This buying guide aims to provide you with the most up to date information to consider when looking to purchase or update your clinical chemistry analyzer. The process by which clinical laboratories purchase chemistry analyzers depends on the type of laboratory (for example private, government, hospital, reference, point-of-care clinic), and its geographical location.

NHS and European hospitals/clinics must adhere to European procurement directives and tender procedures and protocols, depending on the value of the product to be purchased. All Public Sector organizations are obliged to abide by The Public Procurement Regulations 2006, the law relating to Procurement that is common to all European member states, following the European Procurement Directive 2004/18/EC. Under these rules, tenders must be advertised in Europe by appropriate processes, following a mandatory timescale.

Medical devices placed on the UK/EU market must have been certified safe with a CE mark.

US medical centers are not bound by such stringent procurement directives, however approximately 80% of hospitals in the U.S. are either a part of a Group Purchasing Organization (GPO) and/or an Integrated Health Network (IHN).

A hospital that is affiliated with a GPO or an IHN will be covered with their GPO or IHN contracts. Levels of contract compliance may vary and it is possible for hospitals that are affiliated with a GPO or IHN to purchase instruments from a vendor outside of the agreement. All clinical chemistry analyzers must have been approved by the Food and Drug Administration (FDA) for diagnostic use.

Advances in automation have led to a new generation of clinical chemistry analyzers, with advanced software and hardware solutions. These analyzers can offer laboratories fast, reportable, cost-effective and accurate results.

Some companies offer dedicated systems for use only with specific kits, these are known as closed systems. Others offer open systems which can be used with a number of different assays and so require careful calibration and validation of parameters by the user.

Modern biochemistry analyzers can usually:

• Test for a variety of specific analytes such as proteins, electrolytes and enzymes, as well as general chemistries.

• Use a number of different measurement technologies:
• absorbance photometry
• turbidimetry
• ion selective potentiometry
• latex agglutination
• homogenous EIA
• Analyze a range of sample types:
• serum
• urine
• plasma
• cerebrospinal fluid

Clinical applications of these analyzers include the monitoring of disease states such as anemia, diabetes, cardiac markers, drugs of abuse, metabolic functions, hepatic function and therapeutic drug monitoring.

It would not be unreasonable to expect a large, modern, automated chemistry analyzer to offer the following technical specifications:

• Random access capabilities - the ability to access an element at an arbitrary position in a sequence in equal time, independent of sequence size.
• Qualitative checks for hemolysis, lipemia and icterus.
• Liquid level sensing, crash protection, clot/clog detection, short sample detection.
• Auto dilution and automatic reflex/repeat testing.
• STAT functions – either simultaneous sampling, or ability to interrupt a sample run.
• Sophisticated software which can be connected to LIS/LIMS.
• Bi-directional interface.

Not all laboratories are legally bound to follow tender procedures and directives; however the process is still widely utilized by many laboratories to purchase expensive equipment.

Anyone looking to purchase an analyzer may find it useful to ask the following questions:

1. Does it represent value for money?
2. Is it fit for purpose?
3. What are the ‘whole life’ costs?
4. What are the service costs?
5. Is it flexible and easy to operate?
6. Is the product of high quality?

Typical Tender Process

1. Identify the need and develop an outline specification.
2. Receive financial approval and the authority to proceed.
3. Identify prospective suppliers / contractors.
4. Finalize specification and prepare the invitation to tender documents (ITT).
5. Issuing ITT and handling enquiries.
6. Evaluation of tender.
7. Award and manage the contract.

Manufacturers usually offer a number of customizable options and functions depending on the needs of each individual laboratory, for example throughput of photometric or ISE tests per hour, and the number of tests and assay types available. A variety of analyzers are available to suit the smallest point-of-care clinic, or the most demanding, high-throughput clinical laboratory.

Factors to Consider when Choosing your Analyzer.

Consider the demands of the instrument.

How many operators will it require, will it be a shared resource, and how will it integrate into your current workflow (is it stand alone or fully integrated)? The various options to integrate fully automated systems, for higher throughput testing, can be discussed with the individual manufacturers.

Complex technology often requires intensive training.

Does the manufacturer offer a comprehensive training programme and how will this information be shared with the laboratory team? Some manufacturers offer residential training programmes for a limited number of people, who will then become the trainers for the rest of the user group. Others will hold training sessions at the laboratory itself and issue certificates to attendees on completion of a test. Training typically takes 3-5 days.

Compatibility of software.

Limitations resulting from the compatibility of software with external hardware are important to consider. Some systems include integrated software with features such as inbuilt protocols and the ability to select languages. Software should be validated to global standards. Interfacing options and LIMS compatibility is an important consideration when choosing a new analyzer.

Other important considerations include the number of users, length of usage, flexibility, pre-analytical processing, ease-of-use, reliability, budget and customer support.

Taking into consideration current and future trends is essential in maximizing the lifespan of any analyzer. As systems become more sophisticated, integration, convenience and application specificity are key.

New assays are constantly in development to improve the diagnostic capabilities of laboratories and ultimately improve patient care. The continuing emergence of new, clinically significant biomarkers, and technological advancements have a significant impact on such assay development.

Biochemistry systems will also become faster and more efficient as technology and software is developed and enhanced. Manufacturers strive to take into consideration customer feedback and requirements, and many are developing strategies for making analytical systems ever more user-friendly.

The purchase of a new analyzer requires considerable thought, planning and assessment of the laboratory or clinics needs and requirements. It is wise to identify these requirements before drawing up a shortlist of analyzers which have the potential to meet them. Purchasers should conduct a thorough comparison of analyzer capabilities and balance this with the all important issue of price, before making a decision.

Click here to access further articles and case studies about hospitals which have recently implemented new laboratory systems.