Analysis of short-term variation and long-term drift during reagent kit lot change in an NABL accredited clinical biochemistry laboratory.

Vivek Ambade,Bhasker Mukherjee,Madathan Kandi Sibin,Ponnaiah Rasu,Yaongamphi Vashum,Prakash Berthwal Indra,Kapil Bhatia,Mukul Sharma,Pratibha Misra,Manoj Puliyath

doi:10.5937/jomb0-25597

Vivek Ambade, Bhasker Mukherjee + Show 8 more

Open Access

https://doi.org/10.5937/jomb0-25597

Copy DOI

Abstract

BackgroundKit lot change in clinical biochemistry labs leads to variations in patient results. This study planned to identify variations during 60 reagent lot changes in our laboratory during the period from June 2018 to May 2019.MethodsA statistical analysis was performed to identify the difference between patient samples results variations and QC results. The long term drift was analyzed using a regression test.ResultsThere was a significant difference between the patient and QC results in 16.7% of reagent lot changes. Moreover, the extent of variation in QC results was 3.3%. No long-term drift was seen in three analytes which were studied using regression analysis.ConclusionsOur results showed that, during reagent kit lot change, along with QC material, the patient samples should also be run in order to identify the variation. However, this practice is presently ignored by most of the laboratories. There was no accumulated effect in our laboratory due to reagent kit lot change.

Highlights

Delivering consistent and reliable test results is the primary objective of a clinical chemistry laboratory, for which various steps of quality control (QC) are to be followed properly
Our results showed that, during reagent kit lot change, along with QC material, the patient samples should be run in order to identify the variation
According to NABL, the kit lot change should be accompanied by QC run, and the values of QC should not surpass the range set for the old lot [6]

Summary

Introduction

Delivering consistent and reliable test results is the primary objective of a clinical chemistry laboratory, for which various steps of quality control (QC) are to be followed properly. In an automated clinical biochemistry lab, the autoanalyser uses various consumables like reagents, calibrators and QC materials for the routine testing of patient samples. The amount of reagents consumed is determined by the total number of tests a laboratory receives, and the frequency of reagent kit change further depends on this. The manufacturing conditions in which each of these lots is produced will be slightly different and it can lead to a slight change in the analytical process which is generally acceptable [2]. In Indian laboratories, National accreditation board for testing and calibration laboratories (NABL) is the agency which gives the certification and accreditation for the quality of the work they perform. According to NABL, the kit lot change should be accompanied by QC run, and the values of QC should not surpass the range set for the old lot [6]

Methods

Results

Conclusion