Establishment and optimization of inductively coupled plasma mass spectrometry (ICP-MS) for the determination of aluminum residues / 中国输血杂志

【Objective】 To establish and optimize a method for the determination of aluminum (Al) residue by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 Nitric acid solution was used to treat samples and standards. The concentration of nitric acid solution and equipment parameters were optimized, and the specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision of the optimized detection method were investigated to confirm whether it was suitable for the determination of Al residue in human serum albumin. 【Results】 The concentration of nitric acid was 5%, and digest time was 4 h. The equipment condition of ICP-MS was as follows: RF power: 1600 W, sampling depth: 10 mm, atomizer / carrier gas flow rate: 1.0 L/ min, compensation flow rate: 0.5 L/ min, experimental mode: standard mode, integration time: 0.2 s, data acquisition: 3 times. Specificity: The recoveries of Al: 92% (high concentration, RSD=3.5%), 98% (low concentration, RSD=4.9%). Linearity: In the range of (0~40) μg/L, the correlation coefficient between concentration and optical energy signal (CPS) of standard / sample were higher than 0.999 0. Accuracy/ Repeatability: The recoveries of sample (3 concentration): 108% (RSD=4.7%), 110% (RSD=4.9%) and 110% (RSD=2.8%). The detection limit was 0.006 μg/L, and the quantitation limit was 0.019 μg/L. Intermediate precision: personnel factor and date factor, P>0.05, RSD (12 times)=2%. Comparison between ICP-MS and atomic absorption spectrometry (AAS): the deviation between ICP-MS and AAS was 8%, and that of samples was 3%, with no significant difference noticed between the two methods. 【Conclusion】 After optimization, ICP-MS method has shown good performance in terms of specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision, and is suitable for the determination of Al residue in human albumin products of our company.

Information Statistics and Discussion on the Results of Aluminumion Content Determination of Retention Samples of Human Albumin / 中国药学杂志

OBJECTIVE: To evaluate the quality of human albumin products, and determine the content of aluminumion in the upcoming expired human albumin samples of both domestic and imported products for batch release. METHODS: Statistics was carried out for domestic and imported human albumin products in 2017 about the approved registration, import approval number, storage conditions, aluminumion content of batch release and other information. Aluminumion contents of the samples were detected by National Institutes for Food and Drug Control which banded with 7 authorized agencies for batch release of blood products according to the atomic absorption spectrometry or verified inductively coupled plasma mass spectrometry (ICP-MS)method for the determination of aluminumion content in China Pharmacopoeia 2015. RESULTS: There were a total of 28 domestic manufacturers of blood products and 158 human albumin drug approval numbers (totally 40 for daily production, 2017), among which 21 were approved for the storage condition of "room temperature" and 7 for "refrigerate". A total of 185 batches of human albumin samples from 25 domestic manufacturers were sampled. The mean aluminumion content in the batch release reports was 61 μg·L-1(8-134 μg·L-1), while that in the samples of the upcoming expired products was 137 μg·L-1(20-487 μg·L-1). The mean aluminumion content increased by about 1 time after the storage period. There were about 17.8% (33/185)samples having aluminumion content over 200 μg·L-1. There were a total of 13 manufacturers of imported human albumin with a total of 17 import specifications in 2017. The approved storage condition was all "room temperature". A total of 78 batches of human albumin products for batch release from 11 import enterprises were sampled. The mean aluminumion content in the batch release reports was 27 μg·L-1(7-60 μg·L-1), while that in the samples of the upcoming expired products was 50 μg·L-1(1-175 μg·L-1). The overall mean increased about 1 time after the storage period, which was consistent with the domestic human albumin products. But the two parameters of the imported products were both lower than the domestic ones. None (0/78)of the samples having aluminumion content over 200 μg·L-1. CONCLUSION: The aluminumion contents of some batches of upcoming expired domestic human albumin products are over 200 μg·L-1. The overall aluminumion contents in the initial batch release and the upcoming expired products in the import albumin products are lower than the domestic ones.

