scholarly journals Evaluation of Analytical Performance of Variant II Turbo HbA1c Analyzer According to Sigma Metrics

2019 ◽  
Vol 38 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Giray Bozkaya ◽  
Nuriye Uzuncan ◽  
Sibel Bilgili ◽  
Ozlem Demirezen
Keyword(s):  
Quality Control ◽  
Control Measures ◽  
Analytical Performance ◽  
Major Constituent ◽  
General Evaluation ◽  
Quality Control Materials ◽  
Allowable Error ◽  
The Difference ◽  
Analytical Variation

Summary Background: Hemoglobin A1c, (HbA1c) which is the major constituent of glycated hemoglobin, has been used in the follow-up of retrospective glycemia for years and in the diagnosis of diabetes mellitus nowadays. Since the analytical performance of HbA1c should be high likewise all laboratory tests, various quality control measures are used. Sigma metrics is one of these measures and it is the combination of bias, precision and total allowable error that ensures a general evaluation of analytical quality. The aim of our study was to evaluate the analytical performance of Bio-Rad’s Variant Turbo II HbA1c analyzer according to sigma metrics. Methods: Sigma levels were calculated using the data obtained from two levels of internal and 12 external quality control materials (Bio-Rad) of Variant II Turbo HbA1c analyzer according to s= (TEa% - Bias%) / CV% formula. Results: The mean sigma levels for low and high quality control materials were found to be 3.0 and 4.1, respectively. Conclusions: The annual mean analytical performance of Variant II Turbo HbA1c analyzer was found to be acceptable according to sigma metrics. In order to be sure of the difference in HbA1c results indicating the success or failure in treatment but not arise from analytical variation, it is thought that more stringent quality control measures should be applied to reach higher sigma levels.

Trueness assessment of HbA1c routine assays: are processed EQA materials up to the job?

2019 ◽  
Vol 57 (10) ◽  
pp. 1623-1631 ◽  
Author(s):  
Vincent Delatour ◽  
Noémie Clouet-Foraison ◽  
Stéphane Jaisson ◽  
Patricia Kaiser ◽  
Philippe Gillery
Keyword(s):  
External Quality Assessment ◽  
Measurement Procedure ◽  
Enzymatic Assays ◽  
Clinical Specimens ◽  
Medical Laboratories ◽  
Ion Exchange Hplc ◽  
Quality Control Materials ◽  
Allowable Error ◽  
The Difference ◽  
Assay Precision

Abstract Background With the worldwide increase of diabetes mellitus prevalence, ensuring that HbA1c assays are accurate is essential. External quality assessment (EQA) programs enable laboratories to verify that analytical methods perform according to the manufacturers’ specifications. However, assessing trueness requires commutable materials, a property that is rarely characterized for EQA materials. Methods The difference in bias approach was used to assess commutability of 26 processed quality control materials for 17 of the most frequently used HbA1c assays. Involved assays included immuno-assays, enzymatic assays, affinity, ion-exchange HPLC boronate affinity HPLC and capillary electrophoresis. The measurements were performed at manufacturers or expert laboratories. Assay trueness was additionally assessed against the IFCC reference measurement procedure using fresh clinical specimens that were distributed to 450 medical laboratories. Results Commutability of processed EQA materials was highly heterogeneous and globally insufficient to rigorously assess the trueness of HbA1c assays. Using fresh clinical specimens, mean bias was −0.13 mmol/mol for low HbA1c (34 mmol/mol), between +1.0 and +1.3 mmol/mol for intermediate HbA1c (49 and 58 mmol/mol) and +1.2 mmol/mol for elevated HbA1c (90 mmol/mol). Conclusions This study demonstrates that due to insufficient commutability, most processed EQA materials are unsuitable to assess trueness of HbA1c assays and agreement between the different assays. These materials can only provide information on comparability of individual laboratory results with its peers and on assay precision. Using fresh whole blood samples, this study additionally shows that most HbA1c assays are fairly accurate and meet the total allowable error quality target of 5 mmol/mol.

scholarly journals Evaluation of Twenty-Three Blood Culture Media

1978 ◽  
Vol 8 (3) ◽  
pp. 288-292
Author(s):  
Jegdish P. Babu ◽  
Ronald F. Schell ◽  
Jack L. Le Frock
Keyword(s):  
Quality Control ◽  
Blood Culture ◽  
Recovery Rate ◽  
Culture Medium ◽  
Culture Media ◽  
Control Measures ◽  
Rate Of Recovery ◽  
The Difference

Several investigators have evaluated clinically a variety of commercially available blood culture media. No agreement has been reached as to which of these media is optimal for detection of bacteremia. The purpose of this study was to determine the rate of recovery of microorganisms from various blood culture media. A total of 23 blood culture media were inoculated with 7 to 15 microorganisms per bottle in the presence or absence of an erythrocyte-serum mixture. The results demonstrated that blood culture media differed in their ability to support the growth of microorganisms. At 4 days after inoculation, only 10 of the 23 blood culture media supported the growth of 91% (10 of the 11) or more of the test microorganisms. The recovery rate of microorganisms depended not only upon the type of medium but also upon the manufacturer of the type of blood culture medium. The addition of an erythrocyte-serum mixture to the blood culture media did not influence the difference in the recovery rate of microorganisms among media and the same type of medium prepared by different manufacturers. The majority (15 of the 23) of the blood culture media supplemented with the erythrocyte-serum mixture failed to support the growth of 91% or more of the test microorganisms at 4 days after inoculation. These results have demonstrated that blood culture media need to be improved. Better quality control measures should also be implemented to evaluate commercial blood culture media.

Re-Increased Male Suicide Rates in the Recovery Phase Following the Great East Japan Earthquake

Crisis ◽  
2020 ◽  
Vol 41 (6) ◽  
pp. 422-428 ◽  
Author(s):  
Masatsugu Orui
Keyword(s):  
Social Connectedness ◽  
Recovery Phase ◽  
Great East Japan Earthquake ◽  
Temporary Housing ◽  
Period Analysis ◽  
Suicide Rates ◽  
Male Suicide ◽  
The Social ◽  
The Difference

Abstract. Background: Monitoring of suicide rates in the recovery phase following a devastating disaster has been limited. Aim: We report on a 7-year follow-up of the suicide rates in the area affected by the Great East Japan Earthquake, which occurred in March 2011. Method: This descriptive study covered the period from March 2009 to February 2018. Period analysis was used to divide the 108-month study period into nine segments, in which suicide rates were compared with national averages using Poisson distribution. Results: Male suicide rates in the affected area from March 2013 to February 2014 increased to a level higher than the national average. After subsequently dropping, the male rates from March 2016 to February 2018 re-increased and showed a greater difference compared with the national averages. The difference became significant in the period from March 2017 to February 2018 ( p = .047). Limitations: Specific reasons for increasing the rates in the recovery phase were not determined. Conclusion: The termination of the provision of free temporary housing might be influential in this context. Provision of temporary housing was terminated from 2016, which increased economic hardship among needy evacuees. Furthermore, disruption of the social connectedness in the temporary housing may have had an influence. Our findings suggest the necessity of suicide rate monitoring even in the recovery phase.

Guideline for radioimmunotherapy of rituximab relapsed or refractory CD20+ follicular B-cell nonHodgkin´s lymphoma

2004 ◽  
Vol 43 (05) ◽  
pp. 171-176 ◽  
Author(s):  
T. Behr ◽  
F. Grünwald ◽  
W. H. Knapp ◽  
L. Trümper ◽  
C. von Schilling ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Medical Physics ◽  
Essential Elements ◽  
Background Information ◽  
After Care ◽  
Complete Treatment ◽  
Close Cooperation ◽  
Work Up

Summary:This guideline is a prerequisite for the quality management in the treatment of non-Hodgkin-lymphomas using radioimmunotherapy. It is based on an interdisciplinary consensus and contains background information and definitions as well as specified indications and detailed contraindications of treatment. Essential topics are the requirements for institutions performing the therapy. For instance, presence of an expert for medical physics, intense cooperation with all colleagues committed to treatment of lymphomas, and a certificate of instruction in radiochemical labelling and quality control are required. Furthermore, it is specified which patient data have to be available prior to performance of therapy and how the treatment has to be carried out technically. Here, quality control and documentation of labelling are of greatest importance. After treatment, clinical quality control is mandatory (work-up of therapy data and follow-up of patients). Essential elements of follow-up are specified in detail. The complete treatment inclusive after-care has to be realised in close cooperation with those colleagues (haematology-oncology) who propose, in general, radioimmunotherapy under consideration of the development of the disease.

scholarly journals POS0208 GENDER DIFFERENCES IN RESPONSE TO BIOLOGICALS. WOMEN FARE WORSE ACROSS INFLAMMATORY ARTHRITIS DISEASES - DATA FROM THE BIOREG

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 320.1-321
Author(s):  
E. Loibner ◽  
V. Ritschl ◽  
B. Leeb ◽  
P. Spellitz ◽  
G. Eichbauer-Sturm ◽  
...  
Keyword(s):  
Gender Differences ◽  
Psoriatic Arthritis ◽  
Gender Difference ◽  
Disease Activity ◽  
Inflammatory Arthritis ◽  
Tnf Inhibitors ◽  
Significant Difference ◽  
The Difference ◽  
All Diseases

