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Research Article Volume 7 Issue 1
Quality analytical planning in blood bank serological screening qualitative assays
Jeel Jr. Moya-Salazar, Rommel F Díaz-Rosado
Received: January 21, 2019 | Published: February 28, 2019
Citation: Moya-Salazar J, Díaz-Rosado RF. Quality analytical planning in blood bank serological screening qualitative assays. Int Clin Pathol J. 2019;7(1):22-26. DOI: 10.15406/icpjl.2019.07.00194
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.
Keywords: quality control, serological screening, ELISA, transfusion-transmissible, disease, transmission, risk, Infections, serological, infectious, statistic, control, cards
©2019 Moya-Salazar, et al. This is an open access article distributed under the terms of the, which permits unrestricted use, distribution, and build upon your work non-commercially.