Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240099794
Category : Medical
Languages : en
Pages : 33
Book Description
The document is developed for manufacturers who are interested in applying for WHO prequalification assessment, to assist in the compilation of their product dossier. The document summarizes the minimum analytical and clinical performance studies to be conducted for rapid diagnostic tests (RDTs) for the qualitative detection of mycobacterial lipoarabinomannan (LAM) antigen for point of care professional use in urine of HIV positive individuals.