This study is currently not recruiting participants.

BIO-FLASH? HSV-1 lgG a nd BIO-FLASH? HSV-2 lgG on the BIO-F LASH? Instrument

Investigation of Herpes Simplex Virus Types 1 and 2 Antibody Testing

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to assess the clinical performance of the BIO-FLASH HSV1-IgG and BIO-FLASH HSV2-IgG on the BIO-FLASH instrument by comparison to the FDA-approved device, HerpSelect 1 and 2 Immunoblot IgG.

Detailed description of study

The purpose of this study is to assess the clinical performance of the BIO-FLASH HSV1-IgG and BIO-FLASH HSV2-IgG on the BIO-FLASH instrument by comparison to the FDA-approved device, HerpSelect 1 and 2 Immunoblot IgG.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 100 years or below
  • Gender: All

This study investigates the clinical performance of a testing method for detecting antibodies related to HSV1 and HSV2. HSV1 and HSV2 are types of herpes viruses that can cause infections in humans. The study compares a new testing method with an existing FDA-approved device to understand its effectiveness.

Participants will undergo testing using the investigational method and the FDA-approved device. The study will involve comparing the results from both methods to evaluate the accuracy and reliability of the investigational testing method.

  • Who can participate: Participants must be adults aged 18 and older, who have not been diagnosed with any immunodeficiency disorders. Additional inclusion criteria may apply.
  • Study details: Participants will undergo testing using both the investigational method and the FDA-approved device to compare results.
Updated on 19 Feb 2024. Study ID: 1503088099

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