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Benefits of Liquid Stable Clinical Reference Materials for Clinical Laboratories

Benefits of Liquid Stable Clinical Reference Materials for Clinical Laboratories

A liquid stable design improves laboratory efficiencies and productivity

Robert Janetschek, MS, MT(ASCP)

Robert Janetschek is a veteran of the clinical laboratory and IVD industry with more than 35 years of experience. He held technical, marketing, and business development leadership positions with such...

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Published:Jun 16, 2021
|2 min read

The clinical laboratory has witnessed a steady progression in the movement away from traditional lyophilized/dry-fill product platforms—typically associated with products as diagnostic reagents, QC products, and calibration materials—to completely liquid stable and ready-to-use formats. Products that clearly benefit from such a product design are those categorized as being clinical reference materials. As defined here, these clinical reference materials are those products specifically used for the calibration and calibration verification of clinical testing systems, along with the validation testing of both diagnostic assays and instrumentation. This testing is vital to determining a clinical system’s overall accuracy, sensitivity, linearity, and reportable range, as required under the current CLIA directives. 

Aside from the obvious ease-of-use conveniences one associates with liquid stable products, the primary reason for this design is to eliminate the inherent drawbacks associated with lyophilized/dry-fill products. 

First, all lyophilized/dry-fill products require some type of reconstitution using deionized water or special diluents. This not only results in a direct increase in labor, but there is also the added risk of possible procedural error and product waste by the laboratorian performing this task. 

Second, if materials require serial dilution, or any product manipulations to achieve desired target concentration levels (which is common with such products), the potential for procedural errors and product wastage apply again. 

Third, if deionized water is used, the quality and efficiency of the water supply plays a major role, as an inferior water system is guaranteed to result in problems with the product. 

Fourth, lyophilized products are time consuming—they take time to prepare, to fully dissolve, and to stabilize—all of which can take anywhere from 15 minutes to a full hour. Simply put, a liquid stable design improves laboratory efficiencies and productivity. 

Despite the obvious conveniences that a liquid stable format offers, there are other challenging and exigent product design specifications associated with a liquid stable product format that need to be addressed and overcome. Manufacturers of in vitro diagnostic (IVD) products incorporating a liquid stable design need to address these specifications so that their results are not only transparent, but also beneficial to the clinical laboratory. Considering that clinical reference materials are, for the most part, only used on an as needed basis, the laboratorian responsible for their acquisition not only needs to be cognizant of the aforementioned specifications, but to other product attributes to ensure that the laboratory receives as much value for their money. That said, a few of the most important and key facets to consider when acquiring liquid stable clinical reference materials include the product’s stability claims, formulation and composition, overall packaging and fill volumes, available instrument applications, and finally, regulatory compliance concerns.

In summary, all of the product attributes associated with a liquid stable and ready-to-use offering of clinical reference materials result in a product line featuring unparalleled convenience, stability, and accuracy. Now actively producing reliable results in some of the most demanding clinical testing facilities, the availability of these materials is certain to meet the needs of a wide variety of medical laboratory professionals, including those involved in routine laboratory testing, clinical research applications, and in the development and manufacturing of IVD products.