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

Completed

Conditions studied: Herpes Simplex

In brief

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.

Key facts

Study ID

NCT02685956

Run by

Vela Diagnostics

People needed

2295

Starts

2016-04-01

Expected to finish

2017-04-07

Last updated by the study team

2020-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tampa General Hospital — Tampa, Florida, United States
• Baystate Health — Springfield, Massachusetts, United States
• Beaumont Health — Royal Oak, Michigan, United States
• BioReference Labs — Elmwood Park, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Geisinger Health — Danville, Pennsylvania, United States
• Quest Diagnostics — Horsham, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• MedFusion — Lewisville, Texas, United States

Full record on ClinicalTrials.gov

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