Selecting Clinical Reagent Assay Kits

It is important to select a Clinical Reagent Assay kit that is suitable for your needs and laboratory conditions. This article covers the various aspects of a clinical reagent assay kit including the performance of the reagents, the expiry date and variations. We also cover Verification panels and reference material. We hope this article has been useful in making your choice easier. To make the right decision, always consider the following points before purchasing a reagent kit:

Expiration dates

Expiration dates for Clinical Reagent assay kits are determined by the lot number printed on the label of the reagents. You can also look up the expiration dates on the Reagent Shelf-Life Chart. If the reagent expiration date is not mentioned, the product code number can be helpful. A good rule of thumb is one year from the date of manufacture. However, it is advisable to follow the expiration date label to avoid purchasing expired reagents.

Expiration dates on Clinical Reagent Assay kits are required by law. If a product is no longer usable after a specific date, the manufacturer can request FDA authorization. The manufacturer must notify customers of the new expiration date. FDA also recommends that the test manufacturer conducts stability testing on its products to verify that they perform as expected. If the expiration date on a reagent is too long, the manufacturer must consider extending the shelf-life.

Variation in reagent performance

One common cause of variability in clinical reagent performance is variation in raw materials. Raw materials may change during production, transport, and storage. As a result, clinical laboratories should periodically test new lots of clinical reagents to ensure consistency in their performance. In addition to raw material differences, variation can occur between reagent lots as well, depending on the manufacturing process and the sample matrix. Clinical laboratories should also consider the effect of the manufacturing process on QC materials and patient samples.

In some instances, significant variations in clinical reagent performance can result in false results. However, in most cases, the impact of reagent lot variations is minimal because patients' laboratory results are closely tracked, and a sudden change in outcome can be stressful. Therefore, clinicians should use patient specimens as the basis for reagent comparability tests. For example, when analyzing cardiac troponin, serial measurements are completed using the same reagent lot.

Verification panels

Clinical reagent assays that use reference materials have the potential to produce false results. This is one reason why it is critical to perform validation studies using samples prepared according to the manufacturer's recommendations. The laboratory used to produce these materials should have an established reference range and a process to validate the results. Several factors should be considered when performing the validation process. First, the reference material must be derived from a clinical specimen.

Next, the validation process must be documented, as per the ISO definition. During validation, specific information such as the identity of the analyte, the examination procedure, the objective of the test, and sample dilutions or incubation times should be documented. Secondly, the validation process must include additional information such as interfering substances, potential sources of variation, and performance specifications.

Reference material

Reference materials (RMs) are used to ensure the quality and reproducibility of routine clinical reagent assays. They help U.S. clinical diagnostic manufacturers comply with the European Union directive requiring traceability of calibration and control values. There are over 30 SRMs available in the clinical diagnostics market. Each of these materials has been reviewed and certified by the National Institute of Standards and Technology (NIST), which is the nation's official scientific body for clinical measurements.

The use of a calibrator requires first-class reference materials to ensure accurate results. A certified reference material meets the international standards for a specific chemical or biological compound. MilliporeSigma provides a wide range of first-class reference materials that are traceable to international standards. Its accredited calibration laboratories comply with the general requirements of ISO 17025. It also has the necessary expertise to help laboratories achieve high quality control and meet the high standards of accreditation.