• Home
  • About
  • UPCOMING WEBINARS & SEMINARS
  • Consultation
  • USP 61/62 FAQ
  • Contact

Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

BEST METHOD TO DETERMINE THE IDENTIFICATION OF A MICROORGANISM

June 2, 2011 By Barry Friedman Leave a Comment

DIFFERENTIATION BETWEEN PHENOTYPIC AND GENOTYPIC IDENTIFICATION MECHANISMS

Recently, a Blog was published that identified the fifteen most common bacterial isolates identified by Accugenix, Inc, Newark, DE during 2010.  This Blog created an interest in other related areas to include the best methods to assure a definitive identification of an isolated bacterium.

In a poster presented at the most recent American Society for Microbiology, Accugenix compared multiple technology solutions to determine the fitness for use studies beyond routine panels provided by manufacturers to understand both the performance and operation impact vs. the various environmental monitoring systems.  The goal was to assure each customer the highest percentage of accurate identification to the species level.  The systems compared permitted identification by either phenotypic or genotypic methods.

The data suggests that the greatest percentage of satisfactory matches occurred in the following order (from highest to lowest):

            Accugenix (DNA Sequencing using the Accugenix Bacterial library 04APR11)*

            Applied Biosystems MicroSEQ® v. 2.2*

            Bruker MALDI-TOF® v. 3.1.2*

            Biolog GENIII®**

            bioMerieux Vitek® v. 2.2**

NOTE: *=Genotypic Method; **=Phenotypic Method

One additional system, MIDI, also known as Fatty Acid Methyl Ester (FAME), which had been utilized by Accugenix for a number of years, was not included since its use had been discontinued (by Accugenix).

None of these systems is designed to compare microorganisms of the same species.  The DuPont Qualicon RiboPrinter® system is available to compare strain-specific characterization where additional subspecies identification is required.

The above systems also exhibit some unique features and requirements.  For example, the Vitek, Biolog and MALDI-TOF systems require living microorganisms to obtain identification.  The Applied Biosystems and the Accugenix modification of the same do not require living cells, but it is desirable to use them if possible.  In selected instances, testing laboratories will not test nor will postal authorities permit the shipment of live, hazardous or pathogenic microorganisms and these bacteria can only be shipped to the testing laboratories once they have been killed. 

Other limitations of the MALDI-TOF system include the age of the culture, temperature of storage, not in a sporulation state and requirement for fresh growth.  Please discuss exact requirements with your testing facility.

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on Facebook (Opens in new window)

Related

Filed Under: FDA Compliance, Regulatory Compliance Tagged With: Accugenix, Applied Biosystems, BioLog, FAME, genotypic method, identification of microorganisms, MALDi-TOF, MicroSEQ, phenotypic method, RiboPrinter, Vitek

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

New Reader? Learn More

Connect With Me:

  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Webinar Registration & Information

FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

TOP OBSERVATIONS:

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010

Top Posts:

Top Posts for 2012

Top Posts for 2013

Top Posts Year To Date

Recent Posts

  • Upcoming Microbiological Webinars
  • Microbiological Webinars
  • Microbiological Webinars 2020 (Upcoming)
  • General Chapter (USP<60>) on B. cepacia Complex to Issue December 1, 2019
  • Les Produits Chimiques B.G.R., Inc. Receives FDA Warning Letter (07/24/2018) for Failure to Perform Laboratory Testing

Categories

follow us in feedly
  • Home
  • About
  • UPCOMING WEBINARS & SEMINARS
  • Consultation
  • USP 61/62 FAQ
  • Contact
  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter

Thank You For Visiting Barry A. Friedman, PhD LLC - 2015

Welcome To My Blog!
Please enter your name and email below to receive my newsletter.
Your information will *never* be shared or sold to a 3rd party.