Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics.

Background Urine reagent strip test (URST) results are semi-quantitative; therefore, the precision of URSTs is evaluated as the proportion of categorical results from repeated measurements of a sample that are concordant with an expected result. However, URSTs have quantitative readout values before ordinal results challenging statistical monitoring for internal quality control (IQC) with control rules. This study aimed to determine the sigma metric of URSTs and derive appropriate control rules for IQC. Methods The URiSCAN Super Plus fully automated urine analyzer (YD Diagnostics, Yongin, Korea) was used for URSTs. Change in reflectance rate (change %R) data from IQC for URSTs performed between November 2018 and May 2020 were analyzed. Red blood cells, bilirubin, urobilinogen, ketones, protein, glucose, leukocytes, and pH were measured from 2-3 levels of control materials. The total allowable error (TEa) for a grade was the difference in midpoints of a predefined change %R range between two adjacent grades. The sigma metric was calculated as TEa/SD. Sigma metric-based control rules were determined with Westgard EZ Rules 3 software (Westgard QC, Madison, WI, USA). Results Seven out of the eight analytes had a sigma metric >4 in the control materials with a negative grade (-), which were closer to the cut-offs. Corresponding control rules ranged from 12.5s to 13.5s. Conclusions Although the URST is a semi-quantitative test, statistical IQC can be performed using the readout values. According to the sigma metric, control rules recommended for URST IQC in routine clinical practice are 12.5s to 13.5s.