Premium
Multi‐centre evaluation of pre‐transfusional routine tests using 8‐column format gel cards (DG Gel ® )
Author(s) -
Taylor J.,
Hyare J.,
Stelfox P.,
Williams M.,
Lees R.,
Maley M.
Publication year - 2011
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/j.1365-3148.2010.01054.x
Subject(s) - abo blood group system , antibody , medicine , predictive value , immunology
Background: Advances in immunohaematology laboratory practice to improve performance, cost‐effectiveness and patient safety are desirable. Objectives: To perform a multi‐centre evaluation of the 8‐column Grifols DG Gel ® cards and reagent system to assess its performance, suitability and adaptability to the daily blood transfusion laboratory routine in the United Kingdom. Methods/Materials: A total of 4281 immunohematological analyses {1825 ABO/D grouping, 1921 antibody screening, 75 Rh phenotyping and K antigen determination, 361 antibody identification and 99 neonates [ABO/D and DAT (direct anti‐globulin test)]} were performed on 2255 specimens. All cases were run in parallel with the reference method of each laboratory (DiaMed‐ID ® cards or conventional tube technique in some cases). Results: Concordant results between Grifols DG Gel ® system and the reference method were obtained in 97·7% of tests. For ABO grouping by the Grifols DG Gel ® system, sensitivity was 99·95%, specificity was 99·96%, predictive positive value (PPV) was 99·89% and predictive negative value (PNV) was 99·98%. For D grouping, sensitivity was 99·78%, specificity was 100%, PPV was 100% and PNV was 99·78%. For antibody screening, sensitivity was 90·63%, specificity was 99·94%, PPV was 99·32% and PNV was 99·15%. Of the Rh subgroups and K types, results were 100% concordant. For antibody specificity detection, accuracy was 96·95% for Grifols DG Gel ® system and 95·29% for DiaMed‐ID ® system. For the newborn tests, concordant results were obtained in 100% of ABO/D grouping and in 89·9% of DAT. Conclusion: The Grifols DG Gel ® 8‐column system is reliable and safe for routine tests performed in the immunohaematology laboratory.