How have the needs of molecular diagnostics laboratories evolved over time?
Screening blood donations and molecular diagnostics for patients started in the nineties. At the beginning, the level of automation in molecular diagnostic testing was limited; most of the work had to be done manually.
At the end of the nineties it was possible to automate parts of the procedures. Then, around 2008, different semi-automated systems became available. This opened the possibility of increasing the number of assays and reduced the failure rate by introducing the ability to track the different steps of the assay automatically.
Roche recently announced the commercial availability of the cobas® 6800/8800 systems. Please can you explain how these systems are built on PCR technology?
The Polymerase Chain Reaction (PCR) has become the basis of modern molecular biology. Real-time PCR, which the cobas® 6800/8800 is built on, is an advanced form of the Polymerase Chain Reaction that maximizes the potential of the technique.
In the cobas® 6800/8800 system, the hepatitis B virus DNA, HIV-1/HIV-2 RNA and hepatitis C virus RNA are all simultaneously amplified during PCR. The viruses are detected separately by molecular probes with different fluorescent dyes, whilst the whole process is monitored in real-time.
This is beneficial because the assay is able to discriminate between the three viruses easily, quickly and accurately. In addition, two different regions of HIV-1 are amplified and detected. This is particularly important for detection of recently discovered HIV-1 subtypes which are not detected by some current single target assays. In Germany dual target testing for HIV-1 will be mandatory as of January 2015.
What impact do you think these systems will have on laboratory operations?
I think the biggest impact for laboratory technicians will be being able to process a higher number of samples in less amount of time, allowing them to reduce the potential for human error.
For instance, three mixed batched tests can be performed simultaneously in less than eight hours, without even the need for pre-sorting.
They will also be able to “walk-away” from the machine and concentrate on other tasks in the lab, as well as performing up to three different tests from a single sample including donor screenings (MPX test – HIV, HBV, HCV; WNV), plasma screenings (DPX – HAV and Parvo B19; HEV) and patient diagnostics.
How do the cobas® 6800/8800 systems compare to other molecular diagnostics instruments on the market?
An important advantage of the cobas® 6800/8800 system is its ability to load many reagents at once and keep the reagent cassettes in the onboard storage and refrigeration system. For some reference labs, the utility channel may be important as it can be used to run their own in-house developed assays.
What further innovations would you like to see from molecular diagnostics instrument manufacturers?
We would like to see more fully integrated automated systems which would include both serology screenings for infectious diseases, and pre-analytics, for example, the sorting, centrifugation, handling and transportation of samples to an analyser.
What do you think the future holds for molecular diagnostics and blood screening systems?
In our opinion, complete integration is the way forward. Fully integrated systems for pre-analytics, serology, blood typing and molecular diagnostics with almost no “hands on” time would provide laboratory technicians with even more time to focus on other activities.
Where can readers find more information?
For information about the research we conduct on advances in blood supply you can visit www.sanquin.nl. There is also information about the cobas® 6800/8800 systems which can be found at www.cobas68008800.com.
About Dr Bos and Dr Koppelman
Harry Bos (left) studied Biology at the Free University of Amsterdam and obtained his PhD in Immunology in 1989. Part of his education was spent at the Department of Cellular Physiology and Immunology of Prof. R. Steinman, (Nobel Price Winner 2011) at the Rockefeller University, New York,and the Division of Human Retrovirology of the Dana Farber Cancer Institute, Harvard Medical School in Boston.
In 1991 he became the Manager Production, Laboratory and Quality control of the Bloodbank in Arnhem. He joined Sanquin in 1998 when it was founded as a fusion of all Dutch blood banks and the Central Laboratory of the Blood transfusion Services of the Dutch Red Cross (CLB).
During his years at Sanquin, Dr. Bos hold a variety of positions as Manager Laboratory, Manager Screening and Quality Control (blood products), and Manager Production. He became the Head of the National Screening Laboratory in Amsterdam when Sanquin decided to concentrate the back-office functions of the screening lab into a single unit in Amsterdam for efficiency reasons – a process that lasted for over a year under much influence of Dr. Bos’ experience.
His most recent position is Director of the Diagnostic Division of Sanquin Blood Supply, one of the largest diagnostic labs in the Netherlands. The Diagnostic Division serves Sanquin Bloodbank, Sanquin Plasma Products, Centrale Afdeling voor Fractionering van het Rode kruis (C.A.F.-D.C.F. cvba-scrl), Belgium, Tissue banks, Hospitals, a variety of other laboratories and DEKRA. The Diagnostic Division collaborates with diagnostic companies in Clinical Trials and in developing, validation and certification (CE marking) of new assay’s,and equipment.
The Diagniostic Division is ISO 9001, ISO 15198, FDA and GMP certified.
Dr Marco Koppelman (right) is the Head of Nucleic-Acid Testing (NAT) at the National Screening Laboratory ‘Sanquin’ in Amsterdam, the Netherlands, a post which he has held since 2008. His interest in blood screening began at university, where he studied biology with an emphasis in Molecular Biology at the University of Utrecht in The Netherlands. His PhD, published in 2006, investigated the viral safety of blood donations, focusing on the molecular detection of transmittable blood viruses.
The cobas® 6800/8800 Systems are available in all markets accepting the CE mark in Europe, Latin America, Middle East, Africa and Asia. The Systems are not currently available in the United States.