Determination of Citrate ion Content and Analysis of Related Factors of Aluminum Content in Human Albumin Products / 中国药学杂志

OBJECTIVE: To determine the citrate ion and aluminum contents in human albumin products and investigate the related factors of aluminum content. METHODS: Sixty-five batches of human albumin products which were very close to the end of shelf life or would be expired within not more than 2 m, including 54 batches of imported ones and 11 batches of domestic ones, were analyzed. The content of citrate ion was determined using the enzyme reaction method, and aluminum content was determined using the atomic absorption method. Factors related to human albumin production, such as ultrafiltration time, glass bottles, sample storage conditions, and the initial value of aluminum content were investigated and analyzed, especially the relationship with the aluminum content at the end of the shelf life. RESULTS: The overall mean content of citrate ion in 65 batches of human albumin was 24 μmol•L-1 (0 - 144 μmol• L-1), the mean content of citrate ion in 54 batches of domestic human albumin was 24 μmol•L-1, and that in 11 batches of imported human albumin was 23 μmol•L-1. The linear correlation coefficients between final aluminum content and citrate ion content of 65 batches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0.315 5, 0.331 8 and 0.746 6, respectively. The linear correlation coefficients between the final aluminum content and storage time of 65 batches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0.102 6, 0.059 3 and - 0.037 4, respectively. The linear correlation coefficient between the final and initial aluminum contents of 54 batches of domestic human albumin was 0.325 5. The linear correlation coefficients between final aluminum content and ultrafiltration process time, citrate ions and ultrafiltration process time of 54 batches of domestic human albumin were 0.011 8 and - 0.108 2, respectively. CONCLUSION: Citrate ion content in human albumin retention samples are lower than 150 μmol•L-1. Citrate ion content and final aluminum content are weakly correlated, however, the correlation coefficient between the two indexes of imported human albumin is much higher than that of domestic samples. The initial and final aluminum contents shows low correlation, and ultrafiltration time shows very weak correlation with storage time.

Establishment of a Method for Determination of Molecular-Size Distribution of Human Serum Albumin by Ultra Performance Liquid Chromatography / 中国药学杂志

OBJECTIVE: To establish a determination method of molecular-size distribution of human serum albumin (HSA) by ultra performance liquid chromatography (UPLC). METHODS: An UPLC method was developed to specifically determine the polymers and other components in HSA on UPLC PROTEIN BEH SEC analysis column with Waters Alliance UPLC system and Waters UPLC TUV detector. The separation was performed using a mobile phase consisting of PBS at a flow rate of 0.6 mL•min-1 and the UV detection wavelength was set at 280 nm. HSA samples were diluted to different concentrations (0.5-20 mg•mL-1) to confirm the optimal concentration range of the injection. The change of component percentage and the linear relationship between HSA concentration and chromatographic peak height were confirmed and the molecular-size distribution was calculated by area normalization method. Within the optimum injection concentration range, the national control sample for HSA was diluted to 12 mg•mL-1 and tested by UPLC method and the methodology was confirmed. Twenty batches of HSA samples were determined by both UPLC and existing HPLC methods, and the samples were determined in parallel. The consistency of the methods was compared and the method was reconfirmed. RESULTS: The UPLC retention time of HSA polymer was 1.469 min, of dimer was 1.972 min, and of monomer was 2.267 min, respectively. The resolution of dimer and monomer was 2.20 and the USP tailing of monomer peak was 1.18 respectively. In the range of the injection concentrations, 0.5-20 mg•mL-1, there was linear relationship between the concentrations of the components of 11 HAS samples, including polymer, dimer and monomer peak, and the peak area%, peak height, peak area, and the squares of linear correlation coefficient were all greater than 0.997 0. The components peak area percentage of HSA samples remained relatively stable within the concentration range of 10-16 mg•mL-1 (total injection amount of 100-160 μg). The RSDs of the percentage of polymers were 0.00% (n=3, 10 mg•mL-1), 0.10% (n=3, 12 mg•mL-1), and 0.10% (n=3, 16 mg•mL-1), respectively. The UPLC method was used to determine the national control sample for human albumin of 12 mg•mL-1, and the mean value of peak area% was 5.62% (n=10). The results were consistent with those of the parallel determination by HPLC (5.58%), both of which were in accordance with the quality control range of the national standard for human albumin. The RSD of the percentage of the peak area of the polymers in national standard for human albumin by UPLC was 0.40% (n=10). The HPLC and UPLC methods were used to determine the polymer peak area percentage of 20 batches of HSA samples from 7 domestic and foreign enterprises at the concentration of 12 mg•mL-1. The correlation coefficient of the two methods was 0.996 0 (P> 0.05) and there was no significant difference between the two methods (P>0.05). CONCLUSION: Compared with the traditional HPLC method, the detection time of HSA SEC by the proposed UPLC method is shortened by at least 10 times, and the accuracy and repeatability of the determination are satisfactory. UPLC method can save much more analysis time, is simple and much faster, and can be used for high-throughput determination of molecular-size distribution of human serum albumin.

