Results Of Standard Laboratory Tests Research Articles

S02.2 Overview of Rapid/Point of Care Diagnostic Tests For HIV and Current Challenges Associated with HIV Testing

Advances in rapid/point of care testing (RPOCT) for HIV have transformed global capacity to reach individuals who might not otherwise have been tested for HIV, particularly in non-traditional health care...

Juvenile Bullous Pemphigoid – a Case Report

Abstract Bullous pemphigoid is an autoimmune blistering disease that predominantly affects elderly persons and rarely children. We present a 12-year-old girl with sudden appearance of tense blisters on an erythematous base on the trunk, neck, hands and legs with intense pruritus. Standard laboratory test results were within the normal range except for blood eosinophilia of 12% of the total white cell count. Skin biopsy specimens showed evolving subepidermal blisters with perivascular lymphohistiocytic, eosinophil and neutrophil infiltrations in the papillary dermis. Direct immunofluorescence of perilesional skin showed linear, continuous deposits of IgG and C3 along the dermoepidermal junction. Indirect immunofluorescence showed circulating anti-basement membrane zone IgG autoantibodies at a titer of 1:80. We started treatment with systemic corticosteroids, methylprednisolone 0,5 mg/kg per day and 500 mg erythromycin 4 times a day during 10 days. After 3 days 50 mg dapsone (DDS, 4,4-diaminodiphenylsulphone) per day was added. After a few days, there were no new changes on the skin and pruritus disappeared completely.

Feasibility of Using Rotational Thromboelastometry to Assess Coagulation Status of Combat Casualties in a Deployed Setting

Coagulopathy in trauma patients is currently defined by the results of standard laboratory tests (prothrombin time and activated partial thromboplastin time). These results offer little in the hemostatic resuscitation that occurs in the treatment of battlefield patients who receive massive transfusions. Thromboelastometry (TEM) is a technique that can offer rapid, near-patient testing of coagulation status. A prospective observational field study was performed in a deployed military setting to determine the feasibility of using TEM to assess the coagulation status of patients admitted to the emergency department and who subsequently received a massive transfusion. TEM was performed on 31 patients, 25 were direct admissions to the emergency department, 19 of whom were enrolled into the massive transfusion protocol, and 60% were involved in a blast incident. Standard laboratory testing showed that 10% of all patients were coagulopathic on admission compared with 64% with an abnormal TEM trace (p = 0.0005). All patients had abnormal maximum clot firmness. The TEM amplitude at 10 minutes is associated with the subsequent development of abnormal maximum clot firmness. Two exemplar cases are discussed, which illustrate the potential benefit of using TEM to monitor and guide and individualize therapy during a massive transfusion. It is feasible to use TEM in a deployed military setting. We have shown that rotational thromboelastometry significantly detects more abnormalities in the coagulation status than the standard laboratory tests (prothrombin time, and activated partial thromboplastin time).

Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry

To establish whether reagent-supported thrombelastometry with the rotation thrombelastometry system (ROTEM) point-of-care device correlated with fibrinogen level in postpartum haemorrhages. Prospective observational study. Ninety-one women at the third trimester of pregnancy: 37 with postpartum haemorrhage (study group) and 54 without abnormal bleeding (control group). Standard laboratory test results were compared with those obtained at bedside from the ROTEM with the FIBTEM test (54 tests in the control group and 51 in the study group). Analysis of correlations between fibrinogen levels and FIBTEM test results: clotting time (CT), clot amplitude at 5 and 15 minutes (CA5; CA15) and maximal amplitude [maximum clot firmness (MCF)]. Median fibrinogen level was significantly lower in the haemorrhage group than in the control group (3.4 and 5.1 g/l, respectively, P < 0.0001). Median CT was higher in the haemorrhage group than in the control group (P = 0.05). CA5, CA15 and MCF were significantly lower in the haemorrhage group than in controls (P < 0.0001) and strongly correlated with fibrinogen levels in both groups (r = 0.84-0.87, P < 0.0001). A cut-off value of CA5 at 5 mm and CA15 at 6 mm presented an excellent sensitivity (100% for both parameters) and a good specificity (respectively 85 and 88%) to detect fibrinogen levels <1.5 g/l in postpartum haemorrhage. Conclusions The early parameters obtained from the FIBTEM test correlated well with fibrinogen levels. ROTEM might be helpful in guiding fibrinogen transfusion during postpartum haemorrhage.

