Expired reagent with Galileo

[FRahman]

can anybody comment if we can use expired system liquid in galileo and how long post expiry, thanks.

[RR1]

Hi FRahman,

I presume you mean the PBS, in which case as this is used for washing the Capture-R plates you need to be very careful . If you failed to detect an antibody that subsequently caused problems it would be difficult to prove the fault was with anything other than the expired saline that you knowingly used, and the company would wash their hands of any responsibility (just as any company would), so it would be down to negligence by the laboratory. This is regardless of how well your controls worked.

If you are willing to take this responsibility then you need to document the reasons- and possibly check pH daily as a minimum?

[Lcsmrz]

CLIA says you can't use expired reagents ...

Our Medical Director allows the use of expired panel cells in specific situations with his written approval.

[adiescast]

I do not recommend using expired system liquid. I don't think any regulatory group would approve of it and I think the quality issue would come back to bite you as Rashmi says.

[TimOz]

Another perspective:

Apart from CLIA regulations, I think the best way to look at this is that IF you use expired reagents the reagent manufacturer is no longer legally responsible for the product performance. This is important as they will not support you in any way if there is a problem and perhaps more importantly, their indemnity insurance cover will not apply. In other words, you become legally responsible for the reagent performance. Have you validated the performance of the expired reagent under all conditions? Does your own facility have indemnity insurance that will cover an unfortunate event?

If not, it is simply not worth the risk to use an expired product or to put it another way, "those days are gone".

Edited February 15, 2010 by TimOz