Doubling immunochemistry laboratory testing efficiency with the cobas e 801 module while maintaining consistency in analytical performance.

OBJECTIVES: The new immunochemistry cobas e 801 module (Roche Diagnostics) was developed to meet increasing demands on routine laboratories to further improve testing efficiency, while maintaining high quality and reliable data. DESIGN AND METHODS: During a non-interventional multicenter evaluation study, the overall performance, functionality and reliability of the new module was investigated under routine-like conditions. It was tested as a dedicated immunochemistry system at four sites and as a consolidator combined with clinical chemistry at three sites. RESULTS: We report on testing efficiency and analytical performance of the new module. Evaluation of sample workloads with site-specific routine request patterns demonstrated increased speed and almost doubled throughput (maximal 300 tests per h), thus revealing that one cobas e 801 module can replace two cobas e 602 modules while saving up to 44% floor space. Result stability was demonstrated by QC analysis per assay throughout the study. Precision testing over 21 days yielded excellent results within and between labs, and, method comparison performed versus the cobas e 602 module routine results showed high consistency of results for all assays under study. In a practicability assessment related to performance and handling, 99% of graded features met (44%) or even exceeded (55%) laboratory expectations, with enhanced reagent management and loading during operation being highlighted. CONCLUSION: By nearly doubling immunochemistry testing efficiency on the same footprint as a cobas e 602 module, the new module has a great potential to further consolidate and enhance laboratory testing while maintaining high quality analytical performance with Roche platforms.

Heavy/light chain specific immunoglobulin ratios provides no additional information than serum proteins electrophoresis and immunofixation for the diagnosis and the follow-up of intact immunoglobulin multiple myeloma patients.

BACKGROUND: Serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) are used for diagnosis and follow-up of patients with intact immunoglobulin multiple myeloma. However, the numerous limitations of these methods led to the development of a nephelometric immunoassay (Hevylite™) for the specific measurement of serum IgGκ, IgGλ, IgAκ and IgAλ concentrations. METHODS: In this study, we evaluated the correlation between this assay and SPE and IFE in 114 sera of 15 patients (12 IgG and 3 IgA patients) and its impact on the clinical care of patients, especially for diagnosis, for the evaluation of residual disease and for early detection of relapse. RESULTS: At inclusion and during follow-up, we found a good correlation between monoclonal immunoglobulin concentrations and SPE (R(2)=0.902 for IgA and R(2)=0.915 for IgG) and nephelometric quantification (R(2)=0.948 for IgA and R(2)=0.920 for IgG) for the evaluation of monoclonal and polyclonal immunoglobulins. Our results illustrate that the Hevylite™ test is less sensitive than the IFE for detection of residual disease: 5 patients who obtained very good partial response or complete response had normalization of the Hevylite™ ratio while IFE was still positive. A relapse had been detectable with the Hevylite™ ratio 1 to 2 months earlier than with SPE and IFE in 3 patients out of 15, but no recommendations for treating patients with only slight biological relapse are available. CONCLUSION: Our results demonstrate that heavy/light chain specific immunoglobulin ratios provides no additional information than serum proteins electrophoresis and immunofixation for the diagnosis and the follow-up of intact immunoglobulin multiple myeloma patients. We also studied the correlation between the concentration of total immunoglobulin measured by Hevylite™ (sum of Ig'κ + Ig'λ) and nephelometric measurement of total IgG or IgA. For this correlation analysis, all 114 sera were analyzed. The correlation coefficient was R(2) = 0.948 for IgA and R(2) = 0.920 for IgG.

[The neutrophil gelatinase-associated lipocalin, or LCN 2, marker of aggressiveness in clear cell renal cell carcinoma]. / La neutrophil gelatinase-associated lipocalin, ou LCN 2, facteur d'agressivité dans le carcinome rénal à cellules claires (CRCC).

OBJECTIVE: To determine the prognostic significance of the neutrophil gelatinase-associated lipocalin (NGAL) and the matrix metalloproteinase 9 (MMP-9) in clear cell renal cell carcinoma (CCRCC). PATIENTS AND METHODS: NGAL and MMP-9 expression were quantified by immunohistochemistry in clear renal cell carcinoma tissues and in sera by Enzyme Linked Immunosorbent Assay (Elisa). Results were associated with clinicopathologic data. RESULTS: Seventy-four patients operated for CCRCC in Rennes between 2003 and 2009 were included. High concentrations of NGAL-MMP-9 complex in serum were associated with short progression free survival (PFS) (33.3 months versus 47.3 months, P=0.016) and poor overall survival (42.5 months versus 51.9 months, P<0.047). High NGAL concentrations in serum were also associated with shorter PFS (13.6 months versus 41.6 months, P=0.04). However, no NGAL expression was observed in renal tumor cells. Interestingly, NGAL was expressed by neutrophils infiltrating CCRCC and we showed that the density of NGAL expressing neutrophils was associated with pejorative PFS and survival (36.9months versus 56.1 months, P<0.006). CONCLUSION: In this study, we showed the pejorative significance of NGAL-MMP-9 complex and NGAL rates in serum of CCRCC. We also confirmed that density of NGAL expressing neutrophils in CCRCC was associated with poor outcome.

