EXCYTE 20

validate the EXCYTE 20 for the performance of Erythrocyte Sedimentation Rate (ESR) by Westerngren Method. EXCYTE 20 performs a complete sedimentation rate test in 30 minutes. It holds up to 20 samples, providing laboratory the capability of performing up to 40 sedimentation rates per hour.

OBJECTIVES:
1. Verification will be run using five normal and five abnormal Accu-Sed Plus controls with known values. Each of these ten samples should be measured three consecutive times for a total of thirty (30) results. The samples should be well mixed before each testing period. Calibrator is not needed for this instrument.
2. After measurement, results should be compared against the known values of the controls. All results should fall within the control ranges. If any of the single results is out of range, the sample should be tested again and the results recorded.
3. Validation of Excyte 20 will be run using 100 patient samples. Samples must be run using the old method and run it parallel with the Excyte 20A and Excyte 20B. Samples must be run within 4 hours from the collection time. Quality control must be done once a day.
4. Test additional 10 abnormally high patient samples.
5. Data statistics will be made using EP evaluator

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