ABSTRACT
Background@#The study aimed to review the initiatives and activities of the Korean Blood Safety Project Group (KBSPG) from 2012 to 2021 to present its work domestically and internationally, and to set up future directions for the KBSPG. @*Methods@#Details of the KBSPG’s projects were organized by task. This project was supported by the Korean Ministry of Health and Welfare. The final annual reports and data posted on the website of the KBSPG were used for analysis. @*Results@#The KBSPG completed 14 tasks, including training and sharing of the latest information with workers of blood centers and transfusion services in medical institutes, external proficiency surveys for donor blood screening tests, and maintenance of a national registration system. The results of these tasks have contributed to the fulfillment of work of the relevant national departments, the establishment and operation of related websites, the publication of annual reports, the implementation of workshops and training programs, the operation of regional networks for blood transfusion management, and the production and distribution of information leaflets and training videos.Additionally, the KBSPG has developed and revised guidelines and standards and published related papers. @*Conclusion@#The KBSPG’s continuous efforts improved the quality of blood centers and transfusion services in medical institutes, thus contributing to the national blood management services. To further improve blood management work and ensure blood safety, the KBSPG must expand its scope and continue to pursue its important mission. (Korean J Blood Transfus 2023;34:1-11)
ABSTRACT
The scientific interest in transfusion medicine as related to COVID19 can be summarized in three important points. 1) How can we identify asymptomatic COVID19 infected potential blood donors from healthy donors, and if the asymptomatic COVID19 infected person has donated blood and it has been transfused, how will it affect the transfused patient? 2) What affect will COVID19 have on blood establishments and medical institutions that use blood? 3) How will convalescent plasma from recovered COVID-19 patients be collected and then be used for patients in need of it? Since COVID19 has a negative effect on blood transfusion and blood management, well developed lines of communication and cooperation from blood establishments, medical institutions, government agencies, and people are urgently needed to overcome the impact of this negative effect.
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Blood is an essential medical resource for treating diseases and trauma of people, but a limited biological resource for which no artificial production is possible. Therefore, systematic and rational management of its supply and use must be carried out under the national responsibility. On the other hand, the low birthrate and aging population have raised the problem of blood shortages in Korea. To help solve this problem, this study examined proposals for the development of a blood management system in Korea. In addition, the works of blood management bodies were analyzed based on the operation subjects and types of blood projects in the United States, the United Kingdom, France, Germany, the Netherlands, Canada, Australia, Singapore, and Japan. Based on these data, this paper proposes a new organization that can best enhance the specialization of national blood services and strengthen its capacity under the current blood supply system in Korea.
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Background@#The Korean Blood Safety Commission established the Regional Networks for Blood Transfusion Management (RNBTM) Project which has operated in 14 regions across the country since 2017 to help blood transfusion management in small and medium-sized medical institutions. Since implementation of the RNBTM, participant’s satisfaction has not been evaluated, therefore in order to evaluate participant’s satisfaction and assist in future planning a survey was conducted. @*Methods@#Fourteen facilitators participated in an anonymous on-line survey (5 questions). Laboratory Medicine (LM) doctors from small and medium-sized medical institutions from 14 regions also participated in a separate anonymous on-line survey (15 questions). @*Results@#14/14 (100%) facilitators responded to the survey. In addition to the RNBTM they were also in favor of establishing a Network of University Hospitals. 135 LM doctors responded to the survey. Of the RNBTM participants, 94.1% (111/118) replied that RNBTM was helpful in providing and exchanging blood transfusion information. Respondents indicated that they wished to remain part of RNBTM into the future because they felt that RNBTM not only helped improve quality of blood transfusions but also other aspects in the laboratory. In 70.4% (95/135) of participating medical institutions, LM doctors have been the Chairperson of the Hospital Transfusion Committee. @*Conclusion@#Extremely positive survey results were received from LM doctors. These survey results from LM doctors and facilitators will be helpful in developing and planning future projects related to RNBTM.
