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View Full Version : Industry inter-lot variation standard for Enzyme Linked Immuno Sorbent Assay (ELISA) Rocke 13th February 2009, 06:26 AM 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 Ajit Basrur 13th February 2009, 10:07 AM 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 (http://www.fda.gov/cber/gdlns/grasstab.htm#ii) 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 13th February 2009, 02:28 PM 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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