Diagnostic Approach In Patients Research Articles

Evaluating the Atrial Myopathy Underlying Atrial Fibrillation: Identifying the Arrhythmogenic and Thrombogenic Substrate.

Atrial disease or myopathy forms the substrate for atrial fibrillation (AF) and underlies the potential for atrial thrombus formation and subsequent stroke. Current diagnostic approaches in patients with AF focus on identifying clinical predictors with the evaluation of left atrial size by echocardiography serving as the sole measure specifically evaluating the atrium. Although the atrial substrate underlying AF is likely developing for years before the onset of AF, there is no current evaluation to identify the preclinical atrial myopathy. Atrial fibrosis is 1 component of the atrial substrate that has garnered recent attention based on newer MRI techniques that have been applied to visualize atrial fibrosis in humans with prognostic implications regarding the success of treatment. Advanced ECG signal processing, echocardiographic techniques, and MRI imaging of fibrosis and flow provide up-to-date approaches to evaluate the atrial myopathy underlying AF. Although thromboembolic risk is currently defined by clinical scores, their predictive value is mediocre. Evaluation of stasis via imaging and biomarkers associated with thrombogenesis may provide enhanced approaches to assess risk for stroke in patients with AF. Better delineation of the atrial myopathy that serves as the substrate for AF and thromboembolic complications might improve treatment outcomes. Furthermore, better delineation of the pathophysiologic mechanisms underlying the development of the atrial substrate for AF, particularly in its earlier stages, could help identify blood and imaging biomarkers that could be useful to assess risk for developing new-onset AF and suggest specific pathways that could be targeted for prevention.

Hypersensitivity to Aspirin and other NSAIDs: Diagnostic Approach in Patients with Chronic Rhinosinusitis.

Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) associated with chronic rhinosinusitis (CRS) and/or asthma comprises a distinct clinical syndrome referred to as NSAIDs exacerbated respiratory disease (NERD). Patients with NERD tend to have more severe course of both upper (CRS and nasal polyps) and lower airway (asthma) diseases and are usually recalcitrant to conventional treatment modalities. Diagnosing and phenotyping of patients with NERD are critical for prevention of drug-induced adverse reactions and open novel options for management of underlying chronic airway inflammatory diseases. Diagnosis of NERD is based on detailed clinical history confirmed by challenge with aspirin, but new diagnostic approaches are currently being developed. This review article focuses on the diagnostic approach to a patient with CRS and hypersensitivity to NSAIDs, emphasizing the importance of diagnosis for proper patient’s management.

Mosaico del cromosoma X en diferentes tejidos de pacientes con falla ovárica prematura

BackgroundPremature ovarian failure (POF) is the cessation of ovarian function accompanied by oestrogen deficiency and follicle-stimulating hormone (FSH) levels ≥40 IU/ml before the age of 40. Chromosomal abnormalities, mainly involving the X chromosome, are the most common genetic cause, with a prevalence of up to 15%. The presence of X chromosome mosaicism is associated with the onset of the disease. ObjectiveTo determine the presence of mosaicism in different tissue samples from patients with POF compared to a control group. Materials and methodsSamples of oral mucosa, peripheral blood and urine were collected from 6 patients diagnosed with POF who presented a normal karyotype, as well as from 6 age-matched controls, between May and November 2014. We analysed 3,000 nuclei from each patient and their respective control (1,000 nuclei from each tissue), thus obtaining a total of 6,000 nuclei per pair of case and control subjects. These nuclei were used to determine the percentage of X chromosome mosaicism using the fluorescent in-situ hybridisation (FISH) technique. ResultsIn the study group, FISH analysis of interphase nuclei from the 3 tissues analysed showed a cell line with monosomy X in 0.94% (0.3-2%) and a cell line with trisomy X in 0.52% (0-3.4%) of the total 18,000 cells analysed. Cells with 45,X were more frequent in the urothelium. In the control group, FISH analysis showed a cell line corresponding to monosomy X in 0.32% (0-0.7%) and to trisomy X in 0.4% (0%-3.4%) of cases. DiscussionA statistically significant difference (p <0.05) between the percentages of mosaicism for X chromosome monosomy was found between patients and their matched controls. Likewise, there was a statistically significant difference between the percentage of mosaicism found in urothelial cells and in cells from peripheral blood and oral mucosa. ConclusionThe presence of low-grade mosaicism can be a cause of POF. This study indicates that more than 1 tissue type is necessary to identify low-grade mosaicism. The study of urothelial cells should be included in the diagnostic approach of patients with POF.

