Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine最新文献

Background: An increasing number of wearable medical devices are being used for personal monitoring and professional health care purposes. These mobile health devices collect a variety of biometric and health data but do not routinely connect to a patient's electronic health record (EHR) or electronic medical record (EMR) for access by a patient's health care team.

Methods: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM) developed consensus recommendations for consideration when interfacing mobile health devices to an EHR/EMR.

Results: IFCC C-MHBLM recommendations cover personalized monitoring and privacy concerns, data security, quality assurance of data transfer, and incorporation of alert triggers to warn users of important health conditions.

Conclusions: Considerations for interface ease-of-use, display of patient data in the EHR/EMR, and needs-based training programs for healthcare staff to understand the critical requirements, proper use, and integration of mobile health devices with EHR/EMRs are provided. Cooperation between healthcare providers, device manufacturers, and software developers is also recommended to drive future innovation in mobile health device technology development.

Background: Chronic kidney disease (CKD) concomitant with diabetes mellitus (DM), anemia and uremia. Thus, monitoring HbA1c levels presents a complex clinical challenge.

Methods: This analytical cross-sectional study was conducted from May 2022 to April 2023 at Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow. We compared HbA1c values obtained by the turbidimetric inhibition immunoassay (TINIA) and high-pressure liquid chromatography (HPLC) methods among non-dialysis CKD patients (n=127).

Results: HbA1c was not detectable among 27 patients by TINIA but measurable with HPLC, all being's anemic. The remaining 100 patients, it was detectable by both the methods. Among these 100 patients, linear regression analysis showed a very strong positive correlation between TINIA-HbA1c and HPLC-HbA1c (R2=0.861; p<0.0001). The agreement between methods was substantial (Cohen's kappa 0.657; p<0.0001). However, HbA1c levels were detected significantly higher with HPLC (Median 7.9, IQR 2.7) than that of TINIA (Median 7.0, IQR 2.9;p=0.025) in diabetics while the difference was not significant in non-diabetic group with both HPLC (Median 5.4,IQR 0.8) and TINIA (Median 5.1,IQR 1.1). Carbamylated Hb (CHb; as detected by HPLC as a side product) was correlated to both HbA1c by HPLC (r=0.299;p=0.007) and TINIA (r=0.336;p=0.006) as well as to serum urea levels (r=0.439;p<0.0001).

Conclusion: HPLC estimates all HbA1c patients in our study group while TINIA failed to do so in around 21.26% cases. The very low hemoglobin levels and high carbamylated hemoglobin were apparent as two most common causes. Also, the values with TINIA are significantly lower in comparison to HPLC among diabetics with CKD.

Background: Clinical biochemistry analyzers are essential for diagnosing and monitoring various diseases and conditions. However, the procurement of these analyzers is often based on the initial purchase cost, which does not reflect the total cost of ownership.

Methods: We applied a novel approach to include all hidden costs to run parameters (consumables and accessories) on a cost-per-reportable test (CPRT) basis. Fixed expenses like water purification plant, HIS connectivity, and electricity backup were assumed to be included in the cost per test itself, while the calibration cost was distributed uniformly in the calculation of CPRT itself. This CPRT was taken to compare the financial results of different bids.

Results: The cost per reportable test received after applying our novel approach in maintenance-free reagent rental basis bid was 47.4% lower than the previous cost per test for the purchased equipment.

Conclusion: This substantial decrease in cost with our novel approach reduced laboratory expenses possible with accurate comparison among analyzers with uniform specifications after eliminating the hidden expenses.

Introduction: Most circulating cancer and other disease biomarker concentrations increase during disease progression, roughly correlating with tumor burden or disease severity. During the biomarker discovery phase, several studies (some published in high-impact journals) report decreases in serum biomarkers at the time of disease diagnosis or during progression (in comparison to control, non-diseased populations). It is suggested these biomarker decreases between normal and diseased populations may have utility in diagnostics.

Methods: We briefly examine if a serum cancer biomarker concentration is likely to decrease as cancer progresses through empirical data.

Results: We propose a simple model, which, if correct, would suggest that in most cases, the biomarker decrease during disease progression could be an artifact or epiphenomenon (thus representing false discovery). Our suggestion is supported by the very few examples of decline of serum biomarkers during cancer development and progression.

Conclusions: The notion that a serum biomarker concentration could be inversely associated with tumor burden seems to be an epiphenomenon.

