Industry inter-lot variation standard for Enzyme Linked Immuno Sorbent Assay (ELISA)

Rocke

Involved In Discussions
#1
Hello,
Does anybody have any input as to what inter-lot variation is to be expected for ELISA's or immunoassays in general?

Reagrds
Camilla

Note: ELISA stands for Enzyme Linked Immuno Sorbent Assay
 
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Ajit Basrur

Staff member
Admin
#2
Re: Industry inter-lot variation standard for Enzyme Linked Immuno Sorbent Assay (ELI

Hello,
Does anybody have any input as to what inter-lot variation is to be expected for ELISA's or immunoassays in general?

Reagrds
Camilla

Note: ELISA stands for Enzyme Linked Immuno Sorbent Assay
As per, FDA

It is also noted that different analyses are appropriate when the bounds of the release criteria are independent of the assay (e.g., bounds of 80-120% of a set value and an assay precision of 1%).
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Re: Industry inter-lot variation standard for Enzyme Linked Immuno Sorbent Assay (ELI

It depends on your sensitivity and specificity requirements (label claim).

Also must take into account dynamic range, cutoff values prevalence, etc.

The answer: it depends.
 
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