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This report summarizes the 2019 survey results of the external quality assessment (EQA) scheme for the Transfusion Medicine Program (TMP) in Korea. Proficiency testing materials were prepared at the Asan Medical Center for the biannual distribution to participating laboratories. The average accuracy rates and number of participants (in parenthesis) for ten survey items were as follows: ABO typing, 99.4%–99.9% (N=875); RhD typing, 99.8%–100% (N=864); crossmatching, 90.8%–99.6% (N=760); ABO subtyping, 98.2% and 100% (N=58); Rh CcEe antigen testing, both 100% (N=55); weak D test, 97.9%–100% (N=232); antibody screening, 99.7%– 100% (N=316); direct antiglobulin test (DAT) using a polyspecific reagent, 99.6%–100% (N=273); DAT using an immunoglobulin-G monospecific reagent, both 100.0% (N=67); DAT using a C3d monospecific reagent, 95.6%–98.5% (N=67); antibody identification, 87.9%–99.2% (N=132); and ABO Ab titration, 85.7%–100% (N=134). The number of participants showed an average increase of 14% across the ten survey items, with the ABO antibody titration showing the highest increase at 83.6%. While results were generally excellent, antibody identification and ABO antibody titration results showed room for improvement. The 2019 EQA scheme for TMP has contributed to the improvement and maintenance of the participating laboratories to the program.
ABSTRACT
Background@#Since there is a paucity of red blood cells (RBCs) with a weak expression of A, B, or D antigens, they cannot be used as routine Blood Bank quality control materials. This study aimed to prepare glutaraldehyde-treated RBCs to be weakened ABO and RhD antigen expressions for blood typing. @*Methods@#RBCs from A1B RhD positive blood group donors were treated with 0.5%, 0.375%, 0.3125%, 0.25%, and 0.125% concentrations of glutaraldehyde. The treated RBCs were then used for ABO and RhD blood typing using the tube technique. Differences in agglutination reaction strength and potassium concentrations were compared using treated RBCs stored days for 0, 1, 4, and 7 days at 2℃–8℃. @*Results@#With an increase in the glutaraldehyde concentrations, the strength of agglutination reaction against anti-A, anti-B, anti-D, and anti-A1 reagents reduced. Most tests showed 2+ strength with 0.25% glutaraldehyde treated RBCs. Hemolysis increased with increasing storage time; however, there were no significant differences in strengths until the 7th day of storage. @*Conclusions@#The preparation of 0.25% glutaraldehyde-treated RBCs is simple, and it can be used as a cheap ABO subtype or D variant quality control material. The use of these treated red cells may improve the accuracy of blood typing in Blood Banks.
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Background@#The current Korean Blood Inventory Monitoring System (BMS) has several drawbacks. It does not provide real-time data and only monitors 211 of the more than 2500 institutes that performed blood transfusions.This survey study investigated the status of BMS use and the preparation status of the data input system of medical institutions to help in the revision of BMS in preparation for the full surveillance of BMS. @*Methods@#A survey questionnaire was given to 200 hospitals participating in the current BMS, along with another set of questionnaires to 150 non-participating hospitals. The questionnaire consisted of the method of data registry to BMS, the current status of electronic medical records (EMR) and order communication system (OCS), perception, and readiness of adaptation of an open application programming interface system (API). @*Results@#Two hundred and one BMS participating hospitals responded to the survey. Approximately 75% entered data with a comma-separated value (CSV) or Excel spreadsheet (xls) files, and approximately half had an in-house developed EMR and OCS. The majority showed enthusiasm for the introduction to an open API. Among the non-participating hospitals, 138 responded. Approximately 70% counted the blood inventory daily, but approximately half did not use electronic methods for this process. The response to the introduction to an open API was positive, but the readiness for a prompt introduction was low at 15.9%. @*Conclusion@#These results will help revise the current BMS. On the other hand, full surveillance of BMS is anticipated to be hindered by the ready state of each medical institute. Moreover, the encouragement of participation would require supportive government administrative measures.
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Background@#Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. @*Methods@#The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. @*Results@#The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. @*Conclusion@#South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.
