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UK Medical Devices Agency (MDA) praises Amerlite Processing Center

This article was originally published in Clinica

Executive Summary

Johnson & Johnson's automated Amerlite Processing Center is a significant advance on the previous system, says a UK Medical Devices Agency evaluation. The reviewers did experience some assay problems but said these would only affect a few samples. Most kits showed robustness and good calibration curve stability for at least six weeks. All except the oestradiol assay had imprecision under 10% and heterophilic antibodies only affected tests at high concentrations.

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