Ecological models in support of regulatory risk assessments of pesticides: developing a strategy for the future

This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used routinely in regulatory submissions? What actions are needed to overcome the identified obstacles? What recommendations should be made to ensure good modeling practice in this context? The workshop focused exclusively on population models, and discussion was focused on those categories of population models that link effects on individuals (e.g., survival, growth, reproduction, behavior) to effects on population dynamics. The workshop participants concluded that the overall benefits of ecological modeling are that it could bring more ecology into ecological risk assessment, and it could provide an excellent tool for exploring the importance of, and interactions among, ecological complexities. However, there are a number of challenges that need to be overcome before such models will receive wide acceptance for pesticide risk assessment, despite having been used extensively in other contexts (e.g., conservation biology). The need for guidance on Good Modeling Practice (on model development, analysis, interpretation, evaluation, documentation, and communication), as well as the need for case studies that can be used to explore the added value of ecological models for risk assessment, were identified as top priorities. Assessing recovery potential of exposed nontarget species and clarifying the ecological relevance of standard laboratory test results are two areas for which ecological modeling may be able to provide considerable benefits.

Progressive Ataxia and Palatal Tremor

ANOTHERWISE HEALTHY middle-aged woman was experiencing gait instability.Neurological examination revealed truncal ataxia. Family history was negative. Brain and spinal cord 1.5-T magnetic resonance imaging (MRI) was performed and yielded normal results. Thyroid hormone, vitamin B12, and folic acid levels were normal. During the next 4 years, her walking difficulties progressed. She also developed palatal tremor. Repeated brain MRI revealed T2 hyperintensities in both olivary nuclei. Therefore, she was referred to our institution for further evaluation. On admission, the patient had severe palatal tremor (a video is available at http://www.archneurol .com) with Romberg and walking instability. She had no signs of pyramidal or sensory involvement and cognitive examination results were normal. Magnetic resonance imaging (3-T) was performed and revealed atrophy of the vermis and both cerebellar hemispheres and bilateral symmetrical hyperintensity of olivary nuclei (Figure). Brain singlephoton emission computed tomographic r esults w ere n ormal. Results of standard laboratory tests (sedimentation rate, complete blood count, serum glucose, electrolytes, liver enzymes, urea, creatinine, creatine kinase, lactate dehydrogenase, and C-reactive protein) were within normal limits. Serum and urine copper and ceruloplasmin levels were also normal. Results of genetic analysis for spinocerebellar ataxias 1, 2, 3, and 6; fragile X–associated tremor; ataxia syndrome; and Huntington disease were negative. Cerebrospinal fluid analysis revealed 1 lymphocyte and a slightly elevated protein level (0.062 g/dL [to convert to grams per liter, multiply by 10.0]) with negative oligoclonal bands. COMMENT Palatal tremors can be divided into essential palatal tremor, which is associated with normal brain MRI findings, and secondary palatal tremor, which is associated with structural lesions of the brainstem or cerebellum. 1 A distinct degenerative disease called progressive ataxia with palatal tremor has recently been described as an idiopathic or familial form of palatal tremor. 2 Characteristic MRI findings of the disease consist of bilateral hypertrophy of inferior olivary nuclei and mild cerebellar atrophy. Fludeoxyglucose F18 positron emission tomography shows hypometabolism in the red nucleus, external globus pallidus, and precuneus. Iodine I 123– radiolabeled 2-carbomethoxy-3(4-iodophenyl)-N-(3-fluoropropyl) nortropane single-photon emission computed tomography shows mild and progressive loss of striatal dopaminergic terminals, implicating dopaminergic dysfunction. 3 A very similar familial progressive ataxia with palatal tremor, spinocerebellar ataxia type 20, has been described with calcification of dentate nuclei. 4 Our patient did not have any structural lesions of the brainstem or cerebellum, and there was no calcification of the dentate nucleus. Her clinical presentation together with the 3-T MRI findings were consistent with a diagnosis of idiopathic progressive ataxia with palatal tremor.