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Background@#The current Korean Blood Inventory Monitoring System (BMS) has several drawbacks. It does not provide real-time data and only monitors 211 of the more than 2500 institutes that performed blood transfusions.This survey study investigated the status of BMS use and the preparation status of the data input system of medical institutions to help in the revision of BMS in preparation for the full surveillance of BMS. @*Methods@#A survey questionnaire was given to 200 hospitals participating in the current BMS, along with another set of questionnaires to 150 non-participating hospitals. The questionnaire consisted of the method of data registry to BMS, the current status of electronic medical records (EMR) and order communication system (OCS), perception, and readiness of adaptation of an open application programming interface system (API). @*Results@#Two hundred and one BMS participating hospitals responded to the survey. Approximately 75% entered data with a comma-separated value (CSV) or Excel spreadsheet (xls) files, and approximately half had an in-house developed EMR and OCS. The majority showed enthusiasm for the introduction to an open API. Among the non-participating hospitals, 138 responded. Approximately 70% counted the blood inventory daily, but approximately half did not use electronic methods for this process. The response to the introduction to an open API was positive, but the readiness for a prompt introduction was low at 15.9%. @*Conclusion@#These results will help revise the current BMS. On the other hand, full surveillance of BMS is anticipated to be hindered by the ready state of each medical institute. Moreover, the encouragement of participation would require supportive government administrative measures.
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Background@#Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. @*Methods@#The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. @*Results@#The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. @*Conclusion@#South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.
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Herein, we report the results of the 2018 survey on the external quality assessment (EQA) scheme for the Transfusion Medicine Program (TMP) in Korea. The proficiency testing specimens were prepared at Ajou University Hospital and were sent to the participants biannually. The average accuracy rates for ten different test items on the regular survey were as follows: ABO typing, 99.5%–99.8% (N=841); RhD typing, 99.8%–100.0% (N=827); crossmatching, 89.4%–99.6% (N=708); ABO subtyping, 94.2% and 94.4% (N=53); Rh CcEe antigen testing, all 100.0% (N=51); weak D test, 80.9% (N=207) for the first trial and not graded for the second trial; antibody screening, 99.7%–100.0% (N=304); direct antiglobulin test (DAT) using a polyspecific reagent, 98.9%–100.0% (N=264); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=66); DAT using a C3d monospecific reagent, 97.0%–100.0% (N=67); antibody identification, 98.4%–100.0% (N=127); and ABO antibody titration, 84.6%–100.0% (N=73). There were approximately 10.5% more participants in the 2018 EQA scheme than that in 2017. Excellent survey results were obtained in the 2018 EQA scheme compared with those in 2017, except for the weak D test. The 2018 EQA scheme for the TMP should be helpful for improving the quality of the participating laboratories.
Subject(s)
Coombs Test , Korea , Laboratory Proficiency Testing , Mass Screening , Quality Improvement , Thymidine Monophosphate , Transfusion MedicineABSTRACT
BACKGROUND: Currently there is no external proficiency testing program for allergen-specific immunoglobulin E assays (sIgE) in Korea. The aim of this study was to evaluate the accuracy of sIgE performed in different laboratories in Korea using Polycheck Allergy Diagnostic (Biocheck GmbH, Germany) or simply ‘Polycheck’ and to further perform an inter-laboratory comparison of sIgE. METHODS: Three inter-laboratory trials were undertaken from June 2016 to December 2017 at nine institutions. Serum samples obtained from three patients who had a history of positive Polycheck results were used in each trial. A total of 59 allergens were evaluated from the standard panel, inhalation panel, and food panel. The acceptable rates (%) of classes 0–6 of the results were calculated using three different criteria, including the consensus of 80% participants of the College of American Pathologists (CAP), the most frequent value (MFV), and the Overall Misclassification Index Score (OMIS). RESULTS: The proportion of laboratories that showed acceptable results for CAP criteria, MFV, and OMIS were around 93.0%–97.7%, 66.3%–76.0%, and 0.1–1.3, respectively, in each trial. Under-performing institutes showed consistently higher (49/68, 72.1%) or lower (19/68, 27.9%) than acceptable results for all criteria. CONCLUSIONS: This is the first study evaluating the inter-laboratory variation of sIgE in Korea using various criteria. It was found that the acceptable rate could be altered based on changes in these criteria. These findings might be useful for the inter-laboratory comparison of sIgE in Korea in the future as well.
