Dr. Carmen Ricos and her colleagues have generously allowed us to post a new database on Biologic Variation within subjects with disease. The previous databases have relied on data from healthy patients. See how the variation changes when you examine patients with different disease states.

CLIA Proficiency Testing criteria

The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process.

This table contains information on Clinical quality requirement that describe medically important changes in test values, or Decision Intervals (D_int) expressed as a percentage change at a certain Decision Level (D_int = change divided by decision level multiplied by 100 to give a percentage). The sources of the decision intervals presented here are the paper by Skendzel, Barnett, and Platt and a series of recommendations for lipid tests from the National Cholesterol Education Program (NCEP).

In the early 1990s, a group of European scientists fromed to recommend the best targets for imprecision, inaccuracy, and total error (calculated from biologic variation). This became called the "European Biologic Goals and Calculated Biologic Allowable Total Errors." While later eclipsed by the work of Dr. Carmen Ricos et al (the biodatabase desirable specifications), these quality requirements remain an important resource.

Updated for 2010! Desirable Specifications for imprecision, inaccuracy, and total allowable error,  calculated from data on within-subject and between-subject biologic variation. This database is updated and compiled by Dr. Carmen Ricos and colleagues. We are honored to be able to host this database.

Dr. Carmen Ricos and colleagues update this database on within-subject and between-subject biologic variation. From this data, they also calculate desirable specifications for imprecision, inaccuracy, and total allowable error. We are honored to be able to host this database. This article lists the references that were used to develop the specifications.

Dr. Carmen Ricos and colleagues update this database on within-subject and between-subject biologic variation. From this data, they also calculate desirable specifications for imprecision, inaccuracy, and total allowable error. We are honored to be able to host this database. This article lists all of the references.

The RCPA (Royal College of Pathologists of Australasia) have developed a thorough set of specifications for allowable error. For those not bound by the CLIA regulations, these can serve as a valuable resource. Many analytes that are non-regulated by CLIA can be found here, too.

In a new paper, two scientists perform a literature survey of the veterinary diagnostic literature and attempt to calculate basic quality requirements for common analytes - for the non-human species.