Preparation of the First Chinese National Standard for Human Albumin / 中国药学杂志

OBJECTIVE: To prepare the first batch of Chinese national standard for human albumin used for the test of batch release or other quality control of human albumin products. METHODS: The first batch of national standard for human albumin was prepared with certificated human albumin products, mixed and filled under aseptic conditions. The standards were distributed to 11 laboratories for cooperative calibration according to the unified methods published on China Pharmacopeia. Seven test items including total protein content, sodium caprylate, polymers content, pH, absorbance, sodium content, and aluminium content were detected. RESULTS: The limits of the six test items except aluminium content were established as follows after the data from 11 collaboration laboratories were received and statistically analyzed: total protein(193.30 ± 5.08)g·L-1;sodium caprylate (0.162 4 ± 0.009 2) mmol· g(Pro)-1; polymers content (2.72 ± 0.29)% (HPLC-SEC);pH(6.71 ± 0.08) [temperature (22 ± 3)℃];absorbance 0.030 ± 0.005;sodium content (134.9 ± 23.6)mmol ·L-1. The range of initially established aluminium content was (88.4 ± 30.5)μg·L-1. However, it was observed to increase obviously after 21 months according to the trend analysis, so it was deleted from the test items for the national standard for human albumin ultimately. CONCLUSION: The prepared national standard for human albumin met the relevant requirements and may be served as the first generation of national standard for human albumin products.

Blood products and related medical equipment for field first aid / 医疗卫生装备

Objective To explore the present situation of US a rmy's blood products and related medical equipment in order to provide references for likely equipment of the PLA.Methods US army's researches on blood products and related medical equipment were introduced,and the blood products and equipment assigned to the forces were analyzed from the aspects of background,approach,key technology,clinical trial,allocation and etc.Results US army gained advantages in the researches on blood and blood products,and also paid attention to field trials of innovative technologies and products.Conclusion The PLA has to emphasize on the researches on blood products and related medical equipment,and draws lessons from US army to test blood products and related medical equipment by filed training of the forces.

Preparation of national standard for enterovirus 71 immunoglobulin / 中国药学杂志

OBJECTIVE: To prepare the first batch of national standard for enterovirus 71 immunoglobulin for the efficacy test of EV71 human immunology products. METHODS: The domestic intravenous immunoglobulin products with batch release certification and high efficacy EV71 immunoglobulin products were mixed, filled, and lyophilized under aseptic conditions to get the first batch of national standard for enterovirus 71 immunoglobulin. The standards were distributed to five laboratories for cooperative calibration according to the unified SOP for microneutralization test. Neutralizing titer which corresponded to the reciprocal of the highest serum dilution that neutralized enterovirus 71 was defined as the efficacy (reported as unit) of the national standard. Sterility test, moisture determination, precision for filling test, and stability of potency were verified. RESULTS: A total of 63 calibration tests were earned out by the five collaboration laboratories, and the results were statistically analyzed after logistic convertion. The inter-laboratories variations varied from 1.5%-4.1% and the intra-laboratories variation was 3.1%. The geometric mean of the prepared national EV71 immunoglobulin standard was 327 U and defined as 330 U for convenience of use. The potency of the prepared standard was stable after 22 m and the contents of monomer plus dimer determined by HPLC-SEC were more than 98.0% during storage at a wide range of temperatures. The prepared national EV71 immunoglobulin standard was qualified in the sterility test, and the moisture content and precision for filling were 0.6% and 0.56%, respectively. CONCLUSION: The prepared national EV71 immunoglobulin standard met all the relevant requirements and may be served as the first generation of national standard for the potency test of EV71 immunoglobulin products.

