Measurement of serum anti-Müllerian hormone by revised Gen II or automated assay: Reproducibility under various blood/serum storage conditions / 대한생식의학회지

Objective@#We investigated the agreement between anti-Müllerian hormone (AMH) levels measured with revised Gen II (rev-Gen II) and automated AMH (Access) assays and evaluated the reproducibility of each method under various blood/serum storage conditions. @*Methods@#AMH levels in blood samples from 74 volunteers were measured by rev-Gen II and Access assays under various conditions: immediate serum separation and AMH measurement (fresh control); serum stored at –20 °C and AMH measured after 48 hours, 1 week, and 2 years; serum stored at 0 to 4 °C and AMH measured after 48 hours and 1 week; and blood kept at room temperature and delayed serum separation after 48 hours and 1 week, with immediate AMH measurement. @*Results@#In fresh controls, all rev-Gen II-AMH values were higher than comparable Access-AMH values (difference, 8.3% to 19.7%). AMH levels measured with the two methods were strongly correlated for all sample conditions (r=0.977 to 0.995, all p<0.001). For sera stored at –20 °C or 0 to 4 °C for 48 hours, Access-AMH values were comparable to control measurements, but rev-Gen II-AMH values were significantly lower. AMH levels in sera stored at –20 °C or 0 to 4 °C for 1 week were significantly lower than in fresh controls, irrespective of method. Across methods, long-term storage at –20 °C for 2 years yielded AMH measurements significantly higher than control values. When serum separation was delayed, rev-Gen II-AMH values were significantly lower than control measurements, but Access-AMH values varied. @*Conclusion@#The rev-Gen II and Access-AMH assays showed varying reproducibility across blood/serum storage conditions, but automated Access yielded superior stability to rev-Gen II.

Reference Values for the Revised Anti-Müllerian Hormone Generation II Assay: Infertile Population-based Study

Anti-Müllerian hormone (AMH) is now accepted as an important clinical marker of ovarian reserve and is increasingly measured as an initial evaluation at infertility clinics. The aim of this study was to establish reference values for the revised second generation (Gen II) assay using population-based data. In this population-based cohort study, AMH data from unselected infertile women aged 25–45 years from June 2013 to June 2014 (n = 15,801) were collected. The AMH values were measured using the revised Gen II assay. We established and validated 5 AMH-age regression models. Based on the optimal AMH-age model, reference values and centile charts were obtained. The quadratic model (log AMH = 0.410 × age − 0.008 × age²− 3.791) was the most appropriate for describing the age-dependent decrease in AMH measured using the revised Gen II assay. This is the largest population-based study to establish age-specific reference values of AMH using the revised Gen II assay. These reference values may provide more specific information regarding the ovarian reserve estimation of infertile women.

Sigma-Metrics of Electrolyte Tests From a Recently Launched New-Generation Proficiency Testing Program of the Korean Association of Quality Assurance for Clinical Laboratory

No abstract available.

Serologic Screening of Pregnant Korean Women for Primary Human Cytomegalovirus Infection Using IgG Avidity Test / 대한진단검사의학회지

BACKGROUND: Primary human cytomegalovirus (CMV) infection during pregnancy is a major cause of congenital malformation. We detected primary CMV infection in pregnant Korean women by using an algorithm that comprises CMV IgG, IgM, and IgG avidity tests. METHODS: During a 2-month period, 744 pregnant women who were at 10-19 weeks of gestation were consecutively enrolled in this study. Human anti-CMV IgG and IgM levels in their sera were determined by chemiluminescence immunoassays. Serum samples from the women who were positive for CMV IgG and IgM were assayed by the ARCHITECT CMV IgG avidity test in order to distinguish primary from non-primary CMV infection. Gross examination of the neonates of the women who were positive for CMV IgM was conducted. RESULTS: The seroprevalence of CMV IgG and IgM was estimated to be 98.1% and 1.7%, respectively. The samples from all the women who were positive for CMV IgM or with grey zone results contained high avidity CMV IgG. Seven women with positive CMV IgG and IgM results who completed follow-up up to delivery showed no gross evidence of in utero CMV transmission. CONCLUSIONS: Maternal primary CMV infection was not detected in any of the pregnant women included in this study cohort. CMV IgG avidity test enabled the identification of women who were at a low risk of transmitting CMV infection and provided informative for subsequent pregnancy outcomes. Compared to previous studies, the seroprevalence of CMV IgG antibody across pregnant Korean women remained unchanged.

