Volume 40, Issue 4

Zusammenfassung Aus dem Lifestyle- und Wellnessbereich werden den Kunden vielfältige Apps angeboten, die die Kundendaten ansprechend digital präsentieren. Auch der politische Wille fordert die Digitalisierung in der Medizin mit dem sog. „E-Health-Gesetz“. In der nationalen elektronischen Patientenakte sollen dazu auch Laborbefunde gespeichert werden. Dafür notwendig ist allerdings eine ausreichende Harmonisierung von Prä-Präanalytik (Terminologie, Testprofile, Testungsintervalle), Präanalytik (Abnahmezeiten, Patientenvorbereitung, Probentransport und Probenlagerung), Analytik (Probenqualität, Methode, Kalibration, Qualitätssicherung) bis hin zur Postanalytik (Einheiten, Datenformate, Referenzintervalle, Entscheidungswerte). Diese Harmonisierung kann aufgrund der vielen verschiedenen Laboruntersuchungen und parameterspezifischen Besonderheiten trotz weitreichender nationaler und internationaler Aktivitäten noch nicht als abgeschlossen gelten. Andere Herausforderungen elektronischer Patientenakten liegen bei der Datensicherheit (d.h. der Integrität der Laborbefunde) und dem Datenschutz unter Berücksichtigung der informationellen Selbstbestimmung der Patienten und weiterer Gesetze wie dem Gendiagnostikgesetz (GenDG). Empfehlung: Wir empfehlen aus Gründen der Patientensicherheit, sich bei der nationalen elektronischen Patientenakte auf wenige ausgewählte Laborbefunde zu beschränken, die unmittelbar zur Dosisanpassung von Medikamenten notwendig sind und die so den elektronischen Medikationsplan unterstützen.

Abstract: The normal and abnormal vaginal microbiome are an ecosystem of up to 200 species influenced by genetic, ethnic, environmental and behavioral factors. Cultural methods release only a small clinically unimportant spectrum. Lactobacilli are the most dominant and maintain a pH value between 3.8 and 4.5. They support a defense system against dysbiosis and infections to care for a healthy outer and inner genital tract, a balanced restitution after intercourse and normal pregnancy and childbirth. Bacterial vaginosis (BV) is the most frequent dysbiosis with a lack of lactobacilli and an overgrowth of anaerobic bacteria. Special Gardnerella vaginalis strains work together with Atopobium vaginae , Clostridiales and others, but also Lactobacillus iners in a vaginal polymicrobial biofilm, which is sexually transmitted and cannot be destroyed by the recommended antibiotics.

Background: The aim of this study was to explore longitudinal changes of serum osteocalcin during normal, uncomplicated pregnancy and after delivery, and its correlations with parameters of glucose homeostasis, lipid status, and oxidative status in late pregnancy. Methods: Osteocalcin, glucose, insulin, lipid status parameters, total oxidative status (TOS), and total antioxidant capacity (TAC) were measured in sera of 38 healthy pregnant women. The sera were collected at the midpoint of the 1 st , in the 2 nd and 3 rd trimester, and after delivery. Homeostatic model assessment (HOMA) indices were calculated and used as surrogate markers of insulin resistance. Results: Repeated measures analysis of variance showed a progressive increase in total cholesterol, triglycerides, and low density lipoprotein (LDL)-cholesterol, with a postpartum decrease. High density lipoprotein (HDL)-cholesterol increased in the 2 nd trimester and decreased after delivery. Total oxidative status (TOS) increased significantly in the 3 rd trimester (p<0.001). TAC showed a significant increase after delivery (p<0.05). Insulin showed a significant increase in the 3 rd trimester (p<0.05). Homeostatic model assessment (HOMA)-%B increased significantly in the 3 rd trimester (p<0.001). Osteocalcin showed a decrease in the 2 nd trimester, and a marked increase in the 3 rd trimester and postpartum (p<0.001). Osteocalcin was significantly positively correlated with BMI, insulin, HOMA of insulin resistance (HOMA-IR), HOMA-%B, TAC (p<0.05), triglycerides and uric acid (p<0.001). Multiple regression analysis showed that TAC is independently associated with osteocalcin level during 3 rd trimester (p<0.05). Conclusions: We observed the changes in pregnancy that may lead towards atherogenic, prooxidant and insulin resistant state, which are possibly counterbalanced by various protective systems, one of which might be osteocalcin.

