Innovative Journal Innovative Journal of Medical and Health Science 2589-9341 10 4 2020 4 13 Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini) 1 Neelam Gusain Tutor, Department of Biochemistry, Alfalah School Of Medical Science and Research Centre, Haryana, India. Anuradha B Patil Professor and Head, Department of Biochemistry, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India. Journal Article 37149729197 Abstract Introduction: Medical laboratories provide information and services that contribute to the effective healthcare delivery of the system. Laboratory results permit physicians and different healthcare professionals to make acceptable evidence-based diagnostic or therapeutic decisions for their patients. Methods: The Clinical Laboratory Standard Institute (CLSI) Guideline was used to determine the efficiency of ARK Diagnosis FALCON mini based on its Precision and Linearity. Glucose and Urea were analyzed, precision was done using three levels of pooled sera twenty sample of each level and for linearity testing done by preparing five different dilutions. The performance of the ARK Diagnosis FALCON mini is compared with manufacture’s claim. The results were presented as mean, standard deviation, coefficient of variation (CV %) and correlation coefficient (r) by using SPSS. Results: For Precision, Calculated CV% of all three levels was within the manufacturer’s CV%. The linearity results were also within the allowable range. The performance comparison revealed that the expected value and observed value are comparable, with Correlation coefficients (r) >0.9978 for glucose and urea. Precision and linearity both are within the allowable criteria. Conclusion: The cross-sectional study conducted to see whether the newly installed analyzer meets the performance criteria. Our results demonstrate that intraassay precision and linearity of the ARK analyzer meets the requirement of laboratory as per the CLSI guidelines. This gives a green signal for installation of the instrument. Maintaining the quality thereafter is another challenge and an ongoing process it should be maintained by internal and external quality control protocol. Abebe, N, Analytical Evaluation of the Clinical Chemistry Analyzer AU 480 Beckman Coulter, European Journal of Clinical and Biomedical Sciences, 2016, 2, 6, 59, 62 Álvarez, S I, Andreu, F A, Procedures for validation of diagnostic methods in clinical laboratory accredited by ISO 15189, Modern Approaches to quality control, 2011 Hartmann, Alfred E., Validation Protocol for New Methods or Instruments in the Clinical Laboratory, Laboratory Medicine, 1983, 14, 411, 416, 0007-5027, 1943-7730, Oxford University Press (OUP), 10.1093/labmed/14.7.411, https://dx.doi.org/10.1093/labmed/14.7.411 Ahir, K B, Singh, K D, Yadav, S P, Patel, H S, Poyahari, C B, Overview of validation and basic concepts of process validation, Sch. Acad. J. Pharm, 2014, 3, 178, 90 , Quality System Regulation Process Validation- FDA Das, B, Validation protocol: first step of a lean-total quality management principle in a new laboratory set-up in a tertiary care hospital in India, Indian Journal of Clinical Biochemistry, 2011, 26, 3, 235, 278 Guideline, I H, Text on validation of analytical procedures, International Conference on Harmonization, 1994, Geneva, 1, 5 Moffat, A C, Trafford, A D, Jee, R D, Graham, P, Meeting the International Conference on Harmonisation’s Guidelines on Validation of Analytical Procedures: Quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets The opinions expressed in the following article are entirely those of the authors and do not necessarily represent the views of either The Royal Society of Chemistry or the Editor of The Analyst, Analyst, 2000, 125, 7, 1341, 51