Biomedical Laboratory Science

Saturday, October 29, 2016

Validation of Hematology Analyzers

Perhaps the most common laboratory procedure performed for hospital patients and outpatients is complete blood count (CBC) or CBC with differential. CBC serves as a screening and diagnostic test for a wide range of conditions and diseases as well as a monitoring tool for treatment and disease status. Given its foundational nature and despite its relative simplicity, the veracity of this basic blood testing is essential. Therefore, thorough validation testing on all new hematology analyzers must be performed to ensure patient safety.

It is reasonable to assume that a newly acquired piece of diagnostic equipment would run as intended, as manufacturers perform their own validation testing to prove intended use and to fulfill regulatory requirements prior to launching a product in the market. However, the ultimate responsibility of verifying instrument performance specifications and characteristics prior to the patient testing falls to the end-user laboratory.

Source: MedLabMag

Male Birth Control Shot Shows Promise

When it comes to birth control methods, women have more options than ever before. However, for men, the choice is limited to condoms, withdrawal, and vasectomy. A new study - published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism - has established that a male birth control shot is effective at preventing pregnancy.

In the last 40 years, studies have demonstrated that reversible hormonal suppression of spermatogenesis - the process of sperm cell development - in men can prevent pregnancies in their female partners, although the commercial development of the product has been stalled.

In previous studies, testosterone management in men demonstrated birth control efficacy comparable with female methods. However, participants had to be given much greater doses than are typically found in the body and the method caused long-term adverse effects in healthy men.

While giving progesterone alongside can reduce the dose of testosterone, there have been few studies that have evaluated the efficacy and safety of such a combination. With 40 percent of all pregnancies worldwide unintended in 2012, better birth control options are required for men.

The male birth control shot may provide more choice for controlling male fertility in the future.

Evaluation of Diabetic Marker HbA1c and Anemia in the Context of Kidney Disease

Each year, more than 100,000 people in the United States are diagnosed with kidney failure, the final stage of kidney disease.1 The most common cause is diabetes, accounting for nearly 44 percent of new cases. Often, a consequence of kidney disease is anemia. This occurs when kidneys fail to generate enough erythropoietin hormone to trigger adequate red blood cell production. For decades, clinicians have successfully used the hemoglobin A1c (HbA1c or A1C) assay to monitor long-term blood glucose control for patients with chronic diabetes. More recently, researchers have studied the HbA1c assay’s use as a potential diagnostic marker for diabetes complications such as kidney disease.

The HbA1c test measures average plasma glucose—hemoglobin in a red blood cell that was combined with glucose over the previous eight to 12 weeks. The higher the HbA1c value, the greater the risk that the diabetes patient will develop kidney disease, and perhaps, anemia, a common consequence of renal disease. However, a chemically modified derivative of hemoglobin called carbamylated hemoglobin (CHb) can affect the accuracy of the HbA1c test results. Studies have shown that the formation of CHb due to abnormal urea concentration is linked to both the severity and the duration of renal failure. Research findings have inspired conflicting viewpoints on the efficacy of HbA1c test results in the presence of CHb and on the level of CHb it takes to affect results. This article explores the links between diabetes and renal failure. It discusses what research has discovered about the effect of CHb on HbA1c testing. Finally, it shows how testing technology has improved to ensure HbA1c testing accuracy.

Breast Cancer: The Body of Knowledge Grows

Scientists’ understanding of the genetics/genomics of breast cancer continues to grow; a revolution is underway both in terms of categorizing breast cancers and targeting treatment that will be effective in individual cases. New perspectives are being offered on the interpretation of biopsies, too. Here is a round-up of some very recent studies.

Genetic variants alter cells’ response to estrogen
An international study of almost 120,000 women has newly identified five genetic variants affecting risk of breast cancer, all of which are believed to influence how breast cells respond to the female sex hormone estrogen.

Estrogen acts as a trigger, binding to a molecule known as an estrogen receptor in most breast cells and triggering a cascade of signals that cause the cell to behave normally. However, the estrogen receptor is switched off in some cells and these do not respond to the hormone.

Biochemistry Lecture Notes - Uremia: Background, Pathophysiology, Etiology

Uremia is a clinical syndrome associated with fluid, electrolyte, and hormone imbalances and metabolic abnormalities, which develop in parallel with deterioration of renal function. The term uremia, which literally means urine in the blood, was first used by Piorry to describe the clinical condition associated with renal failure.

Uremia more commonly develops with chronic kidney disease (CKD), especially the later stages, of CKD, but it also may occur with acute kidney injury (AKI) if loss of renal function is rapid. As yet, no single uremic toxin has been identified that accounts for all of the clinical manifestations of uremia. A number of toxins, such as parathyroid hormone (PTH), beta2 microglobulin, polyamines, advanced glycosylation end products, and other middle molecules, are thought to contribute to the clinical syndrome.

Source: Medscape

Biochemistry Lecture Notes - Azotemia: Background, Pathophysiology, Etiology

Azotemia is an elevation of blood urea nitrogen (BUN) and serum creatinine levels. The reference range for BUN is 8-20 mg/dL, and the normal range for serum creatinine is 0.7-1.4 mg/dL.

Each human kidney contains approximately 1 million functional units known as nephrons, which are primarily involved in urine formation. Urine formation ensures that the body eliminates the final products of metabolic activities and excess water in an attempt to maintain a constant internal environment (homeostasis). Urine formation by each nephron involves 3 main processes, as follows: 
  • Filtration at the glomerular level 
  • Selective reabsorption from the filtrate passing along the renal tubules 
  • Secretion by the cells of the tubules into this filtrate 
Perturbation of any of these processes impairs the kidney’s excretory function, resulting in azotemia.

Source: Medscape

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