Background: Clinical guidelines for H. pylori screening and post-treatment testing endorse the use of urea breath test (UBT), H. pylori stool antigen test (HpSAT), and biopsy-related tests. Due to protracted wait times at our patient service centers and non-compliance in children and elderly with complications for the UBT, we sought to compare UBT and HpSAT in the city of Calgary, Canada with a population close to 1.4 million people.

Methods: To achieve this, a prospective diagnostic trial was performed comparing UBT to HpSAT in patients presenting with dyspepsia. A total of N=150 patients agreed to undergo UBT (13C-UBT kit, Helikit, Isodiagnostika Inc.) and consented to provide a stool specimen for simultaneous HpSAT testing (Diasorin LIAISON® XL H. pylori SA Monoclonal chemiluminescent immunoassay) in our centralized laboratory.

Results: Our data show that concordant results were obtained in 148/150 (98.7%) patients with a positivity rate of 18%. One of two discrepants (UBT positive/HpSAT negative) resolved after repeat testing. Using UBT as the gold standard, HpSAT had a sensitivity of 96.30% (95% CI; 81.03% to 99.91%) and specificity of 100% (95% CI; 97.05% to 100.00%). A positive predictive value of 100% and negative predictive value of 99.2% (95% CI; 94.73% to 99.88%) was obtained. For patients where drug information was available, 38/130 (29.2%) had received an antibiotic associated with H.pylori in the preceding 12 months, with UBT and HpSAT providing concordant results in 37/38 (97.4%) of these individuals. Of note, 6/130 (4.6%) patients had received a specific combination anti-H.pylori treatment, and all 6/6 (100%) had concordant negative results suggesting successful eradication. A post-implementation economic evaluation of labor and materials associated with testing demonstrates a cost-savings of approximately USD 5.47 per specimen in this locale.

Conclusion: Our study confirms that HpSAT is a viable alternative to UBT for H. pylori screening in our jurisdiction with equivalent test performance and cost-savings. Pre- and post-implementation analysis of test compliance rates, waiting times, and test turn around times will also be presented.

Learning Objectives:

• Gain understanding of H.pylori testing options
• Understand challenges and benefits of utilizing  H.pylori stool antigen testing
• Gain skills to effectively manage key clinician stakeholders

LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

High dose of biotin may cause interference with many routine clinical immunoassays and inaccurate results of some of the tests such as cardiac troponin has serious clinical complications. There is an increasing trend of high dose biotin supplement use in the US population, although the exact prevalence is still unknown. High dose of biotin supplement use may continue to increase due to its health and medical benefits and disrupt the diagnostic industry so some of the tests with serious clinical complications should be resigned to avoid biotin interference. Last but not least, more research is needed to understand the nutritional and therapeutic values of biotin.

Learning Objectives:

• Review mechanisms and factors that determine high dose biotin interference with lab tests
• Describe an increasing trend of high dose biotin use and health and medical benefits
• Explain why the continuing trend of high dose biotin use may be a game changer of the clinical diagnostic industry
• Make a case for why more research is needed to understand nutritional and therapeutic values of biotin

Almost 1.5 million Americans are diagnosed with diabetes every year.  In 2012 alone, close to 10% of the population has diabetes and about a third of these individuals do not even know they have diabetes.

More importantly, diabetes remains the 7th leading cause of death in the United States.  In the US, close to $245 billion is spent on individuals with diabetes.  Rendering patients under good glucose control remains the cornerstone of diabetes management.  However, tailoring treatment to the individual is crucial in achieving these goals.  In this talk, Dr. Ajay Rao will go over the laboratory tools available to clinicians to guide their choice of therapeutics for patients with diabetes.

