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Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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SeraCare Team

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How Low Can You Go? Performance at Lower Levels is Critical

Category: Molecular & Serology, Blog

Posted by SeraCare Team on Jun 30, 2022 10:44:00 AM
Qualitative tests produce binary results, usually positive or negative. This presents a challenge for serological testing, since most of it is qualitative. Positive or negative results are determined in relation to a threshold value or cutoff. This cutoff, the line between positive and negative, is the medical decision point. It’s critical that this point is consistently acc urate at the lower limits of detection, where positive becomes negative. Without precision at the lower levels of positive results, laboratories may not feel confident in the results they present. Do they have a higher number of false positives or false negatives than they should?
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Molecular Diagnostics - Part 1: Know What to Verify

Category: Molecular & Serology, Blog

Posted by SeraCare Team on Jun 28, 2022 2:52:33 PM
    Adding a new molecular test to your lab? Make sure you understand the regulations that apply and the required performance characteristics. The following is the first in a series of articles on this topic that will include best practices.  Before we dive into the how of verification for molecular diagnostic assays, let’s take a look at the what. Clinical laboratories performing an FDA-cleared or FDA-approved test must verify that the manufacturer’s performance characteristics can be met or exceeded Laboratories performing laboratory-developed tests (LDTs) and modified FDA-cleared or approved tests, must verify the same characteristics, plus determine analytical sensitivity and analytical specificity
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