Quality analytical planning in blood bank serological screening qualitative assays

Abstract

Background: Transfusion Medicine safety is held by regulations and government legislation inside a total quality frame. In order to develop a quantitative quality planning in the serological screening of seven infectious markers in blood donations, a cross-sectional, study was conducted. Methods: We performed the quality design in Bio-Rad’s xMark microplate spectrophotometer by ELISA for HBsAG, anti-HIV, HTLV-1/2, SYPHILIS and HBcAb; and CHAGAS, and HCV with Bio-Rad and Biokit antibodies, respectively. The guide CLSI EP-12 was used to evaluate the imprecision for each marker. The minimal concentration for each marker from a seropositive asymptomatic donor registered on e-Delphyn® was used to determine the quality requirements, the sigma metric, and the ΔSE. Results: The values found by the sigma metric calculi were 7, 7, 4, 4, 5 and 4 for anti-HIV, HBcAb, HBsAg, HCV, HTLV-1/2, SYPHILIS and CHAGAS, respectively. All Ped near 0.90 had 0.03 or less. The quality control procedures for the qualitative ELISA guarantee a good sensibility. With the statistic control cards, it was possible to select rules with high Ped and low Pfr for each serological marker. Conclusion: we shown a quantitative quality planning during the serological infectious screening of blood donations demonstrating different sigma levels at Peruvian Hospital. The development of strategies to diminish the uncertainty by donation and will secure the safe transfusion of units that will save lives.