Background:Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results.Objectives:The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-modifying antirheumatic drugs (bDMARDs) and apremilast in bDMARD-naïve patients could be observed across the three most prevalent inflammatory arthritis diseases: rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA). Additionally, a response to individual TNF blockers was investigated in this respect.Methods:Data from bDMARD-naïve RA-, SpA- and PsA-patients from Bioreg, the Austrian registry for biological DMARDs in rheumatic diseases, were used. Patients with a baseline (Visit 1=V1) and follow-up visits at 6 months (Visit 2=V2) and 12 months (Visit 3=V3) were included and response to therapy with TNF-inhibitors (TNFi), furthermore to therapy with rituximab, tocilizumab and apremilast was analyzed according to gender. The remaining bDMARDs were not analyzed due to small numbers. Key response-parameter for RA was disease activity score (DAS28), whereas for PsoA the Stockerau Activity Score for Psoriatic Arthritis (SASPA) and for SpA the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were employed; in addition, the Health assessment Questionnaire (HAQ) was used. Data were analyzed in R Statistic stratified by gender using Kruskal-Wallis and Wilcoxon tests.Results:354 women and 123 men with RA (n=477), 81 women and 69 men with PsA (n=150), 121 women and 191 men with SpA (n=312) were included. No significant differences in biometrics was seen between female and male patients at baseline in all diseases.In RA patients overall DAS28 decreased from baseline (V1) to V2 and V3 (DAS28: V1: male: 4.38 [3.66, 5.11], female: 4.30 [3.68, 5.03], p(m/f) = 0.905; V2: male: 2.66 [1.73, 3.63], female: 3.10 [2.17, 3.98], p(m/f) = 0.015; V3: male: 2.25 [1.39, 3.36], female: 3.01 [1.87, 3.87], p(m/f) = 0.002). For TNF inhibitors (n=311), there was a significant difference between genders at V2 (Fig.1a). Patients receiving Rituximab (n=41) displayed a significantly higher DAS28 at baseline in females, which diminished in the follow up: V1: (p(m/f) p=0.002; V2: p=0.019; V3: p=0.13); response to tocilizumab (n=63) did not show any gender differences.In PsA patients overall SASPA decreased from baseline (V1) to V2 and V3 (SASPA: V1: male: 4.00 [2.80, 5.20], female: 4.40 [2.80, 5.80], p(m/f) = 0.399; V2: male: 2.20 [1.20, 3.50], female: 3.40 [2.00, 5.00], p(m/f) = 0.071; V3: male: 1.80 [0.80, 2.70], female: 3.01 [2.35, 4.80], p(m/f) = 0.001). For TNF inhibitors (n=79), there was a significant difference between genders at V3 (Fig 1a). For Apremilast (n=39), there was a significant difference between genders at V2 (Fig.1c).In SpA patients overall BASDAI decreased from baseline (V1) to V2 and V3 (BASDAI: V1: male: 4.70 [2.88, 6.18], female: 4.80 [3.30, 6.20], p(m/f) = 0.463; V2: male: 3.05 [2.00, 4.60], female: 3.64 [2.62, 5.41], p(m/f) = 0.039; V3: male: 3.02 [1.67, 4.20], female: 3.65 [2.18, 5.47], p(m/f) = 0.016). In V3 a differential BASDAI in response to TNFi (n=299) was observed (Fig.1a).Possible differences of response to individual TNFi (etanercept, infliximab, other TNFi) measured by HAQ were investigated in all diseases together. The difference between male and females was significant at baseline for all 3 TNFi; whereas with the use of ETA the significant difference was carried through to V2 and V3, it was lost with the use of IFX and was variable with the other TNFi (Fig.1b)Figure 1.Conclusion:Female patients showed a statistically lower response to TNFi in all three disease entities (RA, SpA and PsoA) to a variable degree in our homogenous central european population. Interestingly, the difference was not uniform across individual TNFi when measured by HAQ. Gender differences were also seen in response to Apremilast.Disclosure of Interests:Elisabeth Loibner: None declared, Valentin Ritschl: None declared, Burkhard Leeb Speakers bureau: AbbVie, Roche, MSD, Pfizer, Actiopharm, Boehringer-Ingelheim, Kwizda, Celgene, Sandoz, Grünenthal, Eli-Lilly, Grant/research support from: TRB, Roche, Consultancies: AbbVie, Amgen, Roche, MSD, Pfizer, Celgene, Grünenthal, Kwizda, Eli-Lilly, Novartis, Sandoz;, Peter Spellitz: None declared, Gabriela Eichbauer-Sturm: None declared, Jochen Zwerina: None declared, Manfred Herold: None declared, Miriam Stetter: None declared, Rudolf Puchner Speakers bureau: AbbVie, BMS, Janssen, Kwizda, MSD, Pfizer, Celgene, Grünenthal, Eli-Lilly, Consultant of: AbbVie, Amgen, Pfizer, Celgene, Grünenthal, Eli-Lilly, Franz Singer: None declared, Ruth Fritsch-Stork: None declared

