CELL-DYN Sapphire Hematology Analyzer Performance Evaluation on Leukocyte Differential Counts / 임상검사와정도관리

BACKGROUND: Recent advances of hematology analyzers have improved performance of leukocyte differential counts and have reduced work load of clinical hematology laboratories. We evaluated CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA, USA) performance on leukocyte differential counts according to Clinical and Laboratory Standards Institute (CLSI) document H20-A. METHODS: We evaluated imprecision (short term imprecision from duplication of 147 patients' sample and long term imprecision from three level commercial controls) and accuracy (n=462) of leukocyte differential counts of CELL-DYN Sapphire and compared with those of Sysmex XE-2100 (TOA Medical Electronics Co., Kobe, Japan), ADVIA 120 (Bayer Diagnostics, Tarrytown, NY, USA) and Beckman Coulter LH 750 (Beckman Coulter, Miami, FL, USA). RESULTS: The imprecision of CELL-DYN Sapphire for neutrophils and lymphocytes differentials was low with coefficients of variation (CV) from 1.4 to 6.2%, but the imprecision for basophils was high with CV from 34.7 to 79.6%. The correlation with manual count was good in samples without flags (n=314), with the exception of basophils (r: neutrophils, 0.921; lymphocytes, 0.921; monocytes, 0.653; eosinophils, 0.869; basophils 0.272). The correlation with other hematology analyzers was high except basophils (r: neutrophils, 0.969-0.986; lymphocytes, 0.986-0.990; monocytes, 0.787-0.887; eosinophils, 0.881-0.962; basophils 0.086-0.327). CONCLUSION: The performance on leukocyte differential counts of CELL-DYN Sapphire is comparable to Sysmex XE-2100, ADVIA 120 and Beckman Coulter LH 750. In regards of enumeration of basophils, the comparison with manual counts and other hematology analyzers shows poor agreement.

Evaluation of HLC-723 G7 Hemoglobin A1c Autoanalyzer / 임상검사와정도관리

BACKGROUND: We evaluated the performance and analysis time of HLC-723 G7 (Tosoh corp. Tokyo, Japan) hemoglobin (Hb) A1c autoanalyzer. It utilizes cation exchange high performance liquid chromatography (HPLC) method and has a reduced analysis time compared with that of an earlier model HLC-723GHb V A1c 2.2(TM) (HLC-723GHb V, Tosoh corp. Tokyo, Japan). METHODS: We evaluated linearity, precision and comparison with HLC-723GHb V following NCCLS guidelines and counted the number of tests per hour to estimate analysis time. RESULTS: Linearity through the range from 5.8% to 13.9% was good (r2=0.9930, relative nonlinearity <2.5%). The within-run coefficients of variation (CVs) for groups of low, middle, and high level were 1.09%, 0.76%, and 0.68% and total CVs for each group were 1.60%, 0.91%, and 1.00%, respectively. Correlation equation between HLC-723 G7 and HLC-723GHb V was HLC-723 G7=1.0308 (HLC-723GHb V)-0.2896 %Hb A1c (r=0.9992, P<0.0001). Analysis time of HLC-723 G7 was 1.2 minutes per test compared with 2.1 minutes of HLC-723GHb V. CONCLUSIONS: HLC-723 G7 showed the acceptable performance and shortening analysis time therefore, it was suitable for reducing turn around time of Hb A1c assay.

Evaluation of VARIANTTM II Hemoglobin A1c Autoanalyzer / 대한임상병리학회지

BACKGROUND: We evaluated newly introduced VARIANTTM II(Bio-Rad Laboratories, CA, USA) hemoglobin(Hb) A1c autoanalyzer, including bar code reading, cap-piercing system and automatic hemolyzing. It utilizes ion-exchange high performance liquid chromatography(HPLC) method. METHODS: Linearity, precision, comparison with Hi-AUTOA1cTM HA-8121(Kyoto Daiichi, Kagaku Co. Ltd, Kyoto, Japan) and analysis time were evaluated. The reference range was determined by VARIANTTM II from 120 healthy subjects. RESULTS: Linearity through the range from 5.8% to 14.7% was good(r2=0.9909). The within-run coefficients of variation(CVs) for groups of low, middle and high level were 3.07%, 1.96% and 2.14% and between-day CVs for each group were 2.35%, 3.09% and 2.10%, respectively. Correlation equation between VARIANTTM II and Hi-AUTOA1cTM HA-8121 was VARIANTTM II = 1.0886(Hi-AUTOA1cTM HA-8121) + 0.4760% Hb A1c(r=0.9906). Two instruments were also compared by Altman and Bland's method and mean bias was 1.20. Analysis time of VARIANTTM II was 15.6 tests per hour compared with 14.8 tests of Hi-AUTOA1cTM HA-8121. The reference range in this study was 2.8-5.9% Hb A1c. CONCLUSIONS: VARIANTTM II showed the acceptable performance and advantage of calibration, and it was suitable for routine use in the clinical laboratory.

Performance Evaluation of TOSOH Automated Glycohemoglobin Analyzer HLC-723GHb V A1c 2.2TM / 대한임상병리학회지

BACKGROUND: We evaluated the performance of the TOSOH glycohemoglobin analyzer HLC-723GHb V A1c 2.2TM (TOSOH Corp. Kyoto, Japan), a recently introduced automated hemoglobin A1c (HbA1c) analyzer using high performance liquid chromatography (HPLC) method without sample pretreatment. METHODS: The performance characteristics evaluated were precision, linearity, comparison with VARIANTTM (Bio-Rad, Germany) and throughput following NCCLS evaluation protocols (EP5-T2, EP6-P, and EP9-T). RESULTS: The within-run and between-day CV's were 0.910 and 1.328 for low level (6.2%), 1.214 and 1.460 for middle level (8.5%), and 0.789 and 1.449 for high level (10.7%), respectively. We found the perfect linearity of HbA1c (%) from 6.5 to 10.2 (r2=0.9995). Comparison studies between A1c 2.2 and VARIANTTM yielded the following correlation equations; A1c 2.2TM = 0.9915 (VARIANTTM) + 0.1198 %HbA1c (r=0.9936, P < 0.0001). Throughput was 28.0 tests per hour for A1c 2.2TM compared with 15.2 tests for VARIANTTM, which were determined including red blood cell lysis time before sample loading for VARIANTTM. A1c 2.2TM did not need sample pretreatment. CONCLUSIONS: With the above results, A1c 2.2TM shows acceptable performance and is suitable for routine use in the clinical laboratory.