Marketing GI Immunohematology Unexpected Antibody Screening & Identification 제품 소개 주식회사 유니온랩.

Marketing GIImmunohematology

Unexpected Antibody Screening & Identification 제품 소개

주식회사 유니온랩


DIAGNOSTIC GRIFOLS • Spain 에 본부를 둔 약 50 년 역사의 수혈의학관련 제품 및

면역혈청진단 및 치료제 전문기업입니다 .• 1998 년 , 세계 최초로 전자동 혈액은행 검사 장비 WADiana 를

출시하였습니다 .• 혈액은행검사 자동화 분야에 있어서는 가장 앞서 있는 선두주자입니다 . • DiaMed 사에는 ID Gel Station 이란 이름으로 , J&J Ortho 에는 ProVue

라는 이름으로 자동화 장비를 OEM 공급하고 있습니다 . • 2006 년 현재 , 전세계에 1,700 여대의 장비가 가동 중에 있습니다 . • WA Diana 는 미국 FDA 의 승인을 받은 유일한 혈액은행검사 자동화

장비입니다 .


• 안정한 반응• 표준화 기법• 높은 감도• 보다 분명한 결과• 간편한 취급• 항글로불린검사시 세척과정 불필요• 적은 검체량• 자동화 용이

Gel Column Technique


Grifols DG Gel ® Cards 종류Cat # DG Gel Configuration

1 210310 DG Gel ABO/Rh A B AB D CDE Ctrl A1 B

2 210311 DG Gel ABO/Rh (2D) A B AB D D' Ctrl A1 B

3 210313 DG Gel ABO-CDE A B AB D C E A1 B

4 210312 DG Gel Confirm 2 x (A B D Ctrl)

5 210314 DG Gel Anti-D 4 x (D' Ctrl)

6 210315 DG Gel Rh 2 x (C c E e)

7 210316 DG Gel Rh+Kell D' C Cw c E e Kell Ctrl

8 210319 DG Gel Coombs 8 x (AHG)

9 210320 DG Gel Neutral 8 x (N)

10 210321 DG Gel Neutral/Coombs N N N N AHG AHG AHG AHG

11 210317 DG Gel Neonatal A B AB D D' Ctrl IgG AHG

12 210323 DG Gel DC Scan 2 X (AHG IgG CD3 Ctrl)

13 210318 DG Gel CT A B D Ctrl N N AHG AHG

14 210324 DG Gel AB 4 X (A B)

15 210322 DG Gel IgG 8 x (IgG)


Unexpected Antibody Test 용 진단제품• DG Gel Coombs Card

– 마이크로 컬럼법을 사용하는 혈액형판정용 카드제품중 Sephadex Gel column 방식은 Micro glass bead column 방식보다 specificity 가 뛰어납니다 . 또 , Gel column 방식은 Glass bead column 방식에 비해 false positive 율이 거의 없습니다 .

– 카드 한 개당 8개의 column (4 환자분 ) 으로 구성되어 있습니다 .


Unexpected Antibody Test 용 진단제품• SeraScan Diana - 비예기항체 선별용 Screen

cells

• 제품 사용기간이 제조일로부터 8주로서 타제품들 (6주 ) 보다 사용기간이 길어 손실율이 적습니다 .

• 제품 자체가 LISS (Low Ion Strength Solution) 처리되어 있어 항체 검출율을 높이고 별도의 LISS 용액시약이 필요없으며 따라서 검사과정도 간단합니다 .

• 검출 가능한 비예기항체의 종류는 국제표준인 23종의 항체를 포함합니다 . D,C,E, c, e, K, k, Kpb, Jsb, M, N, S, s, Fya, Fyb, Jka, Jkb, Lea, Leb, Lub, P1, Xga


Unexpected Antibody Test 용 진단제품• SeraScan Diana - 비예기항체 선별용 Screen cells

• Cw 항체를 항상 포함하고 있습니다 .

• 가장 흔히 검출되는 Rh, Duffy, MNS, Kidd 시스템을 망라하고 있습니다 .

• Homozygous 인 D, C, c, E, e, Fya, Fyb, Jka, Jkb 를 각각 검출합니다 .

• R1R1 와 R2R2 profiles 이 있습니다 .


Unexpected Antibody Test 용 진단제품• IdentiSera - 비예기항체 동정용 cells

• 비예기항체 동정을 위한 적혈구 시약으로 11 vial 로 구성되어 있습니다 .

• 정확히 동정되지 않는 특수케이스를 위해 추가동정을 할 수 있는 4 vial 이 별도로 준비되어 있습니다 . (IdentiSera Extend)

• 세 개의 Kell-positive cells 을 함유하고 있습니다 .

• Homozygous 항체 - M, N, S, s, C, c, E, e, D, Lub, k, Kpb, Jsb, Fya, Fyb, Jka, Jkb 모두 동정 가능합니다 .


