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Use and Application of QC organisms

QC organisms
Key Characteristics
  • QC organisms are traceable type cultures with defined characturistics
  • commerical products are available in a variety of presentations
  • suitable for use in a routine quality control laboratory

Introduction
It is essential that all microbiological tests are quality controlled to guarantee the result is true and this will normally form part of a laboratory's accreditation compliance. Part of the QC procedure requires that standard or type culture organisms are used to represent 'real samples' but in a controlled manner. These should be traceable back to a known type culture with normally less than five subcultures or passes (repeated subculture of organisms can result in possible genetics changes or contamination). Many organisms for QC are available commercially in a range of different presentations, these are easy to store, easy to use (with little or no preparation time), economical and most importantly reliable and consistent.

There are a range of applications for which these quality control organisms can be used:
  • Media QC
    media prepared in house will require various growth promotion tests according to GLP, even with commercial ready to use media where most of the QC testing work has already been done, some limited growth promotion testing is still needed, particularly with media containing light or heat sensitive components.

  • Positive and Negative Controls for biochemical tests, kits and slide stains
    using qualitative inoculant for assays, kits and slide staining, the controls should reflect the organism(s) being tested for and demonstrates that the test was correctly performed. Slides for Gram and Acid Fast staining are available with positve and negative control organisms already incorporated.

  • Antimicrobial Efficacy Testing or MIC Determination
    reference strains of bacteria with known sensitivites are tested in parallel with the clinical culture to to monitor antimicrobial content of the discs/broths and the performance of the media and incubation conditions.

  • Determining Measurement of Uncertainty (MOU)
    as no method is perfect, by using a quantitative inoculum the amount of uncertainty for a particular assay can be calculated, commercial products are an easy standardised way of using a known inoculum number.

  • Determining Limits of Detection
    of qualitative or quantitative routine testing or for method validation, particularly useful if naturally contaminated materials rarely occur.

  • Challenge testing /Preservative Efficacy Testing (PET)
    using quantitative preparations of known organisms a products preservative system can be challenged and monitored using a reliable and consistent inoculum.
Packaged QC organisms are also very useful during method validation, particularly for determining measurement of uncertainty (MOU), limits of detection and other tests where a quantitative inoculant is required. When using the quantitative systems they provide greater precision and consistency batch-to-batch than self prepared organisms.

The format the QC organisms are supplied in varies, from a film of preserved organisms in the lid of a vial to freeze-dried discs or beads. All are rehydrated in some form prior to use. Some need to be kept refrigerated, others require freezing. The systems supplied in vials can be used with a pipette or culture loop, others are presented in a swab format that can be streaked directly onto a plate.

ATCC Licensed Derivative Program
The American Type Culture Collection, ATCC, runs a license program to ensure the integrity of culture organisms purchased in commercial formats. The ATCC Licensed Derivative emblem assures customers of the quality of the ATCC ingredient contained in the product. Companies who are members of this scheme are denoted with an asterisk in the tables below.

Most freeze dried/lyphilized products now come with an easy re-hydration step using supplied fluid, followed by inoculation by swab or loop.

Qualitative Testing
Supplier reference
for these items:

slide stain control

ready to use

freeze-dried/lyophilized

Qualitative tests provide a yes/no answer to questions such as does a particular media support the growth of a target organism(s).

The products listed are ideal for use in standard media QC and assay controls.
Quantitative Testing
Supplier reference
for these items:

freeze-dried/lyophilized

ready to use

Quantitative tests allow a count to be determined - how many organisms are recovered, this requires a known inoculum level. The products listed are ideal for use in method validation studies and other tests where a precise inoculum level is required.

Microscopic slides (staining controls)
There are commercially available microscopic slides that have a positive (organism) control and a negative control pre-prepared on the slide alongside a space for the test isolate or specimen. This allows for quality control of the staining technique and provides easier interpretation.
Specialist Applications
Supplier reference
for these items:

PCR

for ID systems

mixed populations

water testing

Giardia/Cryptosporidium

There are some products available that provide a simulated specimen, a mixed (clinical) population that can be very useful as assay quality controls.

For PCR testing, a specific DNA target is inserted into a typical organism and by having a known number of organisms you can obtain a known number of target sequences and so aid the QC procedure of your PCR technique.

Comments
  • Choice of supplier depends on personal preference of presentations, it can be a fiddly step getting individual pellets out of small vials

  • The ATCC Licensed Derivative program assures the safety and quality of the ATCC® ingredient provided by ATCC.

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