Usefulness of NMP22 BladderChek for the Diagnosis and Monitoring of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: As bladder cancer is a superficial tumor with frequent recurrences, early detection and confirmation of recurrence are important. We evaluated the usefulness of NMP22 BladderChek (NMP22BC) for the diagnosis and monitoring of bladder cancer. METHODS: From July to December 2004, we enrolled in the study 670 patients who visited the urology clinic in Ewha Womans University, Dongdaemun Hospital with hematuria or dysuria and were tested with NMP22BC. We also performed the NMP22BC and BTA stat tests simultaneously in 21 patients and interference test in 10 patients. RESULTS: NMP22BC tests were negative in 97% of the patients who had been cured of bladder cancer and were positive in 95% of the patients with recurred bladder cancer. The diagnostic sensitivity, specificity, positive and negative predictive value, and efficiency were 95.0%, 91.5%, 25.7%, 99.8%, and 91.6%, respectively, with 8.5% false positive and 5% false negative rates. Fifty-five patients showed false positive in the NMP22BC test, the main cause of which was the presence of WBCs in urine. There was a good agreement between the NMP22BC and BTA stat tests (kappa agreement value, 0.5; P=0.008). According to the interference test, two patients with more than 3+ in leukocyte esterase results showed false positive in the NMP22BC test. CONCLUSIONS: NMP22BC test was simple to perform, rapid to produce the results, and useful in diagnosing a bladder cancer recurrence; the test shows a high efficiency with a high sensitivity, specificity, negative predictive value, and low false negative rate.

Evaluation of Architect Total PSA Chemiluminescence Immunoassay for Diagnosing Prostate Cancer / 대한진단검사의학회지

BACKGROUND: Serum prostate specific antigen (PSA) is used as a marker for early diagnosis, monitoring of therapy, and detection of recurrence of the prostatic tumor or benign prostatic hyperplasia (BPH). In Korea, over 15 instruments have been used for measuring PSA. In this study, chemiluminescence microparticle immunoassay Architect total PSA (Abbott Lab., Abbott Park, IL, USA) was evaluated for analytical performance and diagnostic usefulness as a marker for prostate cancer. METHODS: The within-run and between-run precision, lower detection limits, correlation with AxSYM total PSA (Abbott Lab., Abbott Park, IL, USA) and clinical investigation were evaluated. Three level control serums (0.5, 4.0, and 23.0 ng/mL) were used for a precision test. The linearity was evaluated using a patient serum sample with a PSA concentration of 100 ng/mL. Functional and analytical sensitivities were tested using a patient serum sample with a PSA concentration of less than 0.1 ng/ mL and saline. A correlation study with AxSYM total PSA was done with 42 serum samples. Clinical evaluation was done with 230 patients of whom 17 had prostate cancer. RESULTS: The total PSA showed a good precision result with less than 5 % of CV and showed linearity to 100 ng/mL. The functional sensitivity was 0.025 ng/mL and analytical sensitivity 0.001 ng/mL. The correlation evaluation showed Y (Architect)=1.0575X(AxSYM)+0.1895, r=0.9960. A Cut-off value of 8.35 ng/mL showed 88.2% sensitivity, 80.3% specificity as a diagnostic marker for prostate cancer. CONCLUSIONS: Architect total PSA showed an acceptable analytical performance with its high sensitivity and could be a useful marker for early detection and recurrence of prostate cancer.

The Serogroup and Antimicrobial Resistance of Salmonella spp. Isolated from the Clinical Specimens During 6 years in a Tertiary University Hospital / 대한임상미생물학회지

BACKGROUND: Recently, non-typhoidal salmonellosis is increasing and it constituted over 90% of total salmonellosis in 1990s. The antimicrobial resistance of non-typhoidal Salmonella gets higher. So we described the change of serogroup and antimicrobial resistance of Salmonella isolated from clinical specimens in Ewha Womans University Mokdong Hospital during 6 years. METHODS: Clinical specimens were submitted from 1997 to 2002. Stool cultures were inoculated onto MacConkey (MAC) agar and Salmonella-Shigella (SS) agar and into Selenite F (SF) enrichment broth. Identification of Salmonella were performed by Vitek GNI card (BioMerieux, Marcy-I'Eltoile, France) and serotyping were done. Antimicrobial resistance test were performed by Vitek GNS card (BioMerieux, Marcy-I'Eltoile, France). RESULTS: From 1997 to 2002, 594 strains of Salmonella were isolated. Non-typhoidal Salmonella and Salmonella typhi constituted 94.4% and 5.6%. Non-typhoidal Salmonella were mainly composed of group B (21.5%) and group D (48.0%), but in 2002, group C (12.4%) and group E (27.9%) were increased in number. The antimicrobial resistance rate of non-typhpoidal Salmonella were 28% to ampicillin, 4.1% to SXT, 0.2% to ciprofloxacin and 0.7% to ceftriaxone. The animicrobial resistance rate of group B and D Salmonella showed 37.5% and 32.6% to ampicillin, 7.8% and 4.2% to SXT, respectively. CONCLUSIONS: Serogroup B and D Salmonella were most frequently isolated, but group C and E Salmonella have been increased in 2002. Antimicrobial resistance of group B and D Salmonella were higher than other serogroups and have been increased year by year.