A national surveillance program for evaluating new reagent lots in medical laboratories.

OBJECTIVES: Differences between laboratory results attributable to the use of different reagent lots can potentially affect the diagnosis and monitoring of patients. To minimize patient risks, all laboratories should verify that new reagent lots meet agreed analytical performance specifications (APS). We propose a simplified, pragmatic approach for laboratories that involves compilating results into a national surveillance program, and present the first results obtained when applying this approach to troponins, glycated hemoglobin (HbA1c), prostate-specific antigen (PSA) and D-dimer. METHODS: In the surveillance program we have (i) determined APS for selected analytes, (ii) implemented a simplified procedure for lot evaluation with patient samples used in laboratories across Norway and (iii) performed central processing of the results from the participating laboratories. RESULTS: Over a one-year period, 27 Norwegian laboratories returned results from 28 lot changes for troponin I, 11 for troponin T, and 29 for HbA1c, PSA and D-dimer. The mean difference between two reagent lots was 4.5% for troponin I (for a concentration interval of 20-32 ng/L), 5.1% for troponin T (10.7-17.5 ng/L), 2.2% for HbA1c (40-50 mmol/mol), 3.7% for PSA (3-5 µg/L) and 5.5% for D-dimer (0.4-1.0 mg/L FEU). CONCLUSIONS: A novel procedure for reagent lot evaluation is proposed in which information about multiple lot changes from different medical laboratories can be accumulated nationally. Sharing this information allows simplification of lot evaluations in individual laboratories and provides real-world data about lot-to-lot variations.

The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument.

Regular measurement of prothrombin time as an international normalized ratio PT (INR) is mandatory for optimal and safe use of warfarin. Scandinavian evaluation of laboratory equipment for primary health care (SKUP) evaluated the microINR portable coagulometer (microINR®) (iLine Microsystems S.L., Spain) for measurement of PT (INR). Analytical quality and user-friendliness were evaluated under optimal conditions at an accredited hospital laboratory and at two primary health care centres (PHCCs). Patients were recruited at the outpatient clinic of the Laboratory of Medical Biochemistry, St Olav's University Hospital, Trondheim, Norway (n = 98) and from two PHCCs (n = 88). Venous blood samples were analyzed under optimal conditions on the STA-R®Evolution with STA-SPA + reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR®. The imprecision of the microINR® was 6% (90% CI: 5.3-7.0%) and 6.3% (90% CI: 5.1-8.3) in the outpatient clinic and PHCC2, respectively for INR ≥2.5. The microINR® did not meet the SKUP quality requirement for imprecision ≤5.0%. For INR <2.5 at PHCC2 and at both levels in PHCC1, CV% was ≤5.0. The accuracy fulfilled the SKUP quality goal in both outpatient clinic and PHCCs. User-friendliness of the operation manual was rated as intermediate, defined by SKUP as neutral ratings assessed as neither good nor bad. Operation facilities was rated unsatisfactory, and time factors satisfactory. In conclusion, quality requirements for imprecision were not met. The SKUP criteria for accuracy was fulfilled both at the hospital and at the PHCCs. The user-friendliness was rated intermediate.

Blood removal therapy in hereditary hemochromatosis induces a stress response resulting in improved genome integrity.

BACKGROUND: Hereditary hemochromatosis (HH) is a common disease of iron metabolism, manifesting with iron overload and affecting up to 1% of individuals of northern European descent. Untreated HH can result in irreversible damage of the liver and pancreas, potentially leading to cancer and diabetes. Therapy consists of normalizing iron stores by repeated blood donations (phlebotomy). Treated HH patients have normal survival rates and report less tiredness after phlebotomy; however, it is not understood why musculoskeletal symptoms may persist in spite of iron removal. We hypothesize that phlebotomy therapy does not simply reverse iron accumulation but has additional effects at the subcellular level. In particular, the systemic impact of phlebotomy on mitochondria and genome integrity is largely unknown. STUDY DESIGN AND METHODS: The effects of phlebotomy therapy on mitochondrial iron proteins and genome integrity were investigated in peripheral blood mononuclear blood cells from HH patients. RESULTS: After the reduction of systemic iron load in these patients with phlebotomy, we observed increased expression of mitochondrial superoxide dismutase, reduced iron sulfur assembly protein (Iscu1/2), and improved genome integrity. CONCLUSION: We conclude that phlebotomy therapy in HH does not merely restore systemic iron homeostasis, but induces an "oxidative stress" defense response that manifests as improved genome integrity. These findings provide novel insights into an ancient therapy.

