Search

In this case report we present a patient from Germany who developed a severe GBS in the course of Covid-19.

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.

Zusammenfassung Eine labormedizinische Diagnostik ist bei vielen Patienten für eine erfolgreiche medizinische Behandlung notwendig. Sowohl aus ökonomischen als auch aus ethischen Gründen sollten labormedizinische Leistungen weder zu häufig (als „Wiederholungsuntersuchungen“) noch zu selten angefordert werden. Mit diesen Empfehlungen werden für eine Reihe von labormedizinischen Untersuchungen anhand von Studien, pathophysiologischen Zusammenhängen und Konsensus Empfehlungen für eine sinnvolle Wiederholungsfrequenz gegeben. Diese Empfehlungen betreffen das minimale Zeitintervall zwischen 2 Messungen sowie die Kriterien zur Durchführung einer Wiederholungsbestimmung. Ergänzt werden diese Empfehlungen mit grundsätzlichen Überlegungen zur Indikation und Untersuchungsfrequenz von labormedizinischen Untersuchungen.

Zusammenfassung Obwohl die Kosten für die Labormedizin im Verhältnis zu den Gesamtausgaben im Gesundheitssystem verschwindend gering sind, führt der Kostendruck dazu, dass vor allem am Krankenhauslabor gespart wird. Lediglich 7,3% der Krankenhäuser in Deutschland haben eine fachärztliche Leitung des Labors. Um diese Entwicklung aufzuhalten, muss sich das Krankenhauslabor vom Cost-Center zum Kompetenz- und Profit-Center wandeln. Dazu gehört, den Mehrwert des Krankenhauslabors und seine Stellung in der Wertschöpfungskette des Gesamtunternehmens Krankenhaus besser darzustellen und zur Geltung zu bringen. Das Krankenhauslabor muss zum Workflow-Management-System werden. Besonders am Beispiel der Mikrobiologie lassen sich die Vorteile eines Labors vor Ort im Krankenhaus auch ökonomisch darstellen. Die Kompetenz des Krankenhauslabors und seines Fachpersonals muss den medizinischen Disziplinen im Krankenhaus rund um die Uhr zur Verfügung gestellt werden. In Zukunft wird es aber auch darauf ankommen, die Kompetenz der Krankenhauslabormedizin über die Grenzen des stationären und ambulanten Sektors hinaus in Netzwerkstrukturen regional nach außen anzubieten.

In asymptomatic infertility patients, no significant relationship was found between the presence of antisperm antibodies (ASA) in serum and in semen samples (IgG and/or IgA ASA), differentiated with the mixed antiglobulin reaction (MAR), and the microbial colonization of ejaculates covering a broad spectrum of microorganisms. Likewise, there was no significant association of ASA with microbial findings in patients' female partners, who also presented without symptoms of genital tract infection and were screened at the same time. Furthermore, ASA in semen (IgG and IgA) were not significantly related to several potential markers of subclinical male sexual gland infection or inflammation (leukocytes, PMN elastase, albumin, C3c) evaluated in aliquots of the same ejaculates used for immunological testing.

The clinical chemical analysis system Vitros 5,1 FS (Ortho Clinical Diagnostics, Neckargemünd, Germany) combines on one platform multilayer film technology with a newly developed technology based on conventional wet chemistry. We report the first extensive evaluation of this novel analyzer, establishing precision data, accuracy, and linearity of MicroSlide technology analytes and analytes using the newly developed MicroTip technology. For comparison, measurements with the analysis systems Beckman-Coulter DXC800 and Immage or Siemens Healthcare Diagnostics Dimension Xpand, and plasma, serum, urine and cerebrospinal fluid (CSF) samples as well as blood from routine operations were employed, respectively. For within-run imprecision, coefficients of variation between 0.2% and 5.5% were calculated. Coefficients of variation for quality control materials from day-to-day ranged from 0.6% to 7.1%. In all examined analytes, except hemoglobin A1c, calculated inaccuracies were within the acceptable ranges of the national directives for quality assurance (RiliBÄK, directives issued by the German Medical Association). Method comparison demonstrated good agreement between MicroSlide assays and wet chemistry methods with correlation coefficients ranging from 0.872 to 0.998. For the MicroTip assays, the calculated correlation coefficients ranged from 0.968 to 0.994. In conclusion, the Vitros 5,1 FS analyzer is a reliable analysis system which can be easily integrated into clinical chemical routine and which can also be applied for analysis of CSF, urine, and blood samples.

