First assessment the analytical quality specification in Clinical Chemistry laboratory, using Sigma scale and EQA/PT in Iran: a pilot study

Journal Title: World Journal of Pharmaceutical Sciences - Year 2017, Vol 5, Issue 8

Abstract

Background: To assess the analytical performance of quality trough external quality assesses and internal quality program data on sigma scale. Method and material: Imprecision was determined from the cumulative Levey-jenning SD over the 6 month, bias was calculated from the external quality records, Finally, analytical sigma metric estimates were calculated for each Analytes by the following equation: sigma metric: (TEa – Bias)/CV. All function and statistical analysis were done in our Private laboratories. Result: The sigma value >6 was observed for most analytes. Some of analytes have poor sigma metric <3 such as Creatinine and ALP in normal level and Calcium in pathologic level. Glucose, Urea, Uric Acid, Calcium, Phosphorous, total bilirubin, in normal levels and Urea, Creatinine, total and direct bilirubin in pathologic level have intermediate sigma metric 4-6. Conclusion: Chemistry tests are not commodities. Quality varies significantly from manufactures to manufactures and method to method. The sigma-assessment from multiple EQA/IQC programs provides more insight into the performance of methods and quality. Laboratory seeking optimal quality program would do well to consult this data as part of their decision-working process.

Authors and Affiliations

Reza Pahlavan Gharehbaba

Keywords

Related Articles

Formulation development and in vitro evaluation of immediate release tablets of zolpidem tartrate

Zolpidem Tartarate belongs to class II drugs, that is, characterized by low solubility and high permeability therefore, the enhancement of its solubility and dissolution profile is expected to significantly improve its b...

Advancement in Dengue Treatment: A review

This review describes and commentates on recent advances in the understanding of dengue diagnosis and immunity, plus clinical research on vaccines and therapeutics. We expand specifically on the role of the dermis in den...

A study on in-vitro antimicrobial activity of Coconut water and coconut oil on Candida Species

A study on in-vitro antimicrobial activity of Coconut water and coconut oil on Candida Species. The indiscriminate use of antimicrobial synthetic products has led us to the state of resistance and also provoked the need...

Comparative study of Cross povidone and Cross Carmellose Sodium to formulate Immediate Release Tablet of Theophylline

Oral route of drug administration have wide acceptance up to 50-60% of total dosage forms. Solid dosage forms are popular because of ease of administration, accurate dosage, self-medication, pain avoidance and most impo...

Clinical evaluation of nirgundi oil used in ancient Indian medicine – in the management of non-healing ulcers

The management of infected/contaminated wounds modern science is using newer & newer antibiotics are becoming ineffective due to microbial resistance. Along with these antibiotics they use NSAID’S & Multivitamin containi...

Download PDF file
  • EP ID EP330331
  • DOI -
  • Views 23
  • Downloads 0

How To Cite

Reza Pahlavan Gharehbaba (2017). First assessment the analytical quality specification in Clinical Chemistry laboratory, using Sigma scale and EQA/PT in Iran: a pilot study. World Journal of Pharmaceutical Sciences, 5(8), 165-170. https://europub.co.uk/articles/-A-330331