Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay

Accurate detection of BCR-ABL fusion transcripts at and below molecular response (MR) 4 (0.01% International Scale [IS]) is required for disease monitoring in patients with chronic myeloid leukemia (CML). We evaluated the analytical performance of the QXDx BCR-ABL %IS (Bio-Rad, Hercules, CA, USA) droplet digital PCR (ddPCR) assay, which is the first commercially available ddPCR-based in vitro diagnostics product. In precision analysis, the %CV was 9.3% and 3.0%, with mean values of 0.031% IS and 9.4% IS, respectively. The assay was linear in the first order, ranging from 0.032% IS to 20% IS. The manufacturer-claimed limit of blank, limit of detection, and limit of quantification were verified successfully. There was a very strong correlation between the results of the QXDx BCR-ABL %IS ddPCR assay and the ipsogen BCR-ABL1 Mbcr IS-MMR (Qiagen, Hilden, Germany) real-time quantitative PCR assay (r=0.996). In conclusion, the QXDx BCR-ABL %IS ddPCR assay can provide reliable results for CML patients.

Genetic Screening for Chromosomal Abnormalities and Y Chromosome Microdeletions in 846 Infertile Korean Men

BACKGROUND: Chromosomal abnormalities are confirmed as one of the frequent causes of male infertility. The microdeletion of the azoospermia factor (AZF) region in the Y chromosome was discovered as another frequent genetic cause associated with male infertility. The aim of this study was to evaluate the frequency and type of chromosomal abnormalities and Y chromosome microdeletions in Korean infertile men. METHODS: A total of 846 infertile men with azoospermia and severe oligozoospermia were included for genetic screening. Cytogenetic analyses using G-banding and screening for Y chromosome microdeletions by multiplex PCR for AZF genes were performed. RESULTS: Chromosomal abnormalities were detected in 112 infertile men (13.2%). Of these, Klinefelter's syndrome was the most common (55.4%, 62/112), followed by balanced translocation including translocation between sex chromosome and autosome (14.3%), Yq deletion (13.4%), X/XY mosaicism with Yq deletion (12.5%), and XX male (4.5%). The overall prevalence of Y chromosome microdeletions was 9.2% (78/846). Most microdeletions were in the AZFc region (51.3%) with a low incidence in AZFa (7.7 %) and AZFb (6.4 %). Combined deletions involving the AZFbc and AZFabc regions were detected in 26.9 % and 7.7 % of men, respectively. Among the infertile men with Y chromosome microdeletions, the incidence of chromosomal abnormality was 25.6% (20/78). CONCLUSIONS: There was a high incidence (20.1%) of chromosomal abnormalities and Y chromosome microdeletions in Korean infertile men. These findings strongly suggest that genetic screening for chromosomal abnormalities and Y chromosome microdeletions should be performed, and genetic counseling should be provided before starting assisted reproductive techniques.

Assessment of Medical Trainnees' Knowledge and Their Educational Needs on Transfusion Medicine / 대한수혈학회지

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.

Quality Management of Clinical Chemistry Tests in Blood Center / 대한수혈학회지

The main goal of transfusion medicine is safe and appropriate blood transfusion in all situations. To accomplish this, it is essential to have a high level quality management system for the entire process from blood donation to transfusion. Regulations regarding blood management have been adopted and strictly managed in Korea since 2007. Blood center's blood management tasks should establish appropriate quality management systems to ensure the safe supply of blood, as well as the basic resources of personnel, facilities and equipment in accordance with laws and regulations governed by the Ministry of Health and Welfare in Korea. The purpose of this review is to examine the contents and processes for quality control of clinical chemistry tests in Korean blood centers.

Performance Evaluation of the ichroma SMART Analyzer in Measuring C-reactive Protein and Procalcitonin Levels

BACKGROUND: For monitoring infection and inflammation episodes, biomarkers of host response, such as C-reactive protein (CRP) and procalcitonin (PCT), are now being recognized as useful tools in the diagnostic process. We aimed at evaluating the analytical performance of the recently developed semi-automated ichroma SMART system (Boditech Med Inc., Korea), which allows measurements of both CRP and PCT. METHODS: We evaluated the analytical performance of the ichroma SMART system and the agreement between its results and the laboratory standards for CRP and PCT measurements. The precision and linearity as well as the method of measurement were compared to the DxC 800 (Beckman Coulter, USA) for CRP and to the VIDAS (bioMerieux SA, France) for PCT, according to corresponding CLSI guidelines. Additionally, we evaluated the carryover rates between specimens. RESULTS: The total precision (% CV) of the ichroma SMART system in measuring low, middle, and high level controls (level 1, 2, 3) was 6.32%, 5.75%, and 3.56% for CRP, and 8.07%, 6.24%, and 6.53% for PCT. In the linearity test, R2 was 0.9997 and 0.9982 for CRP (0.1-336.8 mg/L) and PCT (0.05-60.91 ng/mL), respectively. Good correlation was observed between ichroma SMART and DxC 800 for CRP (r=0.997), and between ichroma SMART and VIDAS for PCT (r=0.992). Carry-over effect was 0.02% for CRP and 0.04% for PCT. CONCLUSIONS: The ichroma SMART system showed an adequate performance and appeared to be a suitable clinical analyzer with a simple operating procedure for the measurement of CRP and PCT.

Current Status of Pretransfusion Tests and Equipments in Small and Medium Sized Hospitals in Korea / 대한수혈학회지

BACKGROUND: The appropriate procedures and equipment for the pretransfusion test are fundamental to a safe blood transfusion. The present study aimed to assess the current status of procedures and equipment for pretransfusion tests at small- and medium-sized medical institutions, as well as to use this basic raw data to better manage blood transfusions at these institutions. METHODS: Offline and online questionnaire surveys were performed at institutions that used between 24 and 1,000 units of blood products in 2014. A total of 338 institutions participated, and the survey results were subsequently analyzed. RESULTS: Among 307 institutions where on-site ABO blood typing was performed, 15.0%, 2.1%, and 43.5% did not conduct ABO serum typing, RhD typing, and irregular antibody screening tests, respectively, and 12.8% only conducted the saline phase for crossmatching. Moreover, among 338 institutions, only 66.7% of blood banks had centrifuges, 84.5% had 37℃ incubators, 41.1% had slide view boxes; in addition, 66.1% and 18.6% had refrigerators and deep freezers, respectively, for blood storage. CONCLUSION: Certain small- and medium-sized institutions did not have the essential equipment required to operate as blood banks. Moreover, they also needed to improve their testing procedures. To address these issues, the initiation of systematic training programs and the employment of institutional strategies are necessary to enhance testing procedures and equipment, respectively.

The Korean guideline for colorectal cancer screening

Colorectal cancer is the third most common cancer in Korea; it is the second most common cancer in men and the third most common in women. The incidence rate in Korea has continuously increased since 1999 when the National Cancer Registry statistics began. Currently; there are several screening modalities; that have been recommended by expert societies, including fecal occult blood test, colonoscopy, computed tomographic colonography The annual fecal immunochemical test (FIT) has been used in adults aged 50 and older as part of the National Cancer Screening Program in Korea since 2004. Although several study results from regional or national colorectal cancer screening programs in other countries have been reported, the National Cancer Screening Program in Korea has not yet been evaluated with evidence-based methods. Herein report the consensus statements on the National Screening Guideline for colorectal cancer developed by a multi-society expert committee in Korea, as follows: 1) We recommend annual or biennial FIT for screening for colorectal cancer in asymptomatic adults, beginning at 45 years of age and continuing until 80 years (recommendation B). 2) There is no evidence for the risks or benefits of FIT in adults older than 80 years (recommendation I). 3) Selective use of colonoscopy for colorectal cancer screening is recommended, taking into consideration individual preference and the risk of colorectal cancer (recommendation C). 4) There is no evidence for the risks or benefits of double-contrast barium enema for colorectal cancer screening in asymptomatic adults (recommendation I). 5) There is no evidence for the risks or benefits of computed tomographic colonography for colorectal cancer screening in asymptomatic adults (recommendation I).

Carrier frequency of SLC26A4 mutations causing inherited deafness in the Korean population

PURPOSE: The mutation of the SLC26A4 gene is the second most common cause of congenital hearing loss after GJB2 mutations. It has been identified as a major cause of autosomal recessive nonsyndromic hearing loss associated with enlarged vestibular aqueduct and Pendred syndrome. Although most studies of SLC26A4 mutations have dealt with hearing-impaired patients, there are a few reports on the frequency of these mutations in the general population. The purpose of this study was to evaluate the prevalence of SLC26A4 mutations that cause inherited deafness in the general Korean population. MATERIALS AND METHODS: We obtained blood samples from 144 Korean individuals with normal hearing. The samples were subjected to polymerase chain reaction to amplify the entire coding region of the SLC26A4 gene, followed by direct DNA sequencing. RESULTS: Sequencing analysis of this gene identified 5 different variants (c.147C>G, c.225G>C, c.1723A>G, c.2168A>G, and c.2283A>G). The pathogenic mutation c.2168A>G (p.H723R) was identified in 1.39% (2/144) of the subjects with normal hearing. CONCLUSION: These data provide information about carrier frequency for SLC26A4 mutation-associated hearing loss and have important implications for genetic diagnostic testing for inherited deafness in the Korean population.

Epidemiology and Resistance Patterns of Bacterial Pathogens in Urinary Tract Infections in the Northern Gyeonggi-do Area during 2007-2011

BACKGROUND: Bacteria that cause urinary tract infections (UTIs) are found with different frequencies in different regions; moreover, antibiotic susceptibility can also vary by region. We retrospectively studied and compared the species and antimicrobial susceptibility of bacterial pathogens isolated from patients with UTIs in the northern Gyeonggi-do area. METHODS: We analyzed urine specimens collected from patients who visited the Myongji Hospital between 2007 and 2011. The urine specimens were cultured, and bacteria were identified by biochemical examination with an API kit (bioMerieux Inc., USA). Antimicrobial susceptibility was determined by the disc diffusion method and the Vitek II system (bioMerieux Inc., USA). RESULTS: A total of 11,818 (31.4%) urine specimens were culture positive. The most common species identified were Escherichia coli (37.1%), Klebsiella pneumoniae (7.4%), Enterococcus faecium (6.1%), and Candida spp. (5.5%). The proportion of isolates producing extended-spectrum beta-lactamases significantly increased during the study period. CONCLUSIONS: E. coli, K. pneumoniae, and E. faecium were the 3 most common organisms identified. Of note, however, was the increasing frequency of Pseudomonas spp. and Proteus spp. isolated during the more recent years. Further studies are required from other centers in the northern Gyeonggi-do area.

Comparison of COBAS AmpliPrep/COBAS TaqMan HCV Qualitative Test v2.0 with COBAS AMPLICOR Hepatitis C Virus Test v2.0 for the Qualitative Detection of Hepatitis C Virus RNA in Korean Clinical Samples / 임상검사와정도관리

BACKGROUND: We comparatively evaluated the performance of the conventional COBAS Amplicor HCV test v2.0 (CAM; Roche Molecular Systems, USA) and the newly developed COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (CAP/CTM; Roche Molecular Systems) for qualitative detection of hepatitis C virus (HCV) RNA in clinical samples. METHODS: Six hundred serum samples (100 HCV-positive, 500 HCV-negative, as determined by CAM) were selected and analysed using the new qualitative HCV RNA test, CAP/CTM qualitative test. Results were compared by confirmatory CAP/CTM quantitative test, which is a quantitative HCV RNA real-time polymerase chain reaction by Roche Molecular Systems, and anti-HCV test (Roche Diagnostics GmbH, Germany). Twenty-two additional serum samples, which gave a gray zone result by CAM, were selected for comparison. RESULTS: The two qualitative HCV RNA assays yielded concordant results for 586 of 600 tested samples (concordance rate, 97.7%; kappa coefficient, 0.92; 95% confidence interval [CI], 0.87 to 0.96; P<0.001). Upon re-testing by CAM, we found that the concordance rate increased to 98.2% (kappa coefficient, 0.93; 95% CI, 0.89 to 0.97; P<0.001). The additional 22 samples showing gray zone results for CAM were retested and were also tested by CAP/CTM. The results for 13 of these samples changed to negative and were now concordant with the CAP/CTM and confirmatory CAP/CTM quantitative results. For the remaining samples, the results were variable. For all the 22 samples, the results of the new CAP/CTM were in agreement with those obtained by confirmatory CAP/CTM quantitative test. CONCLUSIONS: The results of the two assays were in good agreement, with 97.7% concordance rate. However, CAP/CTM is more sensitive than CAM and showed no gray zone results. Therefore, it can be a more efficient and useful test for the qualitative detection of HCV RNA in clinical samples.

Effects of Long Distance Transportation of Specimens on Test Results

BACKGROUND: Accuracy of laboratory test results is an important issue. New guidelines for specimen delivery systems are needed for appropriate pretreatment of specimens and accuracy of results. METHODS: We evaluated various laboratory profiles, comparing the effects of specimen rack holders and coolants within transport containers. The hematology profiles (complete blood cell count [CBC], erythrocyte sedimentation rate [ESR]), chemistry profiles (aspartate aminotransaminase [AST], alanine aminotransaminase [ALT], gamma-glutamyl transferase [gamma-GT], electrolytes [Na, K, Cl], glucose, lactate dehydrogenase [LD], creatinine kinase [CK]), and coagulation profiles (prothrombin time [PT], activated partial thromboplastin time [aPTT], fibrinogen level). We also investigated the effects of transportation time including the presence or absence of hemolyzation. We received from 9 different university hospital laboratories using conventional transporation methods. RESULTS: Hemolytic features were seen in short drawn specimens. Fewer result variations were observed in specimens transported with coolants. Average specimen transportation time was 11.3 hours, and average temperatures of container was 10.9degrees C with coolant and 25.0degrees C without coolants. Non-centrifuged specimens transported with coolants showed increased serum K levels than centrifuged specimens. Coagulation tests showed less than a 10% differences. Centrifuged specimen prior to transportation showed no hemolyzation and no differences in results. CONCLUSIONS: Appropriate temperatures for each analyte should be defined to ensure the accuracy of results. To reduce hemolyzation, appropriate temperature and rack holder should be used. Temperature of the transport container should be monitored in objectively. Coagulation tests should be added as referral tests, if appropriate specimen transport monitoring system for time and temperature could be adopted.

Annual Report on External Quality Assessment in Immunoassay in Korea (2009) / 임상검사와정도관리

Two trials with 15 test items of external quality assessment survey were performed in 2009. The test items were constituted three immunoassay categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items commonly used in clinical laboratories and performed by immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 494 institutions in the first trial survey and 519 institutions in the second survey. All of the fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used for the two trials in 2009 survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 494 and 519 laboratories and the response rate were 97.6% and 98.3% in 2009. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Stability tests of home-made control materials were performed and confirmed the CV values were in acceptable ranges. 4. Workshops titled "National health examination for tumors" and "Standardization and harmonization of laboratory tests" were held on September 4, 2009 and December 16, 2009 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control, and Immunoserology Subcommittee, respectively. The quality of the participating laboratories seems to be continuously improved. And, this year, new sixty eight laboratories were participated to our Immunoassay Subcommittee.

Current Status of External Quality Assessment of Fecal Occult Blood Test / 대한진단검사의학회지

BACKGROUND: Nationwide external quality assessment (EQA) of the fecal occult blood test (FOBT) in Korea was first introduced in 2007-2009. The EQA results were analyzed to assess the current status of FOBT and to plan the continuation of the EQA program. METHODS: The surveys included 40 hospitals in the preliminary survey conducted in 2007, 249 general hospitals in 2008, and 389 hospitals in 2009. In the surveys, the participating hospitals provided the results of the distributed materials and replies to the questionnaire on the FOBT test procedures and quality controls. RESULTS: In the surveys conducted between 2007 and 2009, a total of 650 institutes submitted 653 test system results; 3 institutes used 2 kinds of methods. All of the institutes used immunologic methods; 107 institutes (16.5%) used quantitative equipments and 546 institutes (84.0%) used qualitative kits. Most quantitative tests yielded consistent positive or negative results; however, their cut-off and measured values differed according to the equipments used. A low-level material tested in 2007 was negative in the quantitative methods but positive in some qualitative methods because of lower detection limits. The discordance rates among quantitative tests were 3.2% in 2007, 4.4% in 2008, and 0% in 2009 and the rates among qualitative tests were 13.8% in 2008 and 2.6% in 2009. Semi-solid EQA materials showed the ability to evaluate the overall test procedures with acceptable stability. CONCLUSIONS: In the first Korean FOBT EQA, commercially available EQA materials were proven to be stable. Continuation of the EQA program and further education of laboratory personnel are needed to reduce inconsistency in results. Further, the test kit, procedures, and result reports must be standardized.

