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24 LABorAtorY Hospital Post Europe 04/08 The intelligent human being is rather lazy and tends to leave more monotonous tasks to others, machines preferably. This is why there’s not only a dishwasher and a washing machine in every household, an ATM at the bank and a welding robot in the car factory, but also a system for laboratory automation, which now has thousands of fans through the 100 systems that have been installed throughout Germany. We talked to its creator, Dr. Robert Hecht of Olympus Life Science Research Europa in Munich. Hospital Post Europe: Being a veterinary doctor, how did you come across the idea to automate laboratory workflows? R. Hecht: After studying mechanical engineering for two years and completing my studies of veterinary medicine, I started to work in a development laboratory for transplantation sciences at the University A Bavarian in Automation Heaven „The Art of Constructing a Complicated System in a Simple Way“ Dr. Robert Hecht of Olympus Life Science Research Europa, Munich of Munich in the Großhadern hospital. While conducting fluorescence measurement, one single test was connected with three to four thousand samples. I did not like us to have to process them manually, so I insisted on buying a robot. We improved its interface for starting the procedures and then automated the measurements. Motivated by the positive feedback from the industry I founded an engineering company. And the connection to Olympus? How did it start? R. Hecht: After several contacts to lab specialists, we decided to develop customerspecific projects in laboratory automation together. There were enough large and non-flexible systems on the market, so we decided to construct small ones that are especially adjustable to the individual needs of laboratories. This brought us in contact with renowned customers. Soon we realized that we could not expand on our own, because development and distribution are two separate things. So we searched for a big and reliable partner who believes in our system. And that’s Olympus. Besides the improved distribution, were there also improvements in the construction? R. Hecht: Indeed, at first we adapted the design of OLA to the Olympus style. Then several mechanical and electronic improvements followed. Since the beginning, we have relied on state-of-the-art components, so quality and long life cycles are always guaranteed. The biggest challenge with Olympus was to develop an industry standard out of this small series. At first every machine was unique. Now it was documentation of assembly, securing of quality and the extreme growth of our number of employees from 30 to 120. Lab Automation Grows from Strength to Strength Just four years after being launched, Olympus has installed its 100 th OLA2500 system for the automation of pre and post analytical processes at the Kyritz Medical Laboratory (MLK) in Brandenburg, Germany. Installed in January, the 100th system has already been responsible for improving workflow efficiency and demonstrates the breakthrough the company has made in the German lab automation market. As is the case throughout the healthcare community, laboratories today require intelligent solutions to successfully combat rising costs. With its diverse automation capabilities, the OLA2500 boasts just such savings potential. One example is in the system’s ability to manage standard processes such as the decapping, aliquoting, barcoding, sorting and sealing of test tubes, saving valuable time, money, and energy. One of the companies taking advantage of the benefits offered by the OLA2500 is the MLK in the northeast German state of Brandenburg, where since the end of January, numerous tasks have been handed over and entrusted to automated lab management. For Olympus, this implementation is an important milestone: “With the The Kyritz Medical Laboratory (MLK) MLK is a partner of the ostprignitz-ruppin Association of Laboratories, a member of the Lab diagnostics consortium for diagnostics and rationalisation (LAdr) and has been certified since 1997 – currently in accordance with dIn En Iso 15189. A total of 65 employees support about 250 privately practising doctors, four emergency hospitals, and four rehabilitation clinics throughout greater Brandenburg, Mecklenburg-Western Pomerania and saxony-Anhalt, providing external medical laboratory diagnostics services. www.labor-dr-hassfeld.de/mlk/mlkindex.htm Besides the launch of its latest fourth-generation rapid HIV diagnostic test, Inverness Medical introduced its new Clearview TB ELISA at the International AIDS Conference (AIDS 2008). Tuberculosis (TB) is a leading cause of death in HIV infected patients, and the unique urine based Clearview TB ELISA LAM antigen test can provide a much needed aid in the diagnosis of TB 100th installation of an OLA2500 in Germany, we’ve crossed a magic threshold. Just four years after the system’s introduction, we’re able to declare successful penetration in the lab automation market in Germany,” said Thorsten Laubert, Product Manager, Lab Automation. One Million Test Tubes a Year Around 2,500 test tubes are analysed at MLK every day. That amounts to roughly one million test tubes a year which previously required labour-intensive management prior to and following analysis. “Since the end of January, the OLA2500 has completed these tasks