N/A
N=2,295
Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT02685956 ↗Enrolled (actual)
2,295
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test — 281; 54; 9; 1237 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vela Sentosa SA HSV1/2 Qualitative PCR Test (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Vela Diagnostics
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test |
281; 54; 9; 1237 | — |
| PRIMARY Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test |
391; 147; 6; 1434 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02685956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.