Design of an algorithm for the detection of intravenous fluid contamination in clinical laboratory samples.

OBJECTIVES: Contamination of blood samples from patients receiving intravenous fluids is a common error with potential risk to the patient. Algorithms based on the presence of aberrant results have been described but have the limitation that not all infusion fluids have the same composition. Our objective is to develop an algorithm based on the detection of the dilution observed on the analytes not usually included in infusion fluids. METHODS: A group of 89 cases was selected from samples flagged as contaminated. Contamination was confirmed by reviewing the clinical history and comparing the results with previous and subsequent samples. A control group with similar characteristics was selected. Eleven common biochemical parameters not usually included in infusion fluids and with low intraindividual variability were selected. The dilution in relation to the immediate previous results was calculated for each analyte and a global indicator, defined as the percentage of analytes with significant dilution, was calculated. ROC curves were used to define the cut-off points. RESULTS: A cut-off point of 20 % of dilutional effect requiring also a 60 % dilutional ratio achieved a high specificity (95 % CI 91-98 %) with an adequate sensitivity (64 % CI 54-74 %). The Area Under Curve obtained was 0.867 (95 % CI 0.819-0.915). CONCLUSIONS: Our algorithm based on the global dilutional effect presents a similar sensitivity but greater specificity than the systems based on alarming results. The implementation of this algorithm in the laboratory information systems may facilitate the automated detection of contaminated samples.

Cord Blood Cardiovascular Biomarkers in Left-Sided Congenital Heart Disease.

Fetal echocardiography has limited prognostic ability in the evaluation of left-sided congenital heart defects (left heart defects). Cord blood cardiovascular biomarkers could improve the prognostic evaluation of left heart defects. A multicenter prospective cohort (2013−2019) including fetuses with left heart defects (aortic coarctation, aortic stenosis, hypoplastic left heart, and multilevel obstruction (complex left heart defects) subdivided according to their outcome (favorable vs. poor), and control fetuses were evaluated in the third trimester of pregnancy at three referral centers in Spain. Poor outcome was defined as univentricular palliation, heart transplant, or death. Cord blood concentrations of N-terminal precursor of B-type natriuretic peptide, Troponin I, transforming growth factor ß, placental growth factor, and soluble fms-like tyrosine kinase-1 were determined. A total of 45 fetuses with left heart defects (29 favorable and 16 poor outcomes) and 35 normal fetuses were included, with a median follow-up of 3.1 years (interquartile range 1.4−3.9). Left heart defects with favorable outcome showed markedly increased cord blood transforming growth factor ß (normal heart median 15.5 ng/mL (6.8−21.4) vs. favorable outcome 51.7 ng/mL (13.8−73.9) vs. poor outcome 25.1 ng/mL (6.9−39.0), p = 0.001) and decreased placental growth factor concentrations (normal heart 17.9 pg/mL (13.8−23.9) vs. favorable outcome 12.8 pg/mL (11.7−13.6) vs. poor outcome 11.0 pg/mL (8.8−15.4), p < 0.001). Poor outcome left heart defects had higher N-terminal precursor of B-type natriuretic peptide (normal heart 508.0 pg/mL (287.5−776.3) vs. favorable outcome 617.0 pg/mL (389.8−1087.8) vs. poor outcome 1450.0 pg/mL (919.0−1645.0), p = 0.001) and drastically reduced soluble fms-like tyrosine kinase-1 concentrations (normal heart 1929.7 pg/mL (1364.3−2715.8) vs. favorable outcome (1848.3 pg/mL (646.9−2313.6) vs. poor outcome 259.0 pg/mL (182.0−606.0), p < 0.001). Results showed that fetuses with left heart defects present a distinct cord blood biomarker profile according to their outcome.

Prediction of chorioamnionitis in cases of intraamniotic infection by ureaplasma urealyticum in women with very preterm premature rupture of membranes or preterm labour.