Subject(s)
Humans , Academies and Institutes , Allergens , Consensus , Hypersensitivity , Immunoglobulin E , Immunoglobulins , Inhalation , Korea , Laboratory Proficiency Testing , Mass Screening , Quality ControlABSTRACT
BACKGROUND: A massive blood transfusion (MT) requires significant efforts by the Blood Bank. This study examined blood product use in MT and emergency O Rh Positive red cells (O RBCs) available directly for emergency patients from the Trauma Center in Ajou University Hospital. METHODS: MT was defined as a transfusion of 10 or more RBCs within 24 hours. The extracted data for the total RBCs, fresh frozen plasma (FFP), platelets (PLTs, single donor platelets (SDP) and random platelet concentrates (PC)) issued from Blood Bank between March 2016 and November 2017 from Hospital Information System were reviewed. SDP was considered equivalent to 6 units of PC. RESULTS: A total of 345 MTs, and 6233/53268 (11.7%) RBCs, 4717/19376 (24.3%) FFP, and 4473/94166 (4.8%) PLTs were used in MT (P < 0.001). For the RBC products in MT and non-MT transfusions, 28.0% and 34.1% were group A; 27.1% and 26.0% were group B; 37.3% and 29.7% were group O, and 7.5% and 10.2% were group AB (P < 0.001). The ratios of RBC:FFP:PLT use were 1:0.76:0.72 in MT and 1:0.31:1.91 in non-MT (P < 0.001). A total of 461 O RBCs were used in 36.2% (125/345) of MT cases and the number of O RBCs transfused per patient ranged from 1 to 18. CONCLUSION: RBCs with the O blood group are most used for MT. Ongoing education of clinicians to minimize the overuse of emergency O RBCs in MT is required. A procedure to have thawed plasma readily available in MT appears to be of importance because FFP was used frequently in MT.
Subject(s)
Humans , Blood Banks , Blood Platelets , Blood Transfusion , Education , Emergencies , Hospital Information Systems , Plasma , Tertiary Healthcare , Tissue Donors , Trauma CentersABSTRACT
BACKGROUND: The management of red blood cell inventory in hospital's blood bank is crucial. The Australian Red Cross Blood Service developed a RBC safety stock calculation method (abbreviated as the ‘Australian formula’). In this study, we applied this method to four Korean hospitals to calculate the safe RBC stock level. METHODS: The hospitals included in this study were three tertiary teaching hospitals and one teaching hospital. The number of hospital beds in these hospitals were 1093, 1330, 1400, and 854, respectively. The data were collected from the Korea Blood Inventory Monitoring System of Centers for Disease Control & Prevention. The target/minimal/maximal RBC inventory levels and inventory days (inventory level/average daily usage) by ABO blood types were calculated using the daily red cell transfusion, wastage, and supply data between May and October 2016. RESULTS: The enrolled hospitals showed different levels for the target/minimal/maximal RBC inventory according to each blood group. The average of RBC inventory days in the four hospitals was 4.2 days. For each blood group, RBC inventory days were 3.2~4.4 days for O blood group type, 3.5~4.7 days for A blood group, 3.9~4.5 days for B blood group, and 3.9~5.5 days for AB blood group. CONCLUSION: Because the optimal RBC inventory levels are different depending on the hospital characteristics and the ABO blood group, it is necessary to set the RBC inventory levels for each hospital distinctly. The data obtained in this study will help manage blood product inventory in various hospital blood banks.
