A Medical Device Daily

Siemens Medical Solutions Diagnostics showcased its portfolio of what it called “performance-driven” solutions for the first time at the American Association of Clinical Chemistry (AACC; Washington) annual meeting and Clinical Lab Expo in San Diego last week at the San Diego Convention Center.

The company’s portfolio results from its bringing together two players in the diagnostics industry: former Bayer Healthcare Diagnostics (Tarrytown, New York), completed in January and first disclosed a year ago (Medical Device Daily, Jan. 4, 2007/July 5, 2006), and Diagnostic Products Corporation (DPC; Los Angeles), completed in July 2006 (MDD, July 31, 2006).

With these acquisitions, Siemens said it expects to transform the healthcare industry by bringing together medical imaging, information technology and laboratory diagnostics to form the “first-ever” full service diagnostics company, which the company said is positioned to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the world.

“In today’s healthcare environment, we realize that labs are faced with more challenges than ever – doing more with less while improving overall patient care and physician satisfaction. Our solutions and services are built with these key challenges in mind,” said Tony Bihl, president/CEO, Siemens Medical Solutions Diagnostics. “Siemens continues to provide labs with the current products of both former organizations and new solutions to improve the efficiencies of the lab and advance the level of patient care.”

Siemens said it focuses on the business of diagnostics for laboratorians, clinicians and patients by offering a comprehensive portfolio of products and services designed to combine the right balance of science, technology and practicality. The new entity has a market leading assay menu that will be augmented by growth in key areas such as cardiovascular, oncology, infectious disease and allergy.

Siemens said it will continue to invest in menu expansion across both the Immulite and Advia immunoassay systems.

At AACC, Siemens presented its full product and solutions portfolio, designed to optimize efficiency, improve workflow, ensure patient safety and provide the highest levels of productivity and flexibility.

Siemens showcased a system that merges the strengths of the ADVIA 1800 Clinical Chemistry Analyzer and the Immulite 2500 Immunoassay System onto single testing platform by connecting to a Sample Management System (SMS). With the design of the SMS, laboratories are expected to get the benefits of consolidation without compromising throughput, as well as get full menu capabilities in a scalable platform.

The technology physically links the immunoassay and clinical chemistry components to offer a single entry point for samples, significantly reducing the need to pre-sort specimens. It also enables continuous loading for 200 samples and can move tubes at a speed of 200 tubes per hour while providing laboratorians access to over 80 chemistry assays and more than 160 immunoassays. SMS software optimizes sample processing in order to maximize throughput and simultaneous sample analysis, which ensures that peak workloads can be handled quickly.

A Virtual work Connection allows operation of the individual analyzers at the central SMS computer, which is connected by a single Lab Information System interface for improved efficiency and ease of use.

The Versant 440 Molecular System has recently been approved for marketing by Health Canada for viral load testing of the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV); is CE-marked for HIV, HCV; the hepatitis B virus (HBV); and is filed in the U.S. for FDA review.

The automation of the Versant 440 provides laboratories with greater throughput and less hands-on time, maximizing productivity to meet the evolving needs of the clinical laboratory, Siemens said. The system uses branched DNA technology (bDNA) that simplifies testing by eliminating nucleic acid extraction and removing the risk of cross-contamination. The product is a viral load platform designed for flexible walkaway automation, and it streamlines workflow by integrating bar code data entry, automated reagent processing, and detection, as well as downloadable patient worklist and results through an FDA cleared LIS interface.

Nearly 100 systems are placed worldwide, the company said.

Other products showcased by Siemens at AACC included:

The DCA Vantage Analyzer, a point-of-care diabetes patient management platform that tests HbA1c and Albumin-to-Creatinine Ratio for diabetes management.

The company said that in more than 100 third-party papers, the DCA HbA1c tests has been proven to be the most precise and accurate tool in managing patients with diabetes, at the point-of-care, and considered the gold standard.

New capabilities have been added to the DCA Vantage for better patient management of patients with diabetes by providing an on-board printed patient record, patient trending graphs, and a powerful database for improved patient management. Features, such as connectivity to LIS, QC reminders, lock-out and remote access, slope and offset to standardize testing that make the system a fit for point-of-care coordinated sites that require compliance and control of decentralized testing, Siemens said.

The Advia Decapper has been developed as a seamlessly integrated on-line feature for existing ADVIA WorkCell and LabCell Automation configurations that easily fits onto the existing track with no additional spacing requirements. The unit handles a variety of sample tube types, including screw caps, rubber stoppers, and Hemoguard stoppers at a speed of 600 tubes/hour.

Novius Lab is a rules-based LIS that optimizes workflow across multi-entity settings. It provides macro-management of all laboratory workflows and result repository of all laboratory results

At the patient’s bedside, the wireless, simple-to-use BD.id Patient Identification System for Specimen Management identifies the healthcare provider, the patient, the specimen container, and the order of draw. The system then prints instrument-readable labels only for specimens actually collected, with both the actual time of collection and the collector’s ID printed on the label. Actual collection date and time sent to the LIS in real-time, enables accurate turn around time calculations and efficient laboratory workflow.

The Clinitek Advantus analyzer is a semi-automatic urine chemistry analyzer that can perform up to 500 tests/hour. The analyzer delivers improvements such as the ability to consolidate microscopic test results. The system enables automated reading of the Multistix family of urinalysis test strips in medium to high-throughput settings and delivers all the reliable functionality and testing flexibility of the Clinitek 500. It offers a menu of urine tests that help healthcare professionals deliver quality patient care and aid in the diagnosis of diseases and conditions, such as diabetes, kidney disease/disorders, urinary tract infections, and liver function.