OBJECTIVES: First, to determinate the frequency of chorioamnionitis and funisitis in cases of intramniotic detection of Ureaplasma urealyticum. Second, to assess the predictive capability of some biological markers in the amniotic fluid of these women to predict histological inflammation. SUBJECTS AND METHODS: We prospectively studied 20 cases of women with premature rupture of membranes or preterm labour (PROM) or preterm labour and intraamniotic detection of Ureaplasma urealyticum. Gestational age at admission was 26.74 ± 2.53 weeks. Amniotic fluid concentrations of IL18, IL 2, IL4, IL6, IL10, IL12, TNF-alpha, IFN-g, and MMP-8 were measured by the Multiplex method. Amniotic fluid glucose and leukocyte count were also measured by standard methods. Placental detailed histological studies were performed. Student's t-test, forward stepwise conditional binary logistic regression analysis and ROC curves were used. RESULTS: Histological chorioamnionitis was present in 45% of cases (9/20) and funisitis just in 15% (3/20). Interleukins 6, 8, 12, MMP-8, and leukocyte count were significantly elevated in cases of histological inflammation, defined as choriamnionitis or chorioamniotis + funisitis (p = .007, .03, .01, .03, .03, respectively) while glucose was decreased (p = .04). Binary logistic regression for the prediction of inflammation showed a high predictive value (R2 = .66, p = .002) including in the equation only the IL6 value. CONCLUSIONS: A significant percentage of cases with intraamniotic detection of Ureaplasma urealyticum shows no pathological signs of histological inflammation. Concentration of Interleukin 6 in amniotic fluid can be useful for the diagnosis of subclinical chorioamnionitis in these cases.

Differential amniotic fluid cytokine profile in women with chorioamnionitis with and without funisitis.

OBJECTIVES: To evaluate whether the amniotic fluid (AF) cytokine profile in women with chorioamnionitis may differentiate between those with and without funisitis. SUBJECTS AND METHODS: Forty women at high risk of chorioamnionitis were studied. Gestational age at study was 26.94. Amniocentesis, universal and specific polymerase chain reaction, and microbiological cultures were performed. AF IL-1ß, IL-2, IL-4, IL-6, IL 8, IL-10, IL-12, TNF-alpha, IFN-gamma, and MMP-8 were measured by multiplex assay. After delivery, the placenta and umbilical cord were studied histologically. Comparisons were made between three groups: controls, and chorioamnionitis with and without funisitis. RESULTS: In 25 cases, the histological findings were normal (61.5%). The remaining 15 composed of 9 cases of chorioamnionitis alone (9/40; 23.1%) and 6 cases of chorioamnionitis plus funisitis (6/40; 15.4%). All AF cytokine levels were significantly higher in the cases with chorioamnionitis in comparison to controls, except for IFN-gamma. The comparisons between the three groups showed significant differences between chorioamnionitis alone and chorioamnionitis plus funisitis in IL-1ß, IL-6, IL-10, IL-12, IL-8, and TNF-alpha, with the levels being higher when funisitis was present. Logistic regression found a powerful predictive model for funisitis including the following cytokinesIL-4, IL-10, IL-12, and IL-8. CONCLUSIONS: Measurements of AF interleukins 4, 10, 12, and 8 allow to identify cases with funisitisin women at high risk of chorioamnionitis.

The Laboratory Medicine and the care of patients infected by the Ebola virus. Experience in a reference hospital of Madrid, Spain.

The ongoing Ebola virus outbreak in several countries in West Africa was considered by the World Health Organisation (WHO) as a public health emergency of international concern. Healthcare providers must be prepared by organising specific procedures in our hospitals based on recommendations from national and international healthcare organisations. Two aims should be considered: appropriate medical care for patients with suspected or confirmed disease must be ensured, as must measures to prevent transmission to healthcare workers. The clinical laboratory plays an important role and must define and establish its own procedures in accordance with clinicians and integrated into those of the institution, starting with the definition of the organisation model in the laboratory to achieve those goals. In this review we present our experience based on the care of three patients with confirmed cases. We hope it will help other colleagues to plan for Ebola.

