Objective: To calibrate and assess the suitability of international candidate standard for human pituitary luteinizing hormone(LH),lot No.81/535,and to provide data support for the applicability of candidate as 3rd international standard.Methods: The assay and stability of LH international candidate standard,lot No.81/535,were tested by radioimmunoassay,enzyme-linked immunosorbent assay;chemiluminescence immunoassay and time-resolved fluoroimmunometric assay using the 2nd IS(LH,lot No.80/552)as reference standard.Results: The geometric means of immunoreactivity for LH,lot No.81/535,was 34.2 IU per ampoule by our laboratory,which was corresponding to 103.0% of those provided in WHO report.The geometric means of immunoreactivity for stability samples B(26 years,37℃)and sample F(26 years,4℃) were 24.8 IU per ampoule and 32.4 IU per ampoule,respectively.Conclusion: Eleven laboratories around the world presented data.The geometric mean of the laboratory estimates of the LH immunoreactivity of the candidate standard,coded 81/535,is 33.2 IU per ampoule(95% confidence limits 32.1 IUper ampoule-34.3 IUper ampoule)with acceptable stability data.It is proposed by WHO Expert Committee on Biological Standardization that the candidate preparation in ampoules coded,lot No.81/535 can be used as the 3rd IS for Human Pituitary LH for immunoassay with an assigned content of 33 IU LH per ampoule.
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