Q: How frequently should I test targets for my molecular multiplex testing assays? A: This is a common question for inspectors, vendors, and laboratorians. Unfortunately, there are no cut-and-dried answers, but there are some best practices that you can apply…
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Microbiologics offers four unique QC microorganism products designed specifically for GPT that provide 10-100 CFU per 0.1 ml of hydrated suspension as required by USP guidelines. Learn more. Visit our website for helpful technical documents and instructional videos including a step-by-step tutorial on how…
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Dear Stanley, Lately, our lab has been experiencing PCR results that don’t fit with what is expected. We will see occasional positive results in a negative sample. I think the issue could be related to contamination in the lab, but…
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Cannabis has become a widely accepted form of medicine for patients across the United States. These patients, many of whom are immunocompromised, rely on testing laboratories to ensure the safety of the products they use. The lack of consistent and…
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Microbiologists use the streak plate method every day to isolate colonies. Streaking may seem like Microbiology 101, but bad habits can lead to errors and contamination. Follow these best practices to get your streaking technique down to a science. 1….
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Think you’re a microorganism growth requirements expert? Our culture method quiz will challenge even seasoned microbiologists while providing an opportunity to learn about some common and rare strains. Good luck and have fun! Read Next – Ask an Inspector: When…
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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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