Cystatin C - a fast and reliable biomarker for glomerular filtration rate in head and neck cancer patients.

PURPOSE: Determination of renal function is a prerequisite for planning therapy in cancer patients. Limitations of creatinine as marker for the glomerular filtration rate (GFR) led to the proposal of cystatin C as a more accurate biomarker especially in mild renal insufficiency or in patients with low muscle mass. We compared the accuracy of cystatin C- and creatinine-based equations to estimate GFR in head and neck cancer (HNC) patients receiving platinum-based radiochemotherapy. PATIENTS AND METHODS: The study population consisted of 52 HNC patients (GFR range, 37-105 mL/min/1.73 m(2) complemented by 17 patients with known renal insufficiency (GFR range, 10-60 mL/min/1.73 m(2)). Intraclass correlation coefficients were calculated between the reference method (51)Cr-EDTA clearance and estimated GFR by creatinine clearance and equations based on creatinine (Cockroft-Gault, modification of diet in renal disease (MDRD), Wright) or cystatin C (Larsson, Dade-Behring, Hoek). In addition, sensitivity and specificity to discriminate GFR > 60 mL/min/1.73 m(2) were evaluated by receiver operating characteristic curve (ROC). RESULTS: The highest correlation coefficients were found for the cystatin C-based estimates in comparison with creatinine-based estimates or creatinine clearance, even though Bland-Altman plots revealed GFR overestimation for all equations tested. The cystatin C-based Hoek formula exhibited the highest overall precision and accuracy. GFR of < 60 mL/min/1.73 m(2) was assumed as a cut-off for chemotherapy. ROC analyses revealed the highest AUC to predict a GFR > 60 mL/min/1.73 m(2) for the creatinine-based Wright formula, closely followed by the MDRD formula and cystatin C-based equations of Larsson, Dade-Behring, and Hoek. CONCLUSION: Cystatin C-based GFR estimates showed the overall strongest correlation to the reference method. Thus, we recommend cystatin C for GFR estimation in HNC patients as an alternative method to the estimated creatinine clearance in clinical practice.

Vitamin C supplement use may protect against gallstones: an observational study on a randomly selected population.

BACKGROUND: Animal experiments have shown a protective effect of vitamin C on the formation of gallstones. Few data in humans suggest an association between reduced vitamin C intake and increased prevalence of gallstone disease. The aim of this study was to assess the possible association of regular vitamin C supplementation with gallstone prevalence. METHODS: An observational, population-based study of 2129 subjects aged 18-65 years randomly selected from the general population in southern Germany was conducted. Abdominal ultrasound examination, completion of a standardized questionnaire, compilation of anthropometric data and blood tests were used. Data were collected in November and December 2002. Data analysis was conducted between December 2005 and January 2006. RESULTS: Prevalence of gallstones in the study population was 7.8% (167/2129). Subjects reporting vitamin C supplementation showed a prevalence of 4.7% (11/232), whereas in subjects not reporting regular vitamin C supplementation, the prevalence was 8.2% (156/1897). Female gender, hereditary predisposition, increasing age and body-mass index (BMI) were associated with increased prevalence of gallstones. Logistic regression with backward elimination adjusted for these factors showed reduced gallstone prevalence for vitamin C supplementation (odds ratio, OR 0.34; 95% confidence interval, CI 0.14 to 0.81; P = 0.01), increased physical activity (OR 0.62; 95% CI, 0.42 to 0.94; P = 0.02), and higher total cholesterol (OR 0.65; 95% CI, 0.52 to 0.79; P < 0.001). CONCLUSION: Regular vitamin C supplementation and, to a lesser extent, increased physical activity and total cholesterol levels are associated with a reduced prevalence of gallstones. Regular vitamin C supplementation might exert a protective effect on the development of gallstones.

Long-term outcome after total parathyroidectomy for the management of secondary hyperparathyroidism.