Background: Ataxia-telangiectasia (AT) is a rare hereditary genetic disease caused by one of more than 500 mutations in the ataxia-telangiectasia mutated gene ( ATM ). AT is characterized by cerebellar ataxia, telangiectasia of blood vessels, immunodeficiency with frequent lung infections, susceptibility to cancer, and sensitivity to ionizing radiation. A correct immunophenotyping of lymphocytes is necessary to identify the cause of the immunodeficiency. Methods: We evaluated a patient (female, 15 years) with AT by estimation of antibody titers, characterization of peripheral B- and T-cell subsets and investigation of proliferation response of B- and T-cells undergoing specific stimulation with PHA, CD3/CD28, and R848/CD40L. A healthy volunteer was used as a control. Results: The patient showed a heterozygous mutation in the ATM gene (c.5932G>T[p.E1978X]/c.7788+3A>G). Interestingly, despite a very low level of class-switched memory B-cells normal levels of serum immunoglobulins and antibody titers to viral and bacterial antigens could be observed. Furthermore, the analysis revealed an increase in total numbers of T-cells, caused by an extraordinarily high amount of γ/δ T-cells (CD3+CD4–CD8) (>75% of T-cells). Remaining CD4+/CD8+T-cells were decreased, naïve cells and recent thymic emigrants (RTEs) were strongly deficient. Subsequently, the proliferation activity of T-cells was strongly impaired, in contrast to normal B-cell proliferation both compared to the healthy control. Conclusions: Initial lymphocyte immunophenotyping suggested a defect in T- and B-cell differentiation, but normal humoral antibody titers and B-cell proliferation were inconsistent with this suspicion. Therefore, the results revealed an underlying T-cell defect and low levels of class-switched B-cells results from the lacking assistance from T-cells.

Several concepts of analytical bias and remedies to minimize bias have been suggested with the ultimate goal to disregard it. Short-term bias (within one control cycle) should be treated as a random error if it is less than the permissible limits. Long-term bias should be eliminated if it is known or circumvented by estimating intra-laboratory reference limits (RLs). Consequently, analytical uncertainty could be reduced to permissible imprecision. Then, models combining imprecision and bias would become irrelevant, and the numerical value of total analytical error would become identical with imprecision. The purpose of the present report is to simplify quality assurance schemes considerably by disregarding bias either by estimating RLs or by verifying the applied reference limits (checking the transferability) as requested by ISO and CLSI.

Many laboratories observe that requirements of the Guideline of the German Medical Association RiliBÄK for the internal quality assurance are difficult to fulfill in the lower part of the measurement interval (e.g. thrombocyte count at 50·10 9 /L). With 10 measurands, the RiliBÄK contain special limits for lower measurement quantities. But, these limits lead to artificial “jumps” and even may be too stringent in the very low region of the measurement interval. Requirements which are too stringent usually lead to repeats and unnecessary costs, and to unnecessary time delay. The DGKL working group Guide Limits proposes variable permissible limits depending on the measurand concentration applied in the control material. Then, in the 10 critical cases, higher permissible limits are obtained in the very low part of measurement intervals. The control materials used in ring trials should contain concentrations close to the lower decision limits. Then, the permissible limits provided by the RiliBÄK also appear too stringent in the lower part of the measurement intervals of many measurands.

Background: Most of the urine cultures give negative results, leading to inefficient use of resources. The aim of this study was to evaluate and optimize screening by urinalysis and urine microscopy allowing elimination from the culture workflow, and find out if it might be cost effective in Turkey. Methods: A total of 1511 urine specimens were evaluated. Urinalysis and automated microscopy was performed by Iris iQ200 (Iris Diagnostics, USA). Results for nitrite, leukocyte esterase (LE), white blood cell (WBC), red blood cell (RBC) and all small particles (ASP) were compared to urine culture results. Savings were calculated, in case specimens predicted to be negative were not cultured. Results: Microbial growth was detected in 279 (18.5%) specimens. Using the most efficient algorithm, 400 (26.5%) specimens could be excluded from the workflow, leading to three (0.2%) false negatives. Second algorithm could predict negative result for 15.7% of the specimens with a negative predictive value (NPV) of 100%, saving $562. Conclusions: Screening urine specimens using multiple criteria might help predicting urine culture results. Although the cost of urine culture is low in Turkey, screening might still decrease cost and workload. All the variables should be considered to achieve efficient management of resources in the healthcare system without compromising patient safety.

Background: Case-based learning (CBL), an educational method of problem-based learning, provides students with a venue to relate content learned in the classroom to performance in professional practice. This study compared CBL in the teaching of a clinical laboratory immunology (CLI) course to lecture-based learning (LBL), and evaluated the effect on students regarding the CBL. Methods: Data were collected from senior students (n=85; 46% males, 54% females) at Lanzhou University in China. The students were divided into two groups, one group was offered CBL, while the other LBL as a teaching instrument. After intervention, perceptions of both the groups about their respective teaching method were evaluated using questionnaires, the resulting scores were compared to those obtained in the LBL group. Results: The CBL group showed significantly better scores in course examination (p<0.05) as compared to the LBL group. Seventy-seven (90.6%) students in the CBL group opined that CBL improved their learning and clinical problem-solving skills. CBL also provided them with better understanding (90.6%) and preparation for examinations (90.6%). CBL group improved markedly in comparison to the LBL group with regard to learning motivation (p=0.040), clinical reasoning ability (p=0.023) and clinical problem-solving ability (p=0.022). Conclusions: Our findings demonstrate that CBL is a more effective teaching strategy as compared to LBL in a CLI course. Consequently, the implementation of CBL in teaching a CLI course helps students to improve their learning motivation, problem solving abilities and mastery of knowledge.