Trial Outcomes & Findings for A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections (NCT NCT06369220)
NCT ID: NCT06369220
Last Updated: 2026-07-13
Results Overview
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
331 participants
Primary outcome timeframe
On the day of the medical encounter (Day 1)
Results posted on
2026-07-13
Participant Flow
A total of 331 participants at increased risk of sexually transmitted infection (STIs) who have known contact with Liat Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)/ Mycoplasma genitalium (MG) or participants with symptoms suggestive of STI took part in the study at 4 sites in the United States of America from 29 July 2024 to 28 May 2025. One participant was excluded from analysis due to invalid results.
The clinicians referred to as any health care professional (e.g., doctor, provider, pharmacist, nurse, etc.) involved with performing diagnostic tests on participants, interpreting the results, and providing participant care were not enrolled in the study. No participant flow/baseline/safety data was collected for the clinicians. The clinician only completed the Clinician Satisfaction with Diagnostic Test Questionnaire (CSDT-Q).
Participant milestones
| Measure |
Point of Care Arm
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
171
|
|
Overall Study
COMPLETED
|
160
|
170
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Point of Care Arm
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Overall Study
Invalid MG Result
|
0
|
1
|
Baseline Characteristics
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
Baseline characteristics by cohort
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the Centers for Disease Control and Prevention (CDC) guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 10.25 • n=20 Participants
|
33.8 years
STANDARD_DEVIATION 11.22 • n=20 Participants
|
33.4 years
STANDARD_DEVIATION 10.75 • n=40 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=20 Participants
|
104 Participants
n=20 Participants
|
198 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=20 Participants
|
66 Participants
n=20 Participants
|
132 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=20 Participants
|
66 Participants
n=20 Participants
|
129 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=20 Participants
|
102 Participants
n=20 Participants
|
197 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=20 Participants
|
45 Participants
n=20 Participants
|
105 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=20 Participants
|
85 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: On the day of the medical encounter (Day 1)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR.
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Outcome measures
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
|
11.88 percentage of participants
|
21.76 percentage of participants
|
SECONDARY outcome
Timeframe: On the day of the medical encounter (Day 1)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR.
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Outcome measures
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants Given Inappropriate Treatment for CT Infection
|
10.63 percentage of participants
|
15.88 percentage of participants
|
SECONDARY outcome
Timeframe: On the day of the medical encounter (Day 1)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR.
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Outcome measures
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants Given Inappropriate Treatment for NG Infection
|
2.50 percentage of participants
|
4.71 percentage of participants
|
SECONDARY outcome
Timeframe: On the day of the medical encounter (Day 1)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR.
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Outcome measures
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants Given Inappropriate Treatment for MG Infection
|
1.88 percentage of participants
|
6.47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until end of study (approximately 9.9 months)Population: All clinicians involved in the study who completed a CSDT questionnaire. Overall number is the number of clinicians with who responded to the CSDT questionnaire. Number analyzed is the number of clinicians who answered specific questions of the questionnaire.
The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off.
Outcome measures
| Measure |
Point of Care Arm
n=10 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=10 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Ease of use: Very Satisfied
|
100 percentage of clinicians
|
44.4 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Ease of use: Satisfied
|
0 percentage of clinicians
|
44.4 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Ease of use: Neutral
|
0 percentage of clinicians
|
11.1 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Time Taken to Perform: Very Satisfied
|
50.0 percentage of clinicians
|
50.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Time Taken to Perform: Satisfied
|
25.0 percentage of clinicians
|
40.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Time Taken to Perform: Neutral
|
25.0 percentage of clinicians
|
10.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Speed of Results: Very Satisfied
|
30.0 percentage of clinicians
|
10.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Speed of Results: Satisfied
|
60.0 percentage of clinicians
|
70.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Speed of Results: Neutral
|
0 percentage of clinicians
|
20.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Speed of Results: Very Dissatisfied
|
10.0 percentage of clinicians
|
0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Ease of Results Interpretation: Very Satisfied
|
60.0 percentage of clinicians
|
40.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Ease of Results Interpretation: Satisfied
|
40.0 percentage of clinicians
|
60.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Care Plan: Very Satisfied
|
60.0 percentage of clinicians
|
30.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Care Plan: Satisfied
|
30.0 percentage of clinicians
|
70.0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Care Plan: Neutral
|
10.0 percentage of clinicians
|
0 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Consultations: Very Satisfied
|
30.0 percentage of clinicians
|
33.3 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Consultations: Satisfied
|
70.0 percentage of clinicians
|
55.6 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Consultations: Neutral
|
0 percentage of clinicians
|
11.1 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Workload/Workflow: Very Satisfied
|
30.0 percentage of clinicians
|
22.2 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Impact on Workload/Workflow: Satisfied
|
70.0 percentage of clinicians
|
77.8 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Guidance and Training: Very Satisfied
|
83.3 percentage of clinicians
|
44.4 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Guidance and Training: Satisfied
|
16.7 percentage of clinicians
|
44.4 percentage of clinicians
|
|
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)
Guidance and Training: Neutral
|
0 percentage of clinicians
|
11.1 percentage of clinicians
|
SECONDARY outcome
Timeframe: Baseline until end of study (approximately 9.9 months)Population: All clinicians involved in the study who completed a CSDT questionnaire. Overall number is the number of clinicians who responded to the CSDT questionnaire.