In patients with chronic renal failure, secondary hyperparathyroidism (sHPT) is a common problem requiring surgical parathyroidectomy (PTX) if medical treatment with active vitamin D and calcimimetics fails. To minimize the risk for recurrence, we perform total PTX (tPTX) without autotransplantation. From October 1997 to January 2004, 46 patients (31 men and 15 women) underwent tPTX without autotransplantation (median age 51 years; range 19-80 years; median dialysis time before PTX 5 years; range 0-25 years). Indications for PTX were hyperparathyroid bone disease in 41 cases and calciphylaxis in 5 cases. Postoperatively, all patients were supplemented with vitamin D analogues, both calcitriol and cholecalciferol. Patients were followed up for 4-107 months (median 63 months). Although tPTX was intended in all cases, we saw recurrent or persistent hyperparathyroidism in 26% and supernumerary glands in 15% of cases. In 7 patients (15%), five or more glands were documented and in another four suspected confirming the clinical relevance of intraoperative parathyroid hormone (PTH) measurement. In our study, the positive predictive value of a low intraoperative PTH (<20 pg/ml) for a successful tPTX was 92%. 15 patients received a renal transplant after tPTX without autotransplantation. Here, an uncomplicated hypocalcaemia was noted in 3 patients. Last available calcium levels were between 1.72 and 2.66 mmol/l (median 2.35 mmol/l). After follow-up, active vitamin D was given in a median daily dose of 0.5 microg calcitriol (range 0-2.5 microg/day). There was no evidence of clinical bone disease and no pathological fractures after tPTX after a median observation period of 63 months. tPTX still offers the highest percentage of cure for sHPT, it is safe and postoperatively easily manageable. It allows for adequate supplementation with active vitamin D, and it is the most cost-effective procedure. It should be reconsidered an option for the treatment of sHPT.

Determination of reference values for the soluble transferrin receptor (sTfR) on a cross sectional population sample.

BACKGROUND: Aim of the study was to determine reference values for the soluble Transferrin Receptor (sTfR) in a cross sectional population sample. METHODS: For the determination of reference values, using a standard calibrated fluorescence-immunoassay, the samples (990 females; 1060 males; 13 - 65 years old) were divided into five groups according to age and sex. Soluble transferrin receptor and ferritin were measured by a fluorescence-immunoassay with AIA-21 (TOSOH BIOSCIENCE, Tessenderlo, Belgium). The sTfR/logFer-Index was calculated by dividing the sTfR by the logarithm of ferritin, the logsTfR/Fer-Index by dividing the logarithm of sTfR by ferritin. RESULTS: Mean sTfR concentration was 1.75 +/- 0.39 mg/l in group I (13-17 years), 1.65 +/- 0.34 mg/l in group II (18-30 years), 1.60 +/- 0.39 mg/l in group III (31-40 years), 1.54 +/- 0.39 mg/l in group IV (41-50 years), and 1.59 +/- 0.34 mg/l in group V (51-65 years), respectively. A gender-specific difference between the groups was observed: sTfR concentrations were lower in group I (p < 0.005) and group II (p = 0.01) for women. The mean sTfR-concentration decreased consecutively in the age group I-IV (13-50 years). CONCLUSIONS: This is the first cross sectional population based study to determine reference values for sTfR-concentrations. Our results demonstrated age- and gender-specific differences.

Comparison of whole blood interleukin-8 and plasma interleukin-8 as a predictor for sepsis in postoperative patients.