Absence of VHL gene alteration and high VEGF expression are associated with tumour aggressiveness and poor survival of renal-cell carcinoma.

BACKGROUND: The von Hippel-Lindau gene (VHL) alteration, a common event in sporadic clear-cell renal-cell carcinoma (CCRCC), leads to highly vascularised tumours. Vascular endothelial growth factor (VEGF) is the major factor involved in angiogenesis, but the prognostic significance of both VHL inactivation and VEGF expression remain controversial. The aims of this study were to analyse the relationship between VHL genetic and epigenetic alterations, VHL expression and VEGF tumour or plasma expression, and to analyse their respective prognostic value in patients with CCRCC. METHODS: A total of 102 patients with CCRCC were prospectively analysed. Alterations in VHL were determined by sequencing, Multiplex Ligation-dependent Probe Amplification (MLPA) and methylation-specific MLPA. Expression of pVHL and VEGF was determined by immunohistochemistry. Plasma VEGF was measured by enzyme-linked immunosorbent assay (ELISA). RESULTS: VHL mutation, deletion and promoter methylation were identified in 70, 76 and 14 cases, respectively. Overall, at least one VHL-gene alteration occurred in 91 cases (89.2%). Both VEGF tumour and plasma expression appeared to be decreased in case of VHL alteration. Median progression-free survival and CCRCC-specific survival were significantly reduced in patients with wild-type VHL or altered VHL and high VEGF expression, which, therefore, represent two markers of tumour aggressiveness in CCRCC. CONCLUSION: Stratifying CCRCCs according to VHL and VEGF status may help tailor therapeutic strategy.

[Pilot epidemiologic study of transmission of cytomegalovirus from mother to preterm infant by breastfeeding]. / Transmission du cytomégalovirus par le lait maternel cru aux enfants prématurés: étude épidémiologique pilote.

UNLABELLED: Transmission of cytomegalovirus (CMV) infection from mothers to preterm infants during breastfeeding may be symptomatic and long term consequences are unknown. This study evaluated the kinetics of CMV load in breastmilk and the rate of postnatal CMV transmission via breastmilk from mothers to their preterm infants. METHODS: Prospective study of mother-child pairs after preterm delivery before 33 weeks. Exclusion of donor breast milk and of CMV-seropositive blood products. Material used was maternal CMV serostatus, ear swab of the infant at birth, weekly screened breast milk and children's urine by rapid viral culture. RESULTS: During a 5-month period 28 mother-infant pairs with 34 preterm infants were studied. Eighteen women (64.3%) were CMV-seronegative at birth; breastmilk samples and the infants' urine remained CMV-negative. Eight of the 10 seropositive mothers, who had 11 preterm infants, excreted CMV into breast milk (80%). CMV excretion into breast milk was detected during the first week after delivery in 66% cases and was at its peaked between 3 to 5 weeks after delivery. Out of the 7 CMV-exposed infants, CMV transmission was confirmed in only one asymptomatic case. Total quantity of breast milk intake did not seem discriminative for CMV transmission. CONCLUSION: In CMV-seropositive mothers of preterm infants a high incidence of CMV excretion into breast milk was detected. Despite this high rate, symptomatic infection did not occur. However, potential risk and severity of infection may be difficult to establish. Because breastfeeding is beneficial, new procedures for gentle virus inactivation of seropositive breast milk should be assessed.

[Methodological issues of health research]. / Questões metodológicas da pesquisa no campo da saúde.

This work aims at presenting a reflection on the method of research in the health field. Some questions are presented which involve the use of the method of natural sciences and that of social sciences in an attempt at understanding some methodological problems concerning the former and the latter. Problems related to the methodological issues in the elaboration of investigation projects in this field and the need for continuous discussion are pointed out as to: the differentiation of the nature of the object of investigation; the context in which a determined problem is identified; the type of question which is asked when it is problematized; technical procedures, the theory and the interpretative scheme on which it is founded; the dichotomy concerning the subject/object of knowledge; the researcher's neutrality; the concept of casualty.

[Nursing research: progress and challenges]. / A pesquisa em enfermagem: avanços e desafios.

