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 (%CV WL -0.6%), while the %CV -repeatability (%CV R -0.54%) was greater than the manufacturer's claim (rR-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 Á EP 15 A3 Á Precision Á Trueness Á 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 Electronic supplementary material The online version of this article (

Background/Objective: NACO has laid down three structured algorithms (I, II, III) for HIV screen, surveillance and diagnosis. It is the responsibility of the laboratories to select, verify and evaluate the methods fitting into the algorithm of HIV testing. The present study has attempted to evaluate VITROS® HIV combo assay through comparison with Abbott Architect HIV combo assay. Method:The study evaluated VITROS® HIV combo assay through precision verification and diagnostic accuracy assessment by adopting CLSI guidelines. Precision verification of the VITROS HIV combo assay is done based on CLSI EP15A3 and diagnostic accuracy verification based on CLSI EP12A2.Result: Precision verification showed a repeatability CV% (CVR) -2.35% and within lab CV% (CVWL)-3.77%. This was compared against the manufacturer's claims (σR-3%, σWL-4.8%) and found to be within acceptable limits. Diagnostic accuracy verification showed that difference in paired sensitivity between VITROS® HIV combo assay and Abbott Architect HIV combo assay was zero and difference in paired specificities was 0.3%. This difference was proved to be statistically insignificant based on 95% confidence interval for the paired sensitivities and specificities. Conclusion:The study showed an acceptable performance of VITROS HIV combo assay in terms of precision and diagnostic accuracy.

One among the many potential errors in clinical laboratory is the analytical errors, which are bound to occur in the examination phase of testing process. The two most significant errors in the analytical process are imprecision and inaccuracy. 2 The clinical laboratories worldwide have developed two effective tools for the imprecision and inaccurate investigation; those being internal quality control (IQC) tool for imprecision monitoring and EQA tool for inaccuracy assessment. 3 In shaping the analytical quality from accuracy perspective, EQA holds a major share. But this depends on how a laboratory perceives an EQA, understands it, and uses it efficiently for inaccuracy assessment. General perception in clinical laboratory practice is that "an unacceptable EQA result means poor accuracy and otherwise." 4 But whether this perception holds true in all occasions and what are the factors to be considered while interpreting an EQA forms the focus of this study. Our case study includes three brief case reports through which we have tried to understand how to interpret and troubleshoot EQA.

Aim and objective: The study aims to illustrate how laws of nature govern man and his machine and aid laboratory medicine specialists to revisit basics of good clinical laboratory practices (GCLP) without which none of the modern tools of quality including sigma, lean, 5S, etc., would bring improvement in the quality of performance of a clinical laboratory and add on to patients' safety. Background: The culture, tradition of India is deep-rooted in its history and heritage, which are governed by laws of nature. The modern era of healthcare has evidenced magnanimous evolution in terms of technological revolution wherein machines equipped with artificial intelligence would in near future take center stage in the field of clinical laboratory medicine. To whatever heights evolution might climb, in terms of technology, it has to obey laws of nature which, in simple terms, means GCLP. Case description: We experimented with a study of the impact of five elements of nature on specific analytes' performance in the VITROS 5600 integrated testing platform. Performance characteristics of these analytes were analyzed and we have tried to explore the outcome of this study through five case scenarios wherein we have attempted to invigilate whether the basic elements of nature play a significant role in the quality of results produced by a testing system. Conclusion: Hence, it is a need of the hour to focus on the fundamentals of clinical laboratory medicine which stand as pillars of quality and contribute to patient safety. Clinical significance: There is a constant surge in the number of clinical laboratories globally, moving toward technological advancements. But the basic ingredients for achieving the ultimate goal-the quality of the result and patient safety lies deep in form of panchabooth, which are five key essential elements that govern the laws of nature including man and his environment (testing environment) in the field of laboratory medicine.