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…
Read more
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…
Read more
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…
Read more
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…
Read more
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…
Read more
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…
Read more
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…
Read more
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…
Read more
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…
Read more