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Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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Molecular Diagnostics - Part 3: Accuracy and Precision

Category: Molecular & Serology, Blog

Posted by SeraCare Team on Oct 25, 2022 9:45:00 AM
  We continue our series on molecular diagnostics. Previous articles covered: what you need to verify your molecular assay and the three major components of the verification process. FDA-cleared or FDA-approved tests have four performance characteristics that must be verified and documented: accuracy, precision, reportable range, and reference interval. Laboratory-developed tests and modified FDA-cleared or approved tests have two additional characteristics for verification (analytical sensitivity and analytical specificity). Now, it’s time to turn our attention to best practices for each of the performance characteristics. First up – accuracy and precision.
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Molecular Diagnostics - Part 2: Tackling the How

Category: Molecular & Serology, Blog

Posted by SeraCare Team on Aug 30, 2022 11:48:55 AM
  3 Important Stages of Assay Verification Molecular diagnostic tests are widely available in clinical microbiology laboratories now. It’s important to a lab’s success to understand the requirements before adding a new test. Protocols aren’t specified by regulators, so they vary by lab. The assay influences the controls and parameters, but the type of verification and its complexity are determined by lab directors. In a recent article, we took a look at what to verify. This is the first of several articles that will cover how to confirm a molecular assay performs as expected.
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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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Looking for the Silver Lining in the Cloud of SARS-CoV-2 Emerging Variants

Category: Accuplex, SARS-CoV-2, Disease trends

Posted by Catherine Huang, PhD on May 19, 2021 12:00:00 AM
As an RNA virus, SARS-CoV-2's genome replication is innately error-prone such that mutations are expected (1). Every now and then, a mutation will provide an adaptive advantage (such as increased transmissibility or infectivity to a human host), and will be positively selected for in the population. This process drives viral genome evolution, and gives rise to the rich diversity of viral strains and lineages that we see. However, for SARS-CoV-2, the unexpected emergence of such diversity since late 2020 has led to considerable anxiety around the progression of disease, and the efficacy of diagnostics and vaccines to control its spread.
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Key Strategies for Reducing Turnaround Time in Your Clinical Lab

Category: Molecular & Serology

Posted by Eric Morreale, PhD on Mar 3, 2020 12:00:00 AM
  They say good things come to those who wait, but when it comes to laboratory testing, faster is almost always better (assuming, of course, that accuracy is never compromised). The more rapidly that reportable results are generated, the quicker clinicians and patients can make decisions and embark on an effective treatment program. Furthermore, the more efficiently labs can run tests and generate results, the more they can accomplish. Faster turnaround times (TAT) can free up staff and resources for other activities, like growing the overall test menu. And let’s not forget the reputation factor. Labs want to be the reliable go-to for the clinicians they serve. They want to be trusted for their accuracy, professionalism, and speed.
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Is Your Lab Struggling with Burnout Like Other Labs? Here's How Reference Materials May Help.

Posted by Eric Morreale, PhD on Feb 25, 2020 12:00:00 AM
  A staffing crisis may be looming in the nation’s clinical testing laboratories, and many labs are already facing the problem. Labs are understaffed, while the demand for clinical testing is only going up. Turnover is high among lab technicians, as burnout and job dissatisfaction leads them to seek employment elsewhere or abandon their lab tech careers altogether. For lab directors, frequent turnover, diminished staffing, and employee unhappiness are vexing issues. A staff of motivated, qualified, and experienced technicians is one of the keys to generating the high volume of accurate, reportable results clinicians and healthcare organizations demand. How can you hold on to your best technicians while getting your newest team members up to the same skill level quickly? As we’ll see, an efficient and effective training program is essential. Well-trained technicians are more likely to stay in their jobs. New technicians perform at a higher level sooner when their labs prepare them for the variations they’ll encounter when working with real patient samples.
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4 Best Practices for QC in a Clinical Testing Lab to Ensure Accurate Results

Category: Molecular & Serology

Posted by Eric Morreale, PhD on Feb 18, 2020 12:00:00 AM
  What is a clinical laboratory director’s worst nightmare? That’s an easy one. The thought that, somehow, an inaccurate testing result has escaped their lab and convinced an unsuspecting clinician to make a poor patient care decision. So much of modern medical care is grounded in treatment decisions based on diagnostic testing results. According to one review of the data, 98 percent of in-patient populations get lab tests. False negatives can delay life-saving and life-improving patient care. False positives can cause patients to undergo unnecessary treatment, which can result in needless psychological, physical, and financial distress. No wonder lab directors are troubled by the possibility, no matter how small, of reporting inaccurate results - critical patient care decisions hang in the balance. (Not to mention the professional reputations of lab directors, the reputations of their labs and hospitals, and the trust of patients and clinicians.) To prevent errors in testing and reporting, quality control is a must. You need to be confident every time you report a result that your assays are working the way they are intended. Here are four tips for optimizing quality control to ensure accurate results in your clinical lab:
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How to Comply With CLIA and Pass PT With Ease

Posted by Eric Morreale, PhD on Feb 11, 2020 12:00:00 AM
  Proficiency testing under CLIA is no joke. Failed tests lead to costly downtime for equipment and personnel as labs troubleshoot to find the source of an error. In the case of proficiency testing (PT), failures lead to time invested in corrective-action measures, and in the worst case, cease-testing directives from regulatory authorities. A failed CLIA proficiency test — multiple failures, especially — is the ultimate black mark not only on the career of a lab director but on the reputation of a clinical lab.  The key to CLIA confidence is the same simple approach you took to ace your exams back in college: preparation. If you run your assays through their paces on a regular basis, and you use high-quality third-party controls to root out any weak points in your testing protocol and train your lab staff, CLIA proficiency testing will be a breeze.
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For Clinical Labs: Avoid False-Positives and Negatives by Being a Control Freak

Category: M&S

Posted by Eric Morreale, PhD on Nov 26, 2019 12:00:00 AM
Do you consider yourself a control freak? And by control, we mean quality control - the procedures and materials implemented to ensure test accuracy and precision. Most importantly, having the proper controls in place provides confidence in the accuracy of your tests and the reported results, reducing the risk of generating false-positives or false-negatives. A strong quality program has the added benefits of reducing both the amount of valuable staff time expended on troubleshooting, as well as costly instrument and assay downtime.
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