Herpes Simplex
Conditions
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.
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.
Interventions
DEVICEVela Sentosa SA HSV1/2 Qualitative PCR Test
medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test
Sponsors
Vela Diagnostics
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 317 |
| 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. | 1,978 |
| Total | 2,295 |
Baseline characteristics
| Characteristic | Anogenital Lesions | Total | Oral Lesions |
|---|---|---|---|
| Age, Customized 0 - 10 | 64 Participants | 118 Participants | 54 Participants |
| Age, Customized 11 - 20 | 275 Participants | 306 Participants | 31 Participants |
| Age, Customized 21 - 30 | 684 Participants | 750 Participants | 66 Participants |
| Age, Customized 31 - 40 | 378 Participants | 418 Participants | 40 Participants |
| Age, Customized 41 - 50 | 257 Participants | 282 Participants | 25 Participants |
| Age, Customized 51 - 60 | 170 Participants | 204 Participants | 34 Participants |
| Age, Customized 61 - 70 | 91 Participants | 123 Participants | 32 Participants |
| Age, Customized 71 - 80 | 41 Participants | 69 Participants | 28 Participants |
| Age, Customized 81 - 90 | 15 Participants | 22 Participants | 7 Participants |
| Age, Customized >90 | 3 Participants | 3 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1978 participants | 2295 participants | 317 participants |
| Sex: Female, Male Female | 1573 Participants | 1753 Participants | 180 Participants |
| Sex: Female, Male Male | 405 Participants | 542 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anogenital Lesions With POSITIVE HSV1 ELVIS Result | 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 |
| Anogenital Lesions With POSITIVE HSV1 ELVIS Result | 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 |
| Anogenital Lesions With Negative HSV1 ELVIS Result | 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 | 54 Participants |
| Anogenital Lesions With Negative HSV1 ELVIS Result | 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 | 1237 Participants |
Primary
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
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
Population: Analysis group included samples from N=1978 anogenital lesions tested for HSV2 using the ELVIS HSV ID and D3 Typing Test System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anogenital Lesions With POSITIVE HSV1 ELVIS Result | 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 |
| Anogenital Lesions With POSITIVE HSV1 ELVIS Result | 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 |
| Anogenital Lesions With Negative HSV1 ELVIS Result | 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 | 1434 Participants |
| Anogenital Lesions With Negative HSV1 ELVIS Result | 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 | 147 Participants |