Author Archive: Microbiologics

Ask a CAP 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…
Read more

Growth Promotion Test Quiz

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…
Read more

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…
Read more

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…
Read more

7 Streak Plate Method Best Practices

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….
Read more

Culture Method Quiz

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…
Read more

Ask a CAP 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…
Read more

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…
Read more

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…
Read more