OBJECTIVE: Interleukin-8 (IL-8, also known as neutrophil-activating peptide 1, NAP1 and CXCL8, CXC chemokine ligand 8) is recognized as a potent effector of neutrophil functions. IL-8 is a major response factor following NfkB activation by cytokines or lipopolysaccharide and several different cell types T lymphocytes, monocytes, epithelial and endothelial cells secrete this polypeptide. IL-8 is not to be determined at significant concentrations in plasma due to its receptor binding but may play a major role in tissues. The prediction of sepsis is a major and current field of research in the treatment of surgical patients. The aim of this study was to compare the determination of IL-8 in whole blood cell lysates (whole blood IL-8) and in plasma for the prediction of sepsis in postoperative intensive care. DESIGN: Whole blood IL-8, IL-8 in plasma, and CRP were measured in the daily routine monitoring of 84 patients in a surgical intensive care unit. Sepsis was defined by the criteria of the Society of Critical Care Medicine (SCCM). For comparison the APACHE II score (APACHE=Acute Physiology and Chronic Health Evaluation) was calculated. The diagnostic value of the three tests was compared by receiver operating characteristic (ROC) curves. RESULTS: Whole blood IL-8 showed higher areas under the curve (AUC) than IL-8 in plasma and CRP. The ROC curves for the APACHE II scores gave similar results. CONCLUSIONS: Sepsis is a complex disease and is induced by systemic infection of patients suffering from systemic inflammatory response syndromes (SIRS). Therefore, the identification of infection or the host response to infection is of crucial importance. The prediction of an individual marker or interleukin or its binding to surface proteins is not necessarily indicative for sepsis. In cases with unequivocally identified bacterial infections, the current results suggest that whole blood IL-8 may have a similar diagnostic accuracy as plasma levels. Of note, this technique needs less blood and is not being affected by hemolysis.

Overweight, physical activity, tobacco and alcohol consumption in a cross-sectional random sample of German adults.

BACKGROUND: There is a current paucity of data on the health behaviour of non-selected populations in Central Europe. Data on health behaviour were collected as part of the EMIL study which investigated the prevalence of infection with Echinococcus multilocularis and other medical conditions in an urban German population. METHODS: Participating in the present study were 2,187 adults (1,138 females [52.0%]; 1,049 males [48.0%], age: 18-65 years) taken from a sample of 4,000 persons randomly chosen from an urban population. Data on health behaviour like physical activity, tobacco and alcohol consumption were obtained by means of a questionnaire, documentation of anthropometric data, abdominal ultrasound and blood specimens for assessment of chemical parameters. RESULTS: The overall rate of participation was 62.8%. Of these, 50.3% of the adults were overweight or obese. The proportion of active tobacco smokers stood at 30.1%. Of those surveyed 38.9% did not participate in any physical activity. Less than 2 hours of leisure time physical activity per week was associated with female sex, higher BMI (Body Mass Index), smoking and no alcohol consumption. Participants consumed on average 12 grams of alcohol per day. Total cholesterol was in 62.0% (>5.2 mmol/l) and triglycerides were elevated in 20.5% (> or = 2.3 mmol/l) of subjects studied. Hepatic steatosis was identified in 27.4% of subjects and showed an association with male sex, higher BMI, higher age, higher total blood cholesterol, lower HDL, higher triglycerides and higher ALT. CONCLUSION: This random sample of German urban adults was characterised by a high prevalence of overweight and obesity. This and the pattern of alcohol consumption, smoking and physical activity can be considered to put this group at high risk for associated morbidity and underscore the urgent need for preventive measures aimed at reducing the significantly increased health risk.

Prevalence of the metabolic syndrome in southwest Germany.

The metabolic syndrome is a highly prevalent multifaceted clinical entity. Obesity, which is part of the metabolic syndrome, is the fastest growing health-related problem worldwide. Since currently prevalence data of the metabolic syndrome are lacking from Germany, we have applied ATP III-criteria in two urban and rural cohorts. Our population-based studies provide evidence that the prevalence of the metabolic syndrome increases with age. It was found to be more prevalent in a rural population and in this group it clustered in males. As a consequence of our population-based studies evidence that especially the rural population is at high risk for future macrovascular complications is substantiated. The urgent need for preventive measures aimed at reducing the significantly increased health risk is underscored.

Chemokine activation within 24 hours after blunt accident trauma.