Reliability of dynamic sentinel node biopsy combined with ultrasound-guided removal of sonographically suspicious lymph nodes as a diagnostic approach in patients with penile cancer with palpable inguinal lymph nodes

Introduction and objectivesDynamic sentinel node biopsy (DSNB) is considered “unsuitable” in patients with penile cancer and palpable inguinal lymph nodes. The aim of this study was to determine the diagnostic reliability of DSNB combined with ultrasound (US)-guided removal of additional suspicious lymph nodes as a minimally invasive diagnostic approach in these patients. Material and methodsA total of 23 consecutive patients with penile cancer and unilaterally or bilaterally palpable inguinal lymph nodes underwent DSNB according to the 2-day protocol. Before the combined staging procedure, the patients underwent preoperative US of both groins. During surgery, sentinel nodes and additional suspicious lymph nodes as determined by the US examination were removed under US guidance. A complete inguinal lymph node dissection was only performed in patients who had tumor-positive nodes. Follow-up consisted of control visits according to the European Association of Urology guidelines, including US investigation of the groins. ResultsThe primary tumors were staged as T1, T2, and T3 carcinomas in 12, 8, and 3 patients, respectively. Grading was good, moderate, and poor in 2, 16, and 4 cases, respectively. Tumor grading could not be determined in 1 patient who underwent surgery of the invasive part of the primary tumor elsewhere. Sentinel nodes or nonsentinel nodes or both were positive in 15 of 36 palpatory-positive groins. DSNB alone showed lymphatic spread in 10 inguinal regions. US-guided removal of suspicious nonsentinel nodes revealed 5 further inguinal basins with metastases, which would have been missed by DSNB owing to rerouting or complete blockage of the lymphotropic tracer. So far, no lymph node relapse has been observed in the 12 patients with node-negative disease by this combined diagnostic approach with a median follow-up of 42 (16–84) months. The morbidity (postoperative bleeding and prolonged lymphorrhea) associated with this procedure was minor (6%). ConclusionsThe results of this study imply that DSNB combined with US-guided removal of suspicious lymph nodes is a reliable diagnostic approach in patients with penile cancer with palpable inguinal lymph nodes. DSNB alone in these patients leads to a significant false-negative rate. These early and promising results have to be confirmed in larger cohort studies.

Protocolo diagnóstico del paciente con debilidad muscular de predominio distal

In the diagnostic approach of patients with distal muscle weakness we must consider conditions at different levels of motor nervous system, the most characteristics those affecting the peripheral nerves and motor neuron (the latter in its earliest phases). Less commonly find that some diseases of the muscle itself may present with this presentation, being the most characteristic of this group predominantly proximal weakness. A detailed medical history and a neurological allow accurate assessment locate the level of injury and thus direct the additional studies needed to confirm the diagnosis.

708 Reliability of dynamic sentinel node biopsy (DSNB) combined with high-resolution ultrasound (US) as a diagnostic approach in patients with palpable inguinal lymph nodes in penile cancer

708 Reliability of dynamic sentinel node biopsy (DSNB) combined with high-resolution ultrasound (US) as a diagnostic approach in patients with palpable inguinal lymph nodes in penile cancer

Diagnosis and staging of pancreatic cancer

Pancreatic cancer is one of the most lethal cancers, and continues to be a major health problem in the twenty-first century. Early-stage disease is usually clinically silent, or manifests with non-specific symptoms that often go unrecognised; therefore, diagnosis is invariably dependent on imaging methods. Although transabdominal ultrasound imaging (TAUS) is frequently the first-line diagnostic approach for patients presenting with jaundice and/or upper abdominal pain, computerized tomography (CT) is the most commonly used imaging method for the diagnosis and staging of pancreatic cancer. The more sensitive multiphase, multidetector helical CT constitutes the method of choice. In addition, magnetic resonance imaging (MRI) can also detect primary pancreatic tumours as well as regional and distant metastases, and, in recent years, positron emission tomography (PET) – stand-alone or in combination with CT – has been established as a useful adjunct. Recently, endoscopic ultrasonography (EUS) has gained popularity as a promising staging modality, and it currently has a complementary role to CT for the evaluation of patients with pancreatic cancer. Nevertheless, despite recent technologic advancements in the diagnostic approach to pancreatic cancer and the refinement of the clinical staging algorithm, early diagnosis remains challenging and a substantial improvement in patient outcomes has not yet been observed.

