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Water for Clinical Diagnostics

A gloved hand places a test tube holding a blood sample into a plastic laboratory test tube rack holding other blood samples with various colored lids

In biomedical laboratories, clinical analyzers are critical instruments that require large quantities of purified water to operate continuously in order to perform timely tests. Any water-related issue, such as a deviation in expected quality or flow rate, could cause analyzer downtime, resulting in decreased laboratory productivity and a delay in delivering results to healthcare professionals and their patients.

The information below is intended to support clinical lab managers and anyone responsible for the water purification systems in a biomedical laboratory. Read to learn how to prevent water contaminants from interfering with the delivery of accurate and reliable chemistry, hematology and immunology assays. You’ll also learn how to maintain maximum water system and analyzer uptime for more efficient clinical lab operations.



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CLRW-grade water supports accurate biomedical analyses

Purified water is a critical reagent in biomedical laboratories, essential for clinical assays and for rinsing and cleaning automated equipment. Water contaminants, quality fluctuations, or supply interruptions can cause analyzer downtime, potential damage, and reduced laboratory efficiency.

The Clinical and Laboratory Standards Institute (CLSI) defines Clinical Laboratory Reagent Water (CLRW) as the required water quality standard for clinical analyzers.¹ Using CLRW-grade water serves two key purposes:

  • Supports accurate and reliable clinical analyses
  • Protects analyzers from contamination, clogging, and damage

Impact of water contaminants on clinical assays

Consistent CLRW-quality water is vital for reliable assay results. Key contaminants and their impacts include:

  • Inorganic ions (e.g., sodium, calcium, magnesium, chloride) can act as catalysts in organic and biochemical reactions
  • Organic molecules may disturb biological experiments
  • Bacteria and their by-products (e.g., alkaline phosphatase) can contaminate samples, disrupt instrument operations, and interfere with immunoassays
  • Particulates and colloids (e.g., silica, salts) can clog analyzers and shorten their lifespan

 

Laboratories should treat water as a critical reagent. While most clinical analyzers require CLRW-quality water, some applications (e.g., DNA sequencing, LC-MS, HPLC, ICP-MS) may require ultrapure water. Proper selection and maintenance of purification units reduces downtime and enhances laboratory productivity. 

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1. Clinical and Laboratory Standards Institute (CLSI). Preparation and Testing of Reagent Water in the Medical Laboratory. 5th ed. CLSI guideline GP40. (ISBN 978-1-68440-266-3 [Print]; 978-1-68440-267-0 [Electronic]). Clinical and Laboratory Standards Institute, USA, 2024.