Analytical validation of the results

Vassault, Anne; Arnaud, José; Szymanovicz, A.

doi:10.1684/abc.2011.0559

Cited by 2 publications

(8 citation statements)

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“…The results of the repeatability and reproducibility study for phosphorus show satisfactory performance in relation to supplier data and CSFB criteria.The study indicates that the two automated systems provide similar results for phosphorus when using the same samples for comparison [6][7][8][9][10][11][12].…”

Section: Discussionmentioning

confidence: 75%

“…These techniques are classified in the flexible category of scope A for method verification, as specified in COFRAC guide SH-GTA-04. [6][7][8][9][10].…”

Section: Discussionmentioning

confidence: 99%

“…The CE marking of Abbott's biochemical techniques guarantees their compliance with regulatory standards applicable to clinical diagnosis in medical laboratories. The flexible category A for method verification, as specified in COFRAC guide SH-GTA-04, provides a recognized and accepted approach for verifying the performance of these techniques in the laboratory [7][8][9][10][11].…”

Section: Discussionmentioning

confidence: 99%

“…Accurate and reliable measurement of serum phosphorus is necessary for satisfactory management, treatment planning and monitoring of patient response [6][7][8][9][10]. The verification process involves a comprehensive assessment of the assay's performance characteristics, including repeatability, reproducibility, sensitivity, specificity and linearity.…”

Section: Discussionmentioning

confidence: 99%

“…The verification process, in accordance with ISO 15189, is a guarantor of the reliability of the laboratory's phosphorus determination method, and enables trust between healthcare providers, patients and stakeholders [1][2][3][4][5][6][7]. Successful verification of the phosphorus determination method, in accordance with ISO 15189, enhances the laboratory's credibility, reputation and competitiveness in the healthcare industry [6][7][8][9]. In our study, we aimed to evaluate the analytical performance of the serum phosphorus determination method using an Abbott kit on the Alinity c automated system at the biochemistry laboratory of the CHU Mohammed VI of Oujda.…”

Section: Introductionmentioning

confidence: 97%

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Verification of the analytical performance of the serum phosphorus assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI University Hospital of Oujda

Sabah Mokhtari,

Loubna Yacoubi,

Imane Naji

et al. 2023

World J. Bio. Pharm. Health Sci.

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Introduction: In our study, we aimed to evaluate the analytical performance of the serum phosphorus determination method using an Abbott kit on the Alinity c automaton at the biochemistry laboratory of Mohammed VI University Hospital of Oujda. Materials and methods: We evaluated the performance of the kit using flexible scope A and conducted a thorough performance study on the Alinity c automaton. This study encompassed assessments of repeatability, reproducibility and comparisons of results obtained from two Alinity c automatons. Results: The obtained results met the acceptability criteria recommended by the supplier and the French Society of Clinical Biology(Société Française de Biologie Clinique SFBC) Valtec protocol, indicating overall satisfaction with the study. The Alinity c automaton exhibited the necessary analytical performance to ensure accurate and dependable determination of phosphorus levels. Discussion: Ensuring accurate and reliable results, the verification of the serum phosphorus determination method in the medical laboratory is crucial. This process entails implementing quality control measures, calibration, and comparing with established reference methods. It guarantees that the laboratory's phosphorus testing method is precise, accurate, and compliant with industry standards, thereby upholding the quality of patient care. Conclusion: The verification study of the serum phosphorus determination method yielded satisfactory results, providing high reliability to the test results from the central laboratory at Mohammed VI University Hospital of Oujda. This verification study serves as a strong foundation in the accreditation process, ensuring the accuracy and quality of laboratory testing, and enhancing the overall reliability of patient care

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Section: Discussionmentioning

confidence: 75%

“…These techniques are classified in the flexible category of scope A for method verification, as specified in COFRAC guide SH-GTA-04. [6][7][8][9][10].…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

See 3 more Smart Citations

Verification of the analytical performance of the serum phosphorus assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI University Hospital of Oujda

Sabah Mokhtari,

Loubna Yacoubi,

Imane Naji

et al. 2023

World J. Bio. Pharm. Health Sci.

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Verification of analytical performance of sodium assay on the Abbott architect ci8200: Experience of the central laboratory Mohammed VI Oujda

Soufiane Beyyoudh,

Mohammed Lahmer,

Dounia El Moujtahide

et al. 2023

World J. Bio. Pharm. Health Sci.

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Introduction: Sodium is the main extracellular cation. It plays a fundamental role in maintaining osmotic pressure and hydroelectrolyte balance, and is therefore implicated in many pathological conditions. Sodium determination is a basic biochemistry laboratory test. Objective: the aim of our work is to verify the method of sodium determination by potentiometry on the Architect CI 8200 automated system (Abbott), in order to meet the quality requirements for laboratory accreditation under standard NF ISO 15189. Materials and methods: following the recommendations of NF EN ISO 15189, we evaluated the repeatability, intermediate precision, accuracy and uncertainty of measurement of the serum sodium assay on the Architect CI 8100 automated system, as well as a mirror comparison of the two Architect CI 8100 1 and 2. The CV values obtained were compared with those set by learned societies (SFBC and RICOS). Results and discussion: The results obtained show satisfactory repeatability for the 3 low, medium and high levels, with CV1= 1.1%, CV2=0.8% and CV3= 0.76% respectively, and satisfactory intra-laboratory reproducibility for the 3 low, medium and high levels, with CV1= 1.05%, CV2= 0.95% and CV3= 0.75% respectively. For comparison, the Bland-Altman diagram showed that the mean bias between the two automata was of the order of 0.29%, the correlation coefficient r= 0.98 with a mean difference of 0.40 mmol/l, a standard deviation of 0.675 mmol/l and a linear regression equation Y = 1.027 X - 4.073. Corrective measures were envisaged to remedy the various errors identified. To solve any malfunction in a sustainable way, it is essential to search for the anomaly by applying the Ishikawa diagram. Conclusion: The results obtained have enabled us to verify the performance of the sodium assay method and compare it with the analytical objectives set, in order to meet the regulatory and normative requirements to which our laboratory is committed.

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Analytical validation of the results

Cited by 2 publications

References 0 publications

Verification of the analytical performance of the serum phosphorus assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI University Hospital of Oujda

Verification of the analytical performance of the serum phosphorus assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI University Hospital of Oujda

Verification of analytical performance of sodium assay on the Abbott architect ci8200: Experience of the central laboratory Mohammed VI Oujda

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