Chest pain out-of-hours - an interview study of primary care physicians' diagnostic approach, tolerance of risk and attitudes to hospital admission.

BackgroundAcute chest pain constitutes a considerable diagnostic challenge outside hospitals. This will often lead to uncertainty in choosing the right management, and the physicians’ approach may be influenced by their knowledge of diagnostic measures and their tolerance of risk. The aim of this study was to investigate primary care physicians’ diagnostic approach, tolerance of risk and attitudes to hospital admission in patients with acute chest pain out-of-hours in Norwegian primary care.MethodsData were registered prospectively from four Norwegian casualty clinics. Data from structured telephone interviews with 100 physicians shortly after a consultation with a patient presenting at the casualty clinic with “chest pain” were analysed. Tolerance of risk was measured by the Pearson Risk Scale and the Tolerance of Risk Scale, the latter developed for this study.Results“Patient history and symptoms” was considered the most important, and “negative ECG” and “effect of sublingual nitroglycerine” the least important aspects in the diagnostic approach. There were no significant differences in length of experience or gender when testing “risk avoiders” against the rest. Almost all physicians felt that their risk assessment out-of-hours was reasonably good, and felt reasonably safe, but only 50% agreed with the statement “I don’t worry about my decisions after I’ve made them”. Concerning chest pain patients only, 51% of the physicians were worried about complaints being made about them, 75% agreed that admitting someone to hospital put patients in danger of being “over-tested”, and 51% were more likely to admit the patient if the patient herself wanted to be admitted.ConclusionsPhysicians working out-of-hours showed considerable differences in their diagnostic approach, and not all physicians diagnose patients with chest pain according to current guidelines and evidence. Continuous medical education must focus on the diagnostic approach in patients with chest pain in primary care and empowerment of physicians through training and emphasis on risk assessment and “tolerance of risk”.

GW25-e3200 Tracheal obstruction mimicking Asthma attack

To investigate the diagnostic approach of patients presenting with obstructing lung disease symptoms but are unresponsive to standard therapy. we describe a case of a 22 year old male who presented with symptoms of asthma which were unresolved by prescribed treatment, further investigations

Diagnosing headache in primary care: a qualitative study of GPs' approaches.

Headache is one of the most common symptoms in primary care. Most headaches are due to primary headaches and many headache sufferers do not receive a specific diagnosis. There is still a gap in research on how GPs diagnose and treat patients with headache. To identify GPs' diagnostic approaches in patients presenting with headache. Qualitative study with 15 GPs in urban and rural practices. Interviews (20-40 minutes) were conducted using a semi-structured interview guideline. GPs described their individual diagnostic strategies by means of patients presenting with headache that they had prospectively identified during the previous 4 weeks. Interviews were taped and transcribed verbatim. Qualitative analysis was conducted by two independent raters. Regarding GPs' general diagnostic approach to patients with headache, four broad themes emerged during the interviews: 'knowing the patient and their background', 'first impression during consultation', 'intuition and personal experience' and 'application of the test of time'. Four further themes were identified regarding the management of diagnostic uncertainty: 'identification of red flags', 'use of the familiarity heuristic', 'therapeutic trial', and 'triggers for patient referral'. GPs apply different strategies in the early diagnostic phase when managing patients with headache. Identification of potential adverse outcomes accompanied by other strategies for handling uncertainty seem to be more important than an exact diagnosis. Established guidelines do not play a role in the diagnostic workup.

Whipple`s disease - clinical spectrum and diagnostic approach (with a contribution of eight cases)

