Almost nine years ago, the Food and Drug Administration (FDA) held a public meeting to discuss the oversight of laboratory developed tests (LDTs). As LDTs became more complex and integral to clinical diagnostics, the agency considered a risk-based approach for…
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Last week, we asked you to determine which common food-borne pathogen, Escherichia coli or Salmonella spp., was causing the enteric infection described in our latest Clinical Case File. The results are in, and we’re proud to share we have some…
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The case of an ambiguous food-borne pathogen causing an enteric infection is the first in our new series of clinical case files. Read the case study below and then use your microbiology expertise to determine which pathogen is causing the…
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Dear Stanley, I’m interested in a Microbiologics Helix Elite™ Synthetic Standards product, but I’m unsure if it will work for my assay. I read your post, Differences Between Synthetic and Inactivated Molecular Standards, but I’m still not confident the product…
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Our team of writers kicked it up a notch in 2018 to create a steady stream of fun and informative posts for our readers. The best of the best from 2018 are listed below. We hope these posts help you…
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Dear Stanley, I’m wondering if you have tips for QC in the molecular lab? We’re starting up a new training program and are looking for best practices to share with our staff. Shirley Columbus, Ohio Dear Shirley, You’ve come to…
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From board games to bacteria leggings, our list of holiday gift ideas has something for every microbiologist on your list. Healing Blade Defenders of Soma: Infectious Disease Card Battle Two player card game that increases familiarity with antibiotic misuse. The…
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Dear Stanley, I’m completely confused about the terms “assayed” and “unassayed” in relation to controls for molecular diagnostic instruments. Does “unassayed” mean the manufacturer of the control hasn’t tested the products? Can you shed some light on what these terms…
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Cold and flu season is right around the corner. These annual illnesses are often paired with another highly contagious infection, strep throat. Its culprit, Group A Streptococcus, can cause a variety of other illnesses including invasive diseases such as cellulitis…
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There are many misconceptions in the clinical industry regarding laboratory quality control materials. With numerous products available and manufacturers using various labeling practices, how do you know what’s best for your laboratory? To help clear up the confusion, we’re answering…
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