Coulter ® Cellular Analysis System 소개 UniCel® DxH 800 Coulter ® Cellular Analysis System 소개 2010. 10. 21. 발표자 : 계 진 철

목 차 1. Unicel DxH 800 도입 배경 2. Unicel DxH 800 소개

1.Unicel DxH 800 도입 배경 1. 기존 사용장비인 SE -9000의 노후화 (2002.11월에 도입) 2. 장비 노후화에 따른 환자 결과의 review rate 증가 3. QC 의 어려움 & QC 소모 증가

2. Unicel DxH 800 소개 DxH 800 + DxH 800 단독 Floor Stand a b So therefore the next generation platform would allow you the option of a stand alone bench top analyzer, [mouse click] or the option of having the analyzer be a floor standing model if you were short on bench space or [mouse click] the ability to connect one or more modules together. DxH 800 + b Floor Stand DxH 800 단독 a

DxH 800의 New Technologies VCSn (Volume-Direct current, Conductivity-Radio frequency, Scatter-Laser) Multiple angles of light scatter (기존 1가지의 Scatter에서 5가지로 늘어남) ALL, LALS, LMALS, UMALS, & MALS. 7 parameters / module * 4 Channels / parameter per plus time = 29 per module Typical Diff (8192*3) = 24,576 events to (8192*29) = 237,568개의 cells 표현 장점 Diff , nRBC Performance Diff, nRBC flagging performance WBC correction.개선 Research 항목 . From 3 internal parameters to 29.

DxH 800의 New Technologies High Definition Digital Analysis

Specimen Processing Module (SPM) Output Buffer Input Buffer Beacon Status Indicators (상태 창)

Cassettes Note that the cassettes have only 5 positions. This is a CLSI guideline for automation and allows for quick processing, rerun and reflex of specimens. All the cassettes have metal pads on the bottom of the cassettes. This allows for magnetic movement of cassettes without accessible moving parts. Up to 20 cassettes can be loaded at one time in the input buffer

Input Buffer Sensor 밑으로 cassette을 올려 놓으면 자동으로 검사 시작. It is important to note that the module will not move the cassette unless the first cassette is loaded in the sensing area. This will be indicated by the green sensor lights lighting up.

시약, Waste, Power supply 가 내장. Floor Stand 시약, Waste, Power supply 가 내장. Here is the floor stand with the doors opened. Note that only 1 drawer at a time can be extended. This shows the 2 diluent boxes (note that they are smaller than previous analyzers). The SPM will automatically switch from 1 diluent box to the other without stopping processing or any action taken from the user. It is important to note the correct box orientation. The cap on the box must face the right of the cabinet, as shown in the picture above.

Floor Stand This shows all the reagents with color coded pickup tubing that corresponds to the same color on the reagent boxes.

Single Tube Presentation으로 검사 진행 Cap piercing 가능 Microtainer 가능 This shows the single tube presentation. The left side is for standard size hematology tubes. The right side is for microtainer specimens.

상태 Icons 1. System Status : 장비 상태 2. Review Result : 환자 결과 확인 3. Daily Checks 4. QC 5. XB / XM 6. Supplies : 시약 및 Waste 7. Event logs This is the System Status Screen. The LH had common icons in the left hand corner. Most user functions are accessed from the top bar (known as Alert status icons). If neutral color, then everything is OK. Yellow or red color indicates that attention is needed.

Daily Checks No longer known as startup. The Daily Checks and setup can be accessed by selecting the daily check icon from the Alert Status area.

Daily Checks Here is the daily check screen. If Daily Checks fail, Click on the Daily Checks tab from this screen to repeat it. Don’t repeat failed Background counts by selecting Background.

Quality Control To view QC select the QC (chart) button on the Alert Status area.

Quality Control 최근 Results – 가장 우측편에 보임 The most recent results appear in the far right side of the screen. The previous 3 results then appear to the left of those results.

QC가 벗어 났을 경우 If there is a QC “out” alarm, the user must acknowledge the alarm by selecting “Click to Review” or the color indicators will continue in the Alert status area. There is also a check box to exclude the result from calculation. “Click to Review를 눌러 주면 위의 빨간색이 없어짐.

QC: Graph View This is the QC graph view. All parameters graphs are shown as thumbnails with the last 10 runs shown. The current parameter selected is shown in an enlarged Levy Jennings chart that shows all runs with the last 10 backlit in blue.

QC: 다른 level 볼 때 To view another control file, click the Select Control tab.

Supplies : 시약 잔량 Supplies can be viewed by selecting the supply button in the alert status area.

Supplies : 시약 및 Waste 상태 표시 Here is the supply list. The color of the reagent “bottles” matches the packaging. Note the 2 diluent bottles. One is backlit and not in use yet. This screen also shows the approximate # of the cycles remaining. To setup low level alerts (in %), click the configure low level button.