PURPOSE : Whipple’s disease (WD) is a rare systemic infection caused by the bacterium Tropheryma whipplei. Since the clinical features of the disease are non-specific, diagnosis still remains a challenge. The aim of the study is to analyse the clinical presentation and diagnostic approach in patients with WD. MATERIAL AND METHODS : Eight patients, six females and two males at an average age of 59 years (range, 46-79 years) were diagnosed with WD from January, 2012 to May, 2013 in the Clinic of Hepatogastroenterology, St. Marina University Hospital of Varna. Laboratory tests, endoscopic, radiologic, ultrasound and histomorphological examinations were performed. RESULTS : The main symptoms are abdominal pain, chronic diarrhoea and meteorism. Only one female patient presents with clinical signs of malabsorbtion, such as weight loss, anasarca, ascites, pleural effusions and anaemia. There are no extraintestinal manifestations. Tests for Chlamydia trachomatis, tuberculosis and Clostridium difficile are negative. Stool examination does not show any parasitic or bacterial infection. Coeliac disease (CD) serological tests are negative, except in one female with co-existing gluten enteropathy since childhood onwards, where Crohn colitis is diagnosed, too. Endoscopy demonstrates mild to moderate atrophy of the intestinal mucosa. Histological examination establishes mild villous atrophy, lymphoplasmatic infiltration and lymph vessel dilation. All the biopsies show PAS-positive inclusions in the macrophages. Doxycycline therapy exerts a favourable effect on the clinical symptoms in all the patients. CONCLUSION : Whipple’s disease (WD) is a rare systemic disease that is commonly late or falsely diagnosed. The prognosis of non-treated patients is poor. The disease should be considered in any patients with prolonged gastrointestinal symptoms such as unexplained abdominal pain, diarrhoea and features of malabsorption syndrome. The appropriate antibiotic treatment achieves remission and improves the patient's quality of life. Keywords: Whipple disease, diagnosis, histology, malabsorption, treatment

Preoperative Diagnostic Approach in Patients with Medically Refractory Epilepsy

Preoperative Diagnostic Approach in Patients with Medically Refractory Epilepsy

The coming of age of the megakaryocyte‐platelet

The coming of age of the megakaryocyte‐platelet

Diagnostic approach of myocarditis: strike the golden mean

Myocarditis is a challenging diagnosis due to the extreme diversity of clinical manifestations. The actual incidence of myocarditis is also difficult to determine as endomyocardial biopsy (EMB), the diagnostic gold standard, is used infrequently. Nevertheless, in up to 30 % of patients with biopsy-proven myocarditis, progression to dilated cardiomyopathy (DCM) can occur and is associated with a poor prognosis. Recent position statements of the European Society of Cardiology (ESC) and the American Heart Association vary widely with regard to indications for performing an EMB in these patients. This makes decision-making, in particular for general practitioners (GPs) and regional hospitals, difficult and unclear. Therefore, we will present a short summary of the ESC Working Group on Myocardial and Pericardial Diseases statement and our suggestions for GPs and regional hospitals for the diagnostic approach in patients with suspected myocarditis.

Metabolic myopathies.

The metabolic myopathies result from inborn errors of metabolism affecting intracellular energy production due to defects in glycogen, lipid, adenine nucleotides, and mitochondrial metabolism. This article provides an overview of the most common metabolic myopathies. Our knowledge of metabolic myopathies has expanded rapidly in recent years, providing us with major advances in the detection of genetic and biochemical defects. New and improved diagnostic tools are now available for some of these disorders, and targeted therapies for specific biochemical deficits have been developed (ie, enzyme replacement therapy for acid maltase deficiency). The diagnostic approach for patients with suspected metabolic myopathy should start with the recognition of a static or dynamic pattern (fixed versus exercise-induced weakness). Individual presentations vary according to age of onset and the severity of each particular biochemical dysfunction. Additional clinical clues include the presence of multisystem disease, family history, and laboratory characteristics. Appropriate investigations, timely treatment, and genetic counseling are discussed for the most common conditions.

D-dimer testing for suspected venous thromboembolism in the emergency department. Consensus document of AcEMC, CISMEL, SIBioC, and SIMeL

D-dimer testing is currently considered a cornerstone in the diagnostic approach of patients with suspected venous thromboembolism (VTE) across different health-care settings, including the emergency department (ED). Nevertheless, inappropriate or incorrect activities developing throughout the total testing process may substantially impair the clinical usefulness of this test and delay or even challenge the fast rule out or diagnosis of VTE. The leading problem of D-dimer is represented by the poor specificity for diagnosing VTE, wherein a minority of patients with a positive D-dimer are finally diagnosed with VTE, and even more importantly, the specificity further decreases with ageing, thus contributing to increase the overcrowding in short stay units such as the ED. Due to the large heterogeneity that characterizes the use of D-dimer in the emergency room, three Italian societies of laboratory medicine (Italian Committee for Standardization of Hematology and Laboratory Methods, Italian Society of Clinical Biochemistry and Molecular Biology, and Italian Society of Laboratory Medicine), along with the Academy of Emergency Medicine and Care, have developed a consensus document about the use of D-dimer testing for diagnostics of patients with suspected VTE in this health-care setting. The evidence-based indications contained in this document will cover the leading preanalytical, analytical, and postanalytical issues that may impair the clinical efficacy of D-dimer testing in the ED.