Chemokines mediate the migration of leukocytes to sites of inflammation. Changes in the plasma concentration of interleukin (IL)-8 and macrophage inflammatory protein (MIP)-1beta have not been investigated in the very early phase starting immediately after unintentional trauma. Enrolled in the study were 94 patients with multiple blunt injuries. Blood samples were collected at the scene of accident, then at regular intervals for 24 h. IL-8 and MIP-1beta plasma levels were determined by commercial test kits. Patients were grouped according to trauma severity, pattern of injury, as well as survivors vs. nonsurvivors. Serious casualties [Injury Severity Score (ISS) > or = 32] revealed a significant increase in IL-8 compared to only a slight elevation in individuals with an ISS < 32. Nonsurvivors showed a highly significant (P < 0.005) increase in IL-8 levels beginning immediately after admission. Trauma resulted in a modest activation of MIP-1beta production without differences regarding trauma severity, pattern of injury, or survival. A very strong trauma stimulus is necessary to activate IL-8 production. In contrast to MIP-1beta, IL-8 levels were significantly elevated in nonsurvivors compared to survivors. Therefore, IL-8 might be an early predictor of survival.

Preoperative oral application of immunoglobulin-enriched colostrum milk and mediator response during abdominal surgery.

Our objective was to evaluate the influence of pre-operative oral application of an immunoglobulin-enriched milk preparation on endotoxin translocation and mediator release during and after abdominal surgery. Forty patients who had been treated by partial (n = 4) or total gastrectomy (n = 8) or pancreatic resection (n = 28) were enrolled in a placebo-controlled pilot study. Pre-operatively, patients were randomly treated for 3 days by oral application of a bovine milk preparation (lactobin 56g/day, n = 20) or placebo (n = 20). In both groups, endotoxin translocation and mediator release was studied pre- and intraoperatively by measuring endotoxin, endotoxin-neutralizing capacity (ENC), interleukin 6, C-reactive protein, transferrin, alpha-2-macroglobulin, albumin, apoliprotein-A1/-B, IgG, IgA, and IgM. The clinical course was followed up by daily evaluation of the Apache-II-score. Clinical data were comparable in both groups. The lactobin group showed significantly lower levels of endotoxin and ENC compared to the placebo group. Acute phase response, endotoxin-binding proteins, and clinical outcome did not differ between both groups. We conclude that prophylactic oral application of lactobin reduces perioperative endotoxemia and prevents reduction of ENC, suggesting a stabilization of gut barrier during abdominal surgery.

Whole blood interleukin-8 concentrations in capillary and cord blood of neonates for the diagnosis of systemic inflammatory states.

An assay is described for the determination of interleukin 8 (IL-8) in whole blood lysate instead of plasma or serum. EDTA-anticoagulated umbilical cord blood or capillary blood was added to a detergent-containing lysing reagent. This sample was used directly for determination of IL-8 using the Immulite IL-8 assay kit (DPC, Bad Nauheim, Germany) and the Immulite Analyzer. Linearity was confirmed for cord blood as well as for venous blood, at a whole blood to lysing agent ratio from 1:20 to 1:1. IL-8 was stable in whole blood hemolysate at 4 degrees C for at least 3 days; thereafter, concentrations decreased remarkably to 32% of the initial concentration after 8 days. Storage of whole blood prior to hemolysis led to increases in IL-8 concentrations of up to 4 fold the original values. The intra-assay CV was 3.4% (at 234 ng/l) and 7.4 % (at 1080 ng/l) using hemolysate samples. Inter-assay CVs of 13.3% (at 108 ng/l) and 11.7 % (at 506 ng/l) were found using control material. Concentrations of IL-8 in whole blood were significantly higher than in the corresponding plasma. In 70% of 135 apparently healthy neonates' cord blood samples, plasma IL-8 concentrations were below the detection limit of the assay (5 ng/l), whereas a range of 69 - 3150 ng/l IL-8 (median, 266 ng/l) was found in the hemolysate samples of these neonates. A preliminary reference range for IL-8 in whole blood may be set at 132 to 820 ng/l (5th and 95th percentile). In 78 neonates, IL-8 concentrations in hemolysate from capillary blood ranged from 120 ng/l to 2000 ng/A (median, 416 ng/l). The fact that concentrations of IL-8 can be determined using only a very small sample volume (10 microl of whole blood) makes the assay format especially suitable for use in neonatal intensive care.

