How to Increase Laboratory Accuracy with Direct HbA1c Testing !

HbA1c:

Diabetes is a global epidemic affecting in the region of 425 million people according to the International Diabetes Federation. Worryingly, this figure is on the rise with forecasts suggesting diabetes will affect up to 629 million people globally by 2045. Such a dramatic increase highlights the fundamental need for better disease management. When we look at the worldwide prevalence of diabetes, the United States is one of the most prominent countries affected.

HbA1c - an important biomarker for diabetes management and control !

HbA1c, also known as hemoglobin A1c or glycated hemoglobin, is an important blood test used to determine how well diabetes is being controlled. It develops when hemoglobin, a protein within the red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming “glycated.” The concentration of HbA1c in the blood of diabetic patients increases with rising blood glucose levels and is representative of the mean blood glucose level over the preceding six to eight weeks. HbA1c can therefore be described as a long-term indicator of diabetic control, unlike blood glucose which is only a short-term indicator of diabetic control. It is recommended that HbA1c levels are monitored every three to four months.

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A Primeview on Sickle Cell Disease !

Primeview:

Sickle cell disease (SCD) is a group of inherited disorders caused by mutations in HBB, which encodes haemoglobin subunit β. Haemoglobin molecules that include mutant sickle β-globin subunits can polymerize; erythrocytes that contain mostly haemoglobin polymers assume a sickled form and are prone to haemolysis. Other pathophysiological mechanisms that contribute to the SCD phenotype are vaso-occlusion and activation of the immune system. SCD is characterized by a remarkable phenotypic complexity. Common acute complications are acute pain events, acute chest syndrome and stroke; chronic complications (including chronic kidney disease) can damage all organs. Hydroxycarbamide, blood transfusions and haematopoietic stem cell transplantation can reduce the severity of the disease. Early diagnosis is crucial to improve survival, and universal newborn screening programmes have been implemented in some countries but are challenging in low-income, high-burden settings.

Sickle cell disease (SCD) is an umbrella term that defines a group of inherited diseases (including sickle cell anaemia (SCA), HbSC and HbSβ-thalassaemia) characterized by mutations in the gene encoding the haemoglobin subunit β (HBB). Haemoglobin (Hb) is a tetrameric protein composed of different combinations of globin subunits; each globin subunit is associated with the cofactor haem, which can carry a molecule of oxygen. Hb is expressed by red blood cells, both reticulocytes (immature red blood cells) and erythrocytes (mature red blood cells). Several genes encode different types of globin proteins, and their various tetrameric combinations generate multiple types of Hb, which are normally expressed at different stages of life — embryonic, fetal and adult. Hb A (HbA), the most abundant (>90%) form of adult Hb, comprises two α-globin subunits (encoded by the duplicated HBA1 and HBA2 genes) and two β-globin subunits.

A single nucleotide substitution in HBB results in the sickle Hb (HbS) allele βS; the mutant protein generated from the βS allele is the sickle β-globin subunit and has an amino acid substitution. Under conditions of deoxygenation (that is, when the Hb is not bound to oxygen), Hb tetramers that include two of these mutant sickle β-globin subunits (that is, HbS) can polymerize and cause the erythrocytes to assume a crescent or sickled shape from which the disease takes its name. Hb tetramers with one sickle β-globin subunit can also polymerize, albeit not as efficiently as HbS. Sickle erythrocytes can lead to recurrent vaso-occlusive episodes that are the hallmark of SCD. SCD is inherited as an autosomal codominant trait; individuals who are heterozygous for the βS allele carry the sickle cell trait (HbAS) but do not have SCD, whereas individuals who are homozygous for the βS allele have SCA. SCA, the most common form of SCD, is a lifelong disease characterized by chronic haemolytic anaemia, unpredictable episodes of pain and widespread organ damage.

This primeview focuses on SCA and aims to balance such remarkable advances with the key major challenges remaining worldwide to improve the prevention and management of this chronic disease and ultimately to discover an affordable cure.

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Before Automating The Blood Bank, Evaluate Compatibility With Existing Systems

Automation in the blood bank can be a turnaround time saver and staffing force multiplier. However, optimizing the testing workflow on the existing platforms should be the first order of business when considering new automation. There are companies that can be hired to do this, and they may present ways to optimize current analyzers with minor adjustments in the workflow process. Beginning with the end in mind, mapping the current workflow processes will provide a baseline for improving operations in any blood bank and laboratory.

Consider the laboratory structure. Is there a core laboratory concept with blood bank and microbiology located in the same workspace? Is it necessary to consider changes to the power, IT connections, and physical space in the planning process for new automation? Many laboratory structures limit the ability to share technologies and products, which creates operational gaps and challenges staffing models. Workflow process mapping will ensure that a lab leader has defined the many interconnected operations that impact the overall efficiency of a laboratory and point out key areas where automation may help make great strides in productivity. Placement of automation can allow for integration and cross training of the technical staff. A well-trained, cross-functional staff can be a great tool in generating efficiencies as well as reducing laboratorian burnout.

Read more: Before Automating The Blood Bank, Evaluate Compatibility With Existing Systems

Source: MedicalLaboratoryObserver

Standardization And Implementation of Lab Policies Ensure Hemostasis Sample Quality

How many of us remember the tilt-tube method for basic hemostasis testing? Fortunately, today’s instruments have automated most of these manual steps. However, until recently, assuring sample quality in the pre-analytical phase of testing had remained a manual process and had been difficult to implement and standardize.

Several questions must be considered when evaluating the integrity of a hemostasis sample: Is the sample tube under-filled? Is the sample hemolyzed, icteric, or lipemic? If so, do the levels of the interferent impact the testing results? Is there a clot in the sample?

All labs have policies on sample acceptance and rejection. Inappropriate rejection of acceptable samples—requiring redraw—directly impacts patient care, patient satisfaction, and cost. Failing to reject inappropriate samples can lead to the reporting of erroneous results, impacting the quality of patient care and associated cost. Let’s take a look at the most common pre-analytical quality issue culprits.

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Source: MedicalLaboratoryObserver

Validating the Performance of Body Fluid Specimens

In health care, the analysis of body fluids plays an important role in the diagnosis and management of a wide variety of conditions. Traditionally, clinical laboratorians have provided analysis of body fluid specimens without question while also recognizing the sometimes difficult work that goes into their collection. As standards for method validation and laboratory developed tests (LDTs) evolve, the analysis of body fluids is receiving increased attention from both laboratories and regulatory bodies.

The clinical laboratory’s overarching goal is to ensure accurate test results from all specimens. Therefore, it is the responsibility of every laboratory to investigate the analytical performance of the tests performed on the various fluid types accepted and to provide a context for result interpretation.

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Source: medlabmag