Clinical, operational and economic outcomes of point-of-care blood gas analysis in COPD patients.

INTRODUCTION: Arterial blood gas analysis is relevant in chronic obstructive pulmonary disease (COPD) management. The aim of this study was to evaluate whether the use of a blood gas analyzer in pulmonology departments improves the clinical, operational and economic outcomes when compared with clinical laboratory measurements. PATIENTS AND METHODS: It is an observational prospective study. 112 patients were selected. After specimen collection, the measurement was performed both in pulmonology office as point-of-care and in laboratory. We evaluated clinical outcomes (modification of the indication of long-term oxygen therapy (LTOT) according to results, changes in blood gas analysis results, relationship of the partial pressure of oxygen (PaO2) obtained in the medical visit and velocity of change of the PaO2, influence of total haemoglobin concentration and the change in PaO2), operational outcomes (turnaround time (TAT) from specimen collection to receiving the blood gas analysis report) and economic outcomes (overall cost per process of patient care). RESULTS: There were discrepancies in the indication of LTOT in 13.4% of patients. All parameters showed changes. PaO2 levels showed changes in 2 ways, though they frequently increase over time. The correlation was not good in the other two clinical outcomes. The median TATs in pulmonology office were 1 min versus 79 in laboratory, with 52 min for specimen preparation and transport and 17 min for TAT intralaboratory. The overall cost for the 112 patients in pulmonology office and laboratory was 16,769.89€ and 22,260.97€ respectively. CONCLUSIONS: The use of a blood gas analyzer in a pulmonology office improves clinical, operational and economic outcomes when compared with clinical laboratory.

Percutaneous posterior tibial nerve stimulation (PPTNS) in faecal incontinence associated with an anal sphincter lesion: results of a prospective study.

PURPOSE: Establish the efficacy of posterior tibial nerve stimulation in treating faecal incontinence associated to sphincter defect. METHODS: Prospective study that included patients with faecal incontinence associated to sphincter lesions between 90 and 180°. Clinical anamnesis, physical examination, reverse visual analogic scale, incontinence diary and Wexner score were recorded at baseline and 6 months. Anal manometry was realized at baseline and 6 months. Subjects underwent one 30-min session every week for 12 consecutive weeks and was continued with 6 additional sessions every 2 weeks. RESULTS: Sixteen patients were analysed, 15 women and 1 men, with a mean age of 56.5 years. The incontinence were obstetric origin (50%) and perineal surgeries (50%). Four patients who did not continue with the second stage. Referring to the retention time, at baseline 12 patients (75%) did not bear even 1 min. At 6 months the retention time was <1 min in only 2 patients (p = 0.008). Median Wexner baseline values were 10; at 6 months decrease to 5 (p = 0.006). The visual analogical scale (VAS) increased from 6 to 7.5 (p > 0.05). After 6 months, maximum resting pressure increased from 40.9 to 51 mmHg (p < 0.001) and maximum squeeze pressure from 82.5 to 94 mmHg (p < 0.001). CONCLUSION: PTNS is an effective treatment for faecal incontinence associated to sphincter lesions because the number of incontinence episodes per week, the Wexner Score, the ability to defer defaecation and the manometric determinations improved significantly.

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation--the case of validation of the biochemistry analyzer Dimension Vista.

INTRODUCTION: Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. MATERIALS AND METHODS: A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients' samples in both devices. RESULTS: 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. CONCLUSIONS: A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.

Microbiological spectrum of the intraperitoneal surface after elective right-sided colon cancer: are there differences in the peritoneal contamination after performing a stapled or a handsewn anastomosis?