Arterial Stiffness Assessed by Cardio-Ankle Vascular Index in Patients With Abdominal Aortic Aneurysm and Its Alterations After Treatment

2021 ◽  
pp. 153857442110232
Author(s):  
Spyridon N. Mylonas ◽  
Konstantinos G. Moulakakis ◽  
Nikolaos Kadoglou ◽  
Constantinos Antonopoulos ◽  
Thomas E. Kotsis ◽  
...  
Keyword(s):  
Arterial Stiffness ◽  
Surgical Repair ◽  
Open Repair ◽  
Abdominal Aortic ◽  
Gender And Age ◽  
Baseline Values ◽  
The Difference ◽  
The Impact ◽  
Repair Group

Purpose: The aim of the present study was to investigate a potential difference on the arterial stiffness among aneurysm patients and non-aneurysm controls, as well as to explore potential changes between patients treated either with endovascular or open repair. Materials and Methods: A 110 patients with an infrarenal AAA were prospectively enrolled in this study. Fifty-six patients received an EVAR, whereas 54 patients received an open surgical repair. Moreover, 103 gender and age-matched subjects without AAA served as controls. The cardio-ankle vascular index (CAVI) was applied for measurement of the arterial stiffness. Results: CAVI values were statistically higher in the AAA patients when compared with control subjects. Although at 48 hours postoperatively the CAVI values were increased in both groups when compared to baseline values, the difference in CAVI had a tendency to be higher in the open group compared to the endovascular group. At 6 months of follow up the CAVI values returned to the baseline for the patients of the open repair group. However, in the endovascular group CAVI values remained higher when compared with the baseline values. Conclusion: Patients with AAAs demonstrated a higher value of CAVI compared to healthy controls. A significant increase of arterial stiffness in both groups during the immediate postoperative period was documented. The increase in arterial stiffness remained significant at 6 months in EVAR patients. Further studies are needed to elucidate the impact of a decreased aortic compliance after stentgraft implantation on the cardiac function of patients with AAA.

scholarly journals Impact of immediate postpartum insertion of TCu380A on the quantity and duration of lochia discharges in Tanzania

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Projestine Selestine Muganyizi ◽  
Grasiana Festus Kimario ◽  
France John Rwegoshora ◽  
Ponsian Patrick Paul ◽  
Anita Makins
Keyword(s):  
Service Providers ◽  
International Federation ◽  
Teaching Hospitals ◽  
Evidence Based ◽  
Contraceptive Device ◽  
Postpartum Contraception ◽  
Gynecology And Obstetrics ◽  
Intrauterine Contraceptive ◽  
The Difference

Abstract Background The insertion of Intrauterine Contraceptive Device (PPIUD) for the purpose of contraception immediately after delivery is becoming popular in countries where the use of IUD for contraception has been extremely low. Since 2015, Tanzania implemented the initiative by the International Federation of Gynecology and Obstetrics (FIGO) to institutionalize PPIUD. As a result of capacity building and information delivery under the initiative, there have been increased uptake of the method. Working in this context, the focus of the study was to generate evidence on the effect of TCu380A IUD on amount and duration of lochia and equip service providers with evidence-based knowledge which can help them in counselling their PPIUD clients. Objective Establish impact of postpartum TCu380A on amount and duration of lochia. Methods A prospective cohort study of delivered women in two teaching hospitals in Tanzania with immediate insertion of TCu380A or without use of postpartum contraception in 2018. TCu380A models; Optima (Injeflex Co. Brazil) and Pregna (Pregna International, Chakan, India) were used. Follow-up was done by weekly calls and examination at 6th week. Lochia was estimated by Likert Scale 0–4 relative to the amount of lochia on the delivery day. An estimated 250 women sample (125 each group) would give 80% power to detect a desired 20% difference in the proportion of women with prolonged lochia discharges among the Exposed and Unexposed groups. Data analysis was by SPSS. Results Two hundred sixty women were analysed, 127 Exposed and 133 Unexposed. Medical complaints were reported by 41 (28.9%) Exposed and 37 Unexposed (27.8%), p = 0.655. Lack of dryness by end of 6th week was to 31 (23.3%) Exposed and 9 (7.1%) Unexposed, p < 0.001. Exposed had higher weekly mean lochia scores throughout with the difference most marked in 5th week (3.556 Versus 2.039, p < 0.001) and 6th week (1.44 Versus 0.449, p<0.001). Conclusion PPIUD is associated with increased amount of lochia and slows progression to dryness within 6 weeks of delivery. The implications of PPIUD clients’ needs to be informed about the possibility of delayed dryness of lochia at time of counseling are discussed.

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