Evaluation of PCR and ELISA assays for screening clinical trial subjects for replication-competent retrovirus
This paper is cited as reference #30 in the FDA’s 2020 guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up https://www.fda.gov/media/113790/download and was included in the original guidance issued. As part of a cross functional team, my group developed a polymerase chain reaction (PCR) assay for RCR provirus detection and an enzyme-linked immunosorbent assay (ELISA) assay for anti-retroviral anti-bodies. No evidence of RCR infection was found in 81 human immunodeficiency virus (HIV)-infected patients receiving multiple injections of a retroviral vector.