Laboratory testing is crucial for the successful medical treatment of many patients. Laboratory tests should neither be ordered too infrequently nor too frequently (in the form of repeat testing). These recommendations summarize the intervals for repeat testing based on studies, pathophysiology and consensus, in regard to both the time intervals between two tests and the additional criteria for the repeat testing. These recommendations are complemented by general principles for the indication and testing frequency of laboratory testing.

Diagnostic pathways are an essential subset of clinical pathways and a logical consequence of DRG-based reimbursement. They combine the principle of stepwise reflex and reflective testing with a management concept that helps to fulfill medical needs with organizational and economic efficacy. The two most common formats describing diagnostic pathways are graphical decision trees on paper and “if…then…else” rules on computers. From a laboratory point of view, diagnostic pathways represent “smart” test profiles, which – in contrast to conventional (inflexible) profiles – are not necessarily worked off completely, but just to a point, where a diagnostic decision can be made. This improves the cost-effectiveness of laboratory testing, while making sure that no essential tests are missed. The paper describes benefits and limitations of diagnostic pathways from a medical, organizational, and economic point of view. Their major advantage is also their major drawback, since they make the diagnostic process on the one hand extremely straight-forward and transparent, while on the other hand oversimplifying the underlying medical decision principles. This may provoke the abuse of their primarily medical intentions for mere economic purposes.

Benchmarking is a systematic and continuous process used to compare products, services, and processes – as regards quantitative and qualitative aspects. Benchmarking in laboratory medicine departments of hospitals is a frequently used but only poorly standardized system. Sophisticated procedures for data collection are necessary due to the large heterogeneity and complexity of activities performed in laboratory medicine with regard to the type of testing, response times, availability and amount of different resources needed for single analysis and reporting. These prerequisites are difficult to fulfill. In internal benchmarking projects – i.e., monitoring of productivity, costs, and revenues within one laboratory over an extended period of time – the current tools for data collection are generally fit for purpose. In external benchmarking, however, several pitfalls may obscure the results. In broad terms, external benchmarking projects compare only partial processes with sufficient validity. Differences in benchmarking have to be controlled for improvements of data collection and for changes in surrounding conditions outside the laboratory. This review lists different approaches for benchmarking projects in laboratory medicine departments and describes their strengths and weaknesses.

To screen for infection with Chlamydia trachomatis in semen samples from asymptomatic men in couples consulting for infertility and to determine the relationship of seminal chlamydial antibodies with clinically relevant parameters of male fertility, 197 randomly chosen patients were enrolled in a prospective study. The median duration of infertility was 4 years (range 1-18). Screening for C. trachomatis and chlamydial antibodies of the immunoglobulin (Ig) A and IgG classes were performed in ejaculates and, in parallel, endocervical material from the partners of the patients and serum samples from both partners were evaluated. A comprehensive examination of semen quality included sperm analyses, semen cultures, local antisperm antibody (ASA) testing, the determination of potential infection markers, and sperm-cervical mucus interaction testing in vitro (SCMPT) and in vivo (post-coital testing). Chlamydial IgA antibodies were found in the semen samples of 18.8% (37/197) of the patients, while chlamydial IgG antibodies were found in 8.1% (16/197) of the patients. Screening for C. trachomatis was negative in all semen and cervical specimens. Only 5.5% of men remembered a past genital infection. Chlamydia antibodies (IgA/Ig/G) in semen were significantly correlated with chlamydia IgG antibodies in serum samples (P < 0.001). No marked relationship was found between the presence of seminal chlamydial antibodies and the major parameters of sperm analysis, semen cultures, local ASA and sperm penetration testing as an indicator of functional capacity. Seminal chlamydial antibodies were not significantly associated with potential infection or inflammation markers in aliquots of the same ejaculates. However, a significant relationship of chlamydial antibodies in patients' semen with past genital infections of their female partners was found with clinical relevance for a tubal infertility factor. The results indicate that in asymptomatic patients the presence of chlamydial antibody IgA or IgG in semen is not associated with reduced semen quality, potential seminal infection markers or impaired functional capacity as important determinants of male fertility; however, seminal chlamydial antibodies suggesting a previous sexually transmitted disease are significantly related to a tubal infertility factor of female partners.