Pneumatosis coli due to pharmacological constipation

A 56-year-old woman was being treated with tramadol (up to 300 mg/day) for joint pain. After 20 days of treatment, tramadol was discontinued because of intense constipation followed by severe lower abdominal pain, diarrhea, and tenesmus. On admission to the hospital, symptoms persisted; results of standard laboratory tests were unremarkable. A CT scan of the abdomen and pelvis showed a myriad of gas-filled cysts in the wall of the rectum, sigmoid, and descending colon (A, middle). Colonoscopy revealed these lesions to be 5 to 20 mm, subepithelial cyst-like lesions protruding into the lumen; the overlying mucosa was normal (B). CT and colonoscopic findings were confirmed by EUS (C). Histopathologic analysis showed a submucosal dissection by gas-filled spaces (D, H&E, orig. mag. x40). Pneumatosis coli due to pharmacological constipation was diagnosed. Antibiotics and high-flow oxygen therapy were followed-up by rapid symptomatic and radiological improvement (A, upper-left corner).

Study on safety and bioavailability of ubiquinol (Kaneka QH ™) after single and 4-week multiple oral administration to healthy volunteers

The safety and bioavailability of ubiquinol (the reduced form of coenzyme Q 10), a naturally occurring lipid-soluble nutrient, were evaluated for the first time in single-blind, placebo-controlled studies with healthy subjects after administration of a single oral dose of 150 or 300 mg and after oral administration of 90, 150, or 300 mg for 4 weeks. No clinically relevant changes in results of standard laboratory tests, physical examination, vital signs, or ECG induced by ubiquinol were observed in any dosage groups. The C max and AUC 0–48 h derived from the mean plasma ubiquinol concentration-time curves increased non-linearly with dose from 1.88 to 3.19 μg/ml and from 74.61 to 91.76 μg h/ml, respectively, after single administration. Trough concentrations had nearly plateaued at levels of 2.61 μg/ml for 90 mg, 3.66 μg/ml for 150 mg, and 6.53 μg/ml for 300 mg at day 14, and increased non-linearly with dose in the 4-week study. In conclusion, following single or multiple-doses of ubiquinol in healthy volunteers, significant absorption of ubiquinol from the gastrointestinal tract was observed, and no safety concerns were noted on standard laboratory tests for safety or on assessment of adverse events for doses of up to 300 mg for up to 2 weeks after treatment completion.

A spinal foreign body

2122 www.thelancet.com Vol 366 December 17/24/31, 2005 A 61-year-old man presented with thoracic back pain and cough. Despite receiving a blow to the back in a fight 3 weeks earlier, his general condition at admission was good. He had an axillary temperature of 37·4oC, and when examined closely, we saw a wound of about 2 cm over the dorsal thoracic midline. Standard laboratory test results were normal. Chest radiographs showed a foreign body projecting from the ascending aorta (figure, A). A CT scan showed a knife blade 12 cm long at the sixth thoracic vertebra (figure, B). The blade extended from the subcutaneous adipose tissue to the middle of the spinal canal and the vertebral body adjacent to the aorta. A neurological examination did not show any sensory or motor problems. The blade was removed surgically under general anaesthetic. As a complication of the procedure, the patient became paraplegic. A spinal foreign body

