Direct Access Diagnostics: HIV Home Test Kit

The Design Challenge: Deliver turnkey design services for developing the first home use, over-the-counter, FDA approved HIV screening test kit. Through its multidisciplinary industrial design services, TKDG developed the kit design from the early concept stages through regulatory agency reviews and final production processes. Extensive human factors and user-behavior research was conducted to ensure the kit would produce reliable and predictable compliance. The patented packaging met stringent government requirements that users have immediate success with the kit and that the mailer provide a safe way to send blood through the mail.