The preparation of a reference serum for the determination of IgG and IgM antibodies against cytomegalovirus and its evaluation in a collaborative trial.

ABSTRACT

It is now generally accepted that laboratory data produced by different laboratories using different techniques can be better compared if the results are related to a reference preparation. Even within one laboratory the use of a stable reference preparation helps to reduce the day to day variation of the results. Although this idea has been firmly established for many years the introduction of reference preparations so far has met only with limited success. One of the reasons for this development may be the lack of adequate preparation to be used for this purpose. Recently, diagnostic virology has introduced new serological methods in an effort to make a rapid diagnosis and to differentiate between acute and past infection by the determination of specific antibodies in the IgM, IgA or IgE fraction of the patient's serum. In such a situation, a reference IgM serum of low activity would help to differentiate between persistent or past and recent infection. It was therefore attempted to establish such a reference serum containing antibodies against CMV in the IgM fraction.