Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals

2020 ◽  
Vol 58 (3) ◽  
pp. 350-356 ◽  
Author(s):  
Martina Zaninotto ◽  
Mario Plebani

AbstractThe recently raised concerns regarding biotin interference in immunoassays have increased the awareness of laboratory professionals and clinicians of the evidence that the analytical phase is still vulnerable to errors, particularly as analytical interferences may lead to erroneous results and risks for patient safety. The issue of interference in laboratory testing, which is not new, continues to be a challenge deserving the concern and interest of laboratory professionals and clinicians. Analytical interferences should be subdivided into two types on the basis of the possibility of their detection before the analytical process. The first (type 1) is represented by lipemia, hemolysis and icterus, and the second (type 2), by unusual constituents that are not undetectable before analysis, and may affect the matrix of serum/plasma of individual subjects. Type 2 cannot be identified with current techniques when performing the pre-analytical phase. Therefore, in addition to a more careful evaluation and validation of the method to be used in clinical practice, the awareness of laboratory professionals should be raised as to the importance of evaluating the quality of biological samples before analysis and to adopt algorithms and approaches in the attempt to reduce problems related to erroneous results due to specific or non-specific interferences.

2022 ◽  
pp. 215-229
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Ioanna Petraki ◽  
Christina Seitopoulou ◽  
...  

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.


2017 ◽  
Vol 28 (1) ◽  
pp. 25-30 ◽  
Author(s):  
Scott J. Pilla ◽  
Nisa M. Maruthur ◽  
Michael A. Schweitzer ◽  
Thomas H. Magnuson ◽  
James J. Potter ◽  
...  

2021 ◽  
Vol 11 (2-S) ◽  
pp. 121-125
Author(s):  
Jasaswi Ray ◽  
Chinmaya Keshari Sahoo ◽  
Rajashree Mohanty ◽  
Rakesh Sahoo ◽  
Rajashree Dalai

Diabetic peripheral neuropathy (DPN) is a common complication of both type 1 and type 2 diabetes affecting over 90% of the diabetic patients. Due to the toxic effects of hyperglycemia there is development of this complication. It is typically characterized by significant deficits in tactile sensitivity, vibration sense, lower-limb proprioception, and kinesthesia. Painful DPN has been shown to be associated with significant reductions in overall quality of life, increased levels of anxiety and depression, sleep impairment, and greater gait variability. Hence DPN is often inadequately treated, and the role of improving glycaemic control in diabetes. Major international clinical guidelines for the management of DPN recommend several symptomatic treatments. First-line therapies include tricyclic antidepressants, serotonin–noradrenaline reuptake inhibitors, and anti-consultants that act on calcium channels. Other therapies include opioids and topical agents such as capsaicin and lidocaine. The objectives of this paper are to review current guidelines for the pharmacological management of DPN. Keywords: DPN, hyperglycemia, depression, lidocaine


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 851-P
Author(s):  
MELISSA S. FAULKNER

2020 ◽  
Vol 17 (1) ◽  
pp. 37-54
Author(s):  
Tatyana Chalakova ◽  
Yoto Yotov ◽  
Kaloyan Tzotchev ◽  
Sonya Galcheva ◽  
Boyan Balev ◽  
...  

: Type 1 diabetes mellitus (T1DM) is a chronic disease that starts early in life and often leads to micro- and macrovascular complications. The incidence of the disease is lower than that of type 2 DM and varies in different countries and ethnic groups, and the etiological and pathogenetic factors are different from T2DM. The aim of this overview is to investigate the effect of T1DM on all-cause mortality and CVD morbidity and mortality. During the last decades, the treatment of T1DM has improved the prognosis of the patients. Still, the mortality rates are higher than those of the age- and sex-matched general population. With the prolonged survival, the macrovascular complications and cardiovascular diseases (CVD) appear as major health problems in the management of patients with T1DM. The studies on the CVD morbidity and mortality in this disease group are sparse, but they reveal that T1DM is associated with at least 30% higher mortality. In comparison to healthy people, CVDs are more common in T1DM patients and they occur earlier in life. : Furthermore, they are a major cause for death and impaired quality of life in T1DM patients. The correlation between diabetic control and the duration of T1DM is not always present or is insignificant. Nevertheless, the early detection of the preclinical stages of the diseases and the risk factors for their development is important; similarly, the efforts to improve glycemic and metabolic control are of paramount importance.


2021 ◽  
pp. 193229682110213
Author(s):  
Stuart Chalew ◽  
Alan M. Delamater ◽  
Sonja Washington ◽  
Jayalakshmi Bhat ◽  
Diane Franz ◽  
...  

Achieving normal or near-normal glycemic control as reflected by HbA1c levels in patients with type 1 diabetes (T1D) is important for preventing the development and progression of chronic complications. Despite delineation and dissemination of HbA1c management targets and advances in insulin pharmacology, insulin delivery systems, and glucose monitoring, the majority of children with T1D do not achieve HbA1c goals. In particular, African Americans are more likely not to reach HbA1c goals and have persistently higher HbA1c than Non-Hispanic Whites. Availability of pumps and other technology has not eliminated the disparity in HbA1c. Multiple factors play a role in the persisting racial disparity in HbA1c outcome. The carefully designed application and deployment of new technology to help the patient/family and facilitate the supportive role of the diabetes management team may be able to overcome racial disparity in glycemic outcome and improve patient quality of life.


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