Pub Date : 2016-12-01DOI: 10.1515/labmed-2016-0058
Katharina Holschbach-Bussian
Zusammenfassung: Die Verbesserung von Prozessen und Ergebnisqualität in medizinisch-diagnostischen Laboratorien konzentriert sich immer stärker auf das wesentliche Ziel, durch genaue, reproduzierbare und stabile Messung und Analyse valide Ergebnisse bereit zu stellen. Laborergebnisse liefern wesentliche Informationen für die Diagnose oder über den Verlauf einer Krankheit. Risikobewertungen dienen der Schwachstellenanalyse im diagnostischen Laboratorium. Das Konzept des Risikomanagements (RM) für die medizinisch analytischen Laboratorien sieht vor, alle kritischen Verfahrensabläufe hinsichtlich ihres Risikos systematisch zu bewerten. Dieser Beitrag stellt eine Orientierung zur Einführung eines RM-Systems im klinisch diagnostischen Laboratorium dar.
{"title":"Risikomanagement in medizinisch-diagnostischen Laboratorien","authors":"Katharina Holschbach-Bussian","doi":"10.1515/labmed-2016-0058","DOIUrl":"https://doi.org/10.1515/labmed-2016-0058","url":null,"abstract":"Zusammenfassung: Die Verbesserung von Prozessen und Ergebnisqualität in medizinisch-diagnostischen Laboratorien konzentriert sich immer stärker auf das wesentliche Ziel, durch genaue, reproduzierbare und stabile Messung und Analyse valide Ergebnisse bereit zu stellen. Laborergebnisse liefern wesentliche Informationen für die Diagnose oder über den Verlauf einer Krankheit. Risikobewertungen dienen der Schwachstellenanalyse im diagnostischen Laboratorium. Das Konzept des Risikomanagements (RM) für die medizinisch analytischen Laboratorien sieht vor, alle kritischen Verfahrensabläufe hinsichtlich ihres Risikos systematisch zu bewerten. Dieser Beitrag stellt eine Orientierung zur Einführung eines RM-Systems im klinisch diagnostischen Laboratorium dar.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"47 1","pages":"399 - 405"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75072423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-12-01DOI: 10.1515/labmed-2016-0065
A. Canbay, A. Leven, C. Fingas, Dominik Heider
Zusammenfassung: Die nicht-alkoholische Fettklebererkrankung (NAFLE) ist ein zentraler Bestandteil des metabolischen Syndroms. Die NAFLE kann über eine Fibrose zur Leberzirrose und letztendlich zur Entstehung eines hepatozellulären Karzinoms führen. Die Diagnostik der NAFLE erfolgt durch Anamnese, klinische Symptome und bildgebende Verfahren. Derzeit gilt die invasive Leberbiopsie als Goldstandard der Beurteilung von Lebererkrankungen. Diese ist jedoch komplikationsträchtig und kostenintensiv. Als nicht-invasives und dynamisches Verfahren ist die Verwendung von serologischen Biomarkern eine wegweisende Möglichkeit eine einfache und reproduzierbare Beurteilung der Lebererkrankung zu erlangen. Aufgrund der zentralen Einbettung der Leber in das metabolische Syndrom, sind Marker des metabolischen Syndroms und der Leber in der Labordiagnostik von größter Wichtigkeit. Zytokeratin-18 (CK-18) ist ein Intermediärfilamentprotein, welches während der hepatischen Schädigung von den Zellen sezerniert wird. Adiponektin wird in den Adipozyten, abhängig von der Größe der Adipozyten, produziert. Somit kann die zusätzliche Bestimmung von CK-18 und Adiponektin eine Aussage über die Aktivität und das Ausmaß der Lebererkrankung zulassen und kann zukünftig im klinischen Alltag zur Therapieentscheidung und zum Monitoring beitragen.
