Trial Outcomes & Findings for Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT (NCT NCT02870101)
NCT ID: NCT02870101
Last Updated: 2019-05-15
Results Overview
NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2767 participants
Primary outcome timeframe
One day
Results posted on
2019-05-15
Participant Flow
Participant milestones
| Measure |
Intervention
Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
|
|---|---|
|
Overall Study
STARTED
|
2767
|
|
Overall Study
COMPLETED
|
2598
|
|
Overall Study
NOT COMPLETED
|
169
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
Baseline characteristics by cohort
| Measure |
Intervention
n=2598 Participants
Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
|
|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2542 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Man
|
2010 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Woman
|
532 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Transman
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Transwoman
|
42 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Genderqueer
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Decline to answer
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
539 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2059 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
772 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1814 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
935 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1285 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
204 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2598 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Negative
|
2340 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Positive
|
9 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Negative
|
28 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Positive
|
195 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Negative
|
11 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Negative
|
2323 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Positive
|
17 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Negative
|
8 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Positive
|
187 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Negative
|
40 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Positive
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Negative
|
2351 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Positive
|
8 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Negative
|
25 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Positive
|
195 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Equivocal; ASIS Negative
|
3 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Equivocal; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Equivocal; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Negative
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Positive
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Negative
|
2359 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Positive
|
5 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Invalid
|
3 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Negative
|
13 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Positive
|
192 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Equivocal; ASIS Negative
|
3 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Equivocal; ASIS Positive
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Equivocal; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Negative
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Negative
|
2356 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Positive
|
28 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Indeterminate
|
4 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Negative; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Negative
|
11 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Positive
|
179 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test Positive; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Negative
|
6 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Positive
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Negative
|
2312 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Positive
|
23 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Negative; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Negative
|
8 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Positive
|
181 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Negative
|
51 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Positive
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Negative
|
2518 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Positive
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Negative
|
6 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Positive
|
47 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Negative
|
11 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Indeterminate
|
4 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Negative
|
2292 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Positive
|
28 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Negative
|
15 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Positive
|
197 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Negative
|
40 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Positive
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Negative
|
2526 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Positive
|
6 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Negative
|
8 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Positive
|
45 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Negative
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Negative
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from analysis.
NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Negative
|
2322 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Positive
|
18 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Invalid
|
3 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Negative
|
25 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Positive
|
197 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Negative
|
5 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Positive
|
5 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Negative
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2590 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Negative
|
2522 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Positive
|
8 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Negative; ASIS Invalid
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Negative
|
4 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Positive
|
42 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Negative
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Negative
|
7 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Positive
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Index Test No Result; ASIS Invalid
|
2 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Outcome measures
| Measure |
Intervention
n=2585 Participants
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
|
|---|---|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Negative
|
2277 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Positive
|
34 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Indeterminate
|
5 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Negative; ASIS Invalid
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Negative
|
19 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Positive
|
190 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Indeterminate
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Positive; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Negative
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Positive
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Indeterminate
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test Equivocal; ASIS Invalid
|
0 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Negative
|
49 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Positive
|
2 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Indeterminate
|
1 Participants
|
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Index Test No Result; ASIS Invalid
|
5 Participants
|
Adverse Events
Intervention
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
Jeffrey D. Klausner, MD, MPH
UCLA David Geffen School of Medicine and Fielding School of Public Health
Phone: 310-557-2273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Following completion of the study, the Investigator may publish the results of this research under the oversight of the Antibiotic Resistance Leadership Group (ARLG) Publication Committee. All public presentations by participating Investigators, participating institutions, SDMC, and ARLG, that use ARLG data and are intended to represent the ARLG, or are supported by the ARLG, will be reviewed by the ARLG Publication Committee per the ARLG Publication Committee Charter.
- Publication restrictions are in place
Restriction type: OTHER