Evaluation of the Automated Blood Bank Instrument QWALYS-3 for Cross-Matching Tests / 대한수혈학회지

BACKGROUND: The cross-matching test is regarded as an essential pre-transfusion test. It serves an important role in confirming the ABO/Rh compatibility of transfusion and screening for possible unexpected antibodies. We evaluated cross-matching tests in QWALYS-3 (DIAGAST, Loos Cedex, France), comparing the automated process to manual tube methods. METHODS: A total of 545 crossmatching tests from 169 patients, collected from RBC concentrate transfusion orders, were performed using both QWALYS-3 and manual tube methods. All patients were follow-up tested later on with antibody identification tests to confirm the presence of unexpected antibodies in plasma. RESULTS: None of the samples were ABO/Rh incompatible. The presence of unexpected antibodies was later confirmed in 277 tests in 56 patients. Out of those 277 tests, the concordance rate between two methods was 83.8% (232/277). In 268 tests which were later confirmed with no unexpected antibodies, manual tube methods did not show any positive results while five tests were false-positive (5/268, 1.9%) only in QWALYS-3. The overall concordance rate between two methods was 90.82%, and the kappa coefficient was 0.696 (P<0.05) (n=545). CONCLUSION: The QWALYS-3 system has its merits in accuracy, precision, and lack of possible human errors, however, the automated procedure showed some disadvantages, including relatively low cost-and-time-effectiveness, less effective cold antibody detection, and difficulties in handling small quantity samples. Thus, the QWALYS-3 system has meaningful, but only a limited value in the automation of routine cross-matching tests.

Evaluation of the Automated Blood Bank Systems Galileo NEO and QWALYS-3 for ABO-RhD Typing and Antibody Screening / 대한수혈학회지

BACKGROUND: An automation system for ABO-RhD typing and antibody screening has been developed and its use is increasing. We compared the results of ABO-RhD typing and antibody screening tests using the manual (ABO-RhD typing) or semiautomated (antibody screening) method and with the automation instruments Galileo NEO (Immucor Gamma, Norcoss, USA) and QWALYS-3 (DIAGAST, Loos Cedex, France). METHODS: A total of 332 blood samples were tested for ABO-RhD typing in comparison with routine manual tests, and 236 samples for antibody screening in comparison with DS-Screening II (Bio-Rad Laboratories, 1785 Cressier FR, Switzerland). We evaluated the performance of Galileo NEO and QWALYS-3 in terms of concordance, carryover, and sensitivity test for ABO-RhD typing and antibody screening. RESULTS: The concordance rates of ABO-RhD typing results between the manual methods and the two instruments were 99.4% for Galileo NEO and 99.1% for QWALYS-3, respectively. On antibody screening tests, a concordance rate of 97.9% was observed between the semiautomated method and Galileo NEO or QWALYS-3, because of discordance in five specimens. The carryover was not observed for ABO-RhD typing and antibody screening. The overall sensitivity of the two automation instruments appears to be parallel with that of DS-Screening II except for anti-E. CONCLUSION: The Galileo NEO and QWALYS-3 system showed good performance, it can be used with confidence for routine pre-transfusion testing in the blood bank.

Evaluation of Automated Blood Bank Systems AutoVue Innova and QWALYS-3 for ABO-RhD Grouping and Antibody Screening / 대한수혈학회지

BACKGROUND: Introduction of automation instruments for the blood bank is essential in order to reduce inspection error and minimize workload. We compared the results of ABO-RhD blood type and antibody screening tests using the manual method and those using the automation instruments AutoVue Innova (Ortho-Clinical Diagnostics, Raritan, NJ, USA) and QWALYS-3 (DIAGAST, Loos Cedex, France). METHODS: ABO-RhD blood type tests using the slide method, the tube method, and the instruments were performed with 200 selected samples. Antibody screening tests using the Ortho BioVue system (Ortho-Clinical Diagnostics, Raritan, NJ, USA), which is used in our laboratory, and the two instruments were performed with 188 specimens and 12 antibody positive samples that were kept in the laboratory. We evaluated the concordance rate of the results, applying CLSI guideline EP12-A2. RESULTS: The concordance rate of ABO-RhD blood type results between the manual methods and the two instruments was 100%. On antibody screening tests, a concordance rate of 100% was observed between the manual method and AutoVue Innova, which uses the gel card manufactured by the company making the gel card used for the manual method. However, using QWALYS-3 in performance of antibody screening tests, the concordance rate was 97.5%, because of discordance in five specimens. CONCLUSION: The concordance rate of ABO-RhD blood type by use of two automation instruments was 100%, however, that of the antibody screening test was 97.5%. Thus, there was a difference in positive rate on the antibody screening test, depending on the instrument. Therefore, introduction of an instrument, considering the pros and cons for each instrument, is necessary. In addition, further discussion of standardized guidelines for quality control is needed.

Evaluation of the Automated Instrument QWALYS-3 for Unexpected Antibody Screening / 대한수혈학회지

BACKGROUND: The use of automated techniques reduces the impact of human errors in blood banking and it improves the standardization and the quality of the achieved results. Erythrocyte Magnetized Technology (EMT) is now being widely used due to its simplicity and efficiency for detecting alloantibody. We evaluated the antibody screening test of the QWALYS-3 (DIAGAST, Loos Cedex, France). METHODS: The evaluation focused on antibody screening using the QWALYS-3 as compared to the standard manual tube method and the Ortho BioVue system in clinical samples (n=100) and frozen stored samples (n=64), which had RBC alloantibody. RESULTS: Using the manual tube method, the sensitivity of antibody screening was 100% by the QWALYS-3 and 42.8% by the Ortho BioVue in the clinical samples (n=7) and 2 results were discrepant by the QWALYS-3 for negative samples. For the known antibodies from the frozen stored samples (n=64) this correspondence rate amounted to 93.7% (n=60). CONCLUSION: The QWALYS-3 system displayed a good match rate with the Ortho BioVue system (92%). It also showed reliable results for the general accuracy when compared to the manual method (concordance rate: 98%). The QWALYS-3 system will facilitate the automation of routine antibody screening with high reliability, sensitivity and specificity compared to the standard manual methods.

Evaluation of the Automated QWALYS-3 System for ABO and RhD Grouping and Unexpected Antibody Screening / 대한수혈학회지

BACKGROUND: One hundred years after the discovery of the ABO blood group system by Landsteiner, agglutination is still the most widely used method for determining the blood grouping and for antibody detection. Yet the demand for suitable automated systems is obvious in the field of transfusion. QWALYS-3 (DIAGAST, Loos Cedex, France) is a fully automated system for determining the ABO and RhD grouping and for antibody screening. We evaluated the ABO and RhD grouping and antibody screening test of the QWALYS-3. METHODS: The ABO and RhD grouping and the antibody screening test were performed by the QWALYS-3 system and the results were compared to the manual methods for the ABO and RhD grouping and to the micro column agglutination method (DiaMed-ID system) for antibody screening. RESULTS: For 574 of 574 clinical samples, there was complete concordance between the QWALYS-3 and the manual methods for determining the ABO and RhD grouping. The concordance rate between the QWALYS-3 and the micro column agglutination method for antibody screening in 210 clinical samples was 97.1%. CONCLUSION: The QWALYS-3 system had a good concordance rate compared to the manual method and the micro column agglutination method. The QWALYS-3 system was robust and it gave accurate results during this evaluation. The QWALYS-3 system will contribute to achieving full automation of all the necessary blood bank tests.