{"title":"Nicht-alkoholische Fettlebererkrankung (NAFLE): kann eine einfache Labordiagnostik die Progression der NAFLE aufzeigen?","authors":"A. Canbay, A. Leven, C. Fingas, Dominik Heider","doi":"10.1515/labmed-2016-0065","DOIUrl":"https://doi.org/10.1515/labmed-2016-0065","url":null,"abstract":"Zusammenfassung: Die nicht-alkoholische Fettklebererkrankung (NAFLE) ist ein zentraler Bestandteil des metabolischen Syndroms. Die NAFLE kann über eine Fibrose zur Leberzirrose und letztendlich zur Entstehung eines hepatozellulären Karzinoms führen. Die Diagnostik der NAFLE erfolgt durch Anamnese, klinische Symptome und bildgebende Verfahren. Derzeit gilt die invasive Leberbiopsie als Goldstandard der Beurteilung von Lebererkrankungen. Diese ist jedoch komplikationsträchtig und kostenintensiv. Als nicht-invasives und dynamisches Verfahren ist die Verwendung von serologischen Biomarkern eine wegweisende Möglichkeit eine einfache und reproduzierbare Beurteilung der Lebererkrankung zu erlangen. Aufgrund der zentralen Einbettung der Leber in das metabolische Syndrom, sind Marker des metabolischen Syndroms und der Leber in der Labordiagnostik von größter Wichtigkeit. Zytokeratin-18 (CK-18) ist ein Intermediärfilamentprotein, welches während der hepatischen Schädigung von den Zellen sezerniert wird. Adiponektin wird in den Adipozyten, abhängig von der Größe der Adipozyten, produziert. Somit kann die zusätzliche Bestimmung von CK-18 und Adiponektin eine Aussage über die Aktivität und das Ausmaß der Lebererkrankung zulassen und kann zukünftig im klinischen Alltag zur Therapieentscheidung und zum Monitoring beitragen.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"24 1","pages":"367 - 372"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77891565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-12-01DOI: 10.1515/labmed-2016-0056
J. Osredkar, Kristina Kumer, T. Fabjan, G. Hlebič, Blaže Podnar, Gordan Lenart, T. Smrkolj
Abstract Background: Prostate-specific antigen (PSA) is an established tumor marker for the diagnosis of patients with prostate cancer. The aim of the study was to evaluate the performance of [-2]proenzyme PSA ([-2]proPSA) and prostate health index (PHI) tumor markers in the differential diagnosis between benign prostatic diseases and prostate cancer. Methods: Total PSA (tPSA), free PSA (fPSA) and [-2]proPSA were measured using antibody-based sandwich enzyme-linked immunosorbent assay with a chemiluminescent detection system in 110 patients, with a tPSA of 1.6–8.0 µg/L. The PHI and %[-2]proPSA were calculated from the PSA values mentioned above. The results were compared with histopathological examination results following a transrectal ultrasound-guided biopsy of the prostate. Results: For the prediction of a malignant histopathological result, the specificity at the 90% sensitivity level was 24.3% for [-2]proPSA, 32.4% for %[-2]proPSA, 28.4% for PHI, 18.9% for tPSA and 28.4% for the free-to-total PSA ratio. The area under the curve for [-2]proPSA, %[-2]proPSA, PHI, tPSA and the free-to-total PSA ratio was 0.663, 0.749, 0.742, 0.616 and 0.625, respectively. Conclusions: Our study found a moderate improvement over tPSA and %fPSA in detecting prostate cancer using the [-2]proPSA assay in patients with a tPSA range of 1.6–8.0 µg/L.
{"title":"The performance of [-2]proPSA and prostate health index tumor markers in prostate cancer diagnosis","authors":"J. Osredkar, Kristina Kumer, T. Fabjan, G. Hlebič, Blaže Podnar, Gordan Lenart, T. Smrkolj","doi":"10.1515/labmed-2016-0056","DOIUrl":"https://doi.org/10.1515/labmed-2016-0056","url":null,"abstract":"Abstract Background: Prostate-specific antigen (PSA) is an established tumor marker for the diagnosis of patients with prostate cancer. The aim of the study was to evaluate the performance of [-2]proenzyme PSA ([-2]proPSA) and prostate health index (PHI) tumor markers in the differential diagnosis between benign prostatic diseases and prostate cancer. Methods: Total PSA (tPSA), free PSA (fPSA) and [-2]proPSA were measured using antibody-based sandwich enzyme-linked immunosorbent assay with a chemiluminescent detection system in 110 patients, with a tPSA of 1.6–8.0 µg/L. The PHI and %[-2]proPSA were calculated from the PSA values mentioned above. The results were compared with histopathological examination results following a transrectal ultrasound-guided biopsy of the prostate. Results: For the prediction of a malignant histopathological result, the specificity at the 90% sensitivity level was 24.3% for [-2]proPSA, 32.4% for %[-2]proPSA, 28.4% for PHI, 18.9% for tPSA and 28.4% for the free-to-total PSA ratio. The area under the curve for [-2]proPSA, %[-2]proPSA, PHI, tPSA and the free-to-total PSA ratio was 0.663, 0.749, 0.742, 0.616 and 0.625, respectively. Conclusions: Our study found a moderate improvement over tPSA and %fPSA in detecting prostate cancer using the [-2]proPSA assay in patients with a tPSA range of 1.6–8.0 µg/L.