Lysosomal Enzyme activity: Establishing Reference Intervals from Patient Data

Abstract

Objectives To develop reference intervals for leukocyte lysosomal enzymology.

Design Standards-based establishment of reference intervals by analysis of 7851 for 17 assays of 15 lysosomal enzymes in leukocyte and plasma (January 1985 through September 2013).

Methods Reference intervals were calculated using MedCalc for Windows version 12.5 (MedCalc Software, Ostend, Belgium), according to the Clinical and Laboratory Standards Institute C-28A protocol (CSLI-C28A).

Results and Conclusion Evidence based reference intervals are presented in tabular form for seventeen assays of fifteen lysosomal enzymes.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Work funded through employment with SA PAthology, a public laboratory.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Data was accessed in the study under and institutional review board waiver for use of data under quality assurance purposes, in this case specifically for the development of reference intervals. The institutional review board is that of South Australia (SA) Pathology.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Not available.

留言 (0)

沒有登入
gif