Predicting cirrhosis in patients with hepatitis C based on standard laboratory tests

Knowledge of the presence of cirrhosis is important for the management of patients with chronic hepatitis C (CHC). Most models for predicting cirrhosis were derived from small numbers of patients and included subjective variables or laboratory tests that are not readily available. The aim of this study was to develop a predictive model of cirrhosis in patients with CHC based on standard laboratory tests. Data from 1,141 CHC patients including 429 with cirrhosis were analyzed. All biopsies were read by a panel of pathologists (blinded to clinical features), and fibrosis stage was determined by consensus. The cohort was divided into a training set (n = 783) and a validation set (n = 358). Variables that were significantly different between patients with and without cirrhosis in univariate analysis were entered into logistic regression models, and the performance of each model was compared. The area under the receiver-operating characteristic curve of the final model comprising platelet count, AST/ALT ratio, and INR in the training and validation sets was 0.78 and 0.81, respectively. A cutoff of less than 0.2 to exclude cirrhosis would misclassify only 7.8% of patients with cirrhosis, while a cutoff of greater than 0.5 to confirm cirrhosis would misclassify 14.8% of patients without cirrhosis. The model performed equally well in fragmented and nonfragmented biopsies and in biopsies of varying lengths. Use of this model might obviate the requirement for a liver biopsy in 50% of patients with CHC. In conclusion, a model based on standard laboratory test results can be used to predict histological cirrhosis with a high degree of accuracy in 50% of patients with CHC.

Gastric xanthomatosis

A 37-year-old woman presented with abdominal pain of several days' duration. Except for a uterine dilation and curettage 3 months earlier, there was no other medical history. Examination disclosed mild generalized abdominal tenderness. The Hb was 9.4 g/dL (normal: 12-16 g/dL), otherwise, the results of standard laboratory tests were within normal ranges. Plain x-ray films of the abdomen, as well as abdominopelvic US, were unremarkable. The initial impression was pelvic inflammatory disease, and the symptoms improved with conservative management. Because of the anemia, EGD was performed and revealed numerous white to yellowish, flat or polypoid mucosal lesions of variable size scattered throughout the stomach (A). Some of them had hematins around the lesions (B). Barium contrast radiography also demonstrated multiple nodular filling defects throughout the stomach (C). On histopathologic evaluation of endoscopically obtained biopsy specimens, numerous foamy histiocytes, separating the gastric glands were noted (D; H&E, orig. mag. ×200). Lipid levels, including total cholesterol and triglycerides, were normal. The patient was asymptomatic at discharge and is undergoing further evaluation for the anemia.

Primary Lymphoma of the Liver: Report of a Case

We describe herein a female patient with non-Hodgkin's lymphoma of the liver and present a review of the related literature. The patient was referred with the diagnosis of malignant hemangiopericytoma (with an open biopsy). The physical examination, standard laboratory test results and tumor marker levels were all normal. A nonstandard left lobectomy was performed. Histopathological and immunohistochemical examinations revealed non-Hodgkin's lymphoma of B-cell type. The findings of a peripheral blood smear and bone marrow biopsy were normal. There was no other site of involvement based on physical or radiological examinations. These findings established the diagnosis of primary hepatic lymphoma. Fewer than 100 cases have been reported in the world literature. The best treatment results have been obtained by a resection followed by chemotherapy when feasible.

Fulfillment of Diagnostic Criteria in Kawasaki Disease

The diagnosis of Kawasaki disease (KD) is made by fulfillment of clinical criteria. The dramatic effectiveness of intravenous immune globulin in this disease might lead to treatment of cases that do not meet those criteria. A retrospective review was conducted of all cases of KD treated at Kosair Children's Hospital between January 1993 and July 1997. Fifty-six patients were identified. Demographic features were similar to reports from other regions of the country. Forty-eight children fulfilled criteria for typical or atypical KD and 8 (14%) did not. The latter children were not distinguished from those meeting criteria by standard laboratory test results. Echocardiographic abnormalities were found in 17 cases, including 3 with coronary artery aneurysms, but all abnormalities eventually resolved. The treatment of 14% of patients despite incomplete diagnostic criteria illustrates the tendency to be liberal in treatment decisions regarding KD. Whether this proportion of patients has a forme fruste of the illness that warrants treatment will await definitive biological markers for the syndrome.

