RT Journal Article
T1 Standardization in laboratory medicine: Two years' experience from category 1 EQA programs in Spain.
A1 Ricós, Carmen
A1 Perich, Carmen
A1 Boned, Beatriz
A1 González-Lao, Elisabet
A1 Diaz-Garzón, Jorge
A1 Ventura, Montserrat
A1 Bullich, Sandra
A1 Corte, Zoraida
A1 Minchinela, Joana
A1 Marques, Fernando
A1 Simón, Margarita
A1 Alvarez, Virtudes
A1 García-Lario, José-Vicente
A1 Fernández-Fernández, Pilar
A1 Fernández-Calle, Pilar
K1 bias
K1 external quality assessment
K1 standardization
K1 traceability
AB Standardization is the ability to obtain interchangeable results leading to same medical interpretation. External quality assessment (EQA) is the main support of the on-going harmonization initiatives. Aim of study was to evaluate results obtained from two years category 1 EQA program experience in Spain and determine the impact of applying this type of EQA program on the analytical standardization. According to the analytical method, traceability and instrument different groups were established which results were evaluated by calculating mean, coefficient of variation and percent of deviation to the reference value. Analytical performance specifications used to the results' evaluation were derived from biological variation for bias and from the inter-laboratory coefficients of variation found in a previous pilot study. Only creatinine measured by enzymatic methods gave excellent results, although few laboratories used this method. Creatine kinase and GGT gave good precision and bias in all, but one instrument studied. For the remaining analytes (ALT, ALP, AST, bilirubin, calcium, chloride, glucose, magnesium, potassium, sodium, total protein and urate) some improvement is still necessary to achieve satisfactory standardization in our setting. The two years of category 1 EQA program experience in Spain have manifested a lack of standardization of 17 most frequent biochemistry tests used in our laboratories. The impact of the information obtained on the lack of standardization is to recommend abandoning methods such as ALT, AST without exogenous pyridoxal phosphate, Jaffe method for creatinine, and do not use non-commutable calibrators, such as aqueous solutions for calcium and sodium.
SN 1330-0962
YR 2018
FD 2018-12-15
LK http://hdl.handle.net/10668/13365
UL http://hdl.handle.net/10668/13365
LA en
DS RISalud
RD Apr 8, 2025