Evaluation of the New Lateral Flow Card MDmulticard® Basic Extended Phenotype in Routine Clinical Practice

Abstract

Background: Transfusion emergencies and critical situations require specifically designed devices to simplify and optimize the standard procedures. In addition, matching antigens over and above ABO-Rh-K would be beneficial. Methods: Routine blood samples were collected in four immunohematology centers and tested with the new MDmulticard Basic Extended Phenotype for the simultaneous detection of the Duffy, Kidd, and Ss antigens, according to the principle of the lateral flow. Results were compared with those obtained using routine serology methods. Discrepancies were analyzed by molecular techniques/genotyping. Results: 310 samples were tested (167 donors; 75 patients; 28 subjects with positive direct antiglobulin test (DAT); 15 newborns; 25 previously transfused patients). The 285 samples with non-mixed-field reaction yielded 1,710 antigen results with 8 discrepancies (0.47%) six of which in DAT-positive subjects: three false-positive (Fy^a) for MDmulticard, and two false-positive (Fy^a) plus three false-negative (Fy^b) for the reference methods (MDmulticard PPA for donors/patients/newborns: 99.82%; negative percent agreement: 100%; sensitivity: 100%; specificity: 99.39%, positive predictive value: 99.75%; negative predictive value: 100%). The MDmulticard detected mixed-field in 15 antigen reactions from 13 transfused patients, undetected by the comparative method, with the opposite result in 8 antigens (5 patients). Conclusion: The MDmulticard Basic Extended Phenotype met the criteria prescribed for the testing of donor, patient, DAT-positive, and newborn samples in transfusion laboratory routine.

DROP and READ: a paper-based device combined with portable readout for ABO, Rh (D, C, c, E, e) and Mia phenotyping

“…Additionally, IgG and IgM antibodies can interfere with the test. 13 For the preliminary study, three DAT-positive samples were tested with the DROP and READ device. One sample that was determined to be negative for the e antigen and positive for the c and Mi a antigen by the DROP and READ device was found to be negative for all antigens when using the CAT method.…”

“…No blood phenotyping method was used to discriminate the transfused and autologous 25 Moreover, mixed-field agglutination in the patients depend on the number of transfused units and on the phenotypes of the transfused cells. 13 In this case, genotyping could be performed to predict the phenotype. Due to the small sample size, the performance of the DROP and READ device must be enhanced and should be further evaluated with a large sample size.…”

“…12 Several weak phenotypes that were previously classified as false negatives were discovered in several blood group systems. [13][14][15] In this life-threatening situation, blood group phenotyping requires a reliable test, interpretations that are easy to make, and quick results. Thus, using fewer steps and less equipment would be beneficial.…”

Development of Mia Phenotyping Using Paper-Based Device

“…First, anticoagulated samples from patients (not transfused within 3 months prior to study) and newborns (cord blood) should be evaluated to ensure the effectiveness of our proposed method. Second, the number of complex samples should be included: reactive DAT-positive samples collected from patients and ‘mixed-field’ samples (two erythrocyte populations) obtained from patients who had been transfused within a few days to 3 months prior to the study require further observation [ 22 , 23 ].…”