Performance of latex-fixation kits used for serologic diagnosis of rheumatoid factor in rheumatoid arthritis sera.

Ten latex-fixation kits (both slide and tube) were evaluated by use of a reference serum containing 250 IU of rheumatoid factor (Communicable Disease Center). All tests were performed with serial dilution of serum; adjacent tubes differed by a factor of 0.10 log10. Geometric titers, means, standard deviations, and variance analysis were used to evaluate commercial kits. Three levels of variance were applied: (1) 0.18 or less for intralaboratory variation when the same serum is tested with the same kit; (2) 0.18-0.35 when various lots or batches of the same serum were used; (3) 1.0 or less when various commercial kits were tested with the same serum. The sensitivity of each commercial kit was determined by assigning to it a value (the minimum detectable unit) arrived at by dividing the number of units in the standard by the titer obtained. The technic presented could be applicable to other serologic tests, and thus provide a general method for their standardization and quality control.