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"46 1","pages":"419 - 424"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82665669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01DOI: 10.1515/labmed-2016-0048
G. Hartmann
Zusammenfassung: Zirkulierende Nukleinsäuren in den zellfreien Bestandteilen des Blutes, Exosomen und anderer Körperflüssigkeiten in Verbindung mit modernen Sequenzierungsmethoden eröffnen der Laboratoriumsmedizin ganz neue Möglichkeiten für die Diagnostik von Erkrankungen. Nukleinsäuren besitzen auch eine bedeutende Funktion im Immunsystem. Das Immunsystem besitzt Rezeptoren, die in der Lage sind, fremde Nukleinsäuren von eigenen Nukleinsäuren zu unterscheiden. Das Verständnis dieser Erkennungsmechanismen für Nukleinsäuren hat in den vergangenen Jahren erheblich zugenommen. Die Immunerkennung von Nukleinsäuren spielt eine zentrale Rolle bei der Abwehr von Viren und intrazellulären Bakterien. Ohne diese Mechanismen ist der Organismus nicht in der Lage, diese Pathogene zu erkennen und zu eliminieren. Dort wo die Immunerkennung von Nukleinsäuren von pathogenen Viren und Bakterien an ihre Grenzen stößt, oder die Prozesse nicht korrekt ablaufen, kommt es zu Infektionen und entzündlichen Erkrankungen. Mittlerweile sind eine Reihe von Erberkrankungen bekannt, die durch eine fehlerhafte Immunerkennung von Nukleinsäuren verursacht werden. Aus diesen Zusammenhängen hat sich ein neues Forschungsfeld etabliert, die Nukleinsäure-Immunität (nucleic acid immunity), mit großer Bedeutung für das Verständnis von Infektionen und entzündlichen Erkrankungen. Die neuen Erkenntnisse werden in den kommenden Jahren auch in der Immundiagnostik Eingang finden. Ziel dieser Übersicht ist es, in die Grundlagen der Immunerkennung von Nukleinsäuren einzuführen, um daraus mögliche Konsequenzen für eine verbesserte Immundiagnostik von Infektionen, Entzündung und Autoimmunität für die Laboratoriumsmedizin abzuleiten.
{"title":"Das Immunsystem der Nukleinsäureerkennung","authors":"G. Hartmann","doi":"10.1515/labmed-2016-0048","DOIUrl":"https://doi.org/10.1515/labmed-2016-0048","url":null,"abstract":"Zusammenfassung: Zirkulierende Nukleinsäuren in den zellfreien Bestandteilen des Blutes, Exosomen und anderer Körperflüssigkeiten in Verbindung mit modernen Sequenzierungsmethoden eröffnen der Laboratoriumsmedizin ganz neue Möglichkeiten für die Diagnostik von Erkrankungen. Nukleinsäuren besitzen auch eine bedeutende Funktion im Immunsystem. Das Immunsystem besitzt Rezeptoren, die in der Lage sind, fremde Nukleinsäuren von eigenen Nukleinsäuren zu unterscheiden. Das Verständnis dieser Erkennungsmechanismen für Nukleinsäuren hat in den vergangenen Jahren erheblich zugenommen. Die Immunerkennung von Nukleinsäuren spielt eine zentrale Rolle bei der Abwehr von Viren und intrazellulären Bakterien. Ohne diese Mechanismen ist der Organismus nicht in der Lage, diese Pathogene zu erkennen und zu eliminieren. Dort wo die Immunerkennung von Nukleinsäuren von pathogenen Viren und Bakterien an ihre Grenzen stößt, oder die Prozesse nicht korrekt ablaufen, kommt es zu Infektionen und entzündlichen Erkrankungen. Mittlerweile sind eine Reihe von Erberkrankungen bekannt, die durch eine fehlerhafte Immunerkennung von Nukleinsäuren verursacht werden. Aus diesen Zusammenhängen hat sich ein neues Forschungsfeld etabliert, die Nukleinsäure-Immunität (nucleic acid immunity), mit großer Bedeutung für das Verständnis von Infektionen und entzündlichen Erkrankungen. Die neuen Erkenntnisse werden in den kommenden Jahren auch in der Immundiagnostik Eingang finden. Ziel dieser Übersicht ist es, in die Grundlagen der Immunerkennung von Nukleinsäuren einzuführen, um daraus mögliche Konsequenzen für eine verbesserte Immundiagnostik von Infektionen, Entzündung und Autoimmunität für die Laboratoriumsmedizin abzuleiten.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"73 1","pages":"355 - 366"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87534851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01DOI: 10.1515/labmed-2016-0039