Learning Objectives:

• Understand the epidemiology of Type 1 and Type 2 Diabetes
• Understand the complexities in distinguishing Type 1 from Type 2 Diabetes in the modern-day clinical setting
• Understand the role of utilizing available biomarkers in order to tailor therapy in diabetes 

Growth hormone (GH) is secreted by anterior pituitary somatotroph cells in a pulsatile manner throughout life. Growth hormone secretion is under control by several hypothalamic peptides (stimulated by growth hormone releasing hormone and gastric ghrelin; suppressed by hypothalamic somatostatin). Growth hormone exerts a wide variety of actions in humans, either directly or indirectly by stimulating the synthesis and secretion of insulin-like growth factor 1 (IGF-1). In turn, IGF-1 acts upon both distant tissues (“endocrine effects”) and local tissues (“paracrine effects”) to mediate several GH actions.  In addition, IGF-1 inhibits GH secretion via a negative feedback loop action exerted upon the hypothalamus and pituitary. 

Both GH and IGF-1 have anabolic effects, while GH alone has prominent lipolytic effects. In addition, GH and IGF-1 have opposing effects on glucose homeostasis. In adults, the diagnosis of GH deficiency generally requires GH stimulation testing. However, serum IGF-1 levels can also be of diagnostic significance in the evaluation of GH deficiency in adults. The diagnosis of GH excess in adults (acromegaly) primarily relies on serum IGF-1 levels and GH suppression testing (oral glucose tolerance test).

In the skeleton, GH and IGF-1 activate both bone formation and bone resorption, culminating in increased bone turnover. In addition to growth-promoting effects in children and adolescents, mediated via effects on epiphyseal growth plates, GH and IGF-1 have an important physiologic role in the adult skeleton. Growth hormone deficiency in adults is associated with decreased bone mineral density and increased fracture risk. Growth hormone excess is associated with increased vertebral fracture risk even though bone mineral density is preserved in these patients in the absence of hypogonadism. Further research is needed in order to fully elucidate the effects of GH deficiency or excess on the adult skeleton and the consequences of therapies aiming at restoring GH physiology in patients with these conditions.

Learning Objectives:

• Discuss the physiology of growth hormone secretion and the diagnosis of growth hormone deficiency or excess in adults.
• Review the consequences of growth hormone deficiency on the adult skeleton.
• Describe the sequelae of growth hormone excess on the adult skeleton.

Practicing Internist and vitamin D researcher Gregory A. Plotnikoff, MD, MTS, FACP, will review how new testing for 1,25-Dihydroxyvitamin D can enhance your clinical practice. Issues to be addressed include identification of patients most likely to benefit, when to test and how to interpret values. Dr. Plotnikoff will also address the latest data on vitamin D production, utilization and breakdown pathways. The program includes opportunities for questions. This presentation will begin on May 17, 2017, 12pm Eastern Time. Please register now.

Learning Objectives:

• Recognize the physiological differences between 25-OH-vitamin D and 1,25 dihydroxyvitamin D including the medical indications for ordering each.
• Identify the clinical scenarios where precise 1,25-dihydroxyvitamin D measurement supports both diagnosis and treatment.
• Understand the value in serial measurement of 1,25-dihydroxyvitamin D status in sarcoidosis.
• Participants will also recognize the emerging literature  which supports the use of 1,25-dihydroxyvitamin D analogues and thus the value in precise measurements to guide therapy.
   

Parathyroid hormone (PTH) is an 84 amino acid that plays a key role in phosphocalcic metabolism. Its measurement is essential to diagnose and treat primary hyperparathyroidism and to evaluate chronic kidney disease-mineral and bone disorders (CKD-MBD).  PTH determination is not an easy task, because of the many similar fragments that circulate in our blood. Among these fragments are a group commonly called (7-84) PTH, which are truncated in the amino-terminal part of the peptide. These fragments are quite low in normal healthy subjects; they accumulate in patients with chronic kidney diseases (CKD) and can be up to 50% of the (1-84) PTH in hemodialyzed patients (HD).

