Clinical trial NCT02685956: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Official title: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex
Lead sponsor: Vela Diagnostics
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 2295
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and females with genital or oral lesions to be tested for HSV 1/2 infection.

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.

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

Primary outcomes:
measure: Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
timeFrame: within 60 days of last sample enrollment
measure: Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
timeFrame: within 60 days of last sample enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Elmwood Park
country: United States
facility: BioReference Labs
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Horsham
country: United States
facility: Quest Diagnostics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Lewisville
country: United States
facility: MedFusion
state: Texas
Study officials:
affiliation: Vela Diagnostics
name: Shaw Chiat Hong
role: STUDY_DIRECTOR
References: