Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02685956
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02685956
Study Brief:
Protocol Section:
NCT02685956