Evaluation of the clinitek status and clinitek 500 urine dipstick analyzers

We evaluated the analytical performance of the Clinitek Status and Clinitek 500 (C500) Urine Dipstick Analyzers (Bayer Corporation, Tarrytown, NY) compared with the Clinitek 50 (C50) and Clinitek 100 (C100). Identical results were obtained on the Status and C50 for more than 90% of samples for all analytes except pH and specific gravity. Concordance for specific gravity was only 24%, and for pH, identical results were obtained on only 36% of samples. Comparison of C500 to C100 resulted in greater than 80% concordance for all the analytes except specific gravity (64%) and pH (62%). If one category (pad) deviation was allowed, agreement between all 4 instruments was greater than 90% for all analytes except specific gravity (84%) and pH (82%). The values for pH and specific gravity obtained using Status were often one category higher than those obtained using C500. Human Chorionic Gonadotropin analysis on the Clinitek Status resulted in 2 false-positive results out of 25 negative samples tested.