Objective To determine the clinical significance of albumin determination in ejaculates by means of an easy office test to screen semen samples for subclinical infection-inflammation. Patients One hundred fifty-nine randomly chosen males of couples with longstanding infertility (median duration of infertility 4 years (range 1 to 19 years) without clinical signs or symptoms of genital tract infection. Setting Outpatient Infertility Clinic of the University of Heidelberg, Germany. Main Outcome Measures Screening of ejaculates for subclinical infection-inflammation by means of a ready-to-use kit for semiquantitative detection of albumin in addition to determination of leukocytes rates by means of monoclonal antibodies for differentiation of round cells and measurement of granulocyte elastase concentration in semen samples. Evaluation of sperm quality by means of standard sperm analysis including determination of local antisperm antibodies with the mixed antiglobulin reaction, evaluation of sperm functional capacity in vitro with the standardized sperm-cervical mucus (CM) penetration test, and semen cultures. All tests were performed from aliquots of the same ejaculates. Results Screening of semen samples for elevated albumin with the modified paper strips proved to be very easy, quick, and suitable for routine use. Positive results were not related markedly to medical history and outcome of clinical examination as well as to standard parameters of sperm analysis and were not influenced by local antisperm antibodies of the immunoglobulin (Ig)G and/or IgA class and microbial colonization. However, albumin-positive semen samples were significantly less frequent in case of very good outcome of the sperm-CM penetration test. A significant relationship was found with high rates of leukocytes of the round cells in semen samples (total range 0% to 96%) and the concentration of granulocyte elastase (total range 1 to 880 μ g/L). Conclusions The results of this prospective study suggest that the determination of albumin in semen samples with ready-to-use test kits might be a valuable additional marker for subclinical infection-inflammation of the male genital tract and therefore suitable for screening during infertility investigation.

Our study describes the production, purification and properties of an enzyme from Pseudomonas aeruginosa displaying the properties of phospholipase A. Maximal amounts of enzyme could be detected in the culture supernatant when the bacterium was grown for 3 to 5 days at 37 degrees C in stirred flask cultures containing brain heart infusion. The enzyme was purified by polyethylenimine precipitation and ammonium sulfate precipitation followed by gel filtration. In sodium dodecyl sulfate-polyacrylamide gel electrophoresis, the enzyme preparation exhibited two bands with molecular weights of 13.5 and 60 kD, respectively. Correspondingly, two peaks of the same molecular weight could be demonstrated by high performance size exclusion chromatography. The activity toward the sn-2 ester binding of phospholipids was characterized and found to be highest towards phosphatidylcholine. Enzymatic activity was not influenced by the addition of calcium or EDTA while magnesium and strontium caused a decrease of activity. The lyophilized enzyme was found to be stable when stored at -70 degrees C and most active at pH 8.0.

