Clinical Diagnostics Equipment and Kits

Clinical Diagnostics: Serving Medicine

Clinical diagnostics instruments are used to detect health and disease state markers. Some of the key measurements that diagnostic analyzers are used for are:

• Metabolic markers (blood chemistry) such as glucose, urea, and potassium
• Liver function tests
• Heart disease and heart attack indicators
• Thyroid disease markers
• Various blood cell counts and blood cell size
• Viral and microbial infection such as HIV or H. pylori
• Immunological markers and antibodies

A Range of Instrumentation:

Central to any clinical diagnostic setting are chemistry analyzers, immunoassay analyzers, assay kits, and hematology analyzers. Specialized analyzers are available for assays that are less commonly performed, or are not yet automated in workhorse equipment. Additionally, assay kits can be purchased to address clinical interrogations in smaller settings or in smaller batches. Typically, these kits can be run with standard lab equipment such as a spectrophotometer, and other equipment used for ELISAs. Diagnostic analyzers are available in a range of portability, sensitivity, and throughput options that cover a wide breadth of work areas – from large analyzers used in central service laboratory to highly portable instruments used at the patient bedside.

What Are Some Key Specifications For Purchasing Clinical Diagnostics Equipment?

The two biggest factors that will drive your decisions will be the setting that the equipment is used in, and regulatory compliance:

• Research science can use RUO (research use only) kits and methods to accomplish their measurements.
• In settings where medical patient testing occurs, FDA approved equipment and kits approved for IVD use are used.
• Match the throughput and footprint of the instrument to the anticipated workload in your setting.

For CLIA-waived point of care equipment, compliance with CLIA standards requires monitoring of both equipment and personnel. Following manufacturer’s instructions and documenting calibrations, trainings, storage and other regulations are paramount.

• When evaluating point of care instruments, consider and envision the training complexities involved with adopting the instrument.