <title>Positive Infected Status</title>
          <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</description>
        </group>
        <group group_id="B2">
          <title>Negative Infected Status</title>
          <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</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="264"/>
            <count group_id="B2" value="1598"/>
            <count group_id="B3" value="1862"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="234"/>
                    <measurement group_id="B2" value="1449"/>
                    <measurement group_id="B3" value="1683"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.5" spread="5.5"/>
                    <measurement group_id="B2" value="28.1" spread="9.8"/>
                    <measurement group_id="B3" value="27.4" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="1170"/>
                    <measurement group_id="B3" value="1313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="428"/>
                    <measurement group_id="B3" value="549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="264"/>
                    <measurement group_id="B2" value="1598"/>
                    <measurement group_id="B3" value="1862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type</title>
        <description>Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)</description>
        <time_frame>Baseline</time_frame>
        <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.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Infected Status</title>
            <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</description>
          </group>
          <group group_id="O2">
            <title>Negative Infected Status</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type</title>
          <description>Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)</description>
          <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.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="1598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vaginal Swab for CT, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal Swab for CT, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PreservCyt for CT, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PreservCyt for CT, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocervical Swab for CT, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocervical Swab for CT, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urethral Swab for CT, AC2 pos (males)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urethral Swab for CT, AC2 neg (males)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal Swab for GC, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal Swab for GC, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PreservCyt for GC, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PreservCyt for GC, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocervical Swab for GC, AC2 pos (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocervical Swab for GC, AC2 neg (females)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urethral Swab for GC, AC2 pos (males)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urethral Swab for GC, AC2 neg (males)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Positive Infected Status</title>
          <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</description>
        </group>
        <group group_id="E2">
          <title>Negative Infected Status</title>
          <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</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1598"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1598"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jennifer Reid, Director of Clinical Affairs</name_or_title>
      <organization>Gen-Probe Incorporated</organization>
      <phone>858-731-5985</phone>
      <email>jennifer.reid@hologic.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733069
org study id: AC2PS-US11-001
secondary id: ACTPS-US10-001
nct id: NCT01733069
lead sponsor: 
has dmc: No
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.
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).
observational model: Cohort
time perspective: Cross-Sectional
measure: APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
time frame: Baseline
description: Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
arm group label: No treatment
intervention type: Device
intervention name: APTIMA COMBO 2 Assay (AC2 Assay)
description: APTIMA COMBO 2 Assay (AC2 Assay
arm group label: No treatment
4 specimens will be collected from each female subject in the following order: 1 first-catch
      urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen
      (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab
      specimen. An additional cervical specimen may be collected from female subjects for other
      clinical trial purposes or research studies. Up to 2 specimens will be collected from each
      male subject in the following order: 1 urethral swab specimen and 1 first-catch urine
      specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Reid, PhD
role: Study Director
affiliation: Gen-Probe, Incorporated
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gonorrhea
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 