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Clinical and technical validation studies for diagnostic companies
• Detection of nonhemagglutinating influenza a(h3) viruses by enzyme-linked immunosorbent assay in quantitative influenza virus culture.
• Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.
• Comparison of the Abbott Realtime HIV-1 and HCV viral load assays with commercial competitor assays.
• Evaluation of the analytical performance of the new Abbott RealTime RT-PCRs for the quantitative detection of HCV and HIV-1 RNA.
• Multicenter evaluation of the new Abbott RealTime assays for quantitative detection of human immunodeficiency virus type 1 and hepatitis C virus RNA.
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Viroclinics Xellerate provides better logistics support for the pharmaceutical, biotechnology, and medical device industries and gives us the opportunity to monitor the quality from the moment the sample is taken to the final test results. All personnel who are involved in the clinical trial are trained and all processes, temperature monitoring and assays are performed according to the ISO 15189 accredited quality system.
Logistic activities include preparation of virology sampling kits, on-site sampling handling instruction, courier transport, sample tracking and tracing (e.g. guaranteeing temperature controlled supply chain and online-sample timelines) , and management of sample processing labs. Viroclinics Xellerate support a smooth logistical flow of samples from all over the globe, and works together with a network of 36 processing laboratories in USA, Turkey, Mexico , Panama, Costa Rica, Argentina, Brazil , Peru ,Japan, South Korea, Singapore , China, Poland, Australia, India, South-Africa , Israel, Russia , Ukraine, Serbia, Colombia, UK, Germany, Spain, Saudi Arabia and Moldova.
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