Zusammenfassung„Benchmarking“ ist ein systematischer und kontinuierlicher Prozess zum Vergleich von Produkten, Dienstleistungen und Prozessen – sowohl in qualitativer als auch in quantitativer Hinsicht. Benchmarking im Krankenhauslabor ist derzeit ein häufig angewandtes aber immer noch wenig standardisiertes Instrument. Aufgrund der großen Heterogenität und Komplexität der labormedizinischen Leistungen hinsichtlich der Art der Untersuchung, der erforderlichen bzw. gewünschten Verfügbarkeit und des für die einzelne Leistung notwendigen Ressourcenverbrauchs setzen aussagekräftige Benchmarkingprojekte eine aufwändige und strukturierte Datenerfassung voraus. Diese Voraussetzungen werden oft nicht ausreichend berücksichtigt. Während bei einem internen Benchmarking, d.h. den Vergleich von Leistungen, Kosten und Erlösen innerhalb einer Einrichtung über einen längeren Zeitraum, die vorhandenen Methoden zur Datenerfassung in der Regel geeignet sind, so sind beim externen Benchmarking eine Reihe von Fallstricken zu beachten, um ein valides Benchmarkingprojekt durchführen zu können. Deshalb können in der Regel laborübergreifend lediglich kleine Teilprozesse mit einer befriedigenden Aussagekraft verglichen werden. Aber auch bei internen Benchmarkingprojekten ist immer zu prüfen, ob die beobachteten Unterschiede tatsächlich durch Veränderungen der Prozesse hervorgerufen wurden oder nur eine Folge einer verbesserten Datenerfassung oder veränderter Rahmenbedingungen außerhalb des Labors sind. In dieser Übersicht werden Vorgehensweisen und Kennzahlen beschrieben, die bei Benchmarkingprojekten in Krankenhauslaboratorien verwendet wurden, und die Stärken und Grenzen dieser Ansätze diskutiert.

Diagnostic pathways in the field of laboratory medicine could contribute economically to integrate modern “disease management” from the perspective of healthcare policy into a complex development with limited resources. The objective is to bridge the gap between medical and economic demand. Diagnostic pathways could be an innovative way to optimise processes in medicine with the objective of transparency of costs, results and performance, especially if technical prerequisites for web-based communication (i.e., order entry, digitised laboratory analysed findings) are given. The precondition is that laboratory diagnostics must be appreciated as a core procedure of a hospital. Furthermore, diagnostic pathways provide the opportunity to define processes concerning disease severity and rate of resource usage. The pathways support the physician by finding the probable or medically worthwhile primary and secondary diagnosis for coding the DRG (Diagnoses Related Groups). This results in guaranteeing revenues and an increase in the quality of therapy. The very visualisation of medical decisions by diagnostic pathways results in the reduction of ill-conceived activities and consequently in an improvement of health economics.

T Bertsch, R EBanks!, M A Forbes', J Aufenanger, M Storr", J M Illingworth-, T J Perren", P J Selby! and R Kattermann From the /nstitut fur Klinische Chemie, Klinikum der Stadt Mannheim der Universitdt Heidelberg, Theodor Kutzer Ufer 1-3, 68167 Mannheim, Germany, I/CRF Cancer Medicine Research Unit, St James's University Hospital, Beckett Street, Leeds LS9 7TF, UK and 2Ares Serono, Geneva, Switzerland

Remarkably elevated levels of phospholipase A(2) (PLA(2)) are measurable in human blood samples in cases of acute pancreatitis. The source of the enzyme was first thought to be exclusively the pancreas, but now it is generally accepted that two isoenzymes the pancreatic PLA(2), group I, and the extrapancreatic PLA(2), group II contribute to the raised activity. In contrast to the group II-PLA(2), the pancreatic PLA(2) is heatresistant for 1 hour at 60 degreesC. The catalytically inactive proenzyme of the pancreatic PLA(2) can be activated by trypsin. The aim of our study was to evaluate the diagnostic value of PLA(2) isoenzyme activity measurements to identify patients with severe complications in acute pancreatitis. Blood samples from patients suffering from acute pancreatitis were analyzed for catalytically active pancreatic PLA(2) on day 1 and 2 of hospitalization with a modified radiometric Escherichia colibased PLA(2) assay. In 10 of 41 patients clearly elevated values of catalytically active, heatresistant pancreatic PLA(2) (7.2 to 81.2 U/l) were observed. This group of patients was characterized by severe complications (necrotizing pancreatitis, shock, sepsis, respiratory problems) of which two patients subsequently died. Patients with low or undetectable activity (