The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.
Outcome measures
| Measure |
Point of Care Arm
n=10 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=10 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q
Neutral
|
10.0 percentage of clinicians
|
0 percentage of clinicians
|
|
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q
Very Confident
|
50.0 percentage of clinicians
|
60.0 percentage of clinicians
|
|
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q
Confident
|
40.0 percentage of clinicians
|
40.0 percentage of clinicians
|
SECONDARY outcome
Timeframe: On the day of the medical encounter (Day 1)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. Number analyzed is the number of participants who answered specific questions of the PSDT questionnaire.
The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off.
Outcome measures
| Measure |
Point of Care Arm
n=160 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=170 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Very Satisfied
|
80.1 percentage of participants
|
71.8 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Satisfied
|
15.4 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Slightly Satisfied
|
2.6 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Neutral
|
1.9 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Slightly Dissatisfied
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Visit Satisfaction: Very Dissatisfied
|
0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Information Provision: Very Satisfied
|
79.4 percentage of participants
|
71.8 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Information Provision: Satisfied
|
18.8 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Information Provision: Neutral
|
1.9 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Completion: Very Satisfied
|
81.3 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Completion: Satisfied
|
17.5 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Completion: Neutral
|
1.3 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Completion: Dissatisfied
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Time Taken to Perform: Very Satisfied
|
67.5 percentage of participants
|
71.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Time Taken to Perform: Satisfied
|
21.3 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Time taken to Perform: Neutral
|
10.6 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Time Taken to Perform: Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Speed of Results: Very Satisfied
|
66.3 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Speed of Results: Satisfied
|
22.5 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Speed of Results: Neutral
|
10.0 percentage of participants
|
30.5 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Speed of Results: Dissatisfied
|
1.3 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Method of Result Delivery: Very Satisfied
|
74.1 percentage of participants
|
65.8 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Method of Result Delivery: Satisfied
|
23.4 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Method of Result Delivery: Neutral
|
2.5 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Understanding: Very Satisfied
|
76.6 percentage of participants
|
72.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Understanding: Satisfied
|
20.3 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Ease of Understanding: Neutral
|
3.2 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Impact on Clinical Pathway: Very Satisfied
|
66.9 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Impact on Clinical Pathway: Satisfied
|
25.3 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Impact on Clinical Pathway: Neutral
|
7.8 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Satisfaction: Very Satisfied
|
74.4 percentage of participants
|
55.0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Satisfaction: Satisfied
|
18.8 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Satisfaction: Neutral
|
6.3 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Satisfaction: Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Overall Satisfaction: Very Dissatisfied
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Comfort: Very Satisfied
|
71.3 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Comfort: Satisfied
|
21.9 percentage of participants
|
31.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Comfort: Neutral
|
5.6 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Comfort: Dissatisfied
|
0.6 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Comfort: Very Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Convenience: Very Satisfied
|
72.5 percentage of participants
|
60.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Convenience: Satisfied
|
23.1 percentage of participants
|
34.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Convenience: Neutral
|
3.1 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Convenience: Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Convenience: Very Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Type of Sample/Measurement: Very Satisfied
|
70.0 percentage of participants
|
59.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Type of Sample/Measurement: Satisfied
|
26.3 percentage of participants
|
32.4 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Type of Sample/Measurement: Neutral
|
3.1 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Type of Sample/Measurement: Very Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Person collecting sample/measurement: Very Satisfied
|
79.4 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Person collecting sample/measurement: Satisfied
|
16.9 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Person collecting sample/measurement: Neutral
|
3.1 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Person collecting sample/measurement: Dissatisfied
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Person collecting sample/measurement: Very Dissatisfied
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Hygiene: Very Satisfied
|
76.9 percentage of participants
|
66.1 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Hygiene: Satisfied
|
20.6 percentage of participants
|
29.2 percentage of participants
|
|
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)
Hygiene: Neutral
|
2.5 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until end of study (approximately 9.9 months)Population: Evaluable population included enrolled participants with a valid result for each of the 3 pathogens by EL-PCR. Overall number is the number of participants who answered the 'Accuracy' question of the PSDT-Q.
The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.
Outcome measures
| Measure |
Point of Care Arm
n=157 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians were provided with point of care (POC) test results using the cobas® liat CT/NG/MG nucleic acid test, which they used to inform their clinical decisions. The clinician evaluated the participant and completed a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter.
|
Standard of Care Arm
n=103 Participants
Participants provided either a urine sample or vaginal self-swabs for analysis. Clinicians evaluated the participants based on standard practice/standard of care (SOC) defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing. The clinician evaluated the participant and completed a standardized form, known as a PMP, at the conclusion of the participant's encounter.
|
|---|---|---|
|
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
Very Confident
|
59.2 percentage of participants
|
50.5 percentage of participants
|
|
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
Confident
|
29.3 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
Neutral
|
10.8 percentage of participants
|
12.6 percentage of participants
|
|
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q
Unconfident
|
0.6 percentage of participants
|
1.9 percentage of participants
|
Adverse Events
Point of Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER