External quality control and training of semen analysis in the Netherlands: starting point for further reduction of outcome variability / 亚洲男科学杂志(英文版)

Semen analysis is characterized by high levels of intra- and inter-laboratory variability, due to a low level of standardization, high subjectivity of the assessments, and problems with automated procedures. To improve consistency of laboratory results, quality control and training of technicians are important requisites. The goals of this study are to evaluate the results of an external quality control (EQC) program and standardized training by ESHRE Basic Semen Analysis Courses (BSAC) on the variability in manual assessments of semen parameters. We performed retrospective analyses of (1) the interlaboratory variability in the Dutch EQC program and (2) the interobserver variability in BSACs for concentration, motility, and morphology assessments. EQC data showed that the interlaboratory coefficient of variation (CV) for concentration assessment decreased (range from 24.0%-97.5% to 12.7%-20.9%) but not for morphology and motility assessments. Concentration variability was lower if improved Neubauer hemocytometers were used. Morphology assessment showed highest CVs (up to 375.0%), with many outliers in the period of 2007-2014. During BSAC, a significant reduction of interobserver variability could be established for all parameters (P < 0.05). The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program (since 2013) and that criteria for morphology assessment changed in time. BSAC results might have been influenced by the pretraining level of participants and the influence of external factors. Both EQC and training show positive effects on reducing variability. Increased willingness by laboratories to change their methods toward standards may lead to further improvements.

Analysis on external quality control results for iodine deficiency disorders laboratories in Shandong in 2016 / 中华地方病学杂志

Objective To evaluate the testing ability of iodine in the disease control and prevention institutes at all levels in Shandong,and to raise their testing ability.Methods The testing ability of salt iodine,water iodine and urinary iodine of iodine deficiency disorders laboratories at provincial,prefectural and county levels in Shandong in 2016 was evaluated.The testing results of salt iodine were evaluated by using reference value ± uncertainty.The testing results of water iodine and urinary iodine of all the participatory laboratories were evaluated by using standard Z score generated from laboratories participated in the examination.Results One provincial and 17 prefectural salt iodine,water iodine and urinary iodine laboratories and 30 county level salt iodine laboratories took part in the national examination.Both the feedback rate and qualified rate of the testing results were 100％.The 65 urinary iodine laboratories at the county level took part in the provincial examination.The feedback rate was 92.3％ (60/65),and the qualified rate was 75.4％ (49/65).Conclusions The results of the national examination have showed that the testing ability at all levels of the laboratory is maintained at a higher level;the results of the provincial examination have showed that the testing ability of most of the county level urinary iodine laboratories is relatively stable at a higher level.The testing ability of some county level urinary iodine laboratories is low.We should focus on strengthening the county level urinary iodine laboratory construction.

Development and Performance Evaluation of External Quality Controls for Allergen-Specific Immunoglobulin E Tests

BACKGROUND: Many companies have developed different methods and products for allergen-specific immunoglobulin E (IgE) tests. Because there is no standardised reference method, external quality assessment (EQA) is important for allergen-specific IgE test to ensure the comparability and reliability of the results from different laboratories. We prepared specimens for EQA of allergen-specific IgE tests and evaluated their stability. METHODS: Four pooled sera with 24 selected allergen-specific IgE levels were prepared and stored at −80℃. The stability of allergen-specific IgE levels was assessed on days 1, 7, and 14 at −20℃, 2℃ to 8℃, and 20℃ to 25℃, and then after 3 months at −80℃. Mock proficiency tests were performed with the four sets of prepared external quality controls for six laboratories, using the commercial multiple allergen simultaneous test (MAST) methodology. RESULTS: About 150 specimens (650 µL each) for EQA were prepared; randomly selected specimens showed similar IgE levels for the 24 allergens (±1 class). The levels of allergen-specific IgE remained stable throughout the study period (P>0.05). Although mock survey results from six laboratories using four MAST assays revealed some variability with a difference (2–3 class), no consistent differences were observed through the allergens or MAST methods. Qualitative results from the mock survey showed 85.4% (cut-off of class 1) and 81.3% (cut-off of class 2) concordance with the results from ImmunoCAP (Phadia, Sweden). CONCLUSIONS: The pooled sera prepared for allergen-specific IgE tests might be adequate and useful for EQA.

