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Objective To evaluate the feasibility of PerkinElmer Genetic Screening Processor(GSP) in the application of newborn screening for congenital hypothyroidism (CH) and congenital adrenal hyperplasia (CAH) by detecting thyroid-stimulating hormone (TSH) and 17-OH-progesterone(17-OHP).Methods The dried-blood spots specimens from Centers for Disease Control and Prevention(CDC) and the quality control in the reagent kit were detected and the accuracy,precision and linearity were calculated.A total of 1 012 samples of TSH(60 of positive and 952 negative samples) and 991 samples of 17-0HP(34 positive and 957 negative samples)were detected.The initial cut-off value was determined by ROC curve determined.The consistency between the results from GSP and clinical diagnosis was analyzed.Results The average of within-run coefficient of variation(CV) of TSH and 17-OHP were 6.69％ to 12.6％ and 7.52％ to 9.29％,and the average of between-run CV were 6.91％ to 10.96％ and 6.86％ to 12.36％,respectively.The average of bias of TSH and 170HP were-14.28％ to-0.74％ and-0.45％ to 12.54％.The linearity of GSP detection was fine.The initial cut-off values were 23.43 U/mL(TSH) and 21.42 ng/mL(17-OHP).The sensitivity of GSP detection was 100％ and the specificity of TSH and 17-OHP were 98.11％ and 99.58 ％ respectively.The results of GSP detection showed good consistency with clinical diagnosis.Conclusion As the first real automatic fluorescence immunoassay analyzer,GSP could be used in routine clinical diagnosis for CH and CAH.
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The physiological and bio-marker function of D-acidic amino acids is now becoming the hot topic on metabolomics study and new drug discovery. A fully automated two-dimensional high performance liquid chromatography (2D-HPLC) system was established by using monolithic ODS column as the first dimension column, acetonitrile-trifluoro acetic acid-water (9: 0. 05: 92, V/ V) as the mobile phase; micro Chiralpak QD-1-AX column as the enantiomer separation column, 10 mmol/ L citric acid in methanol-acetonitrile (50: 50, V/ V) as the mobile phase for the second dimension, 4-fluoro-7-nitro-2,1,3-benzoxadiazole (NBD-F) as the fluorometrical derivative reagent. The separation efficiency ( Rs > 2. 5), determination sensitivity ( LOD =1 fmol) of acidic amino acids enantiomers were higher than those of existing methods, and an online confirmation of the enantiomers amounts was also achieved using this system. The recoveries were around 97-104% , RSD values for intra-day and inter-day precision were less than 5% for the acidic amino acids enantiomers in the biological samples. Furthermore, by analyzing the aging model senescence accelerated mouse prone 1 (SAMP1) mice which have low immunocompetence, the amounts of D-aspartic acid in thymus and spleen were determined as (206±18) and (264±21) nmol/ g, respectively. It is the first time that an obvious trend of the increasement of D-aspartic acid (p<0. 01) was observed in thymus and spleen of SAMP1 mice compare to senescence accelerated mouse resistant 1 (SAMR1) mice.
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Objective To evaluate the function of IRISiQ200 full automated urine analyzer and its clinical application of user re-classification function.Methods The reproducibility,linearity and mutual infection rate of IRISiQ200 were detected.116 fresh urine specimen were obtained from outpatient and inpatient at random.After the specimen were detected with IRISiQ200,the doubtful urine sediment images were discriminated repeatedly by user reclassification.The microscopic quantitation in uncentrifuged samples was used as reference.Results IRISiQ200 showed good reproducibility,linearity and lower mutual infection rate.The performances by using iQ-200 were: erythrocytes Y=0.596X+11.353,R2=0.834;leukocytes Y=0.468X+5.745,R2=0.708;epithelial cells Y=0.524X-2.649,R2=0.815.The performances after reclassification: erythrocytes Y=0.895X-3.328,R2=0.997;leukocytes Y=0.786X-1.880,R2=0.976;epithelial cells Y=0.911X-5.502,R2=0.992.Conclusion IRISiQ200 full automated urine analyzer shows excellent performance.There is fine correlation between iQ-200 and microscopic quantitation in uncentrifuged samples,and the urine sediment can be observed intuitively by using reclassification function.The doubtful urine sediment images can be discriminated.It can degrade the instrument error and increase the detection accuracy greatly.[Chinese Medical Equipment Journal,2008,29(2):82-83,85]