Unexpected Antibody Test 용 진단제품• IdentiSera - 비예기항체 동정용 cells

• Minimum two homozygous cells for: Fya, Fyb, Jka, Jkb, S, s, M, N

• Presence of: P1 negative, Le(a-b-), 2 cells Le(a+)

• 한 판넬에 3 R1R1 cells, 4 rr homozygous cells, 그리고 보조적 Jk, Fy, MNS cells 이 모두 있습니다 .

• With presence of anti-D, anti-C or anti-E, a 2nd antibody of Kidd, Duffy, MNS or Kell can be detected

• 4 possible complementary combinations for Fy and Jk


Identisera + Identisera ExtendedTotal 15 cells – 비예기항체 동정이 완벽합니다 .

1 patient = 2 cards = 15 cells + 1 Control

Control


DG Gel® + Identisera + Identisera Extended

최대수의 homozygous 항원과 보조적 적혈구항원의 조합으로 비예기항체의 검출과 동정을 완벽히 수행

할 수 있습니다 .

Maximum efficiency and information per card and test

Optimization of the unique 8 column format

Grifols Clear Card Technology


Diana Incubator

• 24 Gel cards 동시장착가능

(24 cards X 4 Pt’s/card = 96 Pts)

• Timer 내장

• Incubation 시간 : 37 도 15 분간

• 열전도에 의한 가온법

• 실험 튜브도 가온 가능

Diana System Equipment


DianaFuge •동시 24 Gel cards 원심분리 가능

• 1100 rpm 에서 9분간 원침

Diana System Equipment


Unexpected Antibody Test 용 진단제품• 우수한 성능

– 기존 제품과의 평가에서 가장 우수한 성적을 보였습니다 . (2005 AABB poster 및 2006 논문 full text 참조 ) (J. Cid et al. Comparison of three microtube column agglutination systems for

antibody screening: DG Gel, DiaMed-ID and Ortho BioVue Transfusion Medicine 2006, 16. 131-136)

• 간편한 2 step 법① 혈청 25uL 분주② 선별용 혈구 50uL 분주 (LISS 사용 step 없음 ) Incubation + Centrifuge

• 경제성– 명확한 결과 및 정확한 검사– Gel card 한 개당 4환자 검사


• 8-column format • 분명한 결과 • 간편한 사용법• 쉬운 판독• 사전 수혈검사시 높은 신뢰성

Advantages of DG Gel Card


Joan Cid, Núria Nogués, Rosa Montero, Marta Hurtado, Albert Briega and Rafael Parra.Blood and Tissue Bank. Barcelona, Spain.

Comparison of three microtube column agglutination systems for antibody screening: DG Gel, DiaMed-ID and Ortho BioVueINTRODUCTIONAntibody screening is performed to detect clinically relevant red blood cell (RBC) antibodies in transfusion recipients and blood donors. The classical low-ionic-strength-solution (LISS) tube indirect antiglobulin test (IAT) for detecting clinically significant antibodies has been replaced in many countries by microtube column agglutination systems, described for first time in 1988 and published in 1990 (1). The first microtube system was manufactured and distributed by DiaMed-ID (Switzerland), followed by Otho BioVue (Otho Diagnostic GmBH, Germany). Recently, a new microtube column agglutination system has been launched on the market by Diagnostic Grifols, S.A. (Barcelona, Spain) with the name of DG Gel. The aim of the present study was to evaluate the diagnostic accuracy of this new system, to analyze the antibody reactivity and to compare the data with the two cited well-established methods.

METHODSSamples. We collected 3,024 specimens: 2,408 (79.6%) were plasma samples obtained from EDTA tubes and 616 (20.4%) were serum samples. We obtained 2,422 (80.1%) samples from blood donors in our blood bank; 382 (12.6%) samples from transfusion recipients and 220 (7.3%) from pregnant women in Hospital Vall d’Hebron (Barcelona, Spain). We stored all these samples in the refrigerator at 2-8 ºC and we processed them before 72 hours from extraction. We additionally obtained 100 samples containing antibodies of known specificity from the immunohematology laboratory of our blood bank. These samples had been stored in a frozen state at -30 ºC and were thawed immediately before processing.

Test RBCs. The RBCs used for the antibody screening and for the panel identification were obtained from our selected blood donors. These RBCs were suspended to final concentration 0.8 % in the corresponding modified LISS provided by the manufacturers according to their instructions as follows. We calculated the conductivity of these solutions.

DG Gel: 50 µL of RBCs in diluent provided by Diagnostic Grifols (Cond.: 5.09 mS/cm) + 25 µL of sample. Incubation: 15 min, 37 ºC. Centrifugation: 9 min.

