Multi-center evaluation of analytical performance of the Beckman Coulter AU5822 chemistry analyzer.

OBJECTIVES: Our three academic institutions, Indiana University, Northwestern Memorial Hospital, and Wake Forest, were among the first in the United States to implement the Beckman Coulter AU5822 series chemistry analyzers. We undertook this post-hoc multi-center study by merging our data to determine performance characteristics and the impact of methodology changes on analyte measurement. DESIGN AND METHODS: We independently completed performance validation studies including precision, linearity/analytical measurement range, method comparison, and reference range verification. Complete data sets were available from at least one institution for 66 analytes with the following groups: 51 from all three institutions, and 15 from 1 or 2 institutions for a total sample size of 12,064. RESULTS: Precision was similar among institutions. Coefficients of variation (CV) were <10% for 97%. Analytes with CVs >10% included direct bilirubin and digoxin. All analytes exhibited linearity over the analytical measurement range. Method comparison data showed slopes between 0.900-1.100 for 87.9% of the analytes. Slopes for amylase, tobramycin and urine amylase were <0.8; the slope for lipase was >1.5, due to known methodology or standardization differences. Consequently, reference ranges of amylase, urine amylase and lipase required only minor or no modification. CONCLUSION: The four AU5822 analyzers independently evaluated at three sites showed consistent precision, linearity, and correlation results. Since installations, the test results had been well received by clinicians from all three institutions.

Evaluation of major active components in St. John's Wort dietary supplements by high-performance liquid chromatography with photodiode array detection and electrospray mass spectrometric confirmation.

A RP-HPLC method with photodiode array detection and LC-electrospray ionization (ESI) MS confirmation was established for the determination of major active components in St. John's Wort dietary supplement capsules. The samples alternatively were extracted with ethanol-acetone (2:3) using a 55 degrees C water-bath shaker or an ambient temperature ultrasonic bath. Extracts were separated by RP-C18 chromatography using a 95-min water-methanol-acetonitrile-trifluoroacetic acid gradient. The major components were identified by photodiode array detection and then confirmed by LC-ESI-MS. The quantification of components was performed using an internal standard (luteolin). This method may serve as a valuable tool for the quality evaluation of St. John's Wort dietary supplement products.

The regulation of experiments on animals in the United Kingdom.

In Britain animals being subjected to experiments which are likely to cause them pain have been protected by statute for more than 100 years. The relevant statute is the Cruelty to Animals Act, which was passed by Parliament in 1876. Today, the substance of the Act is exactly the same as it was 100 years ago and it is still an effective instrument for exercising a tight and detailed control over animal experiments in the United Kingdom. The paper describes the essential features of the Act and the methods by which Her Majesty's Government ensures that the provisions of the Act are complied with: these methods include a system of inspection which is also described. Differences between the United Kingdom's method of control and methods used in other countries are referred to where appropriate. Discussions and consultations have been taking place in preparation for the replacement of the Cruelty to Animals Act, 1976 by a new Act which will recognise and reflect the changes in techniques and in attitudes which have occurred during the past 100 years. Her Majesty's Government has indicated the changes it would like to see introduced.