Quality Standards
Now that there are new measurement uncertainty goals, it's time to check if any instruments can hit them. Using the performance data from a recent study of the Alinity i and Alinity c instruments from a US laboratory, we assess the acceptability of the mu of their methods.
Now that there are new measurement uncertainty goals, it's time to check if any instruments can hit them. Using the performance data from a recent study of the Roche cobas 8000 series in France, we assess the acceptability of the mu of methods.
We look at the impact of new EFLM goals for coagulation assays on the assessment of an Atellica COAG 360.
One of the disappointments of the 2023 AACC/ADLM was seeing Siemen's benchmark their newest Atellica assays against the oldest CLIA goals.
A recent study of Abbott Alinity thyroid function tests can be evaluated against the EFLM MAU and the preferred permissible uncertainties proposed by the leading authorities on mu.
- 13 of 15 assays on a Roche Cobas 8000 cannot meet preferred perimissible uncertainty performance specifications
- 13 of 17 assays on a Roche Cobas 6000 c501 cannot hit preferred measurement uncertainty goals
- Six of Eight Assays on a Atellica CH930 cannot meet pU goals
- An Atellica HbA1c assay cannot meet pU goals