Q: When should I validate or recalibrate my rapid diagnostic system? A: With all the rules and regulations, it’s hard to know when a diagnostic system validation or recalibration is required. For most multiplex PCR testing instruments, the requirements are…
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Dear Stanley, I appreciated the CLSI M100 updates you shared 2018. Do you know of any changes made in the latest edition that will impact QC? Ashley from San Diego, CA Dear Ashley, I’m happy to provide a summary of…
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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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What’s all the hype with Acute Flaccid Myelitis (AFM)? Recently, there has been a lot of local and national news coverage around a mysterious, polio-like condition affecting children across the United States called acute flaccid myelitis. As of Monday, November…
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