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Trial Outcomes & Findings for Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test (NCT NCT02685956)

NCT ID: NCT02685956

Last Updated: 2020-06-05

Results Overview

Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).

Recruitment status

COMPLETED

Target enrollment

2295 participants

Primary outcome timeframe

within 60 days of last sample enrollment

Results posted on

2020-06-05

Participant Flow

Participant milestones

Participant milestones
Measure
Oral Lesions
Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
Anogenital Lesions
Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
Overall Study
STARTED
317
1978
Overall Study
COMPLETED
317
1978
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Oral Lesions
n=317 Participants
Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
Anogenital Lesions
n=1978 Participants
Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
Total
n=2295 Participants
Total of all reporting groups
Age, Customized
0 - 10
54 Participants
n=317 Participants
64 Participants
n=1978 Participants
118 Participants
n=2295 Participants
Age, Customized
11 - 20
31 Participants
n=317 Participants
275 Participants
n=1978 Participants
306 Participants
n=2295 Participants
Age, Customized
21 - 30
66 Participants
n=317 Participants
684 Participants
n=1978 Participants
750 Participants
n=2295 Participants
Age, Customized
31 - 40
40 Participants
n=317 Participants
378 Participants
n=1978 Participants
418 Participants
n=2295 Participants
Age, Customized
41 - 50
25 Participants
n=317 Participants
257 Participants
n=1978 Participants
282 Participants
n=2295 Participants
Age, Customized
51 - 60
34 Participants
n=317 Participants
170 Participants
n=1978 Participants
204 Participants
n=2295 Participants
Age, Customized
61 - 70
32 Participants
n=317 Participants
91 Participants
n=1978 Participants
123 Participants
n=2295 Participants
Age, Customized
71 - 80
28 Participants
n=317 Participants
41 Participants
n=1978 Participants
69 Participants
n=2295 Participants
Age, Customized
81 - 90
7 Participants
n=317 Participants
15 Participants
n=1978 Participants
22 Participants
n=2295 Participants
Age, Customized
>90
0 Participants
n=317 Participants
3 Participants
n=1978 Participants
3 Participants
n=2295 Participants
Sex: Female, Male
Female
180 Participants
n=317 Participants
1573 Participants
n=1978 Participants
1753 Participants
n=2295 Participants
Sex: Female, Male
Male
137 Participants
n=317 Participants
405 Participants
n=1978 Participants
542 Participants
n=2295 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
317 participants
n=317 Participants
1978 participants
n=1978 Participants
2295 participants
n=2295 Participants

PRIMARY outcome

Timeframe: within 60 days of last sample enrollment

Population: Analysis group included samples from 290 anogenital and 1291 anogenital lesions tested for HSV1 using the ELVIS HSV ID and D3 Typing Test System (N=1581). A further 397 that tested HSV2 positive by ELVIS were excluded from the HSV1 analysis.

Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).

Outcome measures

Outcome measures
Measure
Anogenital Lesions With POSITIVE HSV1 ELVIS Result
n=290 Participants
Sample collected from an anogenital lesion and tested positive for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Anogenital Lesions With Negative HSV1 ELVIS Result
n=1291 Participants
Sample collected from an anogenital lesion and tested negative for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
HSV-1 POSITIVE by SA201 HSV-1/2 PCR Test
281 Participants
54 Participants
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
HSV-1 NEGATIVE by SA201 HSV-1/2 PCR Test
9 Participants
1237 Participants

PRIMARY outcome

Timeframe: within 60 days of last sample enrollment

Population: Analysis group included samples from N=1978 anogenital lesions tested for HSV2 using the ELVIS HSV ID and D3 Typing Test System.

Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).

Outcome measures

Outcome measures
Measure
Anogenital Lesions With POSITIVE HSV1 ELVIS Result
n=397 Participants
Sample collected from an anogenital lesion and tested positive for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Anogenital Lesions With Negative HSV1 ELVIS Result
n=1581 Participants
Sample collected from an anogenital lesion and tested negative for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
HSV-2 POSITIVE by SA201 HSV-1/2 PCR Test
391 Participants
147 Participants
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
HSV-2 NEGATIVE by SA201 HSV-1/2 PCR Test
6 Participants
1434 Participants

Adverse Events

Oral Lesions

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Anogenital Lesions

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

Jennifer Maas

Global BioClinical

Phone: 206-240-8632

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor has 45 days to review and comment. Sponsor may extend the embargo period for no more than an additional 60 days in order to file a patent application due to patentable subject matter contained in the proposed presentation or publication. If the Sponsor objects to the publication or presentation due to the existence of confidential information, the institution shall remove the confidential information before disclosure.
  • Publication restrictions are in place

Restriction type: OTHER