Procalcitonin in patients with acute and chronic renal insufficiency.

BACKGROUND: Bacterial infections are associated with a high morbidity and mortality rate in patients with acute and chronic renal failure. Because C-reactive-protein (CRP) is elevated in many patients with renal failure, even in the absence of infection, procalcitonin (PCT) might be useful for the detection of systemic bacterial infections. This cross-sectional observation study measured PCT and CRP in several groups of patients with various types, degrees and treatments of kidney diseases, including patients with sepsis treated with renal replacement therapy. PATIENTS AND METHODS: We determined PCT and CRP in 85 renal patients with different stages and treatments of renal insufficiency: chronic renal failure (CRF) n=23, patients undergoing continuous ambulatory peritoneal dialysis (CAPD) n=20, patients undergoing hemodialysis therapy (HD) n=42 and in a group of 40 patients with septic conditions, including 20 patients with acute renal failure (ARF). The infectious status of the patients was monitored. RESULTS: PCT in serum (reference value in healthy controls < 1 microg/l) was within the normal range in patients with CRF and in patients on both short-term HD (< 1 year) and long-term HD (> 1 year) (median of 0.25 microg/l and 0.61 microg/l). However, PCT was elevated in patients on CAPD (median of 1.18 microg/l). In patients with sepsis, PCT was massively elevated in both the presence and absence of ARF. In contrast, CRP (reference value < 5 mg/l) was markedly increased in patients undergoing short- and long-term HD (medians of 14.5 and 51.1 mg/l) but not in patients on CAPD. In patients with CRF and systemic bacterial infections, both PCT and CRP were markedly elevated (median PCT 63 microg/l, CRP 130 mg/l) but, in contrast to PCT, CRP values overlapped in infected and non-infected patients. There was no relevant decrease in plasma concentrations of PCT by hemofiltration or hemodialysis in patients with sepsis. CONCLUSION: With the exception of CAPD patients, PCT levels were not significantly affected by renal diseases or treatments but were markedly elevated in the presence of infections. Thus PCT is a valuable marker for early diagnosis of systemic bacterial infections in patients with CRF or patients undergoing HD. In contrast, CRP is elevated in several groups with renal diseases and has low specificity for the diagnosis of bacterial infections.

[Therapy of diffuse suppurative peritonitis with continuous peritoneal lavage]. / Therapie der diffusen eitrigen Peritonitis mit kontinuierlicher Peritoneallavage.

Peritonitis is a severe illness with a high mortality rate and different treatment modalities. Over a time period of 12 years 510 patients with peritonitis treated with continuous peritoneal lavage (CPL) were retrospectively analyzed. 315 of 510 patients with a mean age of 57.4 and a mean APACHE-II-Score of 10.2 on admission had a diffuse four quadrant peritonitis. 195 had a local and diffuse peritonitis due to perforation of the appendix. 232 of 315 patients with diffuse peritonitis (73.7%) had a secondary peritonitis, mostly due to organ perforation. The most frequent comorbidities were congestive heart failure (36.8%), pulmonary diseases (26%), diabetes mellitus (18.7%), chronic renal failure (16.8%), chronic liver diseases (9.5%) and a history of alcohol abuse (12.4%). On admission 18.7% had pulmonary insufficiency, 18.4% renal failure, 14.3% congestive heart failure and 13.3% hepatic insufficiency. 14% had one organ-, 6.7% two organ-, 2.5% three organ- and 5% four organ failure. The mean duration of lavage was 5.1 days with a fluid amount of 8-24 l/day. 81.3% of all patients could be treated successfully. 46 patients were reoperated due to persistent peritonitis. The mortality rate of the primarily treated patients was 15.6% compared to 37.0% of patients who had to be reoperated. The mortality rate of all patients was 18.7%. The prognosis of the clinical outcome was significantly influenced by preexisting organ failure and by the duration of the peritonitis on admission. Our results on CPL for diffuse peritonitis are in accordance with results from other treatment modalities; a direct comparison was not possible due to the different patient groups.