Application of Damage Control Resuscitation Strategies to Patients with Severe Traumatic Hemorrhage: Review of Plasma to Packed Red Blood Cell Ratios at a Single Institution

When treating trauma patients with severe hemorrhage, massive transfusions are often needed. Damage control resuscitation strategies can be used for such patients, but an adequate fresh frozen plasma: packed red blood cell (FFP:PRBC) administration ratio must be established. We retrospectively reviewed the medical records of 100 trauma patients treated with massive transfusions from March 2010 to October 2012. We divided the patients into 2 groups according to the FFP:PRBC ratio: a high-ratio (> or =0.5) and a low-ratio group (<0.5). The patient demographics, fluid and transfusion quantities, laboratory values, complications, and outcomes were analyzed and compared. There were 68 patients in the high-ratio and 32 in the low-ratio group. There were statistically significant differences between groups in the quantities of FFP, FFP:PRBC, platelets, and crystalloids administered, as well as the initial diastolic blood pressure. Bloodstream infections were noted only in the high-ratio group, and the difference was statistically significant (P=0.028). Kaplan-Meier plots revealed that the 24-hr survival rate was significantly higher in the high-ratio group (71.9% vs. 97.1%, P<0.001). In severe hemorrhagic trauma, raising the FFP:PRBC ratio to 0.5 or higher may increase the chances of survival. Efforts to minimize bloodstream infections during the resuscitation must be increased.

Quantitative analysis of sucrose in human fibrinogen by HPLC / 中国药学杂志

OBJECTIVE: To establish a quantitative determination method of sucrose in human fibrinogen by HPLC. METHODS: An HPLC method was developed to specifically determine sucrose on Zorbax carbohydrate analysis column with Waters Alliance system and 2414refractive index detector. The separation was performed at 30°C using a mobile phase consisting of acetonitrile and water (70:30) at a flow rate of 1.4 mL · min-1. Thirteen batches of recombinant human coagulation factor VM samples were selected for methodology comparison of the established HPLC method with the IEC-HPLC method adopted by Ch. P 2010, because these samples only contained sucrose and did not receive dry-heat treatment. RESULTS: The RSDs (n=6) of the retention time and peak area were 0.17% and 0.09%, respectively. The recoveries of sucrose at low (5 mg · mL-1), middle (10 mg · mL-1), high (15 mg · mL-1) concentration were 96.2%, 98.8% and 100.3%, respectively. The average recovery was 98.4% and the linear correlation coefficient r was 1.0000 in the ranges of 2-20 mg · mL-1. Statistical analysis showed that the amounts of sucrose in 13 batches of recombinant human coagulation factor VIII samples determined by the HPLC method and IEC-HPLC method had no significant difference (P≤0.05) and the correlation coefficient r was 1.0000. CONCLUSION: The proposed HPLC method is simple, accurate and re-peatable for determination of sucrose in dry-heat treated human fibrinogen product. The HPLC method showed good accordance with IEC-HPLC method for assay results of sucrose, thus can be widely applied.

Clinical study on thromboelastography-indicated postoperative blood requirements after abdominal surgery / 中华急诊医学杂志

Objective To investigate the accuracy and promptness of thromboelastography (TEG) to assess the blood transfusion requirements after abdominal operation in comparison with conventional assessments including vital signs (MAP,heart rate,breathing rate),urine output,hemoglobin and hematocrit.Methods From June to December in 2010,there were 57 patients were suspected bleeding in abdominal cavity after operation in SICU.Recorded data including vital signs (MAP,heart rate,breathing rate,oxygen saturation),urine volume per hour,the coagulation tests (Fib,PT,aPTT,INR),TEG parameters (R,K,Angle,MA,CI),the results of blood routine (Hb,Hct,Ph) and whether bleeding or not,blood product requirements within 24 h.Results Vital signs (MAP,heart rate,breathing rate,oxygen saturation),urine output per hour and the coagulation tests (Fib,PT,INR) showed no significant correlations (P ＞ 0.05) with blood transfusion requirements,but aPTT (R =0.513,P =0.000) and MA (R =0.578,P =0.000) correlated with the blood transfusion requirement.Patients with reduced MA needed more blood transfusion requirements.Patients were divided into active bleeding group and insidious bleeding group.MA had significant difference between two groups (P =0.025),but aPTT had not.Conclusions Thrombelastography is a more accurate indicator of blood transfusion requirements,especially in active bleeding patients.

