Performance of a new HIV1/2 point of care test

• Research type

  Research Study

• Full title

  The sensitivity and specificity of One Step HIV 1&2; a new HIV point of care assay compared with Alere Determine HIV-1/2 AG/AB Combo, INSTI HIV-1/ HIV-2 Rapid Antibody test, and a 4th generation laboratory-based Roche assay

• IRAS ID

  162235

• Contact name

  Kaveh Manavi

• Contact email

  k.manavi@nhs.net

• Sponsor organisation

  University Hospitals Birmingham NHS Foundation Trust

• Duration of Study in the UK

  0 years, 5 months, 31 days

• Research summary

  We aim to investigate the performance of a new HIV1/2 diagnostic point of care (POC)assay compared with two well established HIV POC assays and a laboratory HIV assay. We will use the results of the laboratory based HIV assay as the gold standards and compare the sensitivity and specificity of each assay accordingly. We aim to prospectively recruit HIV infected and HIV non-infected patients for the study.

• REC name

  West of Scotland REC 5

• REC reference

  19/WS/0157

• Date of REC Opinion

  9 Oct 2019

• REC opinion

  Favourable Opinion