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Clinical Laboratory Studies

Clinical measurements taken on laboratory study animals provide an important contribution to the overall evaluation of their physiology. Clinical pathology tests often provide information useful for determining the biological significance of findings in toxicity studies not detected by direct examination of organs and tissues.

NTP developed a standard approach for clinical pathology investigations that was integrated into most toxicity studies designed and conducted after 1986. Protocols for these studies include a core set of specific hematology and clinical chemistry analyses selected to permit the evaluation of a variety of organ systems at three different time points in 13-week studies. However, use of a core set does not preclude the inclusion of other clinical pathology tests in a study.

Requirements concerning the anesthetization of animals, collection and analysis of samples, and reporting of results have been established to control sources of variability within and between contract laboratories that perform these studies for NTP.

Clinical measurements include:

  1. Hematology:
    Erythrocyte count
    Mean corpuscular volume
    Packed cell volume
    Mean corpuscular hemoglobin
    Mean corpuscular hemoglobin concentration
    Erythrocyte morphologic assessment
    Leukocyte count
    Leukocyte differential
    Reticulocyte count
    Platelet count and morphologic assessment

  2. Clinical Chemistry:
    Sorbitol dehydrogenase (SDH)
    Alkaline Phosphatase (ALP)
    Creatine Kinase (CK)
    Total Protein
    Urea Nitrogen (BUN)
    Total Bile Acids
    Alanine Aminotransferase (ALT)