BACKGROUND: Although colonic surgery is performed with strict aseptic measures, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite colonic occlusion with clamps while the suture is performed. PATIENTS AND METHODS: A prospective, randomized study was performed between October 2009 and June 2011. Inclusion criteria were a diagnosis of right-sided colon cancer and having undergone an elective surgery with curative aims. The patients were divided into two groups: those patients undergoing a stapled ileocolonic anastomosis (group 1) and those undergoing a handsewn anastomosis (group 2). A microbiological sample was obtained from the peritoneal surface before opening the colon and after finishing the anastomosis in each group. Data were correlated with the wound infection and intra-abdominal infection rates. RESULTS: Eighty-four patients were included in the study: 42 patients in each group. There were two intra-abdominal abscesses (5 %) in each group (NS). Wound infection rate was 10 % in group 1 and 7 % in group 2 (NS). Mean operative time was 98.8 min in the stapled group and 105.2 min in the handsewn one (P = 0.013). Positive cultures were obtained in 79 % of the cases after stapled anastomosis and 73 % after handsewn ones (NS). CONCLUSION: Peritoneal contamination appears in over 70 % of cases after ileocolonic anastomosis. Significant differences in peritoneal contamination, wound infection, and intra-abdominal abscess between stapled and handsewn anastomoses could not be demonstrated.

Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery.

BACKGROUND: Colorectal surgery may lead to infections because despite meticulous aseptic measures, extravasation of microorganisms from the colon lumen is unavoidable. STUDY DESIGN: A prospective, randomized study was performed between January 2010 and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative operation. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. After the anastomosis, a microbiologic sample of the peritoneal surface was obtained (sample 1). A second sample was collected after irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3). RESULTS: There were 103 patients analyzed: 51 in Group 1 and 52 in Group 2. There were no significant differences between the groups in age, sex, comorbidities, or type of colorectal surgery performed. Wound infection rates were 14% in Group 1 and 4% in Group 2 (p = 0.009; odds ratio [OR] 4.94; 95% CI 1.27 to 19.19). Intra-abdominal abscess rates were 6% in Group 1 and 0% in Group 2 (p = 0.014; OR 2.14; 95% CI 1.13 to 3.57). The culture of sample 1 was positive in 68% of the cases, sample 2 was positive in 59%, and sample 3 in 4%. CONCLUSIONS: Antibiotic lavage of the peritoneum is associated with a lower incidence of intra-abdominal abscesses and wound infections.

Parallel downregulation of retinol-binding protein-4 and adiponectin expression in subcutaneous adipose tissue of non-morbidly obese subjects.

CONTEXT AND OBJECTIVE: Adipokines are involved in the etiopathology of obesity-related disorders. Since the role of adipokine retinol-binding protein-4 (RBP4) in obesity remains uncertain and its relationship with other adipokines and inflammatory markers has not been examined in detail, we investigated the relationships of RBP4 mRNA expression and circulating protein levels with obesity, anthropometric and metabolic variables, as well as with obesity-related inflammatory markers adiponectin and C-reactive protein. SUBJECTS AND METHODS: One-hundred and twenty-five subjects participated, 36 lean (body mass index (BMI): <25 kg/m(2)) and 89 obese (overweight/obese; BMI: > or =25<40) whose anthropometric and metabolic variables were assessed. mRNA expression was quantified by real-time PCR in subcutaneous adipose tissue (s.c.-AT) of 46 subjects. RESULTS: There was a tendency for circulating RBP4 levels to positively correlate with waist circumference (beta=0.29, P=0.08; R(2)=0.08), but there was no significant association with the obesity-related parameters analysed. RBP4 and adiponectin mRNA expression levels were similarly downregulated in the s.c.-AT of obese subjects (0.5-fold); however, RBP4 downregulation did not affect its circulating protein levels. The expression of RBP4 and adiponectin was positively correlated even after controlling for confounding factors (beta=0.59, P<0.0001; R(2)=0.40). CONCLUSIONS: In our population, RBP4 circulating levels were not significantly correlated with obesity-related parameters, although a tendency to correlate with waist circumference suggests a relationship with insulin resistance and other metabolic disorders. In addition, our results suggest that the production of RBP4 by other tissues such as liver, rather than s.c.-AT, may be involved in regulating RBP4 circulating levels.