D. Dietrich
Abstract: Aberrant DNA methylation is a hallmark of malignancies and can be detected in circulating cell-free DNA (ccfDNA) in bodily fluids, i.e. blood plasma, serum and urine. The availability of technologies that allow for an accurate and sensitive quantification of ccfDNA DNA methylation enables the precise monitoring of dynamic pathologic processes and pharmacodynamics. Recently, the first ccfDNA methylation biomarker SEPT9 received clearance by the US Food and Drug Administration (FDA) with its intended use for blood-based colorectal cancer screening. In this review, the application of ccfDNA methylation as a biomarker for diagnosis, screening, early detection, prognosis, molecular staging, therapy response monitoring, and recurrence monitoring is discussed. Special emphasis is placed on the potential and the limitations of methylation biomarkers for the clinical management of prostate, lung, colorectal, bladder, and head and neck cancer. Current and future applications of the validated methylation biomarkers SHOX2 and SEPT9 are highlighted. Additional applications of methylation biomarkers in ccfDNA beyond cancer are discussed briefly. Furthermore, preanalytical and analytical procedures are discussed with regard to a possible implementation of ccfDNA methylation biomarkers into clinical laboratories.
{"title":"Current status and future perspectives of circulating cell-free DNA methylation in clinical diagnostics","authors":"D. Dietrich","doi":"10.1515/labmed-2016-0039","DOIUrl":"https://doi.org/10.1515/labmed-2016-0039","url":null,"abstract":"Abstract: Aberrant DNA methylation is a hallmark of malignancies and can be detected in circulating cell-free DNA (ccfDNA) in bodily fluids, i.e. blood plasma, serum and urine. The availability of technologies that allow for an accurate and sensitive quantification of ccfDNA DNA methylation enables the precise monitoring of dynamic pathologic processes and pharmacodynamics. Recently, the first ccfDNA methylation biomarker SEPT9 received clearance by the US Food and Drug Administration (FDA) with its intended use for blood-based colorectal cancer screening. In this review, the application of ccfDNA methylation as a biomarker for diagnosis, screening, early detection, prognosis, molecular staging, therapy response monitoring, and recurrence monitoring is discussed. Special emphasis is placed on the potential and the limitations of methylation biomarkers for the clinical management of prostate, lung, colorectal, bladder, and head and neck cancer. Current and future applications of the validated methylation biomarkers SHOX2 and SEPT9 are highlighted. Additional applications of methylation biomarkers in ccfDNA beyond cancer are discussed briefly. Furthermore, preanalytical and analytical procedures are discussed with regard to a possible implementation of ccfDNA methylation biomarkers into clinical laboratories.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"32 1","pages":"335 - 343"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91351497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01DOI: 10.1515/labmed-2016-0049
Peter Ulz, A. Gerger, J. Belic, E. Heitzer
Abstract: A liquid profiling, i.e. the analysis of cell-free circulating tumor DNA (ctDNA), enables a continuous non-invasive monitoring of tumor-specific changes during the entire course of the disease with respect to early detection, identification of minimal residual disease, assessment of treatment response and monitoring tumor evolution. Technological improvements, advances in understanding the nature of ctDNA, the implementation of ctDNA analyses in clinical trials as well as efforts for the establishment of benchmarks, will bring an actual widespread clinic use within reach in the near future. However, despite this progress there are still hurdles that have to be overcome, which are discussed in this review. Moreover, present knowledge and new findings about the biology of ctDNA as well as selected potential clinical applications for metastatic cancer patients are pointed out.
