Current databases on biological variation: pros, cons and progress.

A database with reliable information to derive definitive analytical quality specifications for a large number of clinical laboratory tests was prepared in this work. This was achieved by comparing and correlating descriptive data and relevant observations with the biological variation information, an approach that had not been used in the previous efforts of this type. The material compiled in the database was obtained from published articles referenced in BIOS, CURRENT CONTENTS, EMBASE and MEDLINE using "biological variation & laboratory medicine" as key words, as well as books and doctoral theses provided by their authors. The database covers 316 quantities and reviews 191 articles, fewer than 10 of which had to be rejected. The within- and between-subject coefficients of variation and the subsequent desirable quality specifications for precision, bias and total error for all the quantities accepted are presented. Sex-related stratification of results was justified for only four quantities and, in these cases, quality specifications were derived from the group with lower within-subject variation. For certain quantities, biological variation in pathological states was higher than in the healthy state. In these cases, quality specifications were derived only from the healthy population (most stringent). Several quantities (particularly hormones) have been treated in very few articles and the results found are highly discrepant. Therefore, professionals in laboratory medicine should be strongly encouraged to study the quantities for which results are discrepant, the 90 quantities described in only one paper and the numerous quantities that have not been the subject of study.