Subject(s)
Blood Banks , Erythrocytes , Hospitals, Teaching , Korea , Methods , Red CrossABSTRACT
Here, we have reported results of the surveys on the external quality assessment scheme (EQA) of the Transfusion Medicine Program (TMP) in Korea that were carried out in 2017. The proficiency testing specimens were prepared at Ajou University Hospital, and sent to the participants biannually. The average accuracy rates (N=the number of participants) for ten different test items on the regular survey were as follows: ABO typing, 99.1%–99.9% (N=714); RhD typing, 99.3%–100.0% (N=695); crossmatching, 88.9%–98.5% (N=618); ABO subtyping, 80.7% and 96.0% (N=51); Rh CcEe antigen testing, 98.8%–100.0% (N=51); weak D test, 99.3% and 100.0 (N=150); antibody screening, 98.6%–100.0% (N=295); direct antiglobulin test (DAT) using a poly-specific reagent, 99.2%–100.0 (N=256); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=68); DAT using a C3d-monospecific reagent, 83.6%–100.0% (N=72); antibody identification, 88.7%–99.2% (N=123); and ABO Ab titration, 84.6%–100.0% (N=73). The number of participants for the EQA for TMP in 2017 was much higher than that in 2016. Except for the case of ABO subtyping, excellent survey results for the 2017 EQA for TMP were obtained, compared to those in 2016. Thus, the EQA for TMP in 2017 should be helpful for improving the quality of the participating laboratories.
Subject(s)
Coombs Test , Korea , Laboratory Proficiency Testing , Mass Screening , Quality Improvement , Thymidine Monophosphate , Transfusion MedicineABSTRACT
BACKGROUND: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. METHODS: Transfusion is one of the most important treatments in patient care. It has been known that there is a lack of transfusion medicine knowledge of doctors in other countries, however it has not been investigated yet in Korea. In this study, we assessed the educational need and the knowledge on transfusion medicine for trainees to provide basic raw data for future education in transfusion medicine. RESULTS: Among trainees, 89.9% said they received more than one hour of transfusion medicine education at medical schools, but 57.3% did not receive transfusion medicine education after finishing medical school. Moreover, 76.4% and 86.5% of respondents stated that additional transfusion medicine education was needed during and after medical school respectively. Among respondents, 43.5%, 53.9%, and 28.1% reported their knowledge on blood products, pretransfusion testing, and transfusion reactions as low or very low. In the assessment of knowledge of transfusion medicine, the mean percentage of correct answers was 65.2%. The rates of correct answers (average) ranged from 25.8% to 80.9% (58.2%), 49.4% to 94.4% (75.7%) 70.8% to 89.9% (80.2%) in case of blood products, pretransfusion testing, and transfusion reactions respectively. CONCLUSION: Transfusion medicine education among trainees after finishing medical school was found to be insufficient, and additional education for transfusion medicine is demanded by trainees.
Subject(s)
Education , Korea , Patient Care , Schools, Medical , Surveys and Questionnaires , Transfusion Medicine , Transfusion ReactionABSTRACT
We report here the 2016 results of surveys on an external quality assessment (EQA) for immunohematology testing in Korea carried out in 2016. The proficiency testing specimens were prepared at Ajou University Hospital, and the specimens were sent to participants biannually. The average accuracy rates (N=the number of participants) for ten different test items on the regular survey were as follows: ABO typing, 98.9%–99.7% (N=627); RhD typing, 98.6%–99.8% (N=607); crossmatching, 90.1%–98.1% (N=454); ABO subtyping, 92.7%–93.0% (N=42); Rh CcEe antigen testing, 97.8%–100.0% (N=46); weak D test, 70.8%–73.6% (N=91); antibody screening, 96.6%–100.0% (N=267); direct antiglobulin test (DAT) using a polyspecific reagent, 92.2%–99.6% (N=49); DAT using an immunoglobulin G monospecific reagent, 84.1%–100.0% (N=68); DAT using a C3d monospecific reagent, 80.0%–100.0% (N=68); antibody identification, 96.7%–99.1% (N=118); and ABO antibody titration, 82.4%–100.0% (N=42). Excellent results for the 2016 EQA for immunohematology testing were obtained, except for those of the weak D test. The EQA for immunohematology testing in 2016 should be helpful for improving the quality of participating laboratories.
