Volume 29, Issue 1

Seit Anfang 2005 ist eine Reihe von Verbesserungen in den elektronischen Ausgaben der LaboratoriumsMedizin und der Clinical Chemistry and Laboratory Medicine (CCLM) wirksam: Zugang zu beiden Zeitschriften erhalten Sieseit Beginn dieses Jahres über die Plattform EXTENZA. Beim Lesen der elektronischen Ausgaben werden Sie vieles einfacher und intuitiv handhabbar finden. Und das obwohl – oder weil – die Zahl der verfügbaren Links reduziert wurde. CrossRef: Bei unseren naturwissenschaftlichen Titeln können Sie direkt zu den Quellen der References navigieren, soweit diese ebenfalls in CrossRef integriert sind. Durch TOC-alerting oder RSS können Sie sich die aktuellen Inhaltsverzeichnisse direkt auf Ihren Computer schicken lassen. Sie können auch Kollegen direkt per E-mail auf einen Titel oder Artikel aufmerksam machen. Abvoraussichtlich 1. März 2005 können Sie auch den Link www.ejournals.degruyter.de nutzen, sollten Probleme mit Ihren Zugangsdaten bzw. beim Öffnen des Pdf-Dokuments auftreten. Weitere Informationen finden Sie im Text der pdf-Datei.

Abstract IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) and IUPAC (International Union of Pure and Applied Chemistry) have developed an elaborate system named NPU system (N: nomenclature; P: properties; U: units) to standardize reports of findings in laboratory sciences. The use of the system allows to provide results that are unambiguous, easily understandable and comparable all over the world. For data transfer, all items with regard to system, component, kind of property and unit of a quantity are represented by one number, the NPU code number. The value of the quantity expressed by the NPU code renders unequivocal information on the measured quantity. Currently, the NPU system is available for measurements e.g. in clinical chemistry, haemostaseology, immunohaematology, allergology, toxicology, microbiology, and molecular biology and is steadily being updated. The adoption of the NPU system does not require a change of the conventional individual way by which results of measurements are presented locally.

Abstract The increasing level of electronic data exchange in the health system and the correlated transmission of laboratory data between different institutions require a harmonization of the data languages. This aim is served by LOINC (Logical Observation Identifier Names and Codes), a system which has evolved for years. The defining axes and the code provide a valid method for the unambiguous identification of laboratory results and more. The existing and defined integration into data exchange standards such as HL7 and LDT highlights LOINC as a bridge between laboratories, medical practices, hospitals, or other facilities in the health system, especially regarding laboratory results. Pertaining to the recording of the performance of a laboratory, the methods are the most relevant data. In this regard, the existing options of the data transmission standards have to be used. In its present form, LOINC by itself is therefore not appropriate for economical analyses and controlling, i.e. cost and output accounting. In the light of the broad international implementation of LOINC and its established adoption in German facilities, LOINC turns out to be the most mature standard among the competing systems for clinical use.

Abstract In Germany, the new Guidelines of the German Medical Association (RiliBÄK) have regulated since 2002 the quality assurance requirements for quantitative laboratory measurements. For all measurands listed in the corresponding annex 1, the maximum allowable bias (related to a target value) is stated for internal and external quality control. Originally, these limits were derived statistically from the results of external quality assessment schemes. However, after they were set into operation, it turned out that they are not applicable to some measurands for internal quality control purposes. Therefore, the advisory board of the BÄK initiated a questionnaire survey among the participants in external quality assessment schemes to get information about the precision and the accuracy of internal quality control measurements. This paper shows the results of this survey which was performed from July to September 2003.

