The invention relates to a method for in vitro diagnosis or prognosis of testicular cancer which comprises a step of detecting the presence or absence of at least one expression product from at least one nucleic acid sequence selected from the sequences identified in SEQ ID NOS: 1 to 6 or from the sequences which exhibit at least 99% identity with one of the sequences identified in SEQ ID NOS: 1 to 6, to isolated nucleic acid sequences and to the use thereof as a testicular cancer marker.

An apparatus and method are provided for performing detection of microorganisms (e.g., viruses) with high sensitivity. The apparatus and method are well suited for point-of-care (POC) testing in resource-limited regions and are capable of being operated with very little manual intervention and without the need for lab equipment. A variety of viruses can be detected with high sensitivity, including, for example, coronaviruses, Zika virus and flu viruses.

The present invention relates i.a. to diagnostic kits and methods for detecting an animal vaccinated with a modified live Swine Influenza virus specific vaccine and diagnostic kits and methods for differentiating animals vaccinated with a modified live Swine Influenza virus specific vaccine from animals infected with Swine Influenza virus, respectively.

Nucleic acid oligomers specific for human parvovirus genomic DNA are disclosed. An assay for amplifying and detecting human parvovirus genotypes 1, 2 and 3 nucleic acid in biological specimens is disclosed. Compositions for amplifying and detecting the presence of human parvovirus genotypes 1, 2 and 3 genomic DNA in human biological specimens are disclosed.

The present invention relates to a stock solution (RLP Stock Solution) of mammalian cell-endogenous retrovirus like particles (RLP), a method of preparing a RLP stock solution, a kit containing a RLP stock solution, and a method of quantifying the amount of RLP removed from a solution. An RLP stock solution will contain a high concentration of RLP and an extremely low amount of any therapeutic proteins of interest. In some instances, an RLP stock solution will contain a very low amount of natural mammalian host cell protein (HCP) and DNA. The method of preparing a RLP stock solution will consist of the production of RLP during fermentation or cell culturing and the subsequent purification of RLP from fermentation or cell culture solution. The kit will comprise at least two containers. One container comprised of RLP stock solution and one comprised of PCR primers or one or more antibodies. The method of quantifying RLP comprises the steps of adding RLP stock solution to an in-process solution containing a recombinant therapeutic of interest, processing the resulting solution through a bioprocess purification technique, and then quantifying the amount of RLP removed.

Provided are methods of detecting replication competent virus, e.g., replication competent retrovirus such as gammaretrovirus or lentivirus, in a sample containing a cell transduced with a viral vector particle encoding a recombinant and or heterologous molecule, e.g., heterologous gene product. The methods may include assessing transcription of one or more target genes, such as viral genes, that are expressed in a retrovirus but not expressed in the viral vector particle. Replication competent retrovirus may be determined to be present if the levels of RNA of the one or more target genes is higher than a reference value, which can be measured directly or indirectly, including from a positive control sample containing RNA from the respective target gene at a known level and/or at or above the limit of detection of the assay.

Nucleic acid oligomers specific for human parvovirus genomic DNA are disclosed. An assay for amplifying and detecting human parvovirus genotypes 1, 2 and 3 nucleic acid in biological specimens is disclosed. Compositions for amplifying and detecting the presence of human parvovirus genotypes 1, 2 and 3 genomic DNA in human biological specimens are disclosed.

The present invention relates to methods and kits for detecting in a sample the presence of a virus particle or a virus-like particle that has reverse transcriptase activity and methods for preparing a retroviral contaminant-free substance. An aspect of the present invention is a method for detecting the presence of a virus particle in a sample of a Virus-like Particle (VLP) drug substance comprising a step of performing PCR-based reverse transcriptase (PBRT) on a sample of the VLP drug substance that has been treated with a protease.

The invention relates to an antibody, a fragment or a derivative thereof, for use as an antiretroviral drug targeting a virus belonging to human endogenous retroviruses type W (HERV-W), wherein said antibody, fragment or derivative thereof is directed against HERV-W Envelope protein (HERV-W Env). The invention also relates to a composition comprising said antibody and a retroviral reverse-transcriptase inhibitory drug, for use as an antiretroviral drug targeting a virus belonging to HERV-W.

Integrated diagnostic devices comprising peptide-DNA conjugates for analyte detection, an embedded biomolecular computing system for sample analysis, and a layered device architecture are provided herein. In particular, provided herein are devices comprising a layered architecture that enables diagnostic reagents, sample components, and reaction products to flow through the system with minimal user intervention.