Verification of examination procedures for 72 biochemical parameters on the atellica® clinical chemistry and immunoassay analyzers.

The verification of examination procedures is a responsibility for clinical laboratories in order to guarantee that their performance characteristics comply with the specifications obtained during the validation process and are congruent with the intended scope of the assay. The aim was to perform an evaluation of precision, bias, linearity, linear drift, sample carry-over, and comparability of 73 assays from Siemens Healthineers, by following the CLSI EP10-A3 guidelines. The verification was performed by measuring 72 biochemical parameters in quality control (QC) materials from Bio-Rad (except for IL6) with 73 assays installed on eight measuring systems (five Atellica® CH 930 and three IM 1600 analyzers from Siemens Healthcare Diagnostics). The following information was collected: validation data from manufacturer, biological variation data from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) database, and specifications for fßhCG and PAPP-A assays to meet the Fetal Medicine Foundation standards. A total of 17550 results were obtained during EP10 verification process. Out of the 73 methods, only Cl-S, Mg-S, and Na-S failed the criteria for adequate precision, trueness, and comparability. The assays did not show significant loss of linearity, linear drift, or sample carry-over. This study allowed the initial training and familiarization with the instruments and the identification of operational issues. It also represented an opportunity to evaluate the QCs and to obtain analytical performance information for application of sigma six metrics for quality assurance. Professionals are advised to adequately standardize and protocolize their verification processes to ensure laboratory competence and patient safety.

Direct identification of urinary tract pathogens from urine samples by matrix-assisted laser desorption ionization-time of flight mass spectrometry.

Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has been suggested as a reliable method for bacterial identification from cultures. Direct analysis of clinical samples might increase the usefulness of this method, shortening the time for microorganism identification. We compared conventional methods for the diagnosis of urinary tract infections (UTIs) and identification of the urinary tract pathogens (automated screening, plate cultures, and identification based on biochemical characteristics) and a fast method based on conventional screening and MALDI-TOF MS. For this latter method, 4 ml of urine was centrifuged at a low-revolution setting (2,000 x g) to remove leukocytes and then at high revolutions (15,500 x g) to collect bacteria. The pellet was washed and then applied directly to the MALDI-TOF MS plate. Two hundred sixty urine samples, detected as positive by the screening device (UF-1000i), were processed by culture and MALDI-TOF MS. Twenty samples were positive in the screening device but negative in culture, and all of them were also negative by MALDI-TOF MS. Two-hundred thirty-five samples displayed significant growth of a single morphological type in culture. Two-hundred twenty of them showed bacterial growth of >10(5) CFU/ml. Microorganism identifications in this group were coincident at the species level in 202 cases (91.8%) and at the genus level in 204 cases (92.7%). The most frequent microorganism was Escherichia coli (173 isolates). MALDI-TOF MS identified this microorganism directly from the urine sample in 163 cases (94.2%). Our results show that MALDI-TOF MS allows bacterial identification directly from infected urine in a short time, with high accuracy, and especially when Gram-negative bacteria with high bacterial counts are involved.