Fulfillment of Diagnostic Criteria in Kawasaki Disease

The diagnosis of Kawasaki disease (KD) is made by fulfillment of clinical criteria. The dramatic effectiveness of intravenous immune globulin in this disease might lead to treatment of cases that do not meet those criteria.A retrospective review was conducted of all cases of KD treated at Kosair Children's Hospital between January 1993 and July 1997.Fifty-six patients were identified. Demographic features were similar to reports from other regions of the country. Forty-eight children fulfilled criteria for typical or atypical KD and 8 (14%) did not. The latter children were not distinguished from those meeting criteria by standard laboratory test results. Echocardiographic abnormalities were found in 17 cases, including 3 with coronary artery aneurysms, but all abnormalities eventually resolved.The treatment of 14% of patients despite incomplete diagnostic criteria illustrates the tendency to be liberal in treatment decisions regarding KD. Whether this proportion of patients has a forme fruste of the illness that warrants treatment will await definitive biological markers for the syndrome.

Proventil HFA and Ventolin Have Similar Safety Profiles During Regular Use

As a secondary objective to a long-term study evaluating the bronchodilator effectiveness of Proventil HFA (albuterol), to assess the safety of Proventil HFA, Ventolin, and hydrofluoroalkane 134a (HFA-134a) placebo over 12 weeks of regular dosing. Randomized, double-blind, double-dummy parallel group, placebo-controlled, multicenter trial of asthmatics requiring inhaled beta-adrenergic bronchodilators for symptom control. Treatment with Proventil HFA, Ventolin, or HFA-134a placebo, qid, for 12 weeks. Adverse events were reviewed at biweekly clinic visits. Between clinic visits, patients recorded morning and evening peak expiratory flow (PEF), asthma symptom and nighttime asthma sleep disturbance scores, and use of rescue beta-adrenergic bronchodilator on diary cards daily. Investigators provided a global assessment of asthma control at weeks 0, 4, 8, and 12. Vital signs were recorded over 6 h after dosing with study drug at weeks 0, 4, 8, and 12. Standard laboratory tests, CBC count, serum chemistries, and urinalysis were obtained at study start and end. Adverse event reporting rates were similar for the three treatment groups. The morning PEF tended to be lower for the Proventil HFA and Ventolin groups than the HFA-134a placebo group, but the evening PEF tended to be higher for the active treatment groups. Daytime asthma symptom scores tended to be lower (better) with active treatment than placebo, but nighttime asthma sleep disturbance scores were similar for all three treatment groups. Use of Ventolin Rotacaps as rescue medication was significantly greater for the HFA-134a placebo group than the Proventil HFA and Ventolin groups. Diary card data did not change within groups over time. Investigator global assessments of asthma scores clustered between fair and good for all three treatment groups throughout the study. Changes in heart rate and BP were small after dosing with study drug and tended to be similar for the active treatments and HFA-134a placebo groups. No clinically meaningful changes in results of standard laboratory tests were found in any treatment group during this study. Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics. Regular use of either Proventil HFA or Ventolin did not cause asthma control to deteriorate.

Safety of Long-term Large Doses of Aspartame

Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a randomized, double-blind, placebo-controlled, parallel-group design in 108 male and female volunteers aged 18 to 62 years. Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks. No persistent changes over time were noted in either group in vital signs; body weight; results of standard laboratory tests; fasting blood levels of aspartame's constituent amino acids (aspartic acid and phenylalanine), other amino acids, and methanol; or blood formate levels and 24-hour urinary excretion of formate. There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject. These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day.