Transfusion Therapy in the Emergency Department / 대한수혈학회지

BACKGROUND: Most patients requiring transfusion are admitted to the general ward; however, the number of patients visiting the emergency department for transfusion is increasing. In this study, we reviewed the transfusion therapies that are performed in the emergency department and analyzed their status. METHODS: We conducted a retrospective review of the charts of patients who visited the emergency department in our hospital for transfusion therapy from October 1, 2008 to October 30, 2012. We collected and analyzed general information on the patients and divided them into groups according to the number and kind of blood products they received. RESULTS: A total of 4,497 patients visited the emergency department for transfusion therapy during the study period. Among 4,497 patients, 2,925 patients were enrolled in the study and 1,572 patients were excluded. Out of 2,925 patients, there were 1,745 male patients (59.66%) and 1,180 female patients (40.34%), mean age was 61.24 (+/-17.49); 2,340 patients (80.00%) were admitted, 364 (12.45%) discharged, 44 (1.50%) expired, and 177 (6.05%) were transferred. The most common cause for transfusion was upper and lower gastrointestinal bleeding (928, 32%), followed by trauma (548, 19%), malignancy (376, 13%), anemia (294, 10%), infection (281, 10%), and gynecologic (137, 5%) respectively. CONCLUSION: Performance of transfusion therapy in the emergency department is not uncommon; therefore, proper protocols by cause of bleeding will be required for prevention of unnecessary complication that may occur during transfusion therapy.

Quality investigation of insoluble particles in freeze-dried and liquid human immunoglobulin for intravenous injection / 中国药学杂志

OBJECTIVE: To determine the insoluble particles in human immunoglobulin (pH 4) for intravenous injection and human hepatitis B immunoglobulin(pH 4) for intravenous injection in both liquid and freeze-dried forms from 14 domestic manufacturers. METHODS: Thirty-two batches of human immunoglobulin products including 19 batches of human immunoglobulin (pH 4) for intravenous injection, 5 batches of human immunoglobulin (pH 4) for intravenous injection (freeze-dried), 5 batches of human hepatitis B immunoglobulin (pH 4) for intravenous injection, and 3 batches of human hepatitis B immunoglobulin(pH 4) for intravenous injection (freeze-dried) were tested by light obscuration particle count test method recommend by appendix of 2010 CHP by GWF-8JA laser particle size analyzers. Insoluble particles greater than 10 and 25 μm were counted, respectively. Microscopy counting was carried out if the test results from light blockage method did not meet the qualification criteria in 2010 ChP. Trend analysis and comparison of the results from NIFDC and enterprises were done. RESULTS: The test results of insoluble particles in 32 batches of human immunoglobulin products indicate that 90.6%(29/32) of the products complied with the requirement of 2010 ChP and the results were in agreement between NIFDC and enterprises. Unfortunately, 3 batches of human immunoglobulin(pH 4) for intravenous injection(freeze-dried) failed in light obscuration particle count test, however, they met the requirement of 2010 ChP when microscopy counting method was used. CONCLUSION: The quality control of human immunoglobulin products in China market is generally fine, and the test results from different laboratories are basically consistent. Test result of insoluble particles in freeze-dried IVIG by microscopy counting method and light obscuration particle count test method show significant difference.

International Comparison of Blood Product Prices / 대한수혈학회지

BACKGROUND: Due to the slowing of population growth, population ageing, and more aggressive medical treatment, Korea will be faced with the challenge of blood shortage. One solution to the blood shortage problem is to take advantage of the multicomponent collection technique. However, clinical application is limited due to the low prices of blood products. In this study, we compared the prices of blood products in 6 major countries. METHODS: Prices of leukoreduced red blood cells (RBC), platelet concentrate (PC), fresh frozen plasma (FFP), cryoprecipitate (CRYO), and apheresis platelets (AP) were compiled from US, United Kingdom, Japan, Australia, Spain, and Korea. Adjusted prices using per capita gross domestic product (GDP) and purchasing power parity (PPP) were estimated and analyzed. RESULTS: The RBC price in Korea was only 30% of the mean RBC price of the other 5 countries. Considering per capita GDP and PPP, the RBC prices in Korea were estimated up to 41% and 46%, respectively. The PPP adjusted price of PC, FFP, and AP of Korea was 70%, 72%, and 70% of mean price of the other 5 countries. Price ratios of PC, FFP, and CRYO to RBC were 0.59, 0.63, and 0.57, which were higher than the means of the other 5 countries (0.38, 0.47, and 0.32). CONCLUSION: Considering per capita GDP and PPP, blood product prices in Korea were cheaper than the mean prices of the other 5 countries. For adoption of multicomponent collection, the prices of blood products should be raised, especially the price of RBCs.

