Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini)

Neelam Gusain*, Anuradha B Patil

Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini)

Neelam Gusain*, Anuradha B Patil

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Neelam Gusain*, Anuradha B Patil, “Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini)”, ijmhs, vol. 10, no. 04, pp. 923–929, Apr. 2020.

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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.
Keywords: Validation study, Precision, Linearity, Glucose, Urea, CLSI,
CV%.

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Innovative Journal of Medical and Health Science

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[1]

Neelam Gusain*, Anuradha B Patil, “Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini)”, ijmhs, vol. 10, no. 04, pp. 923–929, Apr. 2020.

Issue Vol. 10 No. 04 (2020): Innovative Journal of Medical and Health Science
Section Research Articles

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Innovative Journal of Medical and Health Sciences

Evaluation of Validity of New Biochemistry Analyzer ARK Diagnosis FALCON (Mini)

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