Clinical laboratories are often using “intact” PTH assays.  These assays detect the (1-84) peptide and the (7-84) PTH fragments. Because these fragments are recognized differently by the various assays, the values obtained are often very different between “intact” kits. 3rd generation PTH assays, are specific for the (1-84) PTH and do not cross-react with the (7-84) fragments, resulting in less variability.  Up to now, 3rd generation PTH assays have not demonstrated any clinical benefit over intact PTH assays.  However, PTH standardization can be achieved only with 3rd generation and it will be impossible to standardize assays using the intact PTH kits, because of variable cross-reactivities to fragments.

It is important to carefully select the “normal” subjects to establish reference ranges that allow the proper interpretation of the patient’s PTH results. These “normals” should not have secondary hyperparathyroidism and should have eGFR, 25(OH)D, calcium and phosphorus levels within a normal range. Unfortunately, manufacturers have not judiciously selected their “normals”, leading to falsely elevated PTH reference ranges. Using correctly established PTH reference ranges will assist physicians in correctly classifying HD patients in the appropriate bone turnover category.

Learning objectives: 

• To understand the 2nd and 3rd generation PTH assays and their cross-reactivity to different circulating forms
• To understand the importance of good reference range establishment for PTH
• To understand the importance of PTH standardization
• To get up-to-date information regarding PTH stability 

1,25-dihydroxyvitamin D (1,25[OH]₂D) is the active, hormonal form of vitamin D. It is produced from its precursor (vitamin D) by two hydroxylation steps in the liver and the kidneys. Circulating 1,25(OH)₂D levels are regulated by serum calcium and phosphate concentrations, this is mediated by the calcium-regulating hormones, parathyroid hormone (PTH) and phosphate-regulating hormone, fibroblast growth factor-23 (FGF-23). In the human body, 1,25(OH)₂D has a broad range of actions which include endocrine, autocrine and paracrine properties. Due to its picomolar concentrations and its lipophilic nature, 1,25(OH)₂D is a difficult analyte and represents a challenge to the analytical biochemist with respect to quantification. Until recently, relatively large sample volumes and extensive purification and separation steps were required to quantify 1,25(OH)₂D.

The clinical relevance of circulating 1,25(OH)₂D is underappreciated. Besides the well-known suppression of circulating 1,25(OH)₂D in chronic kidney disease, evidence is accumulating that circulating 1,25(OH)₂D is also reduced in other diseases. In addition, several studies have demonstrated that circulating 1,25(OH)₂D is inversely associated with clinical outcome and may complement or substitute traditional laboratory tests. Nevertheless, in the clinical setting there are still several gaps in the present knowledge on circulating 1,25(OH)₂D. These gaps include incomplete data about the effect of activated vitamin D or the influence of dosing and initial 25OHD level on circulating 1,25(OH)₂D; and the effect of different diseases on circulating 1,25(OH)₂D.

In conclusion, circulating 1,25(OH)₂D is less tightly regulated than assumed and may become a reliable predictor of clinical outcomes in some conditions.   

Learning Objectives:

1. Understand the role several hormones, including 1,25-dihydroxyvitamin D play in calcium and phosphate homeostasis.
2. Understand why active vitamin D therapy should be accompanied by measuring 1,25 dihydroxyvitamin D.
3. List the clinical conditions that would benefit from follow-up measurement for 1,25 dihydroxyvitamin D.

Parathyroid hormone testing is important to monitor the progress of chronic kidney disease (CKD) patients. This presentation will review the basic biochemistry that regulates the calcium, which will explain the importance of PTH and 1,25 dihydroxyvitamin D. After defining the various stages of CKD, the focus will be on monitoring of patients that have progressed toward end stage renal disease (ESRD). It is critical to monitor these patients’ PTH to follow whether therapy is working. The discussion will then turn to advantages of using 1-84 PTH versus intact levels to monitor CKD patients.

Learning Objectives

• Define chronic kidney disease and the various stages. At what point along CKD progression are CKD subjects treated and how do PTH levels impact the attending physicians decision making process.
• Understand Parathyroid Hormone's role in chronic kidney patients. Review the basic biochemistry and break it down to the point that we can understand what a nephrologist looks at in the progression and management of CKD.
• Understand the difference between intact and 1-84 PTH tests. Discuss why measuring 1-84 vs iPTH is clinically significant - less misdiagnosis and less over treatment
  • more stability allows for more forgiving sample handling 
  • ex vivo oxidation does not impact the 1-84 where it is misinterpreted as instability by iPTH

Recent studies have shown vitamin D deficiency to be very common in all age groups. Vitamin D and parathyroid hormone (PTH) are important regulators of the bone and mineral homeostasis. 

This presentation will describe the role of vitamin D and PTH on calcium metabolism and bone health and will also review the metabolism and clinical utility of PTH, 1,25 dihydroxyvitamin D and 25 OH Vitamin D.   The discussion will address how the various laboratory assays are used to diagnose and monitor conditions with abnormal calcium levels.

Learning Objectives

• Understand the clinical background of PTH, 1,25 Dihydroxyvitamin D and 25 OH Vitamin D
• Learn the challenges of testing of PTH and Vitamin D 
• Describe the actions and programs for Standardization of Vitamin D and PTH assays.

Hyper and Hypoparathyroid diseases are often latent conditions with significant morbidity and at times mortality. The symptoms range from the obvious, such as kidney stones, bone fractures, and seizures to the more subtle challenges embodied by weakness, tiredness, fatigue, headaches, depression, lack of concentration or underlying elevated blood pressure.  As Dr. Rao picks up the normality enigma, its importance will be addressed diagnostically as it relates to the nuanced choices made in the course of clinical management.

Learning Objectives

• Explain how Parathyroid Hormone is produced in the body and its role in bone and mineral metabolism
• Define the differences and similarities between Primary and Secondary Hyperparathyroidism
• Recognize the patient types that are in most need of PTH monitoring

Infectious mononucleosis has been recognized as a unique disease for more than 100 years and its cause, Epstein-Barr virus (EBV), was discovered more than 50 years ago.  Yet, there is no licensed vaccine and no clear-cut effective treatment for infections due to EBV. This webinar will explain why. We will cover: the clinical findings and laboratory tests for diagnosing and staging primary EBV infection; the mechanisms EBV uses to induce cancer and autoimmune diseases, especially multiple sclerosis; research approaches to prevention of EBV infection. Essentially all of us acquire EBV during our lifetime. Is it better to get it sooner or later? What do you think?

Learning objectives:

• At the conclusion of this webinar, you should be better able to:
• Evaluate the clinical findings and laboratory tests used to diagnose EBV infection.
• Discuss the probable mechanisms of EBV-spurred cancers and autoimmune disease.
• Assess approaches to prevention of EBV infections.

The prevalence of primary hyperaldosteronism among general and resistant hypertensive populations ranges from 5-20%.  It is considered a secondary form of hypertension caused by inappropriate secretion of aldosterone and activation of the mineralocorticoid receptor.  As such, it is a highly treatable and potentially curable form of hypertension.  This webinar will review the prevalence, pathophysiology, screening and diagnostic studies, and treatment options for patients with primary hyperaldosteronism so that the Practitioner can accurately screen and identify cases.

Learning objectives:

1.  Understand the prevalence, pathophysiology and diagnostic studies for patients with primary hyperaldosteronism.
 
2.  Be able to identify screening and treatment options for patients with primary hyperaldoseronism.
 
 

Serology testing continues to be an indispensable tool for the management of several disease states, especially for the qualitative determination IgG antibodies to Herpes simplex virus Type 1 (HSV-1) or Herpes simplex virus Type 2 (HSV-2) in human serum.
 
Come to this educational seminar to learn about key objectives in HSV-1 or HSV-2 type-specific diagnosis:

• Examine how serology assays may be indicated in certain clinical scenarios: in sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-1 or HSV-2 type-specific infection.
• Discuss the US clinical guidelines regarding why HSV-1 and HSV-2 type-specific screening is not indicated in the general US population as it is for other STDs.
• Describe diagnostic methods for diagnosing HSV-1 or HSV-2 type-specific infection: the differences between virologic and serologic assays and their usefulness in herpes diagnosis.

