What this study supports, and what it does not

A passing study supports performance only at the concentrations, materials, and conditions actually tested. It does not establish linearity from five points or replace the procedure’s wider verification and implementation decisions.

What depends on local policy: the exact numeric acceptance limit, which materials are approved, the schedule beyond the six-month CLIA minimum, the number of replicates and levels beyond the low/mid/high floor, the configured reportable range and flag text in the LIS, and who signs off on a failed point, bench technologist or supervisor or laboratory director. None of that is fixed by CLIA itself; CLIA requires the laboratory to have documented, verified criteria, not one universal number.

Not stated here: a specific current CAP checklist number for calibration verification, exact publication years for the CLSI EP06/EP15/EP17 editions beyond their stated designations, and any vendor's actual current lot-specific target values, since those change lot to lot and must come from the assay sheet shipped with the material in use. The Roche cobas GLUC3 example used throughout is one method's numbers; confirm the AMR, reagent, and software version actually installed in your laboratory before treating any number here as current.

Before trusting a reported glucose value from a newly implemented lot or calibration, confirm the reportable range that value falls in was the range actually verified, not assumed.