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A control survey was conducted to check the accuracy of automated analyzers used in the evaluation of clinical chemistry parameters in nonclinical toxicology studies. Pooled serum samples from male Sprague-Dawley rats were delivered refrigerated to each facility 98 laboratory facilities throughout Japan within 18 hours after sample preparation and analyzed. Commercially available normal human serum samples from a single lot were also analyzed at the same time. Survey results were divided into three categories. (1) Parameters with small coefficient of variation (CV) values for both rat and human serum samples included protein, glucose, cholesterol (CHO), urea nitrogen (UN), sodium (Na), potassium (K), chloride (Cl), calcium (Ca), and inorganic phosphate (IP). Definition of normal values in rats should be straight forward for these parameters. (2) Parameters with large CV values, but with a relatively good correlation between rat and human values include triglycerides (TG), glutamic oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), glutamic pyruvic transaminase/alanine aminotransferase (GPT/ALT), and alkaline phosphatase (ALP). Measurements based on different principles gave different mean values, and this values contributed to the increase in CV values. Assessment of normal values would require a consideration of the measurement principles. (3) Parameters with large CV values only in rat serum samples included albumin (albumin/globulin ratio: A/G ratio), creatinine (CRE), and total bilirubin(BIL). Reactivity was different in rat albumin (ALB), depending on the reagents used. This difference needs to be corrected with values available by electrophoresis, or adjusted by rat ALB values, because of the lack of an appropriate measurement method. The enzyme method gave low values for rat CRE, which suggests the need for further examination of this method. The BIL values were extremely low in rat samples. It seems to be necessary to select appropriate methods to measure clinical pathology parameters correctly for rats. There was no deviation in values due solely to the mechanical operations of the analytical equipment. Non-standard initial settings of the equipment (equipment originally intended for human samples, but now applied to animal samples) was the main cause of the wide range of analytical values seen.

Objective: To compare the efficacy of a globulin-containing protein source, Synthetic Serum Substitute (Irvine Scientific, Santa Ana, CA) and human serum albumin (HSA) in the early culture of human oocytes and embryos., Design: Oocytes from 31 consecutive IVF cycles were assigned alternately to dishes containing human tubal fluid (HTF) and either Synthetic Serum Substitute or HSA as the protein source. Each semen sample was split for processing in Synthetic Serum Substitute or HSA. Sperm processed in Synthetic Serum Substitute was added to oocytes cultured in Synthetic Serum Substitute, and sperm processed in HSA was added to oocytes cultured in HSA. After determination of fertilization, zygotes were placed in HTF containing the same protein supplement. Before transfer, the embryos were graded morphologically., Main Outcome Measures: Occurrence of normal fertilization and embryo quality as assessed by morphological grading., Results: There was no significant difference in the occurrence of fertilization or in embryo morphological quality between oocytes cultured in Synthetic Serum Substitute as compared with HSA., Conclusions: The use of a globulin-containing protein source in culture for IVF-ET did not improve the fertilization rate or embryo quality. Our design did not allow for demonstration of an effect on pregnancy rate.