{"title":"Potentials, challenges and limitations of a molecular characterization of circulating tumor DNA for the management of cancer patients","authors":"Peter Ulz, A. Gerger, J. Belic, E. Heitzer","doi":"10.1515/labmed-2016-0049","DOIUrl":"https://doi.org/10.1515/labmed-2016-0049","url":null,"abstract":"Abstract: A liquid profiling, i.e. the analysis of cell-free circulating tumor DNA (ctDNA), enables a continuous non-invasive monitoring of tumor-specific changes during the entire course of the disease with respect to early detection, identification of minimal residual disease, assessment of treatment response and monitoring tumor evolution. Technological improvements, advances in understanding the nature of ctDNA, the implementation of ctDNA analyses in clinical trials as well as efforts for the establishment of benchmarks, will bring an actual widespread clinic use within reach in the near future. However, despite this progress there are still hurdles that have to be overcome, which are discussed in this review. Moreover, present knowledge and new findings about the biology of ctDNA as well as selected potential clinical applications for metastatic cancer patients are pointed out.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"33 9 1","pages":"323 - 334"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79232213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01DOI: 10.1515/labmed-2016-0035
Tanja Hinrichsen, Juliane K. Dworniczak, O. Wachter, B. Dworniczak, B. Dockhorn‐Dworniczak
Abstract: The term liquid biopsy comprises methods of blood-based analysis of nucleic acids, which are increasingly under discussion in oncology and personalized medicine, and are already applied in individual cases. The analysis of tumor markers, which in certain tumor diseases can be found as protein markers in vast amounts in the blood, constitutes a primary form of liquid biopsy. Cell-free circulating DNA fragments in the blood (ctDNA), which reflect the genetic profile of a tumor cell and are released in different ways by the tumor, represent a new class of more specific and sensitive biomarkers that can be correlated with the dynamics of the tumor disease. New technologies based on PCR and sequencing techniques pave the way for diagnostic approaches to define molecular tumor characteristics, not only in tumor tissue but also in the blood, by analyzing cell-free circulating DNA. The combination of molecular profiling of the tumor with ctDNA analytics by liquid biopsy is a promising step in the advancement of precision medicine.
{"title":"Detection and characterization of circulating cell free tumor DNA in cancer patients with malignant solid tumors. Liquid biopsy: a new tool in molecular pathology?","authors":"Tanja Hinrichsen, Juliane K. Dworniczak, O. Wachter, B. Dworniczak, B. Dockhorn‐Dworniczak","doi":"10.1515/labmed-2016-0035","DOIUrl":"https://doi.org/10.1515/labmed-2016-0035","url":null,"abstract":"Abstract: The term liquid biopsy comprises methods of blood-based analysis of nucleic acids, which are increasingly under discussion in oncology and personalized medicine, and are already applied in individual cases. The analysis of tumor markers, which in certain tumor diseases can be found as protein markers in vast amounts in the blood, constitutes a primary form of liquid biopsy. Cell-free circulating DNA fragments in the blood (ctDNA), which reflect the genetic profile of a tumor cell and are released in different ways by the tumor, represent a new class of more specific and sensitive biomarkers that can be correlated with the dynamics of the tumor disease. New technologies based on PCR and sequencing techniques pave the way for diagnostic approaches to define molecular tumor characteristics, not only in tumor tissue but also in the blood, by analyzing cell-free circulating DNA. The combination of molecular profiling of the tumor with ctDNA analytics by liquid biopsy is a promising step in the advancement of precision medicine.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"78 1","pages":"313 - 322"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74024095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-08-01DOI: 10.1515/labmed-2016-0060
B. Isermann
{"title":"Wechsel in der Schriftleitung: Peter Schuff-Werner übernimmt die Schriftleitung bei der Zeitschrift LaboratoriumsMedizin","authors":"B. Isermann","doi":"10.1515/labmed-2016-0060","DOIUrl":"https://doi.org/10.1515/labmed-2016-0060","url":null,"abstract":"","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"11 1","pages":"225 - 225"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78700751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-08-01DOI: 10.1515/labmed-2016-0036
R. Haeckel, E. Gurr, T. Hoff, on behalf of the working group Guide Limits of the
Abstract 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.
{"title":"Bias, its minimization or circumvention to simplify internal quality assurance","authors":"R. Haeckel, E. Gurr, T. Hoff, on behalf of the working group Guide Limits of the","doi":"10.1515/labmed-2016-0036","DOIUrl":"https://doi.org/10.1515/labmed-2016-0036","url":null,"abstract":"Abstract 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.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"518 1","pages":"263 - 270"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77169594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-08-01DOI: 10.1515/labmed-2015-0069
Dolunay Gülmez, G. Hasçelik
Abstract 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.
{"title":"Efficient use of laboratory resources: pre-screening for urine cultures by automated urinalysis and microscopy to allow exclusion of specimens from culture workflow","authors":"Dolunay Gülmez, G. Hasçelik","doi":"10.1515/labmed-2015-0069","DOIUrl":"https://doi.org/10.1515/labmed-2015-0069","url":null,"abstract":"Abstract 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.","PeriodicalId":49926,"journal":{"name":"Laboratoriumsmedizin-Journal of Laboratory Medicine","volume":"130 1","pages":"277 - 282"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72555444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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