The objective of this study is to reflect on the organization and development of nursing research in Brazil, pointing out some knowledge advances and limits until the moment, as well as indicating some of the challenges for the research in nursing. One of these challenges would be establishing the relation between nursing and care.

[Interprofessional and interinstitutional relations of power at a hospital]. / Relações de poderes (inter)profissionais e (inter)institucionais no hospital.

The purpose of this article is to make a critical analysis about power relationships, which permeate daily professional and/or institutional actions in the hospital environment. This reflection is based on a concrete situation experienced by a group of nursing professors from a state university in Paraná, which unleashed conflicts concerning interprofessional and interinstitutional power relationships. This study focuses on power relationships in the hospital emphasizing the interrelations that characterize nursing practice. We believe that these relationships can only be understood, reflected upon and rebuilt in the context of daily practice, as new ways of collective action are sought.

[Care-research interface in nursing]. / Interface cuidado-investigação em enfermagem.

In this study, the authors have as a goal to discuss the care-investigation interface in the caring practice of Nursing in the hospital ambit, starting from their professional experiences. The bases of the discussion is the career/cared being. We surpass care as the object of research and the importance of investigation for the improvement of care quality. Interdisciplinarity is pointed out as one of the possible resources for the construction of integral care and of a therapeutical action that exceeds the biological, in a perspective of co-participation, as well as the need of promoting and stimulating the accomplishment of investigations in the units of hospital care. The meaning of the investigation about care goes beyond its internality, requiring technical competence, ethical compromise and coherence among the different areas of knowledge which involves it. We enlighten the need of overcoming the dichotomies of caring/investigating, researching while caring, and caring while researching. We stress out the importance of creating research groups in Universities; the stimulus to the accomplishment of graduation courses with leave-out time from work; the availability of financial resources; and the incentive to subscribe periodicals and to acquire books.

[Hospitalized children: mothers' perception of the affective bond between child and family]. / Criança hospitalizada: percepção das mães sobre o vínculo afetivo criança-família.

This purpose of this research was to verify the perception of the mother who has her child sick and hospitalized, about the importance of her permanence during the hospitalization time for the maintenance of the affective child-family link. Empiric data were collected with mother's of hospitalized children, who were accompanying the hospitalization of their children in a public hospital at the Cascavel city in the West of Paraná, Brazil, through semi-structured interviews. The analysis of these data demonstrated that the mothers recognize the importance of staying with their children in such a stress time like the hospitalization time, however, the external facts that influence their daily life, often do not allow them to stay with their children.

[Dialectic hermeneutics: a way of thinking in nursing research]. / Hermenêutica dialética: um caminho de pensamento na investigação em enfermagem.

This paper is a theoretical study about dialectic and hermeneutics union and the possibility of its application as a "way of thinking" in nursing research. For this, we retake its origin and discussion at the present time, as well as the theoretical postulates that gives it foundation, looking forward on expanding the horizons in nursing investigation.

[Nurses' aides and the practice of nursing research: study of a reality in hospitals]. / Enfermeras asistenciales y la práctica de investigaciones: estudio de una realidad hospitalaria.

The present study aims at demonstrating the situation of nurses of a particular hospital institution with respect to nursing research, focusing their previous and actual research, the limited and favourable elements to elaborate scientific works and the meaning of research to nursing, according to this study participant's opinion. The data collection were made through questionnaire and semi-structured interview.

[Philosophy of nursing education. Various considerations]. / A filosofia na formação do enfermeiro-algumas considerações.

The study has objective to promote a reflection about the importance of philosophy for nurse's formation. For this purpose, we search of questions in the literature that could give foundations about the theme, focusing on the importance for scientific nursing research.

[Teacher-student communication across the Tizadora pedagogical problem]. / Communicaçäo professor-aluno através da pedagogia problematizadora.

Report of experience in the use of a social-cultural approach during the development of a work done by graduate students of Ribeiräo Preto School of Nursing-USP. As a form of reference for the didactic strategy, it was used the scheme of arch proposed by Charles Maguerez and presented by BORDENAVE, in an attempt to systematize the communication teacher-student talking about "Aspects related to the Undergraduate Teaching Problems".

[Reflections on a controversial topic: nursing ethics]. / Algumas reflexões sobre um tema polêmico: a ética na enfermagem.

The present study does a reflection on the ethics in nursing, considering the context in which it is introduced. The authors approaches it in a broad manner and its historic evolution, going through a discussion inside the health care area, until the nursing related questions emerged, establishing relations between them. The questions and the doubts, much more than answers, are the focus of this study, whose main concern is to contribute to nurse's critical thought necessary to the effective practice of the profession.