Abstract
Manufacturer-supplied reference intervals for routine chemistry analytes are frequently adopted without local verification, despite
published evidence that several common analytes show clinically meaningful differences across ethnic groups. We verified
reference intervals for fourteen routine chemistry analytes in a cross-sectional sample of 2,860 healthy adult volunteers drawn
from a deliberately multi-ethnic regional population, using CLSI-recommended verification methodology, and compared the
verified intervals against the manufacturer's package-insert values. Four of fourteen analytes -- creatinine, high-density
lipoprotein cholesterol, alkaline phosphatase and total bilirubin -- failed manufacturer interval verification when the full
multi-ethnic cohort was analysed together, and sub-analysis showed that failure was driven by systematic between-group
differences rather than by overall population variance. We report the specific intervals that required local adjustment and set out
a practical verification protocol for a laboratory serving a similarly diverse population.
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