Hyperhomocysteinemia is a risk factor for obstructive large-vessel disease. Here, we studied plasma concentrations of homocysteine and vitamins in patients suffering from subcortical vascular encephalopathy (SVE), a cerebral small-vessel disease leading to dementia. These results were compared to the homocysteine and vitamin plasma concentrations from patients with cerebral large vessel disease and healthy control subjects. Plasma concentrations of homocysteine, vascular risk factors and vitamin status (B6, B12, folate) were determined in 82 patients with subcortical vascular encephalopathy, in 144 patients with cerebral large-vessel disease and in 102 control subjects. Patients with SVE, but not those with cerebral large-vessel disease, exhibited pathologically increased homocysteine concentrations in comparison with control subjects without cerebrovascular disease. Patients with SVE also showed lower vitamin B6 values in comparison to subjects without cerebrovascular disease. Logistic regression analysis showed that homocysteine is associated with the highest risk for SVE (odds ratio 5.7; CI 2.5-12.9) in comparison to other vascular risk factors such as hypertension, age and smoking. These observations indicate that hyperhomocysteinemia is a strong independent risk factor for SVE.

The concentration of interleukin (IL) -8 and IL-6 was determined in seminal plasma (SP) samples from 137 randomly chosen subfertile males to evaluate the relationship with other potential parameters of subclinical infection/inflammation such as seminal leukocytes, and with semen quality in a prospective study. All patients were asymptomatic for genital tract infection. A comprehensive semen evaluation included sperm analysis, sperm migration testing, antisperm antibody screening, immunocytochemical round cell differentiation to determine seminal leukocytes counts and the leukocyte ratio, complement fraction C(3) (C(3c)) determination, and semen cultures, in aliquots of the same ejaculates. The SP concentration of IL-8 was inversely related to semen quality, e.g. to the total number of motile spermatozoa or to the outcome of the sperm migration test (motile sperm harvested after a swim-up procedure). IL-8 concentrations were significantly correlated with leukocyte counts per ml (P < 0.0001) and per ejaculate (P < 0.0001), and with the leukocyte ratio (P < 0.001). All leukocytospermic samples had high IL-8 concentrations (< or =2 ng/ml). The SP concentration of IL-6 was much lower, but was significantly correlated with IL-8 (P < 0.0001). Both IL-8 and IL-6 were significantly related with the C(3c). No association of interleukin concentrations with the bacterial colonization of semen samples was found. The results indicate a marked relationship of some pro-inflammatory cytokines with semen quality. The significant association with seminal leukocytes and other potential inflammation markers suggests that IL-8 might be used as sensitive marker for silent male genital tract infection.

Many assays for the determination of phospholipase A2 activity [for review: 1] have been developed. The choice of a detection method depends partly on the purpose of a particular experiment. For example, some assays can be used on purified enzymes but are incompatible with crude systems, some methods provide a continuous assay and generate a time course while others do not, and some methods are amenable to automation while others are not. However, the most important consideration in the choice of the detection method is the sensitivity required for the particular enzyme which depends on the quantity of enzyme available and on its specific activity. This point is especially important for the assay of phospholipases A2 in human plasma, which are found in lower quantities and are, in general, less active than their counterparts from venom.

Procalcitonin is a protein which is found in elevated concentrations in the blood circulation during systemic bacterial, fungal or protozoal infection. In contrast to classical acute-phase proteins like C-reactive protein or interleukin-6, it is not elevated after operative trauma. In this paper we present current opinions on the assumed induction mechanisms of the protein by cytokines and endotoxin. Furthermore, the clinical value for early detection of systemic infections in abdominal and transplantation surgery is demonstrated by examples from the literature. Our investigation shows that eight patients with necrotizing pancreatitis had a PCT mean value of 6.9 ng/ml on the day of admission. Seven patients with edematous pancreatitis had only a PCT mean value of 0.69 ng/ml. Despite these differences in the mean values, a significant difference between the normal value and the mean value of the group with necrotizing pancreatitis or edematous pancreatitis was not observed due to the wide range of PCT levels in the group of patients with necrotizing pancreatitis. The fact that only a few of the patients had a superinfected necrosis with systemic evasion of bacterias or their toxins may be the reason for this wide range. We suggest that a discrimination between superinfected necrotizing or sterile pancreatitis and edematous pancreatitis by PCT could be possible but more extensive studies with microbiological examination of the necrotic material are required to recognize the subgroups and to establish the real diagnostic efficiency of PCT in clinical practice, especially in the prediction of the outcome of acute pancreatitis.