The development of key performance criteria for monitoring laboratory performance in gynaecological cytopathology

AbstractThe measurement uncertainty budget should combine the uncertainty of higher order references, the uncertainty of commercial system calibration, the system imprecision and individual laboratory performance in terms of variability. Here we recommend that no more than one third of the total uncertainty budget, established by appropriate analytical performance specifications, is consumed by the uncertainty of references and approximately 50% of the total budget consumed by the manufacturer’s calibration and value transfer protocol. The remaining 50% should be available for the commercial system imprecision (including the batch to batch variation of the reagents) and individual laboratory performance in order to fulfil the uncertainty goal. For commercial systems to work properly, in vitro diagnostics (IVD) manufacturers will need to take more responsibility and ensure the traceability of the combination of platform, reagents, calibrators and control materials for system alignment verification that only as such (as a whole) are certified (“CE marked”) by the manufacturer itself in terms of traceability to the selected reference measurement system. Particularly, IVD manufacturers should report the combined (expanded) uncertainty associated with their calibrators when used in conjunction with other components of their analytical system (platform and reagents). This is more than what they are currently providing as traceability and uncertainty information.

Download Full-text

The multilayered film analyzer: glucose in serum, plasma, cerebrospinal fluid, and urine; and urea nitrogen in serum and plasma.

Clinical Chemistry ◽

10.1093/clinchem/26.1.133 ◽

1980 ◽

Vol 26 (1) ◽

pp. 133-137 ◽

Cited By ~ 11

Author(s):

K Warren ◽

N P Kubasik ◽

B B Brody ◽

H E Sine ◽

J P D'Souza

Keyword(s):

Cerebrospinal Fluid ◽

Continuous Flow ◽

High Protein ◽

Performance Criteria ◽

Aqueous Samples ◽

Multilayered Film ◽

Urea Nitrogen ◽

Laboratory Performance ◽

Film Analyzer ◽

Glucose Analysis

Abstract Some basic laboratory performance criteria were studied for the Eastman Kodak glucose and urea nitrogen analyzer. Serum, plasma, urine, and cerebrospinal fluid were tested. Precision, both "within-day" and "between-day," for both analytes was less than 2.2% (CV). Both analytes demonstrated linearity, with about 100% recovery of added substrates. Comparisons with continuous-flow procedures demonstrated good correlation. A variety of sera and plasmas can be used for glucose analysis; oxalate--fluoride-treated plasma is unacceptable for use in analysis for urea nitrogen. We saw no effects on glucose or urea nitrogen analysis from hemolysis, lipemia, icterus, some common drugs, ammonia, or abnormally high protein concentrations. Minimum amounts detectable were: glucose (serum) 104 mg/L; glucose (cerebrospinal fluid) 100 mg/L; and urea nitrogen (serum) 21 mg/L. Calibration procedures are discussed for protein-based and aqueous samples.

Download Full-text

The multilayered film analyzer: glucose in serum, plasma, cerebrospinal fluid, and urine; and urea nitrogen in serum and plasma.

Clinical Chemistry ◽

10.1093/clinchem/26.1.0133 ◽

1980 ◽

Vol 26 (1) ◽

pp. 133-137

Author(s):

K Warren ◽

N P Kubasik ◽

B B Brody ◽

H E Sine ◽

J P D'Souza

Keyword(s):

Cerebrospinal Fluid ◽

Continuous Flow ◽

High Protein ◽

Performance Criteria ◽

Aqueous Samples ◽

Multilayered Film ◽

Urea Nitrogen ◽

Laboratory Performance ◽

Film Analyzer ◽

Glucose Analysis

Abstract Some basic laboratory performance criteria were studied for the Eastman Kodak glucose and urea nitrogen analyzer. Serum, plasma, urine, and cerebrospinal fluid were tested. Precision, both "within-day" and "between-day," for both analytes was less than 2.2% (CV). Both analytes demonstrated linearity, with about 100% recovery of added substrates. Comparisons with continuous-flow procedures demonstrated good correlation. A variety of sera and plasmas can be used for glucose analysis; oxalate--fluoride-treated plasma is unacceptable for use in analysis for urea nitrogen. We saw no effects on glucose or urea nitrogen analysis from hemolysis, lipemia, icterus, some common drugs, ammonia, or abnormally high protein concentrations. Minimum amounts detectable were: glucose (serum) 104 mg/L; glucose (cerebrospinal fluid) 100 mg/L; and urea nitrogen (serum) 21 mg/L. Calibration procedures are discussed for protein-based and aqueous samples.

Download Full-text

Predictive Validity of a Selection Procedure for Air Traffic Controller Trainees

Aviation Psychology and Applied Human Factors ◽

10.1027/2192-0923/a000039 ◽

2013 ◽

Vol 3 (1) ◽

pp. 19-27 ◽

Cited By ~ 6

Author(s):

Yvonne Pecena ◽

Doris Keye ◽

Kristin Conzelmann ◽

Dietrich Grasshoff ◽

Peter Maschke ◽

...

Keyword(s):

Predictive Validity ◽

Selection Procedure ◽

Air Traffic ◽

Performance Criteria ◽

Training Phase ◽

Air Traffic Controller ◽

Training Performance ◽

Navigation Service ◽

German Aerospace ◽

Training Success

The job of an air traffic controller (ATCO) is very specific and demanding. The assessment of potential suitable candidates requires a customized and efficient selection procedure. The German Aerospace Center DLR conducts a highly selective, multiple-stage selection procedure for ab initio ATCO applicants for the German Air Navigation Service Provider DFS. Successful applicants start their training with a training phase at the DFS Academy and then continue with a unit training phase in live traffic. ATCO validity studies are scarcely reported in the international scientific literature and have mainly been conducted in a military context with only small and male samples. This validation study encompasses the data from 430 DFS ATCO trainees, starting with candidate selection and extending to the completion of their training. Validity analyses involved the prediction of training success and several training performance criteria derived from initial training. The final training success rate of about 79% was highly satisfactory and higher than that of other countries. The findings demonstrated that all stages of the selection procedure showed predictive validity toward training performance. Among the best predictors were scores measuring attention and multitasking ability, and ratings on general motivation from the interview.

Download Full-text