Comparison of three commercial assays for the measurement of 17α-hydroxyprogesterone (17α-OHPR): limitations of the quality control system

2004 ◽  
Vol 42 (4) ◽  
Author(s):  
Ursula Meier ◽  
Claudia Schnabel ◽  
Dagmar Kunz ◽  
Reinhard Driesch ◽  
Axel M. Gressner
Keyword(s):  
Quality Control ◽  
Moving Average ◽  
External Quality Control ◽  
Acth Stimulation ◽  
Hydroxylase Deficiency ◽  
External Quality ◽  
Stimulation Tests ◽  
21 Hydroxylase Deficiency

AbstractThe measurement of 17α-hydroxyprogesterone (17α-OHPR) is of value for the diagnosis and management of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. In the central laboratory from 2000 to 2002, we observed, using the assay from the manufacturer DSL, an elevation of the moving average of 17α-OHPR concentrations and a number of adrenocorticotropic hormone (ACTH) stimulation tests despite the lack of any changes to the internal and external quality control, of which the criteria were continuously fulfilled. We studied a population of n=49 patients for the measurement of 17α-OHPR, with and without extraction, to evaluate the quality of different commercially available radioimmunoassays. The internal and external quality controls were successful in determining 17α-OHPR. An excellent measurement and correlation of 17α-OHPR was expressed with the assay from the manufacturer IBL without extraction and from the manufacturer DSL with extraction. The quantitative determination of 17α-OHPR requires adequate specificity and accuracy of the 17α-OHPR radioimmunoassays. The results show that internal and external quality control systems are not sufficient to resolve analytical problems described in this study.

scholarly journals External Quality Assessment in the Evaluation of Laboratory Performance of Faecal Culture

2017 ◽  
Vol 10 ◽  
pp. 117863611769125
Author(s):  
Salla J Kiiskinen ◽  
Tarja Ojanen ◽  
Yvonne Björkman ◽  
Harri Laitinen ◽  
Anja Siitonen
Keyword(s):  
Public Health ◽  
Quality Control ◽  
External Quality Assessment ◽  
False Negative ◽  
The Other ◽  
Epidemiological Surveillance ◽  
External Quality Control ◽  
External Quality ◽  
Faecal Culture

In Finland, all laboratories carrying out diagnostics of infectious diseases in humans are approved by the Regional State Administrative Agencies and are obligated to participate in External Quality Assurance rounds. Performance in these rounds is thought to reflect the quality of laboratory work. In the 6-year study period, 17 Finnish laboratories received 48 simulated faecal specimens for the culturing of diarrhoeal pathogens, yielding altogether 586 faecal culture External Quality Control specimens and 581 reports. The results were correct in 92% of all reports and in 67% of all specimens. False-negative Salmonella results were given for 2 of the 18 specimens, one with biochemically atypical Salmonella strain and the other with a low count of Salmonella cells. False-negative Shigella report was given for 6 of the 7 specimens in some participating laboratory. Detection of all common faecal pathogens is especially relevant to patient safety, public health, and epidemiological surveillance.

scholarly journals External quality control of chemical-analytical units of refractory enterprises in 2016

2017 ◽  
Vol 117 ◽  
pp. 238-243
Author(s):  
E. A. Bondarenko ◽  
V. V. Varganov ◽  
N. N. Konchinko
Keyword(s):  
Quality Control ◽  
Chemical Analysis ◽  
Refractory Plant ◽  
External Quality Control ◽  
External Quality ◽  
Analysis Methods ◽  
Central Factory ◽  
Refinery Plant

External quality control of the chemical-analytical departments of the central factory laboratories was carried out: PJSC Krasnoarmeysky Dinas Factory, PJSC Chasovoyarsk Refractory Plant, PJSC Velikoanadol Refinery Plant. During the chemical analysis of samples of refractories of the listed enterprises, the analysis methods, equipment and materials described in DSTU 3305(3, 4, 5)—96 (GOST 2642.(3, 4, 5)—97) — gravimetric (SiO2), complexometric (Al2O3), photometric (Fe2O3). As a result of the work carried out, conclusions were drawn up in which the quality of the work of the chemical analytical units of the central factory laboratories of the PJSC “Krasnoarmeysky Dinas Factory”, PJSC “Chasovoyarsk Refractory Plant”, and PJSC “VELIKOANADOL REFRACTORY PLANT” was considered satisfactory.