The clinical value of routine whole-body magnetic resonance imaging (MRI) in palliative care.

BACKGROUND: Whole-body MRI (WBMRI) has become an accessible method for detecting different types of pathologies both in the skeleton and the viscera, which may explain painful conditions, for example tumors and inflammation. PURPOSE: To assess a possible value of using WBMRI in order to improve palliative care. MATERIAL AND METHODS: Twenty patients (all eligible patients) admitted to the Department for Palliative Care were consecutively included in this study. They underwent a modified WBMRI, with fewer and shorter pulse sequences than in a standard WBMRI, to reduce patient stress. However, the patients' physicians were to exclude patients where little might be obtained and discomfort, distress, and pain could be induced. The treating physicians registered clinical utility directly after receiving the MRI report in a questionnaire. The registration was repeated after ended treatment. RESULTS: Eighty percent had new findings detected, and 40% of the patients had a change in treatment due to the MRI result, mainly changes in analgesics and/or radiation therapy. CONCLUSION: The WBMRI helped the clinicians to improve treatment and a majority of the patients benefited from this. In eight patients the treatment was changed due to the results. The clinical value (utility) was indicated to be high.

Micronutrients in paediatric Intestinal Failure Patients receiving home parenteral nutrition.

BACKGROUND & AIMS: Children with intestinal failure (IF) receive parental nutrition to ensure adequate growth and development. The aim of this study was to assess micronutrient status in paediatric IF patients receiving home parenteral nutrition (HPN) in comparison to a group of healthy children. METHODS: An observational cross-sectional study was performed at Oslo University Hospital and at the Department of Nutrition, University of Oslo from January to September 2017. All children with IF, aged two to 18 years, were invited to participate. A reference group of healthy children was recruited through social media advertisement. Dietary intake was assessed by a four-day food record, and enteral and parenteral provision was recorded. Blood samples were analysed for vitamins, minerals and haematology to assess iron status. Two spot urine samples from each subject were analysed for iodine concentration (UIC) and creatinine. RESULTS: Nineteen children with IF and 50 healthy children were included. The mean age of the participants was 10.0 years. IF-patients received a median of 76% of their estimated energy requirements from parenteral nutrition (PN). Recommended intake (RI) for iodine from the diet was reached by 16% of IF patients and 28% of healthy children. In the IF group there was a significant positive correlation between UIC and the percentage of iodine intake from oral diet and enteral nutrition support (r = 0.57, p = 0.03). Although the IF patients had a median parenteral iodine supply of more than twice the ESPGHAN recommendation, the median UIC was 89 µg/L indicating insufficient iodine status. This may suggest that the ESPGHAN recommendation for iodine in paediatric parenteral nutrition is too low. The healthy children had sufficient iodine status according to the median UIC (133 µg/L). IF patients had significantly lower total provision of iron compared to the healthy children, 4,9 vs 8,4 mg/day (p = 0.01) with 21% of IF patients and 28% of healthy children reaching RI for iron. The prevalence of anaemia was higher in IF patients than in the healthy children (40 vs.10%, p = 0.016). CONCLUSION: The study indicates an insufficient iodine and iron status among paediatric IF patients. Iodine status was associated with enteral provision and patients had insufficient status even if they received the ESPGHAN recommendation of iodine. TRIAL IDENTIFICATION NUMBER: Clinical Trials AEV2017/1. 2016/391/REK sør-øst B.