Multi-centre evaluation of pre-transfusional routine tests using 8-column format gel cards (DG Gel®).
BACKGROUND
Advances in immunohaematology laboratory practice to improve performance, cost-effectiveness and patient safety are desirable.


OBJECTIVE
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
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.


CONCLUSIONS
The Grifols DG Gel(®) 8-column system is reliable and safe for routine tests performed in the immunohaematology laboratory.
Pathology Department, Birmingham Heartlands Hospital, Blood Transfusion Laboratory, Birmingham, UK. james.taylor@heartofengland.nhs.uk
J
J
Taylor
J
J
Hyare
P
P
Stelfox
M
M
Williams
R
R
Lees
M
M
Maley
D000328:Adult; D000906:Antibodies / Q000097:blood; D001331:Automation; D001789:Blood Group Antigens / Q000276:immunology; D001788:Blood Grouping and Crossmatching / Q000295:instrumentation; D001803:Blood Transfusion; D003298:Coombs Test / Q000295:instrumentation; D003955:Diagnostic Tests, Routine / Q000295:instrumentation*; D005782:Gels; D006386:Hemagglutination Tests / Q000295:instrumentation*; D006801:Humans; D007202:Indicators and Reagents; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000295:instrumentation; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016526:Workload
D000906:Antibodies; D001789:Blood Group Antigens; D005782:Gels; D007202:Indicators and Reagents