Prevalence of non-alcoholic fatty liver and characteristics in overweight adolescents in the general population.

Overweight and obesity among children and adolescents are increasing. Fatty liver disease (FLD) is an emerging problem in this age group. We investigated prevalence of overweight and non-invasive FLD and associated clinical characteristics in a representative population-based sample of 378 children and adolescents aged 12-20 years who were randomly selected from the general population in Leutkirch, Southern Germany. Overweight was defined as having a body mass index above the 90th percentile for the respective age and sex. About 15% of female (29 out of 194) and 12% of male participants (22/182) were overweight. Among females, only one non-overweight individual showed signs of FLD but in more than one third of the overweight males (8/22) signs of FLD were present. Overweight subjects in general had an unfavourable lipid profile and abnormal concentrations of obesity-related hormones such as significantly lower concentrations of adiponectin and increased levels of inflammatory markers including C-reactive protein and fibrinogen. Overweight males with signs of FLD showed even more severe altered metabolic responses compared to those who were overweight without signs of liver injury. FLD was not explained by alcohol consumption or other chronic liver disease. In this sample of children and adolescents representative of the general population a high prevalence of non-alcoholic fatty liver disease (NAFLD) is found in overweight males. These individuals showed the most severe metabolic alterations compared to non-overweight and overweight individuals without NAFLD indicating even higher risk for future overweight and obesity-related diseases such as type 2 diabetes and cardiovascular disease.

Clinical value of lipopolysaccharide-binding protein (LBP) determinations in acute pancreatitis.

BACKGROUND: Lipopolysaccharide-binding protein (LBP) is a class 1 acute-phase protein that binds and transfers bacterial lipopolysaccharide (LPS). This study investigated the clinical value of measuring LBP for stratifying biochemical severity in acute pancreatitis by using a recently developed fully automated assay technique. PATIENTS AND METHODS: We studied 71 patients with acute pancreatitis of whom 41 presented with a necrotizing course. Necrotizing pancreatitis was associated with pancreatic infections in 21 patients and with multiorgan dysfunction syndrome (MODS) in 18 patients. Serum LBP was measured for 14 days by a fully automated immunoassay and CRP was assessed on a daily routine basis. RESULTS: The relative quantitative systemic release of LBP was lower than that observed for CRP; however, the two parameters revealed similar dynamics, with a maximum increase in acute pancreatitis around the fourth day after onset of symptoms. As observed for CRP, LBP was significantly higher in patients who developed complications such as necrosis, pancreatic infections, single or combined MODS than in those who did not. Multiple regression analysis revealed that pulmonary failure and MODS were independent variables associated with enhanced LBP release, while the development of necrosis, pancreatic infections and MODS were the corresponding variables for increased CRP levels. CONCLUSIONS: Systemic LBP concentrations are significantly elevated in acute pancreatitis and closely correlate with overall disease severity. However, compared with CRP, LBP does not contribute to an improved severity stratification in acute pancreatitis.

Hemophagocytic lymphohistiocytosis is associated with deficiencies of cellular cytolysis but normal expression of transcripts relevant to killer-cell-induced apoptosis.