Model for predicting the performance of TLP piles in clays : Whittle, A J; Baligh, M M; Azzouz, A S; Malek, A M Proc BOSS '88, Trondheim, June 1988V1, P97–112. Publ Trondheim: Tapir, 1988

The critical loading conditions for friction piles supporting tension leg platforms (TLP) occur during a storm when large cyclic shear stresses take place at the pile-soil interface. In clayey deposits, the mode of shearing imposed on soil elements adjacent to the pile shaft can be equated to that of undrained Direct Simple Shearing (DSS). This paper outlines a new, rate independent, effective stress soil model, MIT-E3, which can be used to describe the mechanical behaviour of clays for cyclic loading conditions. The model is formulated from simple concepts of the behaviour of clays in unloading and reloading, and is characterised using the results of standard laboratory tests. Model evaluation is achieved by comparing predictions with laboratory data for a low plasticity clay including an extensive series of undrained cyclic DSS tests. It is shown that the model provides high quality predictions of the main features of cyclic clay behaviour. Predictions also show that the behaviour of soil elements adjacent to the TLP pile shaft during storm loading are comparable to those of undisturbed normally to lightly overconsolidated clay measured in a laboratory DSS test.

Diagnosis of Wilson's Disease Presenting as Fulminant Hepatic Failure

The clinical course, results of standard laboratory tests, parameters of copper metabolism, and hepatic morphology in 9 cases (3 of our own and 6 from the literature) of Wilson's disease presenting as fulminant hepatic failure were compared with the findings in 5 cases of idiopathic fulminant hepatic failure. Patients with Wilson's disease were usually younger, and 7 of the 9 patients had Kayser-Fleischer rings. Patients with idiopathic fulminant hepatic failure had elevated 24-h urinary copper, decreased ceruloplasmin, and low or normal serum copper. Fulminant hepatic failure with Wilson's disease differed from idiopathic fulminant hepatic failure by the following biochemical findings: (a) higher copper levels in serum, urine and liver; (b) less pronounced elevations of transaminase levels; (c) higher concentrations of total bilirubin; and (d) lower hemoglobin values. Serum copper was the most useful biochemical test in diagnosing Wilson's disease before death. At autopsy, only hepatic copper concentrations clearly separated the two groups. Serial serum copper levels (antemortem) and quantitative analysis of hepatic copper (after recovery or postmortem) in patients with fulminant hepatic failure should help to exclude Wilson's disease.

Rubella in Pregnancy: A Guide to Rational Counseling

In an article elsewhere in this issue (p 1647), Mann and colleagues have made an important addition to our ability to analyze and advise on the risk of congenital rubella after a possible exposure of a pregnant woman to an illnesswith rash. In one sense they are helping to ease the congestion of the national telephone lines, as many physicians in this dilemma call their favorite rubella experts (often at medical schools or at the Centers for Disease Control) for some help in estimating the probabilities of an adverse outcome. The method Mann et al have chosen is the preparation of three algorithms that speak to commonly encountered situations. The three algorithms deal with three periods between exposure to illness -with rash and the time of assessment—within one week, one to five weeks, and greater than five weeks—and the interpretation of the available standard laboratory test results. They also

Human conjunctivitis. I. Diagnostic evaluation.

One hundred forty-three patients (207 eyes) with conjunctivitis or blepharoconjunctivitis were studied. Attempts were made to establish an etiologic diagnosis by clinical and laboratory methods. The etiologic diagnosis that was made on the basis of the initial clinical examination correlated poorly with the results of standard laboratory tests. Conversely, the standard laboratory evaluation failed to establish a definitive diagnosis in the majority of cases. These findings suggest that the diagnostic dogmatism prevalent in conjunctivitis is unwarranted. Morphologic signs and routine laboratory tests leave us without a verified etiologic diagnosis in a substantial number of cases.¿