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Organism Identification

Organism Identification

The Organism Identification tests are used to characterize product bioburden and/or environmental bioburden and to identify organisms in sterility positives and confirm the presence or absence of possible objectionable organisms in tissue.
Nelson Laboratories combines different methods that complement each other in order to provide our customers with the best options for organism identification.

View our Rapid Microbial Identifications options.

Applicable Standards

  • USP 71
  • ISO 11737
  • USP 1113
  • USP 61/62

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test Request Quote
IDG105 Organism ID: Genotypic identification, MicroSeq w/ Gram stain Add
IDG215 Organism ID - Standard: Genotypic, MicroSeq w/ Gram stain (pure culture) Add
IDS330 Organism ID: Vitek 2 Compact - Standard Add
IDS510 Organism ID: Gram Stain only Add
IDS530 Organism ID: Correlation, per set (up to 10 plates) Add
IDS720 Organism ID: Preparation and culturing (mixed org.) Add
IDS750 Organism Identification: Second try - alternate system, per isolate Add
IDG105 - Organism ID: Genotypic identification, MicroSeq w/ Gram stain
IDG215 - Organism ID - Standard: Genotypic, MicroSeq w/ Gram stain (pure culture)
IDS330 - Organism ID: Vitek 2 Compact - Standard
IDS510 - Organism ID: Gram Stain only
IDS530 - Organism ID: Correlation, per set (up to 10 plates)
IDS720 - Organism ID: Preparation and culturing (mixed org.)
IDS750 - Organism Identification: Second try - alternate system, per isolate

Sample Specifications

IDG105: Per isolate
IDG215: sample to be submitted as a pure isolated culture on an agar plate

Study Outline

The Organism Identification tests are performed following bioburden, environmental monitoring, tissue testing, microbial limits and on sterility or BI positives.
 
Test systems available are:
  • MicroSeq® library and an Applied Biosystems/Hitachi 3500xL Genetic Analyzer
  • Gram stain
  • Vitek® 2 Compact
  • Classical Mold Identification (Genus only)
Gram stain: Isolated colonies are examined for colony morphology, Gram reaction and cell morphology.

Vitek: The microorganism is streaked onto the appropriate medium and incubated for 18 – 70 hours. It is then suspended in 3 ml of saline and tested using the appropriate card type. Identification is based on patterns of biochemical utilization in a 64-well card and through the introduction of Advanced Colorimetric™ technology.  A Gram stain is included as part of the test, so that the appropriate card type is chosen.

Classical Mold Identification (Genus only): A lactophenol cotton blue mount is used to visualize the morphological structures of the mold. The identifications are made based on morphological similarities to known organisms.

Genetic identification: This uses DNA instead of traditional biochemical reactions. It entails collecting the DNA from a microorganism (16S ribosomal DNA for bacteria and D2 region ribosomal DNA for fungi), creating many copies of the target region, then sequencing and comparing the unknown sequence to the MicroSeq library. If a match is not found in the MicroSeq library, a public database may be searched.

A Gram stain is done along with the genetic identification when testing involves sterility or BI positives and other liquid preparations. 

The Gram stain is done to verify pure culture.   It provides a phenotypic component which makes the identification more complete. 

Gram stains are recommended to determine if organisms are bacteria or yeast.

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