3. Unicel DxH 800 평가 결과 1. 평가 절차 I. calibration II. 1 With in run Precision – 정상 검체 10번 II.2 Day to Day precision – 6C control 3levels을 5일간 4번씩 측정. III. Linearity – AMR 검증(Lin-X control 사용) IV. carry over 실시 V. 장비간 비교 – Siemens Adivia 2120i 와 비교 및 Manual Count와 비교 (CLSI EP9-A2에 따라) 항목 Group A Group B Group C Group D Group E Range % Hgb < 9.0 15 9.1~12 25 12.1~17 50 17.1~ 10 RBC < 3.0 3.1~4.0 30 4.1~6.0 6.1~ WBC < 2.0 2.1~5.0 20 5.1~11.0 40 11.1~25 25.1~ PLT < 50.0 51.~150.0 151~300 301~450 451~

3. Unicel DxH 800 평가 결과 Calibration : Beckman Coulter에서 판매되는 전용 표준 물질 상품인 S-Cal을 이용하여 Calibration을 실시하였다. WBC RBC HGB MCV PLT MPV Mean 8.511 4.182 12.564 87.456 207.780 10.980 Reference 8.7 4.14 12.7 89.5 204 11.3 SD 0.09 0.02 0.04 0.22 3.13 0.06 %CV 1.06% 0.44% 0.35% 0.25% 1.51% 0.57% Factor %Diff 2.22% -1.00% 1.08% 2.34% -1.82% 2.91% Difference -0.189 0.042 -0.136 -2.044 3.780 -0.320 In use Cal Factor 1.137 1.064 0.968 0.998 0.943 0.946 New Cal Factor 1.162 1.053 0.978 1.021 0.926 0.974

3. Unicel DxH 800 평가 결과 2. Precision 2-1 With in run Precision CBC, Diff 항목에 대한 장비의 Current 재현성을 검증하기 위해 정상 검체를 10번 반복 검사하였다 2-2 Day to day Precision ( Imprecision과 Bias 점검) 장비에 대한 Preliminary decision을 검증하기 위해 EP10-A2에 따라 Beckman Coulter사에서 판매되는 정도 관리 물질인 CBC + Diff – 6C control사용, 4회/ day, 5일간, 총 20회 검사하였다.

3. Unicel DxH 800 평가 결과 3. Linearity – AMR ( Analytical Measurement Range ) 검증 : Beckman coulter LIN-X linearity control을 이용하여 각 level을 6회씩 검 사하여 범위 안에 듦을 확인하였다.

3. Unicel DxH 800 평가 결과 Carry over : 연속적으로 High control 3번, low control 3번을 검사하여 장비의 이월 오차를 확인하 였다. Run WBC RBC HGB PLT High control-1 21.037 5.319 16.55 410 High control-2 21.183 5.393 16.74 394.1 High control-3 21.547 5.284 16.48 411.1 Low control-1 3.713 1.743 5.00 69.6 Low control-2 3.794 1.747 4.95 66.6 Low control-3 3.739 1.740 4.93 Carryover Value -0.15% 0.08% 0.61% 0.87% Limit 0.5 1.0 accept or reject accept * Carry over = [(1st Low – 3rd Low) / (3rd High – 3rd Low)] × 100 , ICSH guidelines 28

3. Unicel DxH 800 평가 결과 Siemens Advia 2120i 비교 항목 Advia mean DxH mean 차이값 Equation R2 비고 WBC 10.24 9.76 -0.48 Y = 0.948x+0.052 0.993 N=58 RBC 4.1 3.92 -0.17 Y= 0.960x-0.008 0.995 Hgb 11.98 12.16 0.18 Y= 1.050x-0.420 0.996 Hct 37.38 36.44 -0.94 Y=0.975x-0.023 0.992 MCV 91.59 93.17 1.58 Y=0.970x+4.298 0.934 PLT 242.95 223.33 -19.62 Y=0.919x+0.022 0.982 NE% 64.38 63.51 -0.87 Y=1.012x-1.689 LY% 23.12 24.87 1.75 Y=1.057x+0.413 0.990 MO% 6.61 8.11 1.49 Y=1.482x-1.691 0.854 EO% 2.93 2.88 -0.05 Y=0.983x-0.003 0.973 BA% 0.63 0.64 0.01 Y=0.553x+0.292 0.229

3. Unicel DxH 800 평가 결과 2. Manual Count와 비교 항목 Advia 2120i DxH 800 비고 Equation R2 NE% Y=0.838x+8.849 0.815 Y=0.846x+7.521 0.750 N = 98 LY% Y=0.821x+4.798 0.631 Y=0.875x+4.934 0.636 MO% Y=0.534x+3.716 0.556 Y=1.092x+3.119 0.671 EO% Y=0.766x+2.125 0.153 Y=0.861x+1.052 0.507 BA% Y=0.359x+0.575 0.274 Y=0.708x+.381 0.512

4. 앞으로의 계획 Normal Range 검증 본원의 기준장비와의 Hormonization 을 위한 Data 축적 필요

감사합니다 Happy WBC