Unilabs AB

Stockholm, Sweden

Unilabs AB

Stockholm, Sweden
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Wallis M.G.,University of Cambridge | Moa E.,Philips | Leifland K.,Unilabs AB | Danielsson M.,KTH Royal Institute of Technology
Radiology | Year: 2012

Purpose: To compare the diagnostic accuracy of two-dimensional (2D) full-field digital mammography with that of two-view (mediolateral and craniocaudal) and single-view (mediolateral oblique) tomosynthesis in an observer study involving two institutions. Materials and Methods: Ethical committee approval was obtained. All participating women gave informed consent. Two hundred twenty women (mean age, 56.3; range, 40-80 years) with breast density of 2-4 according to American College of Radiology criteria were recruited between November 2008 and September 2009 and underwent standard treatment plus tomosynthesis with a prototype photon-counting machine. After exclusion criteria were met, this resulted in a final test set of 130 women. Ten accredited readers classified the 130 cases (40 cancers, 24 benign lesions, and 66 normal images) using 2D mammography and two-view tomosynthesis. Another 10 readers reviewed the same cases using 2D mammography but single-view tomosynthesis. The multireader, multicase receiver operating characteristic (ROC) method was applied. The significance of the observed difference in accuracy between 2D mammography and tomosynthesis was calculated. Results: For diagnostic accuracy, 2D mammography performed significantly worse than two-view tomosynthesis (average area under ROC curve [AUC] = 0.772 for 2D, AUC = 0.851 for tomosynthesis, P = .021). Significant differences were found for both masses and microcalcification (P = .037 and .049). The difference in AUC between the two modalities of -0.110 was significant (P = .03) only for the five readers with the least experience (<10 years of reading); with AUC of -0.047 for the five readers with 10 years or more experience (P = .25). No significant difference (P = .79) in reader performance was seen when 2D mammography (average AUC = 0.774) was compared with single-view tomosynthesis (average AUC = 0.775). Conclusion: Two-view tomosynthesis outperforms 2D mammography but only for readers with the least experience. The benefits were seen for both masses and microcalcification. No differences in classification accuracy was seen between and 2D mammography and single-view tomosynthesis. © RSNA, 2012.


PubMed | Karolinska Institutet, Public Health Agency of Sweden, Sodermanland County, Stockholm South General Hospital and 2 more.
Type: | Journal: Infection ecology & epidemiology | Year: 2016

Hepatitis C virus (HCV) is a major public health concern and data on its molecular epidemiology in Sweden is scarce. We carried out an 8-year population-based study of newly diagnosed HCV cases in one of Swedens centrally situated counties, Sdermanland (D-county). The aim was to characterize the HCV strains circulating, analyze their genetic relatedness to detect networks, and in combination with demographic data learn more about transmission.Molecular analyses of serum samples from 91% (N=557) of all newly notified cases in D-county, 2002-2009, were performed. Phylogenetic analysis (NS5B gene, 300 bp) was linked to demographic data from the national surveillance database, SmiNet, to characterize D-county transmission clusters. The linear-by-linear association test (LBL) was used to analyze trends over time.The most prevalent subtypes were 1a (38%) and 3a (34%). Subtype 1a was most prevalent among cases transmitted via sexual contact, via contaminated blood, or blood products, while subtype 3a was most prevalent among people who inject drugs (PWIDs). Phylogenetic analysis revealed that the subtype 3a sequences formed more and larger transmission clusters (50% of the sequences clustered), while the 1a sequences formed smaller clusters (19% of the sequences clustered), possibly suggesting different epidemics.We found different transmission patterns in D-county which may, from a public health perspective, have implications for how to control virus infections by targeted interventions.


