Physician office analyzers. Do they satisfy medically useful criteria for analytical performance of laboratory tests?

The coefficients of variation (CVs) for several tests on physician office analyzers were compared with published data for medically useful criteria of these tests. Medically useful CVs were based on physicians' opinions of significant changes in laboratory tests. Precision studies using control material were carried out on four physician office analyzers by both a trained technologist and nontechnical personnel, such as physicians, nurses, and medical office personnel. This study was carried out during a six-month period. The instruments that were evaluated were the Reflotron, Seralyzer, Vision, and DT60. Low and high concentrations of quality control material, supplied by the manufacturer and those in use in the study laboratory (Omega I and II, Cooper Biomedical, Fairhaven, NJ), were used. With few exceptions, all instruments satisfied the medically useful CVs criteria, ie, the precision obtained by both the technologist and nontechnical personnel either equaled or exceeded the precision requirements set by physicians.