%0 Journal Article %1 sabah_mokhtari_2024_11245041 %A Mokhtari, Sabah %A Himri, Amina %A Yacoubi, Loubna %A Beyyoudh, Soufiane %A Moujtahid, Dounia El %A houcine Sebbar, El %A Choukri, Mohammed %D 2024 %J World Journal of Biology Pharmacy and Health Sciences %K 19-9(carbohydrate CA antigen) %N 1 %P 129–135 %R 10.30574/wjbphs.2024.17.1.0031 %T Verification of the analytical performance of CA 19-9 assay on Abbott Alinity ci®: Experience of the central laboratory Mohammed VI Oujda %U https://wjbphs.com/content/verification-analytical-performance-ca-19-9-assay-abbott-alinity-ci%C2%AE-experience-central %V 17 %X Introduction: CA19-9 is a marker used in the diagnosis and monitoring of several cancer diseases. The aim of this study is to evaluate the CA19-9 assay on the Abbott ALinity Ci automated system. This evaluation is part of an overall approach to verifying the methods used in the CHU's central laboratory, with a view to compiling an accreditation file in line with the requirements of standard NF EN ISO 15189. Materials and methods: The aim of our study was to evaluate the scope A criteria detailed in the guide to verification/validation of methods in Medical Biology, in accordance with the recommendations of standards NF EN ISO/CEI 17025, NF EN ISO 15189 and NF EN ISO 22870. Verification was carried out on the CA19-9 assay on Alinity® Ci, which uses the immunoassay technique Criteria (repeatability, reproducibility) were verified. Results: The results obtained show good repeatability for the 3 levels with respectively CV1=2,61% , CV2=2,78% , and CV3 =3,26% % and intra-laboratory reproducibility with CV1=3,98% , CV2= 3,16% and CV3 = 3,61%. Discussion and Conclusion: The central laboratory of our University Hospital is committed to a quality policy which includes a control approach for the various analytical systems used. The results obtained for the various CA19-9 assay verification criteria on our Alinity® Ci system, compared with data from the supplier, RICOS and learned societies, are satisfactory and verify analytical performance.

@article{sabah_mokhtari_2024_11245041, abstract = {Introduction: CA19-9 is a marker used in the diagnosis and monitoring of several cancer diseases. The aim of this study is to evaluate the CA19-9 assay on the Abbott ALinity Ci automated system. This evaluation is part of an overall approach to verifying the methods used in the CHU's central laboratory, with a view to compiling an accreditation file in line with the requirements of standard NF EN ISO 15189. Materials and methods: The aim of our study was to evaluate the scope A criteria detailed in the guide to verification/validation of methods in Medical Biology, in accordance with the recommendations of standards NF EN ISO/CEI 17025, NF EN ISO 15189 and NF EN ISO 22870. Verification was carried out on the CA19-9 assay on Alinity® Ci, which uses the immunoassay technique Criteria (repeatability, reproducibility) were verified. Results: The results obtained show good repeatability for the 3 levels with respectively CV1=2,61% , CV2=2,78% , and CV3 =3,26% % and intra-laboratory reproducibility with CV1=3,98% , CV2= 3,16% and CV3 = 3,61%. Discussion and Conclusion: The central laboratory of our University Hospital is committed to a quality policy which includes a control approach for the various analytical systems used. The results obtained for the various CA19-9 assay verification criteria on our Alinity® Ci system, compared with data from the supplier, RICOS and learned societies, are satisfactory and verify analytical performance.}, added-at = {2024-05-31T11:07:34.000+0200}, author = {Mokhtari, Sabah and Himri, Amina and Yacoubi, Loubna and Beyyoudh, Soufiane and Moujtahid, Dounia El and houcine Sebbar, El and Choukri, Mohammed}, biburl = {https://www.bibsonomy.org/bibtex/25ca43a817d64f9ccc4324056b4c18ccc/wjbphsjournal}, doi = {10.30574/wjbphs.2024.17.1.0031}, interhash = {50ed12c5712df2bbc6948bd628c13f4b}, intrahash = {5ca43a817d64f9ccc4324056b4c18ccc}, issn = {2582-5542}, journal = {{World Journal of Biology Pharmacy and Health Sciences}}, keywords = {19-9(carbohydrate CA antigen)}, month = may, number = 1, pages = {129–135}, timestamp = {2024-05-31T11:07:34.000+0200}, title = {Verification of the analytical performance of CA 19-9 assay on Abbott Alinity ci®: Experience of the central laboratory Mohammed VI Oujda}, url = {https://wjbphs.com/content/verification-analytical-performance-ca-19-9-assay-abbott-alinity-ci%C2%AE-experience-central}, volume = 17, year = 2024 }