Wiksell H.,Karolinska University Hospital | Schassburger K.-U.,Karolinska University Hospital | Janicijevic M.,Unilabs AB | Leifland K.,Unilabs AB | And 5 more authors.
British Journal of Cancer | Year: 2010

Background: A side effect of diagnostic needle biopsies is the possibility to disseminate tumour cells into the needle track, which may cause concern in certain malignant tumour types. Methods: In order to prevent tumour cell dissemination we developed a technology that uses radiofrequency (RF) pulses to sterilise the needle track and denaturate tumour cells. To determine feasibility, we applied this technology to fine needle aspiration biopsy (FNAB) and used breast cancer as a model tumour. Routine FNAB was performed in 88 patients with adenocarcinoma and blood droplets passing the skin orifice were cytomorphologically analysed for the presence of tumour cells. Results : The analysis showed the presence of tumour cells in 65/88 cases (74%). When using an experimental anti-seeding device in a subset of patients viable tumour cells were found in 0/31 cases (P< 0.001). In all 31 patients blood passing the skin orifice was sparse. No degrading effect on the cytological sample inside the needle was detected and pain caused by the RF pulses was comparable to that of the biopsy procedure itself. Conclusion : The herein presented method has the potential to prevent the dissemination of viable tumour cells in the needle track and minimize bleeding without additional pain or degradation of the aspirate. © 2010 Cancer Research UK.


Bergman A.,Unilabs AB | Heimer D.,Unilabs AB | Kondori N.,Sahlgrenska University Hospital | Enroth H.,Unilabs AB
Clinical Microbiology and Infection | Year: 2013

The aim of this study was to develop and validate a rapid and sensitive real-time PCR method for detection of all known species of dermatophytes, including identification of Trichophyton rubrum and Trichophyton interdigitale. Fungal DNA was extracted directly from clinical samples by using a pre-lysis step, followed by automated DNA extraction on the MagNA Pure Compact. In total, 202 clinical samples were examined by both conventional culture and by the new PCR method. In 103 (51%) of the samples fungal nucleic acid was detected by PCR, while only 79 (39%) were found to be positive by culture. Out of 103 PCR-positive clinical samples, 94 (91%) were identified as T. rubrum and eight (8%) as T. interdigitale. This real-time PCR is far more sensitive and 2-4 weeks faster than conventional culture for detection of dermatophytes present in clinical samples. © 2013 The Authors. Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.


Schassburger K.-U.,Karolinska University Hospital | Lofgren L.,Capio S t Gorans Hospital | Lagerstedt U.,Unilabs AB | Leifland K.,Unilabs AB | And 4 more authors.
Breast | Year: 2014

The objective of this study was to assess efficacy and safety of percutaneous ultrasound (US) guided preferential radiofrequency ablation (PRFA) in early breast carcinoma under local anesthesia and to evaluate a new assessment protocol. Eighteen breast cancer patients were enrolled in order to receive PRFA treatment three weeks prior to resection. Pain assessment was performed using the visual analoge scale. Analysis of treatment success was performed using magnetic resonance imaging (MRI) as well as histological assays for hematoxylin & eosin (H&E) and cytokeratine 8 (CK8). In a subset of patients contrast enhanced ultrasound (CEUS) was performed before and after treatment. MRI showed no residual tumor growth in 100% (18/18) of cases. Complete tumor devitalization was indicated in 83% (15/18) of patients as judged by H&E staining and in 89% (16/18) as judged by immunostaining for CK8. In 100% (18/18) at least one histologic method showed devitalization in the entire tumor. Treatment was well tolerated. Pain experienced during the procedure was mild. US-guided PRFA of small breast carcinoma is feasible under local anesthesia. MRI and CK8 have proven valuable additions to the RF breast tumor ablation protocol. CEUS shows potential as a modality for radiological follow-up. © 2013 The Authors.


