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- Bjorkander, J, et al.
(författare)
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Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia
- 2006
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Ingår i: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 90:4, s. 286-293
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Tidskriftsartikel (refereegranskat)abstract
- Background and Objectives The aim of this study was to evaluate the pharmacokinetics, efficacy and safety of a newly developed 10% liquid immunoglobulin preparation in patients with primary immunodeficiency diseases. This new preparation for intravenous use includes three dedicated virus clearance steps in its manufacturing process to ensure a high margin of viral safety. Materials and Methods This was a prospective, open-label, non-controlled, multicentre study. Twenty-two subjects with primary immunodeficiency were treated initially with three infusions of a licensed intravenous immunoglobulin to standardize the immunoglobulin G (IgG) replacement therapy of all subjects to the same intravenous product. A total of nine infusions of the new 10% liquid preparation were subsequently administered. Results The median terminal half-life of total IgG following administration of the new preparation was 30.1 days. Median terminal half-lives for IgG subclasses IgG(1), IgG(2), IgG(3) and IgG(4) were 28.3, 31.3, 20.9 and 24.2 days, respectively. The median total serum IgG steady-state trough level was 8.51 g/l. No severe infection episodes started after initiation of treatment with the new preparation. The median rate of mild or moderate infection episodes was 0.48 per month. A total of 194 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0.41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences. Conclusion The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals.
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| 4. |
- Daniels, G, et al.
(författare)
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Report of the First International Workshop on molecular blood group genotyping
- 2005
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Ingår i: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 88:2, s. 136-142
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Tidskriftsartikel (refereegranskat)abstract
- The use of molecular genetic technology for blood group typing is becoming routine procedure in many reference laboratories worldwide. A First International Workshop was organized on behalf of the International Society of Blood Transfusion (ISBT) and the International Council for Standardization in Haematology (ICSH). Thirty laboratories that provide a molecular diagnostic service participated in the workshop. Six samples were distributed: two represented DNA from transfusion-dependent patients for testing for multiple polymorphisms; two represented fetal DNA prepared from amniotic fluid for RhD, Rhc and K-testing; and two represented plasma from RhD-negative pregnant women for fetal RhD testing. Error rates varied from 0 to 11% for different polymorphisms. A consensus arising from discussion on the workshop results between participants at a feedback meeting and by e-mail has resulted in seven recommendations for molecular blood group genotyping. Further international workshops will take place every 2 years, with a more limited exercise being organized in the intervening years.
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| 5. |
- Daniels, G, et al.
(författare)
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Report of the Fourth International Workshop on molecular blood group genotyping.
- 2011
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Ingår i: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 101, s. 327-332
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Tidskriftsartikel (refereegranskat)abstract
- The fourth International Society of Blood Transfusion (ISBT) workshop on molecular blood group genotyping was held in 2010, with a feedback meeting at the ISBT Congress in Berlin, Germany. Fifty laboratories participated, 17 more than in 2008. Six samples were distributed. Samples 1-3 were DNA samples for all red cell blood group tests available to the participants. Of the 46 laboratories that tested these samples, 37 obtained completely correct results, although the extent of testing varied considerably. Sample 4, also a DNA sample, was an Rh problem in which RHDΨ and RHCE*ceCF were present, but the participants were only informed that the donor's red cells typed as positive with some monoclonal anti-D. Of the 42 laboratories that participated in this exercise, seven performed the sequencing necessary to obtain the correct result. Samples 5 and 6 were plasma samples from RhD-negative pregnant women, for foetal RhD testing. These were sent to 25 laboratories, and two incorrect results were reported. Overall, the level of accuracy was about equal to that of the previous workshop. The main conclusion for the last two workshops can be reiterated: with greater care and attention to detail, very high standards could be set for molecular blood group genotyping.
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| 6. |
- Daniels, G., et al.
(författare)
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Report of the Third International Workshop on Molecular Blood Group Genotyping
- 2009
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Ingår i: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 96:4, s. 337-343
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Tidskriftsartikel (refereegranskat)abstract
- The Third International Society of Blood Transfusion Workshop on Molecular Blood Group Genotyping was held in 2008, with a feedback meeting at the International Society of Blood Transfusion Congress in Macao SAR, China. Thirty-three laboratories participated, eight less than in 2006. Six samples were distributed: sample 1 representing DNA from a sample referred because of abnormal serological results in D testing; samples 2 and 3 from transfusion-dependent patients for testing for all clinically important polymorphisms; sample 4 a mixture of two DNA samples designed to simulate a chimera, referred because of abnormal serological results in donor testing; and samples 5 and 6 plasma samples from RhD-negative pregnant women, for fetal RhD testing (only tested by 17 laboratories). For samples 1-3, 24 of 33 laboratories obtained completely correct results. For sample 4, the ability to detect the minority DNA population was partly dependent on method. Of the 17 laboratories that received samples 5 and 6, 13 reported correct results on both samples. Overall a small improvement from previous workshops was noted, but there is still room for improvement. The main conclusion for the 2006 workshop can be reiterated: with greater care and attention to detail, very high standards could be set for molecular blood group genotyping.
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| 10. |
- Hult, Annika, et al.
(författare)
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Blood group genotype analysis for the quality improvement of reagent test red blood cells
- 2005
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Ingår i: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 88:4, s. 265-270
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Tidskriftsartikel (refereegranskat)abstract
- Background and Objectives Reagent red blood cells (RBCs) for antibody detection should express certain important antigens as a double dose, that is, the donors must be homozygous for the corresponding alleles. Traditionally, dose is determined by serological typing and known allele frequencies. However, RHD zygosity cannot be predicted serologically owing to the absence of an antithetical antigen, and FY zygosity is confounded by two variant haplotypes, FY*0 and FY*X. Furthermore, lack of reagents hampers our ability to type for some clinically important antigen pairs such as Do(a)/Do(b). Materials and Methods Genomic DNA was isolated from reagent RBC samples. Established, validated methods were used to determine the RHD, FY, and DO genotypes. Results Three of 52 D+ samples gave results that differed from the predicted genotype: two presumed (RR1)-R-1 samples and an (RR2)-R-2 sample were shown to be R(1)r" and R(2)r', respectively. Five of 59 samples that were from presumed homozygotes for either FY*A or FY*B were heterozygous, together with either FY*X (three samples) or FY*0 (two samples). Seventy-five samples tested for DO were DO*A/A (n = 14), DO*A/B (n = 39), or DO*B/B (n = 22). Conclusions The results show that serologically determined RhD and Duffy phenotypes of reagent RBCs are unreliable and that antigens we thought were represented as a double dose were single dose. The addition of Dombrock genotyping provides information which is useful in antibody identification. We conclude that selected genotype analyses are a valuable quality assurance measure to ensure that reagent RBCs comply with national and international recommendations for test sensitivity.
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