automatically. The time we’ve saved as a result can now be used much more effectively,” adds Dr. Manfred Haßfeld, founder and head of MLK. “What’s more, samples can now be localized much more quickly, while automatic barcoding rules out any chance of a mix up. The system even helps with archiving. In short, the OLA2500 has been a fantastic investment.” www.olympus-europa.com Fighting Back Against TB and HIV in TB/HIV co-infected patients. HIV is driving the TB epidemic in many countries such as sub-Saharan Africa, Asia, and South America where HIV infection amongst the population is high. Inverness Medical is now able to offer a rapid diagnostic kit using ELISA (Enzyme Linked Immunosorbent Assay) technology capable of aiding the diagnosis of TB in these vulnerable patients where previously existing tests have failed. Traditional sputum smear tests for TB incur considerable limitations when used as a primary diagnostic test in co-infected HIV-TB patients, with a sensitivity falling to as low as 20 % in patients who are also HIV infected. Clearview TB ELISA uses antibodies specific to the antigen lipoarabinomannan (LAM) which forms part of the TB cell wall. The elevated levels of the LAM antigen within the urine of TB/HIV co-infected patients provides a specific diagnostic target. When targeting this specific antigen, clinical data shows that in TB-HIV co-infected We had to organize everything properly to start with. Our drawers and sensors, for example, were already working and made our concept superior to others. But to transfer this to serial production with standards that remained identical whilst constructing a complicated system in a simple way, that’s an art. Does that mean that every OLA is the same now? R. Hecht: No, absolutely not. The quality standard of every OLA is identical, yes. But every square millimetre of it is freely configurable. The customer or user does not have to adjust to the machine, because it is extremely flexible in its parameters and able to adapt to its surroundings. Every OLA2500 can be freely defined because every laboratory, every task is different. One user wants to aliquot, but works only with a small throughput, the other user needs to be extremely fast. The hospitals wants to analyse STAT samples first, the large laboratories want to concentrate on routine samples. The very special thing with OLA is its easy handling, so everyone can easily work with it. Hepatitis Tests for all Sizes of Laboratories Siemens Healthcare Diagnostics received CE marking approval to sell the hepatitis B virus e-antigen (HBeAg) and antibody to the hepatitis B virus (anti-HBe) tests in the European marketplace. The two new tests may be used as an aid in the diagnosis of hepatitis B infections and to monitor the effectiveness of hepatitis B virus treatment. With these additions, the company now offers complete hepatitis A, B, and C test panels that can be run on the high-throughput ADVIA Centaur and ADVIA Centaur XP immunoassay systems. Consolidating all A, B, and C hepatitis tests onto one instrument creates cost efficiencies by reducing the time needed for laboratory personnel to produce test results. In addition, Siemens Healthcare received CE marking approval to sell multiple hepatitis B tests for use on the ADVIA Centaur CP immunoassay system in the European marketplace. This allows mid-sized patients detection rates increase to 80.3 %. The use of urine also offers the clinician the advantage of a sample material which is safer and far less invasive than conventional sputum sample collection. The new, user-friendly, Clearview test screens for the LAM antigen in urine samples in less than three hours, significantly faster than bacterial cultures that can take up to six weeks to develop. By using the LAM ELISA technology, Inverness Medical is leading the way in reducing the prevalence of this preventable and curable dis- What do you think is the current trend in development? R. Hecht: The overall trend is obvious: Since 2006 the big track systems have made a comeback. But they are very complex, and in my opinion in laboratories it’s not about cycle times as it is in industry. laboratory workflows can not be compared to production lines, as they are predefined. We regard every lab as an individual, so to speak. The turn-around-time (TAT) must be as short as possible; the system must be able to cope with chaos. That’s why we believe that the true trend is connected to the software. The mechanical part can be handled relatively easily seen from the construction perspective. But one should not let the separate software packages get too big. We focus on modularity, and we know that implementation time has to be short. Who wants to unnecessarily delay his lab workflows? www.olympus-europa.com clinical laboratories to consolidate hepatitis B tests with other immunoassay tests onto one compact, bench top, fully automated immunoassay system. This, again, creates cost efficiencies by reducing the time needed for laboratory personnel to produce test results. The hepatitis B tests approved for use on the ADVIA Centaur CP system are hepatitis B surface antigen (HBsAg), HBsAg confirmation, total antibody to the core antigen of the hepatitis B virus (HBcTotal) and IgM to the core antigen of the hepatitis B virus (HBcIgM). All of these tests are routinely requested by physicians to screen and diagnose hepatitis B infections in patients. “These introductions demonstrate Siemens’ commitment to making quality hepatitis tests available to all sizes of laboratories,” said Jay Snyder, vice president, global clinical chemistry, immunoassay and automation, Siemens Healthcare Diagnostics. www.siemens.com/healthcare ease in areas with a large HIV population through effective early diagnosis. www.invernessmedical.com
