Biomedical Laboratory Science

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Showing posts with label Standardization. Show all posts
Showing posts with label Standardization. Show all posts

Thursday, November 3, 2016

Standardization And Implementation of Lab Policies Ensure Hemostasis Sample Quality

How many of us remember the tilt-tube method for basic hemostasis testing? Fortunately, today’s instruments have automated most of these manual steps. However, until recently, assuring sample quality in the pre-analytical phase of testing had remained a manual process and had been difficult to implement and standardize.

Several questions must be considered when evaluating the integrity of a hemostasis sample: Is the sample tube under-filled? Is the sample hemolyzed, icteric, or lipemic? If so, do the levels of the interferent impact the testing results? Is there a clot in the sample?

All labs have policies on sample acceptance and rejection. Inappropriate rejection of acceptable samples—requiring redraw—directly impacts patient care, patient satisfaction, and cost. Failing to reject inappropriate samples can lead to the reporting of erroneous results, impacting the quality of patient care and associated cost. Let’s take a look at the most common pre-analytical quality issue culprits.



Tuesday, April 19, 2016

Standardizing Immunoassays: The Benefits of Conformity

Interpreting results of immunoassay-based methods frequently presents a challenge for physicians, especially when caring for patients at multiple institutions that use different assay platforms. For many analytes including tumor markers, endocrine hormones, and cardiac biomarkers, results generated on different platforms are not directly comparable. This is due to the absence of a universally accepted reference material, which manufacturers need to calibrate their assays to a common standard.

Instead, test results must be interpreted using assay-specific reference intervals—a concept that comes naturally to clinical laboratorians but often is foreign to many physicians and patients. This lack of uniform results causes confusion that can adversely affect patient care, particularly when patients are diagnosed at one hospital but pursue follow-up care elsewhere. For example, does an increased CA-125 value at follow-up at a different institution reflect disease progression or simply differences in assay calibration? A lack of standardization also makes it impossible to transfer diagnostic cutoffs from one institution to another unless the assay platforms are identical.

Given the confusion associated with non-standardized assays, why haven’t all immunoassays already been standardized?



Source: alfa
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