A Transfusion Experience for a Patient with Cis-A2B3 Phenotype / 대한수혈학회지

We report the case of a 64-year-old man presenting to the hospital for treatment of his anemia. Exact ABO blood typing is an essential step to prevent transfusion reactions. The selection of the wrong blood component for transfusion can be a clinical problem and in this case the patient had a cis-AB blood type that could have caused an ABO discrepancy. In this case neither autologous or directed blood transfusion was possible and O+ red blood cell was transfused without a transfusion reaction.

The Implementation and Effects of a Clinical Laboratory Accreditation Program in Korea from 1999 to 2006 / 대한진단검사의학회지

BACKGROUND: The Korean Laboratory Accreditation Program (KLAP) by the Korean Society of Laboratory Medicine (KSLM) was started in 1999. We summarized history and achievement of KLAP for the last 8 yr. METHODS: We analyzed 8 yr data (1999-2006) of historical events, trends of participating laboratories, and scores according to the impact of the question to the outcome of the tests. Inspection check lists are for 'laboratory management', 'clinical chemistry', 'diagnostic hematology', 'clinical microbiology', 'diagnostic immunology', 'transfusion medicine', 'cytogenetics', 'molecular genetics', 'histocompatibility', 'flow cytometry', and 'comprehensive laboratory test verification report'. The laboratories with score 90 or higher got 2-yr certificate and laboratories with score between 60 and 89 got 1-yr certificate. The laboratories with score below 60 failed accreditation. RESULTS: The number of accredited laboratories was 2.4 times higher in 2006 (n=227) than in 1999 (n=96). Inspection check lists have been revised 5 times till 2006. The average accreditation rate was 99.6% during these periods and the 2-yr accreditation rate was 32.4% in 2000, 45.6% in 2001, 53.3% in 2002, 47.3% in 2003, 68.5% in 2004, 37.7% in 2005, and 47.7% in 2006. Number of participants in inspector training workshops increased from 89 in 2000 to 766 in 2006. CONCLUSIONS: The KLAP has been in place successfully and stabilized over the past 8 yr. It seemed to enhance the laboratory quality. Efforts for improvement of quality control and inspector training workshops appeared to be in the main contributing factors.

Annual Report on External Quality Assessment in Hematology in Korea (2008) / 임상검사와정도관리

Four trials of external quality assessment in diagnostic hematology were performed in 2008 with average 822 participating laboratories in Korea. We performed quality assessment for white blood cell count, hemoglobin, hematocrit, red blood cell count, platelet count, blood cell morphology, prothrombin time and activated partial thromboplastin time. The response rate was more than 96.5%. The coefficients of variation in hemoglobin, hematocrit and RBC was stable but variable in platelet count and WBC count according to measuring cell count. Test results of blood cell morphology showed variation among various cell morphologies.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2008) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2008. The first and the second trials assessed by three test categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items using immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 437 institutions in the first trial survey and 476 institutions in the second survey.Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 437 and 476 laboratories and the response rate were 94.6% and 98.7% in 2008. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Some analyzers of a few test items showed variations of the test results of the same control material probably due to personal factors of the institution. 4. Workshops titled "Quality control of Immunoassay" and " Quality control of tumor markers" were held on September 5, 2008 and December 3, 2008 in cooperation with Annual Autumn Academic Conferences of Clinical laboratory and Quality Control and Immunoserology Subcommittee. The quality of the participating laboratories seems to be thought being continuously improved. And, this year, about 51 laboratories are newly participated to our Immunoassay Subcommittee.

