CREATING CONFIDENCE

HISTORY

As head of the Viral Diagnostic Department of the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service (CLB, Amsterdam) Nico Lelie organised the first international proficiency study for NAT methods in collaboration with the Eurohep Pathobiology Group (Lancet 1993 1993:441:722-724). A manufacturing system was developed in the Viral Quality Control (VQC) unit of CLB (nowadays Sanquin) that proved feasibility of preparing equivalent standard dilutions over time. These standard dilutions were made commercially available by Sanquin as VQC proficiency panels, PeliCheck reference panels and PeliSpy run controls. These reagents were instrumental for standardisation, validation and quality control in the early days of NAT.

In the late 1990s Nico Lelie collaborated with NIBSC (Potters Bar, UK) for preparation and characterization of the first WHO International Standards for viral NAT and serology. From 2000 to 2004 the VQC business unit operated independently in a vacated blood bank in Alkmaar, the Netherlands. In that period the external quality control and assessment programs were further expanded in collaboration with the Dutch Quality Assessment Foundation (MCA, Winterswijk), NRL (Fitzroy, Australia) and DDL (Rijswijk, Netherlands). In 2004. When Nico Lelie left VQC-Sanquin (to become Scientific Affairs Director of Chiron/Novartis) the VQC business unit was acquired by a US based company (Acrometrix, Benicia, CA).

To maintain the original Sanquin/DDL standards (calibrated in copies and IUs) Harry van Drimmelen and Wim Quint continued the VQC program and founded Biologicals Quality Control B.V. (BioQControl), a company that operated from the DDL facilities (Rijswijk, the Netherlands). In 2010, after leaving Novartis Diagnostics, Nico Lelie started his own consultancy firm and joined BioQControl as minority shareholder. Following a management buyout in 2017, Nico Lelie and Harry van Drimmelen became the only shareholders and moved the company to a larger facility (Heiloo, the Netherlands). Significant investment in this new laboratory facility have allowed further growth of the scale of manufacturing and guaranteed more secure storage of viral standard dilutions and products at either -80˚C or -30˚C.