Analysis on external quality control results for iodine deficiency disorders laboratories in Shandong in 2016 / 中华地方病学杂志

Objective To evaluate the testing ability of iodine in the disease control and prevention institutes at all levels in Shandong,and to raise their testing ability.Methods The testing ability of salt iodine,water iodine and urinary iodine of iodine deficiency disorders laboratories at provincial,prefectural and county levels in Shandong in 2016 was evaluated.The testing results of salt iodine were evaluated by using reference value ± uncertainty.The testing results of water iodine and urinary iodine of all the participatory laboratories were evaluated by using standard Z score generated from laboratories participated in the examination.Results One provincial and 17 prefectural salt iodine,water iodine and urinary iodine laboratories and 30 county level salt iodine laboratories took part in the national examination.Both the feedback rate and qualified rate of the testing results were 100％.The 65 urinary iodine laboratories at the county level took part in the provincial examination.The feedback rate was 92.3％ (60/65),and the qualified rate was 75.4％ (49/65).Conclusions The results of the national examination have showed that the testing ability at all levels of the laboratory is maintained at a higher level;the results of the provincial examination have showed that the testing ability of most of the county level urinary iodine laboratories is relatively stable at a higher level.The testing ability of some county level urinary iodine laboratories is low.We should focus on strengthening the county level urinary iodine laboratory construction.

Control de calidad externo en el estudio del semen / External quality control sperm analysis

En diciembre de 2005 se inició el Programa de Evaluación Externa de la Calidad (PEEC) para Laboratorios Andrológicos, organizado por la Facultad de Farmacia y Bioquimica, UBA y la Fundación Bioquímica Argentina. El objetivo del presente trabajo es informar la respuesta obtenida a la convocatoria de participar en el PEEC, dar a conocer los resultados de las primeras encuestas y compararlos con los relatados por otros programas extranjeros. Los parámetros evaluados fueron movilidad (video), morfología (fotografías digitales en CD) y recuento espermático (RE) (suspensiones de espermatozoides). Se solicitó utilizar la estandarización OMS 1999. Participaron 60 laboratorios. Los valores de Error de Medida Permitidos (EMP) fueron de 60%, 50%, 15% y 30% para morfología, movilidad progresiva rápida (MPR), movilidad progresiva (MP) y RE, respectivamente. Los resultados hallados fueron similares a los publicados por el Programa de Control de Calidad Externo del ASEBIR-España para el "nivel óptimo" de las especificaciones de calidad del "estado del arte". Cuando el requerimiento de calidad fue "variabilidad biológica", los EMP disminuyeron significativamente para morfología y MPR: 28,2% y 29,3% no así para MP y RE. La alta aceptación de la convocatoria pone de manifiesto la necesidad de un PEEC-Andrología. El elevado Error de Medida obtenido para morfología y movilidad progresiva rápida denota la necesidad de estandarizar los procedimientos y criterios para lograr el requerimiento de calidad de variabilidad biológica.

In December 2005 began the first External Quality Assessment Scheme (EQAS) for Andrology Laboratories organized by the School of Pharmacy and Biochemistry (University of Buenos Aires) and the Fundación Bioquímica Argentina. The aim of this study was to inform the response obtained after the enrollment to participate in the first Argentine EQAS, to discuss the results obtained in the first surveys and to compare them with the ones reported by other foreign programs. The evaluated parameters were sperm motility (videotapes), morphology (digital photography) and concentration (SC) (suspensions of spermatozoa). Participants were asked to follow WHO 1999. Nearly 60 laboratories throughout Argentine participated. The Total Allowable Error was 60%, 50%, 15% and 30% for morphology, progressive rapid motility (PRM), progressive motility (PM) and SC, respectively. The results found were similar to those published by the External Quality Program of the ASEBIR-Spain for the "optimum quality specification" on the "State of the art". When the established requirement of quality was "Biological Variability", the Total Allowable Error decreased significantly for morphology and PRM: 28.2% and 29.3% but not for PM and SC. The present data confirms the need for a Scheme. The high Total Error obtained for morphology and progressive rapid motility demamds to standardizing the procedures and establishing analytical goals based on Biological Variability.

