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#12716742   2003/04/28 Save this To Up

Diabetes Antibody Standardization Program: first assay proficiency evaluation.

The aims of the first proficiency evaluation of the Diabetes Antibody Standardization Program (DASP) were to assess general implementation of assay methods and to evaluate the new World Health Organization (WHO) reference reagent for autoantibodies to GAD and IA-2. Forty-six laboratories in 13 countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 50 blood donor control subjects, together with the WHO reference reagent and diluent serum. Results were analyzed using receiver operator characteristic (ROC) curves. Sensitivity was adjusted to 90% specificity in workshop controls. The median adjusted sensitivity for GADA (45 laboratories) was 84% (range 62-96%), for IA-2A (43 laboratories) was 58% (50-74%), and for insulin autoantibody (IAA; 23 laboratories) was 36% (13-66%). ROC curve analysis showed all GADA and IA-2A assays, and 18/23 IAA assays found significant differences between patients and control subjects. There was good concordance between laboratories in ranking of samples by GADA and IA-2A levels or if results were expressed in relation to the WHO reference reagent. Assays that achieved the highest sensitivity for IAA were also concordant in ranking samples, but overall concordance for IAA was poor. Differences in assay protocols between laboratories must be addressed so that all centers and kit manufacturers can perform to the same high standard.

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#8911073   1996/12/17 Save this To Up

[Development of highly sensitive assay for detection of low serum level of PIVKA-II and its clinical usefulness].

PIVKA-II is well known as a tumor marker of hepatocellular carcinoma. We describe the adaptations to render a commercially available PIVKA-II immunoassay kit (Eitest MONO P-II: Eisai Co., Ltd, Tokyo) more sensitive and evaluated clinical usefulness of this highly sensitive assay for early diagnosis of hepatocellular carcinoma. We measured serum PIVKA-II concentrations with the Eitest kit as described for the kit. To measure serum PIVKA-II concentrations below the sensitivity limit of the Eitest kit (0.0625AU/ml), linearity was determined using a series of dilutions of standard antigen diluted in standard diluent, including PIVKA-II concentrations of 0.002, 0.004, 0.008, 0.016, 0.031, 0.0625AU/ml. The assay was found to be liner from 0.004AU/ml. In this way, one can detect as low PIVKA-II concentrations as 0.004AU/ml. The repeatability-assay coefficients of variation (CV%) obtained from sixteen repeated assays of four sera were distributed between 3.63 and 18.75% and the reproducibility-assay coefficients of variation (CV%) obtained from ten repeated assays of four sera were distributed between 6.27 and 14.04%. We determined the serial changes in serum PIVKA-II levels of two patients with hepatocellular carcinoma after the resection of hepatic tumor. In these patients, elevation of serum PIVKA-II level determined by the highly sensitive assay preceded the detection of relapse by imaging diagnostic procedures. In summary, the assay system we developed has good accuracy and reproducibility for assaying low concentrations of PIVKA-II in serum and is suitable for detecting small increases in PIVKA-II concentrations. This assay system may be useful to earlier detect a relapse of hepatocellular carcinoma.

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Beta Amyloid (1 42) High EnzyChrom™ NAD NADH Ass 8 Octadecyloxypyrene 1,3, MarkerGeneTM Fluorescent Ofloxacin CAS Number [824 Mouse anti-chick type II Mouse anti-chick type II Mouse anti chick type II Mouse anti-chick type II Mouse anti-chick type II Mouse anti chick type II Mouse anti-chick type II

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#1132150   1975/08/18 Save this To Up

An improved radioimmunoassay of serum gastrin using commercial kit.

Our experience with a commercially available kit for the measurement of serum gastrin has been reported. Significant non-specific interference was noted by the addition of serum contents in the assay which lead to erroneous results. Use of gastrin free serum as a diluent in the standard curve was found to improve the mean recovery of added gastrin. With this modification the procedure was evaluated for its clinical application. In 30 normal subjects, the fasting mean gastrin level was 78.7 plus or minus 31.9 (S.D.) pg/ml; in 18 of these individuals the postprandial mean level was 118.3 plus or minus 26.7 (S.D.) pg/ml. In 15 patients with pernicious anemia the mean level was 912 plus or minus 779 pg/ml; and in 4 patients with Zollinger-Ellison (ZE) syndrome the mean gastrin level was 1950 plus or minus 379 (S.D.) pg/ml. A significant rise in gastrin level was noted in patients with kidney failure during and after dialysis (p smaller than 0.05).

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