Li J.,Karolinska Institutet | Li J.,Genome Institute of Singapore | Szekely L.,Karolinska Institutet | Eriksson L.,Karolinska Institutet | And 5 more authors.
Breast Cancer Research | Year: 2012

Introduction: Mammographic density (MD) is a strong, independent risk factor for breast cancer, but measuring MD is time consuming and reader dependent. Objective MD measurement in a high-throughput fashion would enable its wider use as a biomarker for breast cancer. We use a public domain image-processing software for the fully automated analysis of MD and penalized regression to construct a measure that mimics a well-established semiautomated measure (Cumulus). We also describe measures that incorporate additional features of mammographic images for improving the risk associations of MD and breast cancer risk.Methods: We randomly partitioned our dataset into a training set for model building (733 cases, 748 controls) and a test set for model assessment (765 cases, 747 controls). The Pearson product-moment correlation coefficient (r) was used to compare the MD measurements by Cumulus and our automated measure, which mimics Cumulus. The likelihood ratio test was used to validate the performance of logistic regression models for breast cancer risk, which included our measure capturing additional information in mammographic images.Results: We observed a high correlation between the Cumulus measure and our measure mimicking Cumulus (r = 0.884; 95% CI, 0.872 to 0.894) in an external test set. Adding a variable, which includes extra information to percentage density, significantly improved the fit of the logistic regression model of breast cancer risk (P = 0.0002).Conclusions: Our results demonstrate the potential to facilitate the integration of mammographic density measurements into large-scale research studies and subsequently into clinical practice. © 2012 Li et al.; licensee BioMed Central Ltd.


Grant
Agency: European Commission | Branch: H2020 | Program: IA | Phase: ICT-28-2015 | Award Amount: 4.80M | Year: 2016

Sepsis is a potentially fatal condition that arises when the bodys response to an infection damages its own tissues and organs. It is mainly caused by bacteria and fungi, which spread through the blood circulation. It is one of the biggest public health issue in the EU and worldwide due to its high incidence, mortality, human and economic cost. Early diagnosis is crucial to the management of sepsis, as every hour of delay of appropriate antibiotic therapy increases mortality by 5-10%. Unfortunately, sepsis diagnosis remains one of the greatest clinical challenges in critical care. Current diagnostic methods, including blood culture and different nucleic acid based multiplex technologies, are impaired by the significant time-delay of 1-2 days and/or low sensitivity of 30-50%. Hence there is an urgent need to develop new diagnostic tools that can provide more accurate and earlier sepsis diagnosis, so that patients with sepsis can be administered with rapid and correct initial antimicrobial treatment. The SMARTDIAGNOS project will advance sepsis diagnosis by simplifying clinical sample analysis methods and integrating the currently required numerous steps into a single streamlined device. This will be achieved by combining a number of innovative technologies: 1) 3-dimentional sample concentration to process large amount of raw sample; 2) direct PCR in the 3D microstructure to circumvent DNA extraction step; 3) solid-phase PCR to achieve unlimited multiplexing capability; 4) supercritical angle fluorescence (SAF) microlens array for enhanced fluorescence detection and precise quantification of sepsis-related pathogens. The SMARTDIAGNOS system will go beyond the state of the art for shorter time (1-3 h), higher sensitivity (95%), higher selectivity (99%), multiplexing capability, antimicrobial resistance profiling, and automation. Fast and correct sepsis diagnosis will improve patient outcome, shorten intensive care stay and thus reduce health costs.


Ljungstrom L.,Skaraborg Hospital | Enroth H.,Unilabs AB | Claesson B.E.B.,Unilabs AB | Ovemyr I.,University of Skövde | And 7 more authors.
BMC Infectious Diseases | Year: 2015