Abstract The common trend to form larger organisations has nowadays also reached the health system and the diagnostic laboratories. This development is dominated by economic motivations, notably by the wish to reduce costs. This tendency bears risks, specifically for the quality of medical services. Too much centralisation, which is frequently accompanied by all-inclusive prices and downgrading, puts quality at risk. Quality management does not necessarily increase costs but can also help to reduce costs. For example changes in the organisation, cooperation and management of laboratories may help to reduce costs but yet maintain or even improve quality. The achievement of this goal needs great efforts for defining visions and strategies and developing concepts. Expertise from economic and organisational sciences rather than mere medical knowledge are necessary to reach these objectives. Know-how on methods and problem solution must be gained or obtained from external sources. All involved individuals must be willing to change and to overcome antagonistic attitudes. Legal measures including the Health Care Modernisation Act (Gesundheitssystem-Modernisierungsgesetz =GMG) are aimed to reach integrated medical care, for example in out-patient and in-patient settings. It is important that the involved parties cooperate to overcome the disadvantages and to combine the advantages of the present situation. Thereby the health system will develop innovative solutions, which are efficient and cost-saving but also guarantee the maintenance or even improvement of current quality standards.

Abstract In recent years, commercial HCV antibody screening assays, which were first launched in 1990, have been significantly improved in terms of sensitivity and specificity. Standardized methods for the qualitative and quantitative detection of HCV–RNA are now available and show, due to the introduction of an international standard, a good comparability. Alternatively, the quantification of circulating amounts of viral antigen in the peripheral blood can be performed with a commercially available enzyme immunoassay (EIA). One of the main routes of transmission of HCV infection – blood transfusion and blood products – has almost been eliminated by significant improvements in laboratory diagnostics. Actually, i. v. drug abusers represent the main risk group for HCV infection. Research-based methods used so far for the measurement of cellular immunity and neutralizing antibodies may play an important role in the development of a HCV vaccine.

Abstract Highly sensitive qualitative and quantitative automated nucleic acid amplification tests (NATs) that are commercially available for the detection of hepatitis B virus (HBV) infection have been developed only in the last few years. The potential indications for HBV NATs are: follow-up of chronic hepatitis B, therapy and antiviral resistance monitoring, determination of infectivity and transmission risk, detection of occult (HBsAg-negative and HBV DNA-positive) infection and mutant virus which may escape serologic diagnosis, blood donor screening, and resolution of unusual or discordant serologic constellations. Although NATs are now widely implemented in the routine diagnosis of clinical laboratories, there are several important issues which need to be further investigated. Standardisation of NATs used for the monitoring of antiviral therapy and follow-up of chronic infection is still lacking, and the clinical significance of HBV DNA levels needs to be clarified. The influence of genetic variability in terms of genotype variation has been poorly investigated so far. Although there are highly sensitive automated NATs for blood donor screening available, their implementation is still subject to discussion and certain countries rejected HBV DNA testing for blood donation for reasons of poor cost-effectiveness.

Abstract Infection with the human immunodeficiency virus (HIV) continues to present diagnostic and therapeutic challenges worldwide. Today, many diagnostic laboratories have implemented assays based on molecular techniques for the detection of HIV. Detection of primary HIV infection, however, still relies on serologic testing, except for the screening of blood and plasma donors, which is done by the use of molecular assays. Additionally, molecular methods are employed for the detection of vertical transmission and monitoring of patients undergoing antiretroviral therapy. Although a continuous improvement in assay performance has been observed during recent years, the lack of comparability of different molecular assays remains a problem. Moreover, a better standardization of molecular assays for the detection of HIV-1 group O and HIV-2 must be addressed in the future.

Abstract HIV-1 resistance testing has become an increasingly important feature in antiretroviral treatment and is commonly performed by genotyping. Currently, two different systems are being marketed, and despite being far from easy to use, they have achieved a high degree of quality. Modifications of the standard kit protocols may be advantageous in certain situations. Although resistance reports issued by these systems are based on decision rules, they nevertheless require considerable knowledge and skills by the user to draw useful clinical data out of detected resistance patterns. Both systems described here in detail have their advantages and disadvantages; a decision in favor of one or the other needs to be based on individual requirements. In the future, Microarray systems may achieve a leading position on the market.

Human Cell Culture Protocols Second Edition The Humana Press 999 Riverview Drive, Suite 208, Totowa, New Jersey 07512 USA Edited by: Joanna Picot PhD Southampton, UK Publ. Date: 10/15/2004 400 pages, Methods in Molecular Medicine TM / 107 6×9 ISBN: Hardcover 1-58829-222-3, $ 125.00, £ 78.50 eBook: 1-59259-861-7, $ 110.00