TY - JOUR
T1 - Implementation of new Westgard rules suggested by the Westgard Advisor software for five immunological parameters
AU - Cristelli, Lisa
AU - Occhipinti, Francesca
AU - Tumiatti, Daniel
AU - Antonia, De Luisi
AU - Jani, Erika
AU - Daves, Massimo
N1 - Lehr-kH Clinical Biochemistry Laboratory, Provincial Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy und Hospital of Silandro, Silandro, Italy
PY - 2025/2/15
Y1 - 2025/2/15
N2 - INTRODUCTION: Knowledge and systematic evaluation of analytical errors is the task of internal analytical quality control management. The aim of this study was to assess whether the Westgard rules proposed by Bio-Rad's Westgard Advisor software are more efficient in the monitoring of analytical performance than those previously in use.MATERIALS AND METHODS: The study was carried out on the nephelometer Atellica NEPH630 (Siemens Healthineers, Erlangen, Germany). Five parameters were chosen: serum immunoglobulin A (IgA), alpha 1 - antitrypsin (AAT), prealbumin, lipoprotein (a) (Lp(a)) and ceruloplasmin. The study was divided into 4 phases (A, B, C, D): phase A - old rules used (13s, R4s and 22s); phase B - first introduction of new rules (30 days), (13s/22s for IgA; 13s/22s/R4s/41s/10x for the remaining parameters); Phase C - second intervention (after 60 days) 13s/22s/R4s/41s for IgA and Lp(a), 13s/22s/R4s/41s/8x for prealbumin and ceruloplasmin and 13s/22s/R4s/41s/10x for AAT; and Phase D - values at the end of the study (13s for IgA, 13s/22s/32s/R4s/31s/12x for AAT and ceruloplasmin, 13s/22s/R4s/41s/8x for prealbumin and 13s/22s/R4s/41s/10x for Lp(a).RESULTS: At the end of the study the coefficient of variation (CV%), bias (%) and sigma for IgA were 2.55%, - 1.09% and 5.33, respectively; for AAT 3.88, - 2.21 and 3.25; for prealbumin 3.99, - 0.14 and 2.95; for Lp(a) 8.02, - 0.34 and 3.81; for ceruloplasmin 2.48, - 3.65 and 3.49.CONCLUSIONS: By using newly suggested rejection rules, we did not observe an improvement in monitoring of analytical performance.
AB - INTRODUCTION: Knowledge and systematic evaluation of analytical errors is the task of internal analytical quality control management. The aim of this study was to assess whether the Westgard rules proposed by Bio-Rad's Westgard Advisor software are more efficient in the monitoring of analytical performance than those previously in use.MATERIALS AND METHODS: The study was carried out on the nephelometer Atellica NEPH630 (Siemens Healthineers, Erlangen, Germany). Five parameters were chosen: serum immunoglobulin A (IgA), alpha 1 - antitrypsin (AAT), prealbumin, lipoprotein (a) (Lp(a)) and ceruloplasmin. The study was divided into 4 phases (A, B, C, D): phase A - old rules used (13s, R4s and 22s); phase B - first introduction of new rules (30 days), (13s/22s for IgA; 13s/22s/R4s/41s/10x for the remaining parameters); Phase C - second intervention (after 60 days) 13s/22s/R4s/41s for IgA and Lp(a), 13s/22s/R4s/41s/8x for prealbumin and ceruloplasmin and 13s/22s/R4s/41s/10x for AAT; and Phase D - values at the end of the study (13s for IgA, 13s/22s/32s/R4s/31s/12x for AAT and ceruloplasmin, 13s/22s/R4s/41s/8x for prealbumin and 13s/22s/R4s/41s/10x for Lp(a).RESULTS: At the end of the study the coefficient of variation (CV%), bias (%) and sigma for IgA were 2.55%, - 1.09% and 5.33, respectively; for AAT 3.88, - 2.21 and 3.25; for prealbumin 3.99, - 0.14 and 2.95; for Lp(a) 8.02, - 0.34 and 3.81; for ceruloplasmin 2.48, - 3.65 and 3.49.CONCLUSIONS: By using newly suggested rejection rules, we did not observe an improvement in monitoring of analytical performance.
KW - Humans
KW - Prealbumin/analysis
KW - Software
KW - Ceruloplasmin/analysis
KW - Immunoglobulin A/blood
KW - alpha 1-Antitrypsin/blood
KW - Lipoprotein(a)/blood
KW - Nephelometry and Turbidimetry
U2 - 10.11613/BM.2025.010701
DO - 10.11613/BM.2025.010701
M3 - Original Article
C2 - 39703760
SN - 1330-0962
VL - 35
SP - 010701
JO - Biochemia Medica
JF - Biochemia Medica
IS - 1
ER -