recommended storage temperature of the product and also at its equivalent raised temperature (for example, 9 days at 5°C which is approximately equivalent to 6 hours at 35°C) and comparing a key chemical parameter such as pH for the two conditions may provide insight into if the raised temperature used in the accelerated stability studies creates a change in pH that is not normally observed during real time stability studies. The results of the rapid study may suggest that the accelerated model may not be appropriate for estimating shelf life for a reagent and, consequently, will avoid an accelerated stability study with poor predictive value.
REFERENCES
1. CLSI QRSLDT, Quality System Regulation for Laboratory Developed Tests: A Practical Guide for the Laboratory, January 2015.
2. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, September 2009.
3. EN ISO 23640, In Vitro Diagnostic Medical Devices - Stability Testing of In Vitro Diagnostic Reagents, November 2009.
4. Tinoco JR, Sauer K, Wang JC. Physical Chemistry: Principles and Applica- tions in Biological Sciences, 1st Ed. New Jersey: Prentice Hall; 1978: 294-7.
FDA guidance on using expired lab products By MLO Staff
The U.S. Food and Drug Administration (FDA) offered guidance on the use of expired products in October 20211
due to shortages during the COVID-19 pandemic.
Many critical supplies weren’t available due to supply chain shortages, shipping delays and manufacturing problems, but testing needed to continue. Throughout the COVID-19 response, laboratories have faced limited reagent, kit and material inventories, with some reagents approaching or passing expiration dates. The FDA offered guidance, saying that critical supply shortages may necessitate the use of expired reagents to maintain testing. According to the FDA, a medical product is typically labeled by the manufacturer with an expiration date. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. In some cases, testing has shown that certain prop- erly stored medical products can be used beyond their labeled expiration date if they retain their stability. The FDA is engaged, when appropriate, in various expiration dating extension activities. During the COVID-19 public health emergency, the
Centers for Disease Control and Prevention (CMS) will allow laboratories to use expired COVID-19 test kits, reagents and swabs, as long as the appropriate testing and documentation is maintained and the manufacturer’s instructions do not prohibit use of the expired material (see CMS FAQ #27 [12-17-2020]) (CMS, 2020).2
This guidance stated, “When in-date
reagents are unavailable, it may become necessary to frame written policies for their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would allow for the regular use of expired reagents.” Thus, labo- ratories may use expired supplies until non-expired
supplies become available provided that they put pol- icies and procedures in place to ensure the reagents are performing as expected (e.g., ensuring that any expired supplies pass quality control tests with each assay run).
Guidance offered by the FDA The FDA says laboratories should establish written poli- cies and procedures regarding use of expired reagents, and consider the following key points •When possible, request that the manufacturer pro- vide a letter of expiry extension for the reagent or test kit, or document in writing that the manufacturer would vouch for the accuracy and reliability of the reagents while in use past the expiration date.
•Place these letters in the laboratory’s reagent QC binders. It is important to note that regardless of CMS enforcement discretion, laboratories remain respon- sible for ensuring the accuracy of their test results.
•Setting expiration dates is historically the manufac- turer’s responsibility. Expiration date establishment requires considerable effort, particularly for a testing laboratory during a pandemic.
Expiration date practices are outlined in: CLSI EP25-A Evaluation of Stability of in vitro Diagnostic Reagents and Approved Guideline and ISO EN 13640, Stability Testing of in vitro Diagnostic Reagents. If using expired reagents in a laboratory, QC must be closely monitored and consider doing additional QC. Shortages of supplies and reagents may necessitate additional verifications or validations to add new speci- men types, media types or other testing components.
REFERENCES
1.
https://www.fda.gov/emergency-preparedness-and-response/ mcm-legal-regulatory-and-policy-framework/expiration-dating-extension
2.
https://edit.cms.gov/files/document/frequently-asked-questions-faqs-clia- guidance-during-covid-19-emergency-updated-12-17-2020.pdf
MLO-ONLINE.COM JANUARY 2022 39
Tim Fischer, MS, serves as Associate Director of Research and Development for Bio-Rad Laboratories Quality Systems Division in Irvine, CA, and oversees product development and product enhancement projects.
5. Ebrahim A, DeVore K, Fischer T. Limitations of Accelerated Stability Model Based on the Arrhenius Equation for Shelf Life Estimation of In Vitro Diagnostic Products. Clin Chem, 67, 684-688 (2021).
Karl DeVore, BA, is a Principal Scientist for Bio-Rad Laboratories Quality Systems Division in Irvine, CA. He designs and develops quality controls and evaluates new technologies for stabilization of biomarkers and analytes.
Alireza Ebrahim, PhD, serves as the Associate Vice President of Research and Development for Bio-Rad Laboratories Quality Systems Division in Irvine, CA. His group is involved in the development of independent quality control products used for monitoring the performance of laboratory analyzers.
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