Microbiological screening for earlier detection of central venous catheter-related bloodstream infections

Catheter-related bloodstream infections (CRBSIs) are currently detected with a reactive diagnostic policy, that is, application of tests to patients with clinically suspected CRBSI. The aim of our study was to evaluate whether CRBSIs could be anticipated in an earlier stage by microbiological screening using peptide nucleic acid fluorescence in situ hybridization (PNA FISH) with universal hybridization probes or acridine-orange leucocyte cytospin (AOLC) tests in haemodialysis and haematological patients with CVCs in situ compared with routine test. Peptide nucleic acid fluorescence in situ hybridization (PNA FISH) and AOLC tests using blood samples from both CVC lines in patients undergoing haemodialysis were performed three times a week and from one CVC line in haematological patients were performed daily. Results were compared with those obtained from routinely performed CRBSI diagnostic tests. One hundred fifteen patients with 139 catheter periods were investigated. The mean observation time per catheter period was 25 days (IQR 13.5-43.5), resulting in 5615 CVC days with a total of 4839 tested blood samples. Five CRBSI cases were detected by routine measures resulting in a CRBSI rate of 0.9/1000 catheter days. Four of five CRBSIs could be anticipated by positive PNA FISH and AOLC tests 2-8 days before the diagnosis was established with routine measures. The proactive anticipative strategy using microscopic examination of CVC blood samples to anticipate CRBSI in an earlier stage compared with routine measures is a new diagnostic approach in patients with CVCs and a high risk of developing CRBSI.

Acute Abdomen After Abdominoplasty: Differential Diagnosis

Abdominoplasty is a very common elective procedure in plastic surgery. Surgical accidents can lead to serious complications that result in an acute surgical abdomen, but in rare cases, an acute surgical abdomen not related to the procedure develops. This report discusses the diagnostic approach for patients with an acute abdomen after abdominoplasty and presents a case of appendicitis in the immediate postoperative period. The importance of postoperative follow-up evaluation by the same surgeon who performed the procedure is discussed as well as the need for adequate general surgery training to obtain the correct diagnosis and perform the urgent operation required to avoid a detrimental outcome. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

How to approach and follow adrenal incidentaloma?

