RÉSUMÉ
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.
Sujet(s)
Automatisation , Banques de sang , Céphalosporines , Dépistage de masse , Contrôle de qualitéRÉSUMÉ
BACKGROUND: Despite the advances in total laboratory automation, a considerable amount of work in blood banks is still done using outdated manual methods. Some automated pre-transfusion testing instruments have recently been developed. Of these, we evaluated and compared the AutoVue Innova (Ortho, USA) and the Techno TwinStation (DiaMed AG, Switzerland). METHODS: Forward and reverse ABO/Rh typing and unexpected antibody screening and identification tests were performed on 4,628 samples using the manual method and the two automated instruments. Two different anticoagulants (EDTA and citrate) were compared in ABO/Rh typing and unexpected antibody screening tests. Titrating studies were conducted on the following 7 dilutions using 5 samples of irregular antibodies with anti-E, anti-E & -c, anti-D, and anti-Le(a) with anti-Fy(a): 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, and 1:128. The test throughput per hour, the time required to perform 1 and 100 tests, and a simulation test for total events occurring in 1 day were also measured. RESULTS: No erroneous results were reported between the two instruments and the manual method. Discrepancies observed in 10 cases (0.4%) of ABO/Rh typing were of higher intensity with AutoVue Innova than with the manual method. AutoVue Innova exhibited the highest sensitivity in the titrating study and throughput performance compared with the manual method and the Techno TwinStation. Especially in the throughput and time required to complete 100 antibody screening tests, AutoVue Innova had a 3.3- and 3.5-fold higher performance, respectively, than Techno TwinStation. CONCLUSIONS: Because both of the two fully automated instruments (AutoVue Innova and Techno TwinStation) had high levels of accuracy and performance, it is expected that use of fully automated instruments will reduce human labor, turnaround time, and operator error in the blood bank.
Sujet(s)
Humains , Système ABO de groupes sanguins/sang , Anticorps/sang , Automatisation , Groupage sanguin et épreuve de compatibilité croisée/instrumentation , Transfusion sanguine , Analyse coût-bénéfice , Faux positifs , Système Rhésus/sangRÉSUMÉ
BACKGROUND: Pre-transfusion tests are important for performing safe transfusion and there is a need to standardize the process of these tests. In blood banks, automation of tests is under developed and there is always a high risk of error. Automatic instruments for blood bank tests are used in blood centers where a great volume of tests are performed. However, other small scale hospitals have little experience with automatic blood bank instruments. Here, we evaluated the newly developed automatic instrument, the AutoVue Innova (Ortho-Clinical Diagnostics, Raritan, NJ, USA), for performing unexpected antibody screening tests and we compared this to other well known systems. METHODS: In a comparative study, a total of 136 samples, including 28 antibody screening positive samples and 108 negative samples, were tested in parallel by the LISS/Coombs card (DiaMed Ag, Cresssier, Morat, Switzerland) and the AutoVue Innova. The positive samples that were proven by the LISS/Coombs card and the AutoVue Innova were identified by the ID-DiaCell panel (DiaMed Ag, Cresssier, Morat, Switzerland) and the 0.8% Resolve Panel A (Ortho, Raritan, NJ, USA), respectively. Discrepant samples were rechecked by the Identisera Diana (Diagnostic Grifols, Barcelona, Spain). RESULTS: Among the 136 samples, 134 results (98.5%) of the AutoVue Innova agreed with those of the LISS/Coombs card and 2 results were discrepant. These two results were antibody screening positive only on the AutoVue and they were identified as being anti-Lewis(a). CONCLUSION: The unexpected antibody screening tests using the AutoVue Innova showed reliable results for general accuracy and they were useful in aspect of a decreased workload and increased safety, and even for less experienced persons.
Sujet(s)
Automatisation , Banques de sang , Dépistage de masseRÉSUMÉ
BACKGROUND: Pre-transfusion tests are important for performing safe transfusion and there is a need to standardize the process of these tests. In blood banks, automation of tests is under developed and there is always a high risk of error. Automatic instruments for blood bank tests are used in blood centers where a great volume of tests are performed. However, other small scale hospitals have little experience with automatic blood bank instruments. Here, we evaluated the newly developed automatic instrument, the AutoVue Innova (Ortho-Clinical Diagnostics, Raritan, NJ, USA), for performing unexpected antibody screening tests and we compared this to other well known systems. METHODS: In a comparative study, a total of 136 samples, including 28 antibody screening positive samples and 108 negative samples, were tested in parallel by the LISS/Coombs card (DiaMed Ag, Cresssier, Morat, Switzerland) and the AutoVue Innova. The positive samples that were proven by the LISS/Coombs card and the AutoVue Innova were identified by the ID-DiaCell panel (DiaMed Ag, Cresssier, Morat, Switzerland) and the 0.8% Resolve Panel A (Ortho, Raritan, NJ, USA), respectively. Discrepant samples were rechecked by the Identisera Diana (Diagnostic Grifols, Barcelona, Spain). RESULTS: Among the 136 samples, 134 results (98.5%) of the AutoVue Innova agreed with those of the LISS/Coombs card and 2 results were discrepant. These two results were antibody screening positive only on the AutoVue and they were identified as being anti-Lewis(a). CONCLUSION: The unexpected antibody screening tests using the AutoVue Innova showed reliable results for general accuracy and they were useful in aspect of a decreased workload and increased safety, and even for less experienced persons.
Sujet(s)
Automatisation , Banques de sang , Dépistage de masseRÉSUMÉ
BACKGROUND: The AutoVue Innova (Ortho Clinical Diagnostic, Raritan, NJ, USA) is an automatic instrument for blood bank tests, and it has recently been introduced in Korea for the first time at our hospital. This instrument employs column agglutination technology and it performs blood bank tests automatically. We evaluated this instrument and we report on the results. METHODS: We performed ABO/RhD typing and antibody screening for 250 randomly selected samples, and crossmatching for 261 samples with using the AutoVue Innova in parallel with the conventional manual methods. For a sensitivity test, we added 3 samples of A(2)B(3) and 2 samples of weak-D and serially diluted reagent antisera to the test pool and we measured turnaround time (TAT) for the antibody screening test. RESULTS: The concordance rates between AutoVue Innova and the manual methods for ABO/RhD blood typing, antibody screening and crossmatching tests were 99.6%, 100% and 98.9%, respectively. The overall retest rate was 0.5% and the main cause of the discrepancy was revealed to be hemolysis or an inadequate amount of the samples. The overall sensitivity of AutoVue Innova seems to be same as or better than the manual methods. The TAT for the antibody screening test was significantly shorter for the AutoVue Innova (64+/-43 min, n=512) than for the tube method (89+/-57 min, n=99) (P<0.001). CONCLUSION: The test results of AutoVue Innova were accurate and sensitive for the ABO/RhD typing, crossmatching and antibody screening tests. The TAT for the antibody screening test was remarkably shortened up to five times more samples could be tested without an increase of manpower.