Background: Monoclonal gammopathies (MG) are frequent, especially among older people. This study aims to establish the features and etiologies of MG detected over seven years in the Biochemistry department of Mohammed VI University Hospital in Morocco.

Methods: The study was performed from Jan 1, 2016, to Sept 1, 2023, and involved 224 patients residing in east Morocco. The diagnosis of MG was conducted through capillary zone electrophoresis, followed by confirmation through immunofixation.

Results: The study included 224 patients, with an average age at diagnosis of 65.91 years. There were 122 (54.46%) males and 102 (45.54%) females, for a sex ratio of 1.19. In terms of immunoglobulin isotypes, IgG was found to be the most common monoclonal protein (59.82%), followed by IgA (19.64%) and IgM (6.71%). Furthermore, 11.6% of cases had exclusive free light chain (FLC) secretion, and 2.23% had biclonal gammopathy. The distribution of diagnoses in our study included multiple myeloma (MM) (78.57%), lymphoma (5.35%), plasma cell leukemia (4.02%), Waldenström macroglobulinemia (WM) (3.57%), and MGUS (1.79%).

Conclusions: Our study noted the high frequency of MM over MGUS. Several factors could contribute to this prevalence, including variations in healthcare access, demographic characteristics, and potentially other elements that warrant further investigation.

Background: Diabetes mellitus (DM) is a significant and escalating global health concern, with Type 2 DM (T2DM) constituting approximately 90% of all DM cases. Magnesium (Mg) plays a crucial role in various physiological processes. Hypomagnesemia is prevalent in T2DM patients. The severity of hypomagnesemia correlates with glycemic control and is linked to the development of complications associated with T2DM.

Aim: The objective of our study was to evaluate the occurrence of hypomagnesemia in patients with T2DM and explore its association with both glycemic control and the development of complications in rural and urban populations.

Methods: The study consisted of 300 diabetic and 100 non-diabetic patients between 31 and 55 years of age. Fasting blood glucose, post-prandial blood glucose, and magnesium levels were estimated using a fully automated analyzer, Selectra Pro-XL. HbA1c was measured using Bio-Rad D10. Insulin levels were calculated using the chemiluminescence method. HOMA-IR was also assessed using a formula: fasting insulin (U/mL) multiplied by fasting plasma glucose (FPG) (mmol/L) divided by 22.5.

Result: Magnesium levels were significantly lower in diabetic patients (1.34±0.29) than in the control (2.17±1.87) with p<0.0001. FBS (267.67±89.78 mg/dL vs. 167.87±76.87 mg/dL, p<0.0001), PPBS (376.87±112.87 mg/dL vs. 287.90±99.98 mg/dL, p<0.0001), HbA1c (9.54±2.6 % vs. 7.23±1.8 %, p<0.0001), Insulin (17.21±8.98 IU/mL vs. 14.87±5.98 IU/ mL, p=0.039) and HOMA-IR (7.32±3.67 vs. 6.13±0.99, p=0.012) were significantly elevated in the hypomagnesemia group than the normal magnesium levels. Magnesium levels were negatively correlated with FBS (r=-0.465; p<0.0001), PPBS (r=-0.596; p<0.0001, HbA1c (r=-0.765; p<0.0001), Insulin (r=-0.454; p<0.0001), and HOMA-IR (r=-0.325; p<0.0001).

Conclusion: Our study suggests that monitoring serum magnesium levels is crucial for individuals with Type 2 diabetes mellitus (T2DM) to manage hypomagnesemia, mitigate associated complications, and optimize overall care.

Background: There is a lack of systematic collection of information on the quality control practice and method evaluation approach in clinical laboratories in Nepal. Such data is important to formulate educational activities and policy that may address any potential knowledge and practice gap identified.

Method: The pilot survey included twelve questions regarding quality control practice and method evaluation approach and was distributed among the laboratory medicine professionals in Kathmandu, Nepal. Data were collected using a structured self-reported questionnaire on the Google Docs platform. A total of 43 responses were received.

Results: Internal quality control and method evaluation practice varied considerably in terms of the number of levels of material used, frequency of analysis, type and source of material and acceptance criteria among responding laboratories.

Conclusion: The variability in quality control practice and method evaluation approach highlights need for augmentation of knowledge, attitude, and practice behavior among laboratory professionals in Nepal.