The Usefulness of Internal Quality Control Procedure Using External Quality Control Materials / 임상검사와정도관리

BACKGROUND: It is very important to keep the quality of the process of clinical tests and for that internal & extenal quality control procedures are performed in many clinical laboratorys. With the simultaneous use of external quality control materials for internal and external quality control procedures, not only precision but also bias presumed to be systematic error can be assessed. Also the control limits for internal quality control procedure can be obtained. It is the aim of this study to investigate the useful aspects of the integration of internal and extenal quality control procedures. METHODS: The Korean Association of Quality Assurance for Clinical Laboratory 2006-CC-01 quality control materials for external quality control survey were tested on 19 general chemistry items with Hitachi 7180 (Hitachi, Tokyo, Japan) autoanlyzer once a day for 20 days. Current means and standard deviations(sd) were obtained from internal quality control results for 20 days and were used to calculate the biases with target means from external quality control survey results. Bias, sigma(TEa/sd), method sigma(TEa-|bias|/sd) and total error(TE) of each the 19 items were calculated and the calculated total errors of 19 items were compared with the CLIA'88 allowable total errors(TEa). Contol limits for internal quality control procedures were established according to the method sigma levels and probability for false rejection(Pfr), probability for error detection(Ped), average run length for false rejection(ARLfr) and average run length for error detection(ARLed) according to the control limit levels were estimated. RESULTS: Out of total 19 items, 8 items such as albumin, glucose, triglyceride, total cholesterol, uric acid, total bilirubin, GGT and LDH satisfied the CLIA'88 TEa criteria and 11 items such as total protein, total calcium, inorganic phosphorus, BUN, creatinine, AST, ALT, ALP, sodium, potassium and chloride didn't satisfied. In the 11 items not satisfying CLIA'88 TEa criteria, 6 items such as BUN, creatinine, AST, ALT, sodium and chloride had the method sigma below 1.65 and control limits for internal quality control procedure could not be established. Control limits of the other 13 items were established according to the method sigma leves. In case of 6 method sigma level, Pfr were estimated to be 0.000007 and Ped to be 1.0000 and ARLfr to be 146910 and ARLed to be 1.00. CONCLUSION: The integrated data from both the internal and external quality control results were very useful in assessment of the quality status of the tests and in designing and planning the internal quality control procedures such as control limits.

HLA Typing Proficiency Survey in Korea, 2003-2004 / 대한진단검사의학회지

BACKGROUND: HLA proficiency survey in Korea started in 1996 and the results of the survey were last reported in 1999. In this report, we summarized the results of the survey performed in recent 2 years. METHODS: A total of four proficiency surveys were performed, in which 54-59 laboratories participated. Each survey included 3 tests for HLA class I (serology and DNA) and class II (DNA) typing and 6 for HLA crossmatch test (3 cells x 2 sera). RESULTS: Overall concordance of serologic typing was 99.5% (436/438) for HLA-A, 95.7% (419/438) for HLA-B, and 94.8% (199/210) for HLA-C. The antigens assigned incorrectly by more than 5% of the participating laboratories were B54 (10.3%), B55 (10.3%), B27 (5.4%), Cw6 (22.9%), and C-blank (5.7%). Overall concordance rates of DNA typing were 99.7% (393/394) for HLA-A, 99.8% (415/416) for HLA-B, 100% (156/156) for HLA-C. Correct assignment of HLA-DRB1 and -DQB1 was reportred by 99.7% (98.1-100%) and 99.2% (88.9-100%) for generic and 99.2% and 98.1% (80-100%) for allelic level, respectively. Most laboratories (93.5-97.9%) were using sensitive methods of crossmatch such as T-long, T-AHG, and flowcytometry. The proportion of laboratories evaluated as unacceptable was on the average 3.1% of total laboratories. CONCLUSIONS: The rate of correct identification of HLA antigens was higher this time than in the previous survey in 1999. The rate of unacceptable crossmatch was also low enough to be satisfactory. It is thought that the proficiency survey has contributed to the high quality of HLA tests in the participating laboratories and should be continued to maintain the proficiency in Korea.

Results of the HLA Typing Proficiency Survey in Korea, 2000-2002 / 대한진단검사의학회지

BACKGROUND: HLA proficiency survey was started in 1996 in Korea, and the results of the 1996-1998 surveys were reported previously. Here, we report the results of the surveys performed in recent three years (2000-2002). METHODS: Six surveys were carried out with the participation of 52-54 laboratories. For each survey, 3 peripheral blood samples and 2 sera were distributed for 3 HLA class I serology, 3 HLA class I DNA, 3 HLA class II DNA, 6 HLA crossmatch, and 3 PRA tests. RESULTS: Overall consensus of serologic typing was similar to the results of the previous survey: HLA-A 93.5%, HLA-B 88.3%, and HLA-A, B 82.7%. There were an increasing number of the laboratories that were using DNA typing for HLA-DR (51 laboratories, 94%) and HLA-A and B (26 laboratories, 48%). Overall consensus of DNA typing was very high: HLA-A 100%, HLA-B 99.1%, HLAC 97.9%, HLA-DRB1 low/high resolution 99.2/99.0%, HLA-DQB1 low/high resolution 99.3/97.5%. HLA crossmatch (T cells) was reported by 44-49 laboratories, and the use of sensitive methods was increased: AHG 33 laboratories and flow cytometry 7 laboratories. For incompatible (positive) crossmatches, 4.9% (0-14.3%) of cytotoxicity tests and 7.1% (0-16.7%) of flow tests were reported as negative. PRA was reported by 5 laboratories only. CONCLUSIONS: The use of DNA tests for HLA typing and AHG or flow cytometry methods for HLA crossmatch tests has much increased compared to the previous report. A continuous survey program would play an important role in the standardization and maintenance of laboratory proficiency in histocompatibility testing in Korea.