Impairment of 11β-hydroxylase but not 21-hydroxylase in adrenal 'incidentalomas'

1997 ◽  
Vol 136 (2) ◽  
pp. 196-200 ◽  
Author(s):  
Martin Reincke ◽  
Michael Peter ◽  
Wolfgang G Sippell ◽  
Bruno Allolio
Keyword(s):  
Adrenal Incidentalomas ◽  
Hydroxylase Activity ◽  
Acth Stimulation ◽  
Hydroxylase Deficiency ◽  
Before And After ◽  
Pathogenetic Factor ◽  
17 Hydroxyprogesterone ◽  
21 Hydroxylase Deficiency ◽  
Cortisol Ratio

Abstract Recent reports have shown an exaggerated response of 17-hydroxyprogesterone in up to 70% of patients with incidentally detected adrenal adenomas ('incidentalomas'). This has been explained by pre-existing 21-hydroxylase deficiency which may be a pathogenetic factor in the development of adrenal tumours. However, other defects in steroidogenesis, such as mild 11β-hydroxylase deficiency, could also result in increased 17-hydroxyprogesterone secretion. We therefore studied the glucocorticoid and mineralocorticoid pathways in patients with adrenal 'incidentalomas' by measuring multiple adrenal steroids before and after 1–24 ACTH stimulation. Twenty patients with adrenal 'incidentalomas' (14 females, 6 males) and 27 healthy controls (14 females, 13 males) were studied. All subjects underwent a 1–24 ACTH stimulation test (250 μg i.v.) with determination of progesterone, 11-deoxycorticosterone, corticosterone, 17-hydroxyprogesterone, 11-deoxycortisol and cortisol at O and 60 min. All steroids were measured by RIA after extraction and HPLC. Patients with 'incidentalomas' had higher stimulated concentrations of 17-hydroxyprogesterone (21·6 ± 8·4 vs 4·2 ± 0·3 nmol/l; P ≤ 0·001), 11-deoxycortisol (8·1 ± 1·2 vs 3·6 ± 0·3 nmol/l; P ≤ 0·001), progesterone (8·28 ± 2·82 vs 1·08 ± 0·15 nmol/l; P ≤ 0·001), and 11-deoxycorticosterone (2·1 ± 0·39 vs 0·78 ± 0·12 nmol/l; P = 0·002) compared with controls. In contrast, cortisol and corticosterone concentrations were not different. There was evidence for impairment of 11β-hydroxylase activity by an increased 11-deoxycortisol/cortisol ratio (0·012 ± 0·003 vs 0·005 ± 0·001 in controls; P = 0·002) and 11-deoxycorticosterone/corticosterone ratio (0·04 ± 0·003 vs 0·015 ± 0·003; P = 0·003). The conclusions reached were that patients with adrenal 'incidentalomas' have increased responses of precursors of the mineralocorticoid and glucocorticoid pathway including 17-hydroxyprogesterone after stimulation with ACTH. This seems to be caused by impairment of 11β-hydroxylase activity rather than by impaired 21-hydroxylase activity in these tumours. European Journal of Endocrinology 136 196–200

scholarly journals Internal audit key quality components

Revizor ◽  
2021 ◽  
Vol 24 (94) ◽  
pp. 59-65
Author(s):  
Svetlana Jamandilović
Keyword(s):  
Quality Control ◽  
Internal Audit ◽  
External Quality Control ◽  
External Quality ◽  
Internal Auditors ◽  
Level Of Confidence ◽  
High Level

The services provided by internal auditors are based on a high level of confidence in the quality of their work. Continuous internal and periodic external quality control of internal audit activities are of key importance for maintaining confidence in the work of internal auditors.

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