In 65 patients with hemophagocytic lymphohistiocytosis (HLH), we found an as yet undescribed heterogeneity of defects in cellular cytotoxicity when assay conditions were modified by the incubation time, the presence of mitogen, or interleukin-2 (IL-2). The standard 4-hour natural killer (NK) test against K562 targets was negative in all patients. In patients deficient in type 1 (n = 21), type 2 (n = 5), and type 4 (n = 8) HLH, negative NK function could be reconstituted by mitogen, by IL-2, or by prolongation of the incubation time (16 hours), respectively. Most patients (n = 31) displayed the type 3 defect, defined by a lack of any cellular cytotoxicity independent of assay variations. The characteristic hypercytokinemia also concerned counterregulatory cytokines, such as proinflammatory interferon-gamma (IFN-gamma), simultaneously elevated with suppressive IL-10 in 38% of types 1-, 2-, and 4-deficient patients and in 71% of type 3-deficient patients. Elevated IFN-gamma alone correlated with high liver enzymes, but sCD95-ligand and sCD25 did not-though these markers were expected to indicate the extent of histiocytic organ infiltration. Outcome analysis revealed more deaths in patients with type 3 deficiency (P =.017). Molecular defects were associated with homozygously mutated perforin only in 4 patients, but other type 3 patients expressed normal transcripts of effector molecules for target-cell apoptosis, including perforin and granzyme family members, as demonstrated by RNase protection analysis. Thus, target-cell recognition or differentiation defects are likely to explain this severe phenotype in HLH. Hyperactive phagocytes combined with NK defects may imply defects on the level of the antigen-presenting cell.

Different acute-phase response in newborns and infants undergoing surgery.

In a prospective clinical study, we investigated the inflammatory response in 88 neonatal subjects (43 boys and 45 girls) who underwent major abdominal surgery owing to congenital malformation involving the gastrointestinal tract and compared it with the response in 20 infants (8 boys, 12 girls; mean age, 4 mo) who underwent elective surgery for resolution of an existing temporary stoma. In both groups, plasma levels of endotoxin, IL-6, and C-reactive protein as well as leukocyte counts were determined during and after surgery. Endotoxin was measured by the Limulus amebocyte test, IL-6 by ELISA, and C-reactive protein by nephelometry. Statistical analyses were performed using the Wilcoxon signed-rank test. A significant increase in circulating endotoxin and a leukocyte shift was observed in the infant group only. Postoperatively, IL-6 levels peaked between 2 and 6 h and C-reactive protein after 24 h in the infant group. In contrast, no significant increase in the levels of endotoxin, IL-6, and C-reactive protein in plasma were observed during and after surgery in the neonatal subjects, except those with gastroschisis. Newborns with gastroschisis developed an inflammatory response after surgery that was less pronounced than the response of infants older than 4 mo. The finding that endotoxemia in newborns does not follow surgical trauma is most likely because of the absence of bacterial colonization of the gastrointestinal tract.

Multicenter evaluation of a new immunoassay for procalcitonin measurement on the Kryptor System.

We compared the manually performed LUMItest procalcitonin (PCT) assay with the newly developed fully mechanized Kryptor PCT assay and determined the essential assay characteristics of this assay. The new Kryptor PCT assay was evaluated according to modified NCCLS EP-10/EP-6 protocols in five different laboratories. Samples from 696 patients were assayed using the original LUMItest PCT assay and the new Kryptor PCT assay. Possible interference by hemoglobin, triglycerides and bilirubin was evaluated by spiking patient plasma with the appropriate substances. The functional assay sensitivity (FAS) was determined by analyzing samples with low PCT concentrations. The FAS of the new Kryptor PCT assay was 0.04 ng/ml and the imprecision within- and between-series below 5% and below 10%, respectively. Within the smallest range of determination, from 0.3 ng/ml to 50 ng/ml, common to the LUMItest PCT assay (x) and the Kryptor PCT assay (y) the values correlated well: y=0.64+0.94x, s.xy=2.78 ng/ml. The performance characteristics of the Kryptor PCT assay are fully compatible with the intended clinical use. The assay allows determination of PCT in a turnaround time (TAT) of about 20 minutes and thus is adequate for STAT analyses.