How Do I Validate This Assay When I Don’t Have Positive Specimens?

11月 6th, 2012 / David Polchert

One almost universal frustration in validating a new assay is sourcing the appropriate clinical samples. Wouldn’t it be nice if there was a source for your positive test specimens?

Validating a new clinical diagnostic molecular assay can be extremely challenging. Laboratories face numerous barriers and pitfalls when traveling the road from evaluation to going live. For example, while the Luminex® xTAG® Gastrointestinal Pathogen Panel* assay offers a multiplexed test that allows for many pathogen targets to be detected simultaneously, each of these individual targets must be validated. In addition, completing these validations can be particularly difficult if any of the targets are scarce. We want to help you negotiate this obstacle that stands between your lab and multiplexing bliss.

We are attempting to build a sample repository to resolve this very issue at our laboratories in Austin, TX. Creating this type of resource will allow us to assist laboratories as they begin the journey to bring a multiplexed molecular test on board. But unfortunately, we cannot do this alone.

We need your help! Help us to help you and your colleagues! We are currently seeking any stool samples that are positive for the following pathogens:

  • Cryptosprodium
  • Y. enterocolitica
  • Salmonella
  • E. coli LT
  • E. coli ST
  • Norovirus GI
  • Norovirus GII
  • Rotavirus
  • Adenovirus
  • Shigella
  • C. diff Toxin A
  • C. diff Toxin B
  • Campylobacter
  • Giardia
  • Vibrio
  • E. histolytica
  • E. coli O157
  • Shiga Toxin 1
  • Shiga Toxin 2

Samples should be stored in the freezer in preservative free media. Isolates are welcome as well.

* For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.