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Indian Journal of Clinical Biochemistry

, Volume 34, Issue 1, pp 89–94 | Cite as

EP15A3 Based Precision and Trueness Verification of VITROS HbA1C Immunoassay

  • Srinivas Narasimhachar Chakravarthy
  • Satish RamanathanEmail author
  • Smitha S
  • Thirumalai Nallathambi
  • Micheal S
Original Research Article
  • 89 Downloads

Abstract

Verification of analytical performance of measurands becomes an essential requirement for the laboratories before proceeding to patients’ samples testing. In our study we have verified the performance of HbA1C Immunoturbidimetric assay (VITROS 5600) against manufacturers’ claims using CLSI EP15A3 Guidelines. We performed our study using two concentrations of Quality Control from Bio-Rad (Level 1 and Level 2). A precision verification study was carried out using five replicates of QC per day for five days following which imprecision estimates in form of Within Run (Repeatability) %CV and Within Lab %CV were calculated and compared against manufacturer’s claims. Second part of our study included derivation of grand mean from the results of 25 replicates of QC used for precision verification. This was compared against the Target Value of the assigned QC obtained from the peer group mean of laboratories participating in interlaboratory QC program (unityTM Interlab-Bio-Rad) for %bias estimation. The findings of our precision study showed an acceptable Within Lab imprecision (%CVWL-0.6%), while the %CV -repeatability (%CVR-0.54%) was greater than the manufacturer’s claim (σR-0.5%). Hence upper verification limit for the manufacturer’s claim (0.65%) was calculated against which the %CV Repeatability was compared and was found to be acceptable. The trueness verification showed that our grand mean (5.488%) was within the verification interval of the target value (5.462–5.497%) and hence the actual %bias was not statistically significant. Our study demonstrates that HbA1C immunoassay shows an acceptable performance consistent with the manufacturer’s claims.

Keywords

Verification EP 15 A3 Precision Trueness HbA1c 

Abbreviations

ISO

International organisation for standardisation

CLSI

Clinical laboratory standards institute

QC

Quality control

HbA1c

Glycosylated haemoglobin

SD

Standard deviation

CV

Co-efficient of variation

Notes

Acknowledgements

The authors acknowledge the support of management of Madras Institute of Traumatology (MIOT) Hospital for their encouragement and support in this work.

Funding

This study was not funded by any organization

Compliance with Ethical Standards

Conflict of interest

None of the authors of this study have any conflict of interest.

Ethical Approval

This article contains study only with quality control materials commercially obtained. No patient samples were involved.

Supplementary material

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Supplementary material 1 (JPEG 477 kb)
12291_2017_712_MOESM2_ESM.jpg (141 kb)
Supplementary material 2 (JPEG 140 kb)

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Copyright information

© Association of Clinical Biochemists of India 2017

Authors and Affiliations

  1. 1.Department of Laboratory MedicineMIOT HospitalsChennaiIndia
  2. 2.Department of Clinical BiochemistryMIOT HospitalsChennaiIndia

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