VITROS Progesterone 2 Assay Apparently Healthy Sample Collection

• Research type

  Research Study

• Full title

  VITROS Immunodiagnostic Products Progesterone 2 Assay Apparently Healthy Sample Collection

• IRAS ID

  327122

• Contact name

  Ariun Narmandakh

• Contact email

  ariun.narmandakh@quidelortho.com

• Sponsor organisation

  QuidelOrtho Inc

• Duration of Study in the UK

  0 years, 5 months, 31 days

• Research summary

  The study is to collect blood serum samples from adult males, postmenopausal and pregnant females at 1 visit. Blood serum will be collected from adolescents (12-18) and adult females of reproductive age over 5-6 visits. The samples will be investigated for progesterone testing using the Sponsor's VITROS Immunodiagnostic Products Progesterone 2 Assay for reference interval establishment as per 1. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition, CLSI document EP28-A3c.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  23/NW/0355

• Date of REC Opinion

  5 Jan 2024

• REC opinion

  Further Information Favourable Opinion