Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,295
- 试验地点
- 9
- 主要终点
- Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 HSV
- •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.
排除标准
- •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
结局指标
主要结局
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
时间窗: 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).
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
时间窗: 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).
次要结局
未报告次要终点