Accidents in blood and blood product transfusion practice at B Department of Hai Phong Pediatric Hospital

Background: Blood and blood products are biological products that can not be replaced. Blood transfusion plays an enormous role in the treatment. However, in blood transfusion patients may have severe complications that can lead to death.\r\n', u'Objective: to describe accidents in blood and blood product transfusion practice. Subjects and method: The prospective, clinically descriptive study was carried out on 134 patients with 175 times of blood and blood transfusion at B Department of Hai Phong Pediatric Hospital from 1/1/2004 to 30/06/2008. Each time of transfusion was followed up according to an uniform medical record. Results and conclusion: Amount of blood used was 40.95 lit including total blood: 10.75 lit (26.6%), red cells mass: 28.85 lit (63.2%), fresh plasma 2.45 lit (5.8%), platelet rich fresh plasma rich: 1.9 lit (4.6%). Number of accidents occurring were 20, accounting for 14.1%. Patients with acute leukemia had the highest of incidence rate for transmission accidents (12.5%). Three kinds of the most frequently encountered blood and blood product transfusion accidents were high fever and chill (6.9%), rash (4%) and shock (0.5%). There were no deaths from blood transfusion. Accidents happened mainly to patients who get transfused many times.\r\n', u'

Study the use of blood and blood products for emergency and therapeutic in Bach Mai hospital

Background: Blood transfusion is the process of receiving blood products into one's circulation intravenously. Transfusions are used in a variety of medical conditions to replace lost components of the blood. Objectives: To study the situations of use of blood and blood products, the indications for transfusion and transfusion reactions in some clinical departments of Bach Mai Hospital. Subjects and method: Retrospective study from January 2005 to December 2005 and perspective study from January 2006 to June 2006 through blood records, patient chart and patients. Results & Conclusion: from January 2005 to June 2006, Bach mai Hospital used 45318 units of blood and products, most were erythrocyte concentration (57,9%), plasma (24,9%) and (12,3%). The most used blood group were group 0 (44,5%). Blood-erythrocyte concentration and platelet concentration were most used in Hematology and Transfusion Department, plasma were most used in ICU. 31,1 % and 27,8% of patients were laboratory evaluation before transfusion of erythrocyte concentration and platelet concentration, respectively. The rate of transfusion reactions were 1,04%, most were pruritus - 83,7%. Highest rate of transfusion reaction were belonged to blood (3,4%) and platelet concentration (3%). From January 2005 to June 2006, Bach Mai Hospital used 45318 units of blood and products, most were erythrocyte concentration, plasma, platelet concentration and blood 31,1 % and 27,8% of patients were laboratory evaluation before transfusion of erythrocyte concentration and platelet concentration, respectively.

Studying needs of using blood in National Institute of Hematology and Blood Transfusion (04/2005-03/2006)

Background: Blood is a very special product to use for patients treatment. In order to have better plan to supply enough blood and on time according to the needs of clinics, studying to explore the trend, the needs of using blood and its products in clinics are very necessary. Objective: to identify needs using blood and blood products for patients with blood-related diseases at National Institute of Hematology and Blood Transfusion from 4/2005 - 03/2006. Subjects and methods: The retrospective study was carried out on all of the data about using blood and blood products for patients with blood- related diseases about: Name of patient, age, diagnosis. Kind of blood products, blood group, the time using blood and blood products. Result: The trend using of blood and blood products of clinics has increased (increased 1.64 times) from 2,132 units in April 2005 to 3,499 units in March 2006. Blood products are used 100%.T consumption seemed to increase during months at the end and earlier of year, especially March 2006. Red cell concentrate used mostly. 0 blood type was used most often. Conclusion: Identifying needs using blood for patients with blood-related disease in clinics are base in order to National Institute of Hematology and Blood Transfusion has planned to collect, screen and make blood products to assure supplying blood and blood products enough and safety. \r\n', u'\r\n', u'

