Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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For Clinical Labs: Avoid False-Positives and Negatives by Being a Control Freak

Catagory: M&S

Posted by Eric Morreale on Nov 26, 2019 12:00:00 PM
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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How Third-Party Controls Can Help Keep Your Clinical Lab Within Budget (Without Sacrificing Quality)

Catagory: M&S

Posted by Eric Morreale on Nov 19, 2019 12:00:00 PM
As a clinical lab director, you are driven by two forces which, at first glance, may seem in opposition to each other. The first is your commitment to delivering accurate diagnostic test results to healthcare providers, a responsibility critical to ensuring that patients receive the most effective and timely treatment possible. In your lab, this means instituting a strong quality control (QC) program aimed at ensuring test performance and preventing the release of inaccurate results. The second driving force is the responsibility you have towards to running an efficient, cost-effective clinical lab operation. This entails the responsibility to manage resources efficiently, to stay within allotted budget guidelines, and to avoid unnecessary spending. The obvious assumption is that higher quality translates into higher costs (and bigger budgets). Look closer, however, and you’ll discover that the two forces outlined above are not necessarily opposed. As you’ll see below, increasing accuracy and reliability in a clinical testing lab — through investment in additional QC measures, such as high-quality third-party controls — can actually translate into decreasing costs. Staying within budget and providing reliable results can go hand in hand.
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3 Tips for Reducing Test Repeats and Lab Downtime

Catagory: M&S

Posted by Eric Morreale on Nov 12, 2019 12:00:00 PM
The world of a clinical testing lab is one of high pressure. The pressure comes from clinicians who want their results as quickly as possible. It comes from directors and managers who demand efficiency. And most of all, it comes from a constant stream of samples that never lets up. In this era of largely automated instrumentation (operating almost always at full capacity), few things are more frustrating to lab personnel than errors that result in downtime, troubleshooting, and the need to rerun tests. Reportable results is the most important metric in a clinical lab. Any result that is not reportable translates into higher costs, more downtime, and a growing backlog. What can you do to reduce momentum-killing test failures and repeats while increasing your reportable result rates?
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For Clinical Labs: How to Ensure a Consistent Supply of High Quality Reference Materials

Catagory: M&S

Posted by Eric Morreale on Oct 29, 2019 12:00:00 PM
Healthcare is — to put it mildly — unpredictable. You never know when testing demands will change due to a disease outbreak, or a shift in medical consensus. Thus, clinical labs operate with a basic mindset: be prepared.
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cccDNA and HBV:  New Testing Methods May Allow for Earlier, Non-Invasive Detection of Hepatocellular Carcinoma

Catagory: Accuplex, Molecular & Serology

Posted by Catherine Huang on Aug 23, 2018 12:00:00 PM
A recent study, published in the Journal of Molecular Diagnostics, describes a new, more sensitive Hepatitis B Virus (HBV) assay1.  This study, led by Song-Mei Liu, MD, PhD, of the Center for Gene Diagnosis, Zhongnan Hospital of Wuhan University in China, is particularly exciting because the new assay can be used to diagnose hepatocellular carcinoma (HCC) at an earlier stage and to manage antiviral HBV treatments more effectively. It also highlights the way innovative molecular diagnostics can play a synergistic role with the development of new pharmaceutical therapeutics.
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Ebola Outbreak 2018: Diagnostics Again are Essential to Minimize Spread and to Control Disease

Catagory: Accuplex, reference materials, ebola, Molecular & Serology

Posted by Catherine Huang on Jun 25, 2018 12:00:00 PM
On April 4th, 2018, a new outbreak of Ebola Virus Disease (EVD) occurred in Equateur Province in the Democratic Republic of the Congo. As of June 10th, there have been a total of 55 EVD cases and 28 deaths with a case fatality rate of 50.9%. Although the outbreak remains active, public health authorities have expressed cautious optimism because there have been no new cases in two of the three affected areas (Bikoro and Wangata zones) since May 17th, 2018 and the rate of new cases in the third affected zone (Iboko) has slowed.1
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Rapid and Early detection of Listeria to prevent food poisoning

Catagory: Accuplex, listeria, Molecular & Serology

Posted by Vidya Murthy on Sep 12, 2017 12:00:00 PM
September is National Food Safety Education Month. This is also a time to return to school and learning, so it is a good time to learn about food safety in ready-to-eat and perishable foods often packed in school lunches. Listeria is one of the most common foodborne bacteria and is found in a wide range of foods; from ready-to-eat to produce and meat. The latest draft guidance released by the U.S. Food and Drug Administration, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenes in ready-to-eat foods (1). The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill Listeria and prevent it from growing during storage of food between production and consumption. The guidance emphasizes the importance of routine testing for Listeria. Therefore, it is important to learn about the methods and reagents that can be used to detect Listeria to prevent foodborne outbreaks.
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Improve the Reliability of Your Zika Diagnostic Assays

Catagory: Accuplex, zika virus

Posted by Vidya Murthy on May 9, 2017 12:00:00 PM
What is Zika? Zika virus (ZIKV) is an arbovirus that was first isolated in 1947 in a rhesus monkey from the Zika forest of Uganda. Until 2007, only 14 human cases were reported. The first large human outbreak occurred in 2007 (Yap Island, Micronesia, Pacific) followed by French Polynesia in 2013 that resulted in more than 30,000 cases. In early 2015, the virus came to international attention due to the outbreak in Brazil. Since then the epidemic has spread to more than 50 countries in the Caribbean, Central, and South America, causing tens of thousands of infections. ZIKV is transmitted to people primarily through the bite of an infected Aedes species mosquito (Ae. aegypti and Ae. albopictus). These are the same mosquitoes that spread dengue and chikungunya. ZIKV can also be transmitted sexually and during pregnancy from the infected mother to the fetus.
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SeraCare introduces AccuPlex™ Zika Reference Material

Catagory: Accuplex, zika virus, clinical genomics, Molecular & Serology

Posted by Dale Yuzuki on May 10, 2016 12:00:00 PM
Guest author: Han Joo Lee, Ph.D., SeraCare Technical Product Manager A cursory look at recent Zika Virus outbreak news headlines is alarming enough: “Zika Virus birth defects may be the ‘Tip of the Iceberg’, experts say”; “Brain damage in Zika babies is far worse than doctors expected”; and “Zika mutates extremely quickly, which is why it’s so scary”. In addition, for the United States the estimated range maps of the Aedes aegypti and Aedes albopictus have been recently updated, widening the range previously reported to all but 10 states within the US.
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