Ｔｈｅ ９ｔｈ ＩＳＱＣ Ｒｅｐｏｒｔｓ ２００１／１１

１． STANDARDIZATION　OF REFERENCE INTERVALS FOR CLINICAL CHEMISTRY DATA IN KUMAMOTO DISTRICT
M.SHIMAMURA,1) H.SUGIUCHI,1) E.SUZAKI,1) J.KITAGAWA,1) S.HARUTA,1) S.HARADA,1) S.HAYASHI,1) Y.CHIKAURA,1) H.ETO,1) Y.UJI,2) and H.OKABE 2)
1 Working Group for Standardization of the Kumamoto Medical Association,
2 Department of Laboratory Medicine, Kumamoto University School of Medicine, Kumamoto, Japan

　It is very important for clinical diagnosis that the reference intervals are shared at any laboratories. In Kumamoto prefecture, not only the standardization of clinical chemistry data but also the establishments of the reference intervals have been tried by the Working Group for Standardization in the Kumamoto Medical Association since 1999. In this paper we report the results of reference intervals established for 24 clinical chemistry tests.
　Tests of the enzyme activities were calibrated by using CERM with JSCC consensus method and other tests were calibrated by using the reference materials of CRM-470, NIST-SRM and the reference materials of Health Care Technology Foundation (HECTEF). These assays were performed by three reference laboratories in Kumamoto. Samples were obtained from healthy adults (ages 21-60 years) on the annual health examinations (690 males and 1609 females). The data was analyzed by the method of NCCLS proposed guideline C28-9.
　The reference intervals obtained were as follows; AST; 13-34 U/L, ALT; 7-37 U/L, LD; 112-213 U/L, ALP; 106-350 U/L, r-GT; M12-47, F9-30 U/L, CK; M 57-284, F 45-176 U/L, TP; 6.5-8.2 g/dl, ALB; 4.1-5.1 g/dl, UN; 8.4-21.0 mg/dl, UA; M3.4-8.0, F2.5-5.8 mg/dl, CRE; M 0.62-1.25, F 0.42-0.91 mg/dl, T-CHO; 129-251 (128-220)* mg/dl, TG; M 34-202, F 29-137 (30-150)* mg/dl, HDL-C; 41-108 mg/dl, Na; 138-147 mEq/l, K; 3.5-5.0 mEq/l, Cl; 99-109 mEq/l, Ca; 8.5-10.4 mg/dl, Fe; 49-219 ugldl, IP; 2.5-4.8 mg/dl, AMY;(32-101) U/L, LAP;(32-64) U/L, CHE;(106-230) U/L. The values in brackets were calculated as provisional values. *Cut off values by the Japanese Society of Arteriosclerosis.
　The reference intervals obtained have come to be widely used in 70% of hospitals in Kumamoto prefecture over the past two years. In conclusion, setting the common reference intervals for clinical tests in each laboratory is clinically useful for the minimization of inter-laboratory difference and reducing the test frequency concerning to rapid and correct diagnosis for patients.

２．STANDARDIZATION　FOR ENZYME TESTS IN KUMAMOTO DISTRICT
S.HARUTA,1) H.SUGIUCHI,1) E.SUZAKI,1) S.HARADA,1) S.HAYASHI,1) H.ETO,1) Y.CHIKAURA,1) M.SHIMAMURA,1) J.KITAGAWA,1) Y.UJI,2) H.OKABE,2)
1 Working Group for Standardizations of the Kumamoto Medical Association
2 Department of Laboratory Medicine, Kumamoto University School of Medicine, Kumamoto, Japan

　The control surveys on laboratory data in Kumamoto Prefecture has been performed by Kumamoto Prefecture Association of Medical Technologists from 27 years ago. However, the data from our external quality controls showed great differences on enzyme tests. Therefore, we started the Working Group for standardizations of laboratory data in the Kumamoto Prefecture Medical Association in 1999 to minimize inter-laboratory difference. In this paper, we report the results of our surveys data. Recently, we performed the six times of surveys a year in 82 laboratories of Kumamoto prefecture using the certified enzyme reference material (CERM) according to the JSCC consensus methods for the measurement of six enzyme (AST, ALT, CK, ALP, LD and r-GT) activities and three pooled sera being labeled target activities. Prior to the surveys of every two months, we measured and decided the target activities for three pooled sera using CERM calibrator methods at three reference laboratories in Kumamoto prefecture. The accuracy of laboratories data was evaluated by biases (%) from the target activities. Furthermore, we have discussed and decided that the allowable limits were less than ±10% from the target activities. From our six surveys, inter-laboratory differences were clearly improved compared with past 27 years surveys. Especially, inter-laboratory differences of ALP and r-GT tests were decreased, from 22.5% to 4.9%. Approximately 90% of survey results of 82 laboratories for six enzymes showed within the allowable limits.
　In conclusion, the results may suggest that common calibrators (CERM and/or enzyme calibrators certified by CERM) using in laboratories could be useful to minimize inter-laboratory differences. Now, 80 % of clinical laboratories in Kumamoto prefecture are participating to the surveys. Standardization of other clinical tests is now in progress in the Kumamoto district.

３．STANDARDIZATION OF LABORATORY DATA　BY　ANIMAL ORIGIN CARIBURATOR
M.MANABE,1） H.SUGIUCHI,1) T.UENO,1) S.YAMASITA,1) A.YONEMURA,1) S.NAGATA,1)
Y.UJI,2) Y.ANDO,2) H.OKABE 2)
1 Department of Central Laboratory, Kumamoto University Hospital, Kumamoto, Japan
2 Department of Laboratory Medicine, Kumamoto University School of Medicine, Kumamoto, Japan

　Recently, the certified Enzyme Reference Material (CERM) has been widely used for standardization of external quality controls of enzyme tests to minimize inter-laboratory differences. However, CERM is very expensive for using routine tests of clinical laboratories. 　Therefore, we have certified enzyme activities obtained by JSCC consensus methods and CERM into the manufactured calibrator based on animal-origin enzymes (C-fas, Roche Diagnostics Co.) with 14 routine methods. Automated JSCC consensus methods for AST, ALT, LD, ALP, GGT and CK were prepared by the presenter et al. Data of routine methods were measured by the reagents (Roche Diagnostics Co.) for Hitachi 7070 clinical auto analyzer: AST; GOT-IFCC, ALT; GPT-IFCC, LD; LDH-JSCC (L to P), LDH-SFBC (P to L), ALP; ALP II JSCC, r-GT; GGT-IFCC, GGT-Szasz, CK; CK JSCC, and for COBAS INTEGRA clinical auto analyzer: AST; AST IFCC, ALT; ALT IFCC, LD; LDH IFCC (L to P), ALP; ALP JSCC, r-GT; GGT Szasz, CK; CK IFCC. We compared the results of 14 routine methods on Hitachi-7070 clinical auto analyzer and COBAS INTEGRA clinical auto analyzer (Roche) as reference instrument between JSCC consensus methods on Hitachi-7070 clinical auto analyzer with patient's sera (n=102-292) by certified animal-origin enzyme calibrators and CERM.
　High degrees of correlations were observed between 14 routine methods and JSCC consensus methods, respectively (r=0.99 and/or better).
　In conclusions, calibrator based on animal-origin enzymes certified by JSCC consensus method and CERM could be use for routine clinical laboratories to minimize inter-laboratory differences.