DiaMed-ID: 50 µL of RBCs in ID-CellStab (Cond.: 5.89 mS/cm) + 25 µL of sample. Incubation: 15 min, 37 ºC. Centrifugation: 10 min.

Ortho BioVue: 50 µL of RBCs in Ortho BLISS (Cond.: 3.03 mS/cm) + 40 µL of sample. Incubation: 10 min, 37 ºC. Centrifugation: 5 min.

RESULTS

Antibody screeningWe performed the antibody screening of 3,024 fresh samples with the three microtube systems and we obtained concordant results in 3,019 (99.83%) and discrepant results in 5 (0.17%). Table 1 shows the specificities of the antibody after the identification steps using 11-cell panel and additional techniques, e.g. papain-treated reagent RBCs and IAT with polyethylenglycol (PEG) tube technique (2).

Antibody titrationWe titrated 100 frozen samples containing antibodies with known specificities. The score mean an d standard desviation of the antibody titration for each microtube system were the 34.31±26.7 for DG Gel, 30.3±27.76 for Diamed-ID, and 37.38±28.68 for Ortho BioVue (see Table 2).The antibody titration score was higher with the DG Gel when compared with DiaMed-ID in samples containing anti-K (46.23 vs. 44.38; p<0.05) and in samples containing anti-M (11.88 vs. 5.38; p<0.05). No significant differences were seen in other antibodies specificities.

CONCLUSION

All three microtube column agglutination systems work well showing a high estimated sensitivity and specificity.

REFERENCES1. Lapierre, Y. Rigal, D., Adam, J. Josef, D., Meyer, F., Greber, S. and Drot, C. (1990) Transfusion, 30, 109-113.2. AABB (2002) Technical Manual, 14 th edition, Beshesda.

Table 1. Antibody detected by the three systems using 2 screening cells.

Mean±SD score of antibody titration

37.3830.334.31100Total

7474861Anti-Xga

4333461Anti-Vel

2417171Anti-Ge:2

4829.6941.5037.4748.5034.642Anti-PP1PK

20.6714.1812.3310.6913.3313.793Anti-H/HI/I

161.415.503.5311.502.122Anti-Leb

87.0741.41802Anti-Lea

4121.1530.4020.733417.015Anti-S

29.6718.1424.6727.792417.083Anti-s

4625391Anti-N

16.887.695.382.8211.884.738Anti-M

1912121Anti-Kpb

2614.1416.5012.0217.506.362Anti-Kpa

50.3137.6044.3836.7246.2336.7313Anti-K

5217.3745.4511.1450.2514.684Anti-Fyb

35.8026.0124.4024.703424.875Anti-Fya

21080194.242Anti-Jkb

22.4316.2015.8611.6520.5714.507Anti-Jka

3618.38248.4838.5019.092Anti-Ch

167.2114.679.5015.339.63Anti-Cw

16.5012.021302002Anti-e

34.3029.3333.3028.9837.4023.1410Anti-E

28.2224.802319.5523.6719.449Anti-c

70±19.7160.75±15.5463±16.454Anti-C

82.29±29.3574.43±23.8674.14±24.237Anti-D

Ortho BioVueDiaMed-IDDG GelnSpecificity

030False negative

111Anti-KKell

111Anti-FyaDuffy

101Anti-JkaKidd

302430243024Total

Antibody specificity

299830033000Negative

200False positive200PanaglutininNonspecific

111Anti-Jkb/-K

111Anti-E/c/panaglutinin

222Anti-C/-DMixed

111Anti-LeaLewis

111Anti-S

111Anti-MMNS

313Anti-E

444Anti-c

666Anti-DRh

Ortho BioVueDiaMed-IDDG Gel Number of Samples DetectedBlood Group

System

Table 2. Samples containing antibodies of known specificities used for antibody titration.

99.94%(99.77-99.99)

99.9%(99.72-99.98)

100%(99.88-100)Efficiency

100%(99.88-100)

99.9%(99.71-99.98)

100%(99.88-100)PNV(b)

98.41%(94.38-99.81)

100%(97-100)

100%(97.07-100)

PPV(a)

99.93%(99.76-99.99)

100%(99.88-100)

100%(99.88-100)

Specificity

100%(97.07-100)

97.58%(93.09-99.50)

100%(97.07-100)Sensitivity

Ortho BioVueDiaMed-IDDG Gel

Table 3. Estimated diagnostic accuracy. In parenthesis the 95 % CI. (a) PPV: predictive positive value, (b) PNV: predictive negative value.

Sensitivity and SpecificityIn order to obtain a comparative value between the new test and the other two we calculated the estimated diagnostic accuracy for each system (see Table 3). For calculating estimates of these statistical measures we include the 100 positive samples and we reported the confidence intervals (CI) for a sample size of 3,124.

Marketing GI Immunohematology Unexpected Antibody Screening & Identification 제품 소개 주식회사 유니온랩.

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