See Article on Page 557-564 Adrenal incidentaloma is defined as a previously unsuspected mass ≥ 1 cm in diameter, discovered incidentally during an imaging investigation for a nonadrenal disorder. It is frequently diagnosed, and its prevalence is 1% to 5% in different studies [1]. Advanced imaging techniques and the increased quality of medical services have resulted in more examinations using computed tomography (CT) or magnetic resonance imaging (MRI). Common causes of adrenal incidentaloma may be different according to the ethnicity of the study population. Most studies have shown that a nonfunctioning adenoma is the most frequent cause (60% to 85%) followed by subclinical Cushing syndrome, pheochromocytoma, and adrenal carcinoma; then there are other benign tumors, such as myelolipoma and metastasis, which are rare [2-4]. No consensus exists on the optimal diagnostic approach to adrenal incidentaloma. A report from the National Institutes of Health at a science conference and a review from an experienced clinician both recommended a hormonal evaluation. The diagnostic approach in patients with adrenal incidentalomas should focus on two main questions: 1) whether the lesion is malignant; and 2) whether it is hormonally active [5,6]. A low dose (1 mg) dexamethasone suppression test, providing sensitivity of 98.1% and specificity of 80.5% to 98.9%, is the mainstay biochemical screening test for detecting subclinical Cushing syndrome. A normal result is defined as a cortisol value 20 needs to be further evaluated for aldosterone hypersecretion. A radiological evaluation including noncontrast CT attenuation values expressed in Hounsfield units (HU) is the best tool for distinguishing between benign and malignant adrenal masses. All adrenal tumors with suspicious radiological features, most functional tumors, and all tumors > 4 cm in size that lack characteristic benign imaging features should be removed. All patients should undergo a hormonal evaluation for subclinical Cushing syndrome and pheochromocytoma, and those with hypertension should also be evaluated for primary hyperaldosteronism. One report demonstrated that the cumulative risk of developing endocrine abnormalities is 17% at 1 year, 29% at 2 years, and 47% at 5 years. The risk was high in the first 2 years of follow-up for an initial tumor diameter > 3 cm. The cumulative risk of mass enlargement was 6% at 1 year, 14% at 2 years, and 29% at 5 years, and it was greater in patients with normal adrenal function than in those with subtle hormonal abnormalities [1]. Limited data are available on the possible increase in adrenal mass size and hormonal pattern changes over time according to race or ethnicity. Only one prospective study has been reported in Korean patients with adrenal incidentaloma. Kim et al. [4] observed 24 patients with nonfunctioning adrenal incidentaloma for 3 to 72 months. Among them, two patients had increased tumor size of > 1 cm, and one patient developed Cushing syndrome at 10 to 26 months after the initial diagnosis. In this issue of The Korean Journal of Internal Medicine, Cho et al. [7] observed the clinical characteristics and the 2-year follow-up findings of patients with adrenal incidentaloma. In that study, 282 patients with adrenal incidentaloma were observed. Among them, 86.2% had a nonfunctioning mass, and 13.8% had a functioning mass; 9.9% were subclinical Cushing syndrome; 2.1% pheochromocytoma; and 1.8% primary aldosteronism. During the 22.5 months of follow-up of patients with nonfunctioning tumors, 4.2% developed functioning masses, pheochromocytoma, or subclinical Cushing syndrome. According to the recent experts' opinion, in most patients with an adrenal incidentaloma, particularly if the tumor is > 3 cm in size, annual biochemical follow-up for up to 5 years may be reasonable. Patients with adrenal masses 10 HU should have a repeat CT study in 3 to 6 months and then yearly for 2 years. Adrenal tumors with indeterminate radiological features that grow at least 0.8 cm over 3 to 12 months should be considered for surgical resection [3,8]. In summary, adrenal incidentaloma is a common clinical problem, and the diagnostic challenge is to distinguish the majority of benign lesions from other masses, as either malignant or hormone secreting, which require further treatment. An imaging evaluation (CT and MRI) is the key tool to distinguish malignant from benign lesions. All patients should be tested for hypercortisolism and pheochromocytoma, whereas hypertensive patients should only be tested for aldosteronism. Adrenalectomy should be considered for patients with adenoma with or without subclinical hypercortisolism during follow-up with clinical signs of hormone excess or clinical worsening despite optimal medical treatment. Even though there is no standardized international guidelines for the follow-up of endocrine and imaging tests, most experts recommend that hormonal observations should be performed annually for up to 4 to 5 years, an imaging evaluation at 3 to 6 months, and then annually for 1 to 2 years [9,10].

Analytical performance of the new ACL AcuStar HemosIL D-Dimer

Several lines of clinical evidence as well as guidelines and recommendations suggest that the overall diagnostic performance of D-dimer testing outstrips that of any other biomarker in the diagnostic approach of patients with venous thromboembolism or disseminated intravascular coagulation. Along with specific technical characteristics, the analytical performance of each D-dimer immunoassay should, however, be assessed before implementation in clinical practice. The aim of this study was to evaluate the analytical performance of HemosIL AcuStar D-Dimer immunoassay, a novel chemiluminescent immunoassay specifically designed for the instrument Instrumentation Laboratory ACL AcuStar. The within and between-run imprecision (n = 20) was comprised between 3.6 and 5.8%. The linearity was excellent up to 16 200 ng/ml (r = 1.00; P < 0.001), and optimal between 224 and 69 900 ng/ml (r = 0.992; P < 0.001). A significant agreement of values was observed between HemosIL AcuStar D-Dimer and HemosIL D-Dimer HS for ACL TOP (r = 0.884; P < 0.001), as well as with Vidas D-Dimer (r = 0.791; P < 0.001). Results of HemosIL AcuStar D-Dimer displayed a modest negative bias as compared with those of Vidas D-dimer (mean bias -22%; 95% Confidence Interval, -122% to 49%). The analytical accuracy assessed against Vidas D-dimer also yielded an area under the curve of 0.998 (P < 0.001). As regards, the preliminary definition of cutoff value, optimal sensitivity (100%) and specificity (96%) were found at a diagnostic threshold of 466 ng/ml. The results of this investigation attest that the novel HemosIL AcuStar D-Dimer is characterized by remarkable accuracy and precision, optimal linearity and excellent agreement with the reference immunoassay. As such, its technical and analytical performance would make it a suitable method for the rapid and accurate quantification of D-dimer in clinical laboratories.