Subject(s)
Coombs Test , Immunoglobulin G , Korea , Laboratory Proficiency Testing , Mass Screening , Transfusion MedicineABSTRACT
BACKGROUND: The use of automated systems for pre-transfusion tests is increasing in an attempt to reduce workload and the impact of human errors in blood banks. We evaluated the clinical performance of the automated blood bank systems IH-500 (Bio-Rad Laboratories, Switzerland) and VISION Max (Ortho-Clinical Diagnostics, USA) for ABO-RhD blood typing and unexpected antibody screening. METHODS: ABO-RhD blood typing was performed for 410 samples, and antibody screening was performed for 332 samples, including 15 antibody-positive samples. The results obtained from the two automated instruments were compared with those obtained using manual methods for ABO-RhD blood typing and a semiautomated method (DiaMed-ID system) for antibody screening. Additionally, both instruments were evaluated in terms of concordance rates, sensitivity, and carryover. RESULTS: The concordance rate of the ABO-RhD blood typing results between the manual methods and the two automated instruments was 100%. For antibody screening tests, the concordance rates between the semiautomated method (DiaMed-ID system) and the automated methods were 100% and 99.7% for the IH-500 and VISION Max instruments, respectively. The sole discrepant result was obtained for a sample identified as antibody-positive only on the VISION Max; the antibody was identified as anti-Le(a). The overall sensitivity of the two automated instruments was the same as or higher than that of the semiautomated method. Carryover was not observed in antibody screening. CONCLUSIONS: The IH-500 and VISION Max instruments showed reliable results for ABO-RhD blood typing and unexpected antibody screening, and can be used clinically, with confidence, for pre-transfusion tests in the blood bank.
Subject(s)
Humans , Automation , Blood Banks , Blood Grouping and Crossmatching , Mass Screening , MethodsABSTRACT
BACKGROUND: Because ABO reverse typing reagents approved by the Ministry of Food and Drug Safety (MFDS) for manual typing are rare in Korea, 3% DiaCell ABO A₁ red blood cell (RBC) reagents (DiaCell A₁, BioRad, DiaMed, Cressier, Switzerland) and DiaCell ABO B RBC reagents (DiaCell B) for a manual technique were compared with already approved RBC reagents for the acquisition of an import permit. METHODS: Residual plasmas or sera were collected after routine ABO grouping or other tests. The reverse typing tests were performed by a manual tube technique with DiaCell A₁& B as the test reagents and 0.8% ID-DiaCell ABO A₁& B RBC reagents, ID-Card for NaCl, and an IH-1000 autoanalyzer from the same manufacturer of DiaCell A₁& B as the control reagents. Agreements, clinical sensitivities and clinical specificities between test and control reagents were calculated. RESULTS: Comparison tests were performed in 1000 samples, and agreements were 99.9% for DiaCell A₁ and 100.0% for DiaCell B. Clinical sensitivities and clinical specificities were 99.9% and 100.0% for DiaCell A₁ and all 100.0% for DiaCell B, respectively. CONCLUSION: Because the evaluation results of DiaCell A₁ and B were all satisfied with more than 99% as the evaluation criteria of MFDS, they were concluded to be suitable for use as ABO reverse typing reagents for manual typing. The results of this study are also expected to be useful in the design of clinical trials for approval of future in vitro medical devices.
Subject(s)
Erythrocytes , In Vitro Techniques , Indicators and Reagents , Korea , PlasmaABSTRACT
Accurate D antigen blood typing is needed owing to the clinical importance of the Rh blood group. We describe a female infant who was suspected to suffer from Rh incompatible hemolytic disease of the newborn, and who showed a strong positive direct antiglobin test (DAT) result and false red blood cell (RBC) agglutination in D typing. Using chloroquine dissociation of IgG, we confirmed that the antibodies coating her RBCs were of anti-D type. D typing with 0.8% RBC suspensions in saline using saline gel cards showed 2+ RBC agglutinations. After increasing the incubation time of dissociation by chloroquine for up to 4 hr, the dissociated RBCs began to show agglutination in both the tube technique (2+) and the gel card technique (4+) for D typing, although the DAT rest was still positive. Therefore, in order to prevent mistyping as a false-negative D blood group, whenever the D blood typing of a patient with a strong positive DAT rest does not show RBC agglutination, retesting of the D blood typing is recommended by using saline-suspended RBCs or dissociated RBCs.