Detection of Small Anellovirus DNA from Blood Products / 대한수혈학회지

BACKGROUND: The small anellovirus (SAV) is a new member of the genus Anellovirus infecting humans. SAV can be transmissible by transfusion. However there are no reports on SAV infections in Korea. The aim of this study was to determine the prevalence of SAV in blood products. METHODS: A total of 90 plasma samples from blood products (each 30 units of Red blood cell, whole blood, and platelet concentrate) and 30 serum samples from non-A to C hepatitis patients were tested. SAV DNA was detected using nested polymerase chain reaction (PCR). At the same time, TTV and TTMV DNA were detected using nested PCR. RESULTS: SAV DNA was detected in 34% (31/90) of blood products. TTV and TTMV DNA were detected in 66% (54/90) and 29% (26/90) of blood products, respectively. One of the three anelloviruses (SAV, TTV, TTMV) was detected in a total of 77 blood products (86%). SAV DNA was detected in 40% (12/30) of hepatitis patients. TTV and TTMV DNA were detected in 73% (22/30) and 33% (10/30) of those patients, respectively. One of the three anelloviruses (SAV, TTV, TTMV) was detected in 97% (29/30) of hepatitis patients. CONCLUSION: Blood products are frequently infected with SAV and (or) other anelloviruses (TTV/TTMV) in Korea, and can be transmissible with a high probability.

Distribution of Transfusion-transmitted Virus Genomic Groups in Blood Products / 대한진단검사의학회지

BACKGROUND: Transfusion-transmitted virus (TTV) is a small DNA virus with single-stranded, closed circular, antisense genome infecting humans. The TTV has been classified into five major genomic groups 1-5. There have been a few studies on TTV prevalence in blood donors and blood products in Korea. However there have been no reports on the TTV genomic groups in Korea. The aim of this study was to gain information on TTV genomic groups in blood products in Korea. METHODS: A total of 50 plasma samples from blood products (25 units each of red blood cell and whole blood) were tested. The samples are obtained from the segments of the blood products. TTV DNA was detected using polymerase chain reaction (PCR) with two sets of universal primers (A set and B set), and TTV genomic groups were determined using PCR with group specific primer sets. RESULTS: TTV DNA was detected in 96% (48/50) of the blood products: the TTV genomic group 3 was found the most frequently (52%, 26/50), followed by group 4 (46%, 23/50), group 1 (20%, 10/50), group 5 (10%, 5/20), and group 2 (2%, 1/50). There were seven blood products (14%) infected with TTVs but their genomic groups were not identified with group specific primer sets. Among the blood products, 44% (22/50) were infected with a unique TTV genomic group; 38% (19/50) were coinfected with TTV from 2 (28%, 14/50) or 3 (10%, 5/50) genomic groups. CONCLUSIONS: Blood products are frequently infected with TTV and all five known genomic groups are detected in Korea.

Detection of HBV in Blood and Blood Products by PCR

The aim of this study was to establish a PCR for detecting of the hepatitis B virus (HBV) in blood and blood products. A primer pair set was designed to amplify a 513 bp fragment in the S-region of the HBV genome in the first PCR and a 233 bp fragment of first PCR amplicon in the second PCR with Rubisco (internal control). In order to assess the specificity of the PCR results, all the samples were tested cross-reactivity or interference in the assay. This method did not result in cross-reactivity with the non-HBV (HAV, HCV, HIV, CMV, HPV 18&6b, parvovirus B19/ or HSV 1&2) positive samples and was unaffected. In case of the HBV spiked blood products such as the immunogloubulin and coagulation factors, the lower detection limit of this method for the HBV DNA is 62.5 IU/ml. The PCR method is fully established in this study and will be a valuable method for the detection of the HBV in a variety of blood products, particularly, those derived from starting materials with a high titer of virus.

Transfusion-transmitted Virus and TTV-like Mini Virus Infection in Blood Products / 대한진단검사의학회지

BACKGROUND: Transfusion-transmitted virus (TTV) and TTV-like mini virus (TLMV) are small DNA virus with single-stranded, closed circular, antisense genome infecting man. TTV and TLMV are trans-missible by transfusion. However there had been a few study about TTV prevalence and no study about prevalence in blood donors in Korea. There has been no study about the TTV and TLMV infection in blood products in Korea. The aim of this study was to gain the prevalence of two viruses in blood products. METHODS: A total of 150 plasma samples from blood products (each 50 units of Red blood cell, whole blood, and platelet concentrate) were tested. The samples are obtained from the segments of the blood products. TTV DNA was detected using polymerase chain reaction (PCR) with two sets of primers (A set and B set) and TLMV DNA was detected using nested PCR with primer set C. RESULTS: TTV DNA was detected in 85.3% (128/150) of blood products. TLMV DNA was detected in 41.3% (62/150) of blood products. Either TTV or TLMV was detected in a total of 140 blood products (92.3%) and both TTV and TLMV were detected in 50 products (33.3%). CONCLUSIONS: The blood products are frequently infected with TTV and (or) TLMV in Korea and they can be transmissible by blood products with high probability.