Re: CLIA rules on antibody expiration dates
Wayne Green (Wayne.Green@genetics.utah.edu)
Mon, 23 Oct 1995 10:25:26 -0600
We had a similar dilema which was resolved at the state level in Tennessee. In
discussions with the state we were told that if we could document that these
"expensive reagents" were still funtioning properly we could use them beyond the
expiration date. Several labs across the state helped gather data for
presentation to the state board showing that the initial qc of the reagents,
with respect to per cent positives and fluorescent intensity, remained unaltered
bewond the expiration date. The state then allowed an exception which permitted
continued use of expired reagents IF you had the qc data in your lab to
demonstrate that the bottle of expired reagent was still performing as it had
when first received. A similar approach may work for your situation; after all
the goal is to make sure accurate results are being reported and if you show the
reagent is working properly the results should be correct (al other things being
equal).
I left Tennessee in the summer of 1994 and don't know the current
success of this system. If you want an update check with Jim Price at the
VA/Vanderbilt Flow Lab (615 327-4751 ext. 5859) or Keith Shults at Cytometry
Associates in Brentwood, TN (615 370-8393). Good luck!
--
Wayne Green
wgreen@genetics.utah.edu
CD ROM Vol 2 was produced by staff at the Purdue University Cytometry Laboratories
and distributed free of charge as an educational service to the cytometry community.
If you have any comments please direct them to Dr. J. Paul Robinson, Professor & Director, PUCL,
Purdue University, West Lafayette, IN 47907. Phone:(317) 494-0757; FAX (317) 494-0517; Web http://www.cyto.purdue.edu
EMAIL robinson@flowcyt.cyto.purdue.edu