Hospital Post Europe 04/08 Pronostics, developer and manufacturer of next generation multiplexed diagnostics for healthcare providers and the pharmaceutical industry, has signed a deal with University of Birmingham Medical School (UBMS) to provide next-generation autoimmune testing services for its clinical immunology service. As part of the deal, Pronostics will provide UBMS clinical immunology service with its New Rapid HIV Test Detects Acute HIV Infection Inverness Medical announced the launch of its new 4 th generation rapid HIV diagnostic test – Determine HIV-1/2 Ag/ Ab Combo – at the International AIDS Conference (AIDS 2008 – 3 – 8 August) in Mexico City. Capable of detecting HIV infection several days earlier than HIV antibody only tests, Determine HIV-1/2 Ag/Ab Combo enables simultaneous separate detection of HIV p24 antigen (Ag) and antibodies (Ab) for HIV-1 and HIV-2 in human serum, plasma, or whole blood. The p24 antigen is produced during the first few weeks of HIV infection and is detectable before HIV antibodies are produced, making it an ideal marker in aiding early HIV diagnosis. By simultaneously detecting for p24 antigen and HIV antibodies, Determine HIV 1/2 Ag/Ab Combo increases the ability to detect and diagnose primary HIV infection. The lateral flow test from Inverness Medical provides clear visual results during the patient visit. The easy to use, robust format of Determine does not require electricity, water, or the use of bulky laboratory equipment and can be performed in point-of-care settings and remote locations where laboratory facilities are limited. This gives significant advantages over lab-based EIA and ELISA 4 th generation HIV testing. The Determine HIV-1/2 Ag/Ab Combo test is ideal to help diagnose and screen for early HIV infection. The ability of this test to enhance diagnosis of those with acute HIV infection will provide additional benefits in HIV prevention programs and ultimately contribute to a reduction in the spread of HIV. www.invernessmedical.com LABorAtorY 25 Providing Next-Generation Multiplexed Diagnostics fully automated UltraPlex system and ANA Assay for the diagnosis of autoimmune disease. This follows an independent trial at UBMS in 2007 which compared Pronostics’ UltraPlex ANA assay with existing testing methods employed. The UltraPlex solution eliminates the possibility of subjective errors, removes non-specific positive results and focuses on clinically significant results, with known disease association. Its introduction will also significantly reduce test turn-a-round times. The UltraPlex ANA assay consists of 11 tests in one, providing valuable time and cost savings compared to serial testing approaches or current multiplexing methods. It allows hospitals and laboratories to perform fully automated tests on patient samples and gives both quantitative and qualitative results for antibodies in autoimmune diseases. UltraPlex is an exceptionally accurate, digital multiplexing solution which enables tens to hundreds of tests to be performed simultaneously in a single assay using a microscopic bar coding system. Over the coming year, Pronostics will be launching assays in the cardiovascular and cancer dis- EXPERIENCE A WHOLE NEW DIMENSION OF PATHOLOGY: OLYMPUS dotSlide. Break through the boundaries of conventional microscopy with dotSlide and discover a world full of helpful details for your research. The virtual digital microscopy system provides you with a complete, sharp, true-to-colour image of your sample – with unparalleled image depth. The unique layer technology seamlessly combines the individual scans together into one fi le – making it ideal for sample analysis and documentation, teleconsultation and online conferences, presentations, archiving and online global data sharing. The dotSlide system is fl exible and modular, so it can optimise your complete workfl ow. It is quick and easy to use and all the steps are standardised, saving you time and money. With unlimited applications in pathology, dotSlide opens up new horizons. For more information, contact: Olympus Life Science Europa GmbH Phone: +49 40 2 37 73 54 26 E-mail: microscopy@olympus-europa.com www.olympus-europa.com ease areas to supplement its autoimmune range which currently includes ANA, Coeliac, and Thyroid assays. Timothy Plant, Laboratory Manager for UBMS clinical immunology services said: “We are very pleased to have signed this deal with Pronostics and look forward to enjoying the benefits the UltraPlex platform has to offer”. Rob Booth, CEO of Pronostics added: “This deal highlights the benefits of the UltraPlex ANA solution and we look forward to providing additional assays to UBMS as our relationship progresses. The great thing about UltraPlex is that it provides significant time and cost savings which benefit hospitals and patients alike. Hospitals save money, waiting times are reduced and patients are diagnosed sooner.” www.pro-nostics.com
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