Research project on detection methods for replication-competent lentiviral and retroviral vectors

Biomedical, genetic, and clinical research is often carried out with replication-deficient lenti- or retroviral vectors. During the production of these vectors, the formation of replication-competent virus (RCV) cannot always be excluded. RCV can spread, which poses a risk when working with lenti- and retroviral vectors. However, it is difficult to conclusively demonstrate the absence of RCV. COGEM therefore commissioned research into the tests and methods that can be used to detect RCV.
The research report provides a good overview of currently available RCV tests, their suitability and limitations, available data on test validation, and positive and negative controls used. Based on the research report, COGEM concludes that there is a large variety in the RCV tests available, each with its advantages and disadvantages. COGEM recommends the use of an amplification step prior to an RCV test, as this increases the sensitivity of the test and reduces the chance of a false positive signal. COGEM also notes the importance of validation, and recommends that only validated tests are used in the licensing process.
Data on the origin of RCV and the controls used are often not disclosed by laboratories or companies. COGEM points out that increased openness about these data, which can influence the environmental risk assessment of these vectors, can contribute to improving the licensing process. It therefore advises the Ministry of the Environment to enter into discussions with industry about sharing this information.

The COGEM offer letter can be found under the ‘download publication’ button and the accompanying COGEM research report can be found here: link to the research report.

* A minor correction was made in December 2023 to correct the number of agencies approached.