Comparison of Sensitivity of Tests for Detecting Bacterial Contamination in Platelet Concentrates / 대한수혈학회지

BACKGROUND: The demand for platelet concentrates has increased for patients with hemato-oncologic diseases as well as for patients with chronic diseases. As platelet concentrates are preserved at 22~24degrees C, the chance of bacterial contamination exposure is increased, which can cause fatal outcomes. We evaluated various methods for detecting bacterial contamination in platelet concentrates. METHODS: 0.5 MacFarland standard solutions were prepared using the Staphylococcus aureus ATCC 25923 & Escherichia coli ATCC25922 strains. The platelet concentrates were inoculated with various concentrations (10(1)~10(5) CFU/mL) of bacteria and then gram staining, plate culture, broth culture and 16s RNA were used to detect bacteria. RESULTS: The gram stain method was unable to detect bacteria concentrations less than 10(4) CFU/mL. The plate culture method detected bacterial growth concentrations up to 10(3) CFU/mL, but only 1 specimen of S. aureus was detected at the lowest concentration of 10(1) CFU/mL. The broth culture method detected 10(2) CFU/mL concentrations except for samples from S. aureus and E. coli strains. Among the 10(1) CFU/mL lowest concentrations, bacterial growth detected 3 samples from S. aureus and 2 samples from E. coli. For the broth culture method, detection of bacterial growth up to 10(1) CFU/mL took 58.9 hours, it took 57.5 hours for S. aureus and E. coli respectively, and it took 43.9 hours and 49.0 hours for 10(2) CFU/mL concentrations of S. aureus and E. coli, respectively. The PCR method showed all positive results except for 1 specimen of E. coli. CONCLUSION: The broth culture method showed similar sensitivity to PCR except for the 43.9~58.9 hours of an incubation period to show positive RESULTS. Overall, the PCR method was most sensitive and rapid method for detecting bacterial contamination in platelet concentrates.

Inspection of Blood Collection Center with Small Number of Unit Collection / 대한수혈학회지

BACKGROUND: Transfusion is a choice of treatment and should be used in order to maintain patients' lives and health. In order to supply safe blood, the quality improvements of hospital blood collection centers should be periodically monitored. To establish systematic surveillance of blood management system, we would like to suggest proper program. METHODS: Twenty-nine hospital small scale blood centers, collects less than 100 units of blood collection per year, were evaluated. Qualified were selected among blood bank specialists who were eligible to simultaneously perform inspections and consultations, and who had attended inspectors' workshop. RESULTS: Among twenty-five blood collection centers, four blood collection centers were closed prior to inspections. Among them, two blood collection centers were evaluated as inadequate. Among adequate centers, some questionnaires were evaluated as "not applicable" mainly for reasons pertaining to personnel and facilities, such as blood component preparation rooms and/or center administrators. CONCLUSION: A checklist for an inspection program should be reviewed continuously. Additionally, detailed guidelines for inspection should be standardized prior to commencing of subsequent year's inspection program. Finally, guidelines for inspection should be established for every questionnaire.

Evaluation of Usefulness of the Panel Test Composed of Malaria Non-specific Tests As a Surrogate Marker / 대한진단검사의학회지

BACKGROUND: Although malaria-specific antibody or antigen test is useful for the diagnosis of malaria infection, its cost-effectiveness has to be concerned in the area where malaria prevalence is very low. We created a panel test composed of malaria non-specific parameters, namely hematology autoanalyzer-derived results with or without addition of HDL-cholesterol data, and evaluated its usefulness in comparison with malaria-specific antibody test. METHODS: For 395 patients tested for malaria smear, the hematology parameters such as platelet count, NRBC (%) and VCS (volume, conductivity, scattering) parameters of WBC, and HDL-cholesterol data were analyzed. Statistical significance of each parameter and that of panel test with or without addition of HDL-cholesterol were evaluated. RESULTS: Malaria antibody test showed sensitivity of 97.1% and specificity of 99.1%. Each parameter of platelet count, NRBC (%), D parameter and HDL-cholesterol showed sensitivity of 86.8%, 41.2%, 81.8%, and 70.6%, and specificity of 85.9%, 96.3%, 72.3%, and 81.7%, respectively. Panel test without including HDL-cholesterol showed sensitivity of 91.2% and specificity of 81.6%, and that including HDL-cholesterol showed sensitivity of 91.2% and specificity of 86.2%. CONCLUSIONS: The malaria non-specific panel test composed of hematology autoanalyzer-derived parameters showed relatively good, but slightly lower sensitivity than that of malaria-specific antibody test. It might be used as a screening test for the diagnosis of malaria infection, and addition of HDL cholesterol improved little the usefulness of the panel test.