Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test

• Sponsor: Vela Diagnostics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02685956
• Collaborator: (none)
• Enrollment: 2,295
• Locations: 9
• Actual Duration (Months): 12.2
• Patients Per Site: 255
• Patients Per Site Per Month: 20.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test

Detailed Description

This study will utilize residual samples from male and female patients with signs and symptoms of oral or genital HSV infections. Genital samples will include internal and external genital lesions such as those collected from lesions of the anus, buttocks, vagina, labia, or penis. Oral samples will include those collected from lip, gum, and mouth lesions. For concordance testing, the sample size is based on historical study design and estimates of the expected prevalence of HSV1 and/or HSV2 in the population enrolled.

Study Design

• Study Type: Observational
• Actual Enrollment: 2295 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 7, 2017
• Actual Study Completion Date: Apr 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Vela Sentosa SA HSV1/2 PCR Test Male and female subjects of any age with sample collected from a lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.	Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test; medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test; Other Names: Sentosa HSV Assay

Outcome Measures

Primary Outcome Measures

1. Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test [within 60 days of last sample enrollment]

   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).

2. Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test [within 60 days of last sample enrollment]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sample was taken from a lesion from an internal or external oral or genital site.

• Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.

• The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.

• Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.

• There is sufficient residual sample to perform both test and reference assays.

Exclusion Criteria:

• Sample leaked during shipment or storage prior to assay.

• Sample has undergone more than 1 freeze-thaw cycle before testing;

• Sample eluent is not clear after centrifugation (refer to section 6.3.1).

• Sample ID is missing or ambiguous.

• Sample is collected using alginate calcium swab.

• Sample handling and storage requirement in section 5.4 not followed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33606
2	Baystate Health	Springfield	Massachusetts	United States	01199
3	Beaumont Health	Royal Oak	Michigan	United States	48073
4	BioReference Labs	Elmwood Park	New Jersey	United States	07407
5	Cleveland Clinic	Cleveland	Ohio	United States	44195
6	Geisinger Health	Danville	Pennsylvania	United States	17822
7	Quest Diagnostics	Horsham	Pennsylvania	United States	19044
8	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
9	MedFusion	Lewisville	Texas	United States	75067

Sponsors and Collaborators

• Vela Diagnostics

Investigators

• Study Director: Shaw Chiat Hong, Vela Diagnostics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 16, 2014

More Information

Additional Information:

• Vela Diagnostics Website

Publications

None provided.

• Responsible Party: Vela Diagnostics
• ClinicalTrials.gov Identifier: NCT02685956
• Other Study ID Numbers: Vela Sentosa HSV Study
• First Posted: Feb 19, 2016
• Last Update Posted: Jun 5, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Herpes Simplex

Study Results

Participant Flow

Arm/Group Title	Oral Lesions	Anogenital Lesions
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	317	1978
COMPLETED	317	1978
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oral Lesions	Anogenital Lesions	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	317	1978	2295
Age, Customized (Count of Participants)
0 - 10	54 17%	64 3.2%	118 5.1%
11 - 20	31 9.8%	275 13.9%	306 13.3%
21 - 30	66 20.8%	684 34.6%	750 32.7%
31 - 40	40 12.6%	378 19.1%	418 18.2%
41 - 50	25 7.9%	257 13%	282 12.3%
51 - 60	34 10.7%	170 8.6%	204 8.9%
61 - 70	32 10.1%	91 4.6%	123 5.4%
71 - 80	28 8.8%	41 2.1%	69 3%
81 - 90	7 2.2%	15 0.8%	22 1%
>90	0 0%	3 0.2%	3 0.1%
Sex: Female, Male (Count of Participants)
Female	180 56.8%	1573 79.5%	1753 76.4%
Male	137 43.2%	405 20.5%	542 23.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	317 100%	1978 100%	2295 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
Description	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).
Time Frame	within 60 days of last sample enrollment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Anogenital Lesions With POSITIVE HSV1 ELVIS Result	Anogenital Lesions With Negative HSV1 ELVIS Result
Arm/Group Description	Sample collected from an anogenital lesion and tested positive for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)	Sample collected from an anogenital lesion and tested negative for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Measure Participants	290	1291
HSV-1 POSITIVE by SA201 HSV-1/2 PCR Test	281 88.6%	54 2.7%
HSV-1 NEGATIVE by SA201 HSV-1/2 PCR Test	9 2.8%	1237 62.5%

2. Primary Outcome

Title	Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
Description	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).
Time Frame	within 60 days of last sample enrollment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Anogenital Lesions With POSITIVE HSV2 ELVIS Result	Anogenital Lesions With NEGATIVE HSV2 ELVIS Result
Arm/Group Description	Sample collected from an anogenital lesion and tested positive for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)	Sample collected from an anogenital lesion and tested negative for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)
Measure Participants	397	1581
HSV-2 POSITIVE by SA201 HSV-1/2 PCR Test	391 123.3%	147 7.4%
HSV-2 NEGATIVE by SA201 HSV-1/2 PCR Test	6 1.9%	1434 72.5%

Adverse Events

Time Frame	This trial utilized remnant laboratory specimens and all results were monitored for accuracy and adverse events upon the completion of the testing phase of the study.
Adverse Event Reporting Description	This is a remnant sample study using leftover HSV swab sample media. All case data was fully monitored on completion of the testing phase of the study and no adverse events associated with study subjects contributing biospecimens were identified.. There was also reporting mechanism in place to record device user adverse events however no in vitro diagnostic device user adverse events were reported in the study
Arm/Group Title	Oral Lesions		Anogenital Lesions
Arm/Group Description	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.		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.
All Cause Mortality
	Oral Lesions		Anogenital Lesions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Oral Lesions		Anogenital Lesions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Oral Lesions		Anogenital Lesions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.