Background: Sepsis is a serious medical condition requiring timely administered, appropriate antibiotic therapy. Blood culture is regarded as the gold standard for aetiological diagnosis of sepsis, but it suffers from low sensitivity and long turnaround time. Thus, nucleic acid amplification tests (NAATs) have emerged to shorten the time to identification of causative microbes. The aim of the present study was to evaluate the clinical utility in everyday practice in the emergency department of two commercial NAATs in patients suspected with sepsis. Methods: During a six-week period, blood samples were collected consecutively from all adult patients admitted to the general emergency department for suspicion of a community-onset sepsis and treated with intravenous antibiotics. Along with conventional blood cultures, multiplex PCR (Magicplex™) was performed on whole blood specimens whereas portions from blood culture bottles were used for analysis by microarray-based assay (Prove-it™). The aetiological significance of identified organisms was determined by two infectious disease physicians based on clinical presentation and expected pathogenicity. Results: Among 382 episodes of suspected sepsis, clinically relevant microbes were detected by blood culture in 42 episodes (11%), by multiplex PCR in 37 episodes (9.7%), and by microarray in 32 episodes (8.4%). Although moderate agreement with blood culture (kappa 0.50), the multiplex PCR added diagnostic value by timely detection of 15 clinically relevant findings in blood culture-negative specimens. Results of the microarray corresponded very well to those of blood culture (kappa 0.90), but were available just marginally prior to blood culture results. Conclusions: The use of NAATs on whole blood specimens in adjunct to current culture-based methods provides a clinical add-on value by allowing for detection of organisms missed by blood culture. However, the aetiological significance of findings detected by NAATs should be interpreted with caution as the high analytical sensitivity may add findings that do not necessarily corroborate with the clinical diagnosis. © Ljungström et al.; licensee BioMed Central.


Emanuelsson F.,Skaraborgs Hospital Skovde | Claesson B.E.B.,Unilabs AB | Ljungstrom L.,Skaraborgs Hospital Skovde | Tvede M.,Copenhagen University | Ung K.-A.,Skaraborgs Hospital Skovde
Scandinavian Journal of Infectious Diseases | Year: 2014

Background: Recurrent Clostridium difficile infection (CDI) is a significant problem due to its increased incidence and severity. Failure rates for standard antibiotic therapies are high. In our hospital, faecal microbiota transplantation (FMT), or instillation of a culture mixture of known enteric bacteria in saline as rectal bacteriotherapy (RBT), has long been used as 'rescue therapy' in patients with recurrent disease, in whom repeated courses of standard antibiotic treatment have failed. We wanted to evaluate the effectiveness of FMT and RBT for recurrent CDI. Methods: The records of 31 patients treated with either FMT or RBT for recurrent CDI were reviewed retrospectively. FMT was based on faecal donation by a close relative and RBT on a defined saline mixture of 10 individually cultured enteric bacterial strains originally isolated from healthy persons. Both types of instillation were carried out through a rectal catheter. FMT (500 ml) was given as 1 installation. RBT (200 ml) was given as 2 or 3 installations with an interval of 2 days between courses. Treatment success was defined as a sustained loss of symptoms and discontinuation of diarrhoea within 3 days. Results: Of 31 patients, 23 (74%) responded successfully to the treatment: 16 of 23 (70%) receiving FMT and 7 of 8 (88%) receiving RBT. Conclusion: We found FMT to be effective in patients with recurrent CDI. RBT based on a predefined bacterial suspension was as effective as or better than FMT based on faecal donation; however, multiple installations may be needed. © 2014 Informa Healthcare.


Linde A.,Swedish Institute for Communicable Disease Control | Ternhag A.,Swedish Institute for Communicable Disease Control | Torner A.,Swedish Institute for Communicable Disease Control | Claesson B.E.,Unilabs AB
Eurosurveillance | Year: 2012

Swedish laboratories reported an increase of Mycoplasma pneumoniae during the autumn 2011. Data from the laboratory in Skövde, covering 12.9% of the Swedish population, indicate an approximate increase in the number of laboratory-confirmed cases in the whole country, from around 3,500 in 2009 to 11,100 in 2011. Antibiotics are recommended only for pneumonia, not bronchitis, but compared with the autumn 2009, 42,652 more prescriptions of doxycycline and macrolides were registered in the autumn 2011.

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