Molecular

Ask an Inspector: How Frequently Should Molecular Targets Be Rotated?

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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Dear Stanley: Investigating False Positive Results

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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Microbiology’s Wild West: Cannabis Lab Leaders Talk Testing Methods and Regulations

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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Ask an Inspector: When Should a Rapid Diagnostic System Be Recalibrated?

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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LDT Oversight Deliberation Continues

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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Clinical Case File Results: Enteric Pathogen

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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Clinical Case File: Enteric Pathogen

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: Are Synthetic Standards Compatible with My Assay?

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 Top Posts from 2018

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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