Experience of HLA Antibody Testing in the International Serum Exchange Program / 대한진단검사의학회지

BACKGROUND: When organ transplantation or HLA-matched platelet transfusion is considered, accu-rate identification of HLA antibody specificity in the recipient's serum is very important. In this study, we report our experience in an international quality control program. METHODS: For external quality control in a HLA antibody test, the International Serum Exchange Program distributes serum samples, generally showing polyspecific reactivity for cross-reactive epitope groups (CREGs), to participating laboratories: 4 samples per survey, 10 surveys per year. Participating in the program from May 1998 to August 2000 (24 surveys), we performed HLA antibody identification of 96 serum samples by the AHG-CDC (anti-human globulin-complement dependent cytotoxicity) method using frozen lymphocyte trays (36 lymphocyte panels). We compared the results of our laboratory with those of the total participants (all methods combined, 72 to 92 laboratories per survey) using the analyzed survey results distributed by the program organizer. RESULTS: We analyzed the survey results for the antibodies to relatively common HLA antigens in Koreans (antigen frequency >1%). For the HLA antibodies detected in >or=20% of participants, our detection rate was higher by 10-15% than that of all laboratories (HLA-A, 76% vs 65%; HLA-B, 73% vs 57%). And for the HLA antibodies detected in >or=50% of the participants, our detection rate was as high as 88% for HLA-A and 87% for HLA-B. Our detection rate for a few antibody specificities was lower than that of all laboratories, namely HLA-A1, A3, B35, and B55. Among these, A1, A3, and B55 were of lower incidence antigens in Koreans (antigen frequency 3-4%), indicating that the low detection rate was due to a limitation in the composition of lymphocyte panels. CONCLUSIONS: In general, our detection rate of HLA antibodies was superior to the average detection rate of the total participant laboratories. We would be able to improve the low detection rate for a few antibody specificities to lower incidence antigens by refining the composition of lymphocyte panels.

Two-Year Study on the HLA Typing Proficiency Survey in Korea, 1996-1998 / 대한임상병리학회지

BACKGROUND: To standardize the histocompatibility testing among different laboratories, we have developed and performed a proficiency survey (external quality control) program in HLA typing with participation of nationwide HLA laboratories in Korea. METHODS: During a two-year period, four trials of proficiency survey were performed with 35-39 participating laboratories. Test number and items included in each survey were 3 HLA class Iantigen typings, 2 class II DNA typings, and 6 HLA crossmatch tests (3 cells x 2 sera). RESULTS: HLA class I serological typing was performed on a total of 12 whole blood specimens representing 7 HLA-A and 17 HLA-B antigens. More than 90% of the laboratories correctly identified 7 HLA-A (A2, A3, A11, A24, A26, A30, A33) and 13 HLA-B antigens (B7, B8, B13, B14, B27, B35, B48, B51, B52, B54, B58, B60, B61). Lower consensus (<90%) was obtained for B62, B67, B75, and B15 (B*1511). Considerable difference in antigen detection rate was observed between different commercial trays used. HLA class II DNA typing was performed on a total of 8 DNA specimens representing 13 HLA-DRB1 and 11 DQB1 alleles. For HLA-DRB1 typing (16-26 laboratories), correct assignment rate was very high (98%) for generic level, but lower (80%) for allele level. For DQB1 typing (5-8 laboratories), 100% consensus was obtained for allelic level. With respect to HLA crossmatching, detection rate of incompatibility was very low in the 1st trial. HLA crossmatch workshop on the standardization of typing methods was performed after the 1st trial, and thereafter the number of laboratories using sensitive methods were increased and the detection rate of incompatible crossmatch was much improved (1st 29-46%, 2nd 78-97%). CONCLUSIONS: Through these HLA typing proficiency surveys, standardization of test methods and improvement of typing results were obtained. A continuous survey program would play an important role for improving success rate of organ transplantations in Korea.