Clinical Controversies Recently, both national and international authorities have promulgated conflicting statements on vitamin D testing and treatment. What are clinicians and patients to do?

This webinar will address the existing data so that participants can answer these five key clinical questions:

• Who might be at risk for low vitamin D? 
• Can we assess for vitamin D deficiency by physical exam? 
• Is a multivitamin or prenatal vitamin sufficient?
• What are the best means to assure sufficient vitamin D levels?
• What research questions still need to be answered?
• Sufficient time will be available for a live question and answer period for all real-time participants.

Learning Objectives:

1) Understand the role of vitamin D as a hormone
2) Identify which patients are at greatest risk for low vitamin D
3) Recognize the clinical indications for vitamin D testing and treatment
 
 

Serology testing continues to be an indispensable tool for the management of several disease states, especially treponemal screening to monitor syphilis infection in the US. Come to this educational seminar to learn about key objectives in treponemal screening:

• Discuss CDC Guidelines on treponemal screening: the necessity to perform two independent laboratory syphilis tests to confirm diagnosis


• Describe diagnostic methods for diagnosing syphilis infection: the order in which they are performed impacts interpretation of results


• Describe the potential benefits of screening with a treponema-specific IgG/IgM assay, followed by a non-treponemal test for confirmation: the “Reverse Sequence” algorithm 


•  

Hyper and Hypoparathyroid disease states are often latent with a multiplicity of manifestations ranging from asymptomatic state to obvious symptoms and complications such as fatigue, depression, kidney stones, bone fractures and intracranial calcifications.  Both conditions are associated with significant morbidity related to cardiac and vascular calcifications, hypertension, and seizure disorders.  As Dr. Rao picks up the normality enigma, the altered parathyroid state and its importance will be addressed diagnostically as it applies to the choices made in the course of clinical management.

Serology testing continues to be an indispensable tool for the management of several disease states, especially treponemal screening to monitor syphilis infection in the US. Come to this educational seminar to learn about key objectives in treponemal screening:

• Discuss CDC Guidelines on treponemal screening: the necessity to perform two independent laboratory syphilis tests to confirm diagnosis
• Describe diagnostic methods for diagnosing syphilis infection: the order in which they are performed impacts interpretation of results
• Describe the benefits of screening with a treponema-specific IgG/IgM assay, followed by a non-treponemal test for confirmation: the "Reverse Sequence" algorithm

Clinical laboratories require accurate and precise 25-hydroxyvitamin D (25-OHD) immunoassays to allow comparison of patient results with published decision limits. Automated immunoassays, radioimmunoassay, HPLC and HPLC-Tandem Mass Spectrometry (LC-MS/MS) are the most commonly used methods in routine laboratories. However, even latest generation assays show significant variation in performance. Variable assay performance is caused by differences in assay design and can be assessed by challenging the assays with samples containing common interferences, such as heterophile antibodies, C3-epimer or 25-OH vitamin D2. In addition, analyses of samples with high and low analyte concentration are helpful in identifying the weaknesses of assays. Participants in this webinar will learn how to assess assay performance and how to use this information for selecting an appropriate test for their laboratory.

Reliable data from multiple sources, including the 2010-11 Allina study of 13,500 health care employees, demonstrates that at least 30-60% of North Americans are vitamin D deficient and that, for many, a multivitamin or a quart of milk per day is not nearly enough intake.  Participants in this webinar will learn data-based clinical pearls to identify, assess and treat patients at risk both efficiently and effectively. Participants will also learn the latest pertinent data of great interest for both clinical practice and population health.

Recent studies show a large prevalence of Vitamin D deficiency and insufficiency in populations of all ages.  Concerns about excess supplementation and toxicity have emerged as a result.  This presentation explores Vitamin D levels where toxicity or hypercalcemia is a risk.