P55

Evaluation of Technopath Controls on the ARCHITECT Family of Instruments

Jessie Shih1,*, Didier Brault2, Antonio Croce3, Lieselotte Lennartz4, Matthias Orth5

1Global Scientific Affairs, Abbott Laboratories, Abbott Park, United States, 2Service de biochemie, Hopital Tenon, Paris, France, 3Ospedale Civile Sondrio, Sondrio, Italy, 4Abbott Laboratories, Wiesbaden, 5Instituts for Laboratoriumsmedizin, Vinzenz von Paul Klinikem, Marienhospital, Stuttgart, Germany

Introduction: Quality controls are important for laboratories to ensure that results meet the required quality in regard to accuracy and precision.  Consolidation of controls is an important trend in laboratories to simplify QC testing.  Multi-constituent controls are available cover a wide range of clinical chemistry and immunoassay analytes.

Objectives: To evaluate the performance of the Technopath Multichem S Plus, Multichem IA Plus and Multichem U controls on the ARCHITECT instruments.  Precision and accuracy compared to the target value were evaluated.

Methods: Three European sites evaluated the controls in parallel with their routine QC.  Testing was performed on the ARCHITECT instruments.  Data are from the following clinical chemistry analytes: ALT,AST, total bilirubin, chloride, total cholesterol, creatinine ,glucose, potassium, total protein, sodium, triglycerides and urea; the following immunoassays: CA 19-9, CEA, total PSA, free T3, free T4, TSH, troponin-I, total beta HCG, testosterone, estradiol and FSH; and on the following urine assays: chloride, creatinine (enzymatic and picrate), glucose, potassium, sodium and urea.    Means, standard deviations and ranges were calculated for all controls.

Results: The %CV for the assays with the Multichem S Plus control ranged from 0.42 to 4.71%.  The %CV for the assays with the Multichem U control ranged from 0.50 to 5.24%.  For both controls, the majority of the CVs were less than 2%.  The %CV for the assays with the Multichem IA Plus control ranged from 1.82 to 14.94%; however the majority of the CVs were less than 5%.  Overall little variation was seen instrument to instrument, site to site or reagent lot to reagent lot.

Conclusion: The Technopath S Plus, IA Plus and U controls demonstrated similar performance to the routine quality controls.  The use of these MCCs reduce the  number of controls required for the analytical quality control testing of both clinical chemistry and immunoassay analytes with no compromise on quality.

Keywords: Laboratory organization, Method