Abstract:
BACKGROUND AND OBJECTIVES:Since July 1 1999, four laboratories in the Netherlands have been routinely screening plasma minipools for the release of labile blood components utilizing hepatitis C virus nucleic acid amplification technology (HCV NAT). This report describes the performance evaluation of the HCV NAT method and the quality control results obtained during 6 months of routine screening. MATERIALS AND METHODS:Plasma minipools of 48 donations were prepared on a Tecan Genesis robot. HCV RNA was isolated from 2 ml of plasma by using the NucliSens Extractor and amplified and detected with the Cobas HCV Amplicor 2.0 test system. For validation of the test system the laboratories used viral quality control (VQC) reagents of CLB. RESULTS:Initial robustness experiments demonstrated consistent detection of PeliSpy HCV RNA samples of 140 genome equivalents/ml (geq/ml) in each station of the installed Nuclisens Extractors. Further 'stress' tests with a highly viraemic sample of approximately 5 x 10(6) geq/ml did not contaminate negative samples processed on all Extractor stations in subsequent runs. In the validation period prior to July 1999, 1021 pools were tested with the following performance characteristics: 0.1%, initially false reactive; 0.89%, failure of internal control detection; 0.97%, no eluate generated by the Extractor; and 100% reactivity of the PeliSpy 140 geq/ml control in 176 Extractor runs and a 98% reactivity rate of the PeliSpy 38 geq/ml control in 102 test runs. By testing the PeliCheck HCV RNA genotype 1 dilution panels 49 times, an overall 95% detection limit of 30 geq/ml ( approximately 8 IU/ml) and a 50% detection limit of 5 geq/ml was found by the four laboratories. In the first 6 months of routine screening, the minimum requirement for invalid results (2%) was exceeded with some batches of silica and NucliSens Extractor cartridges. From November 1999 to February 2000, the manufacturer (Organon Teknika) improved the protocol for silica absorption of the Nuclisens Extractor -- the cartridge design as well as the software of the Extractor. During the next 6 months of observation in 2000, the percentages of false initial reactives and invalids were 0.05% and 1.4%, respectively, in 8962 pools tested. Of these invalid results, 0.74% and 0.66% were caused by Extractor failure and negative internal control signals, respectively. The PeliSpy HCV RNA 'stop or go' run control of 140 geq/ml was 100% reactive, but invalid in 16/1375 (1.2%) of cases. The PeliSpy run control of 38 geq/ml for monitoring sensitivity of reagent batches was reactive in 95% of 123 samples tested. CONCLUSIONS:Each of the four HCV NAT laboratories in the Netherlands have achieved similar detection limits that are well below the sensitivity requirements of the regulatory bodies. After improvement of the NucliSens Extractor procedure, the robustness of the test system has proved to be acceptable for routine screening and timely release of all labile blood components.
journal_name
Vox Sangjournal_title
Vox sanguinisauthors
Cuijpers HT,Molijn MH,Bos HJ,Peeters AP,van der Poel CL,Lelie PNdoi
10.1046/j.1423-0410.2001.00055.xsubject
Has Abstractpub_date
2001-07-01 00:00:00pages
12-20issue
1eissn
0042-9007issn
1423-0410pii
vox055journal_volume
81pub_type
杂志文章相关文献
VOX SANGUINIS文献大全abstract:OBJECTIVE:In order to describe the progression of HIV disease in a cohort of Dutch HIV-1-infected patients with haemophilia and to study the influence of clinical and clotting factors, we performed a 15-year longitudinal clinical and laboratory study. METHODS:The progression to AIDS in relation to type of haemophilia,...
journal_title:Vox sanguinis
pub_type: 临床试验,杂志文章
doi:
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Apheresis platelet concentrates sometimes contain persistent aggregates (PA). Because apheresis involves extracorporeal circulation, we hypothesized that interactions between GPIbα and von Willebrand factor (VWF) underlie their origin. MATERIALS AND METHODS:Platelets in donations with PA were...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12365
更新日期:2016-05-01 00:00:00
abstract::We have used the Optical Character Recognition system B (OCR-B) for automatic identification of blood samples on the Groupamatic 360 and in connection with computerized donor file management and control of blood product processing. For the Groupamatic system a device was constructed that lifts that samples, and during...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:
更新日期:1981-03-01 00:00:00
abstract::OCTAPLAS is a cell-free standardized blood group specific human coagulation active plasma for transfusion. The viral safety is mainly based on the treatment with solvent/detergent. SD is known to irreversibly inactivate the lipid enveloped viruses including HIV 1 + 2, HBV and HCV and has been recommended both by Europ...
journal_title:Vox sanguinis
pub_type: 杂志文章,评审
doi:10.1111/j.1423-0410.1998.tb05474.x
更新日期:1998-01-01 00:00:00
abstract::Acute posttransfusion hepatitis C was reported in a recipient of 3 units of red cells. The recipient became acutely icteric 6 weeks after transfusion, and HCV infection was diagnosed. Stored serum samples of the 3 implicated donations, which were negative with ELISA-2, were retested by PCR and 3rd-generation antibody ...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1995.tb02546.x
更新日期:1995-01-01 00:00:00
abstract::The panagglutination phenomenon described by Thomsen and Friedenreich (TF) is due to the reaction of naturally occurring TF-antibodies with the carbohydrate group beta-D-Gal-(1-3)-D-GalNAc of desialylated glycophorin A, the major glycoprotein component of the erythrocyte membrane. The specificity of human TF-antibodie...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1985.tb00179.x
更新日期:1985-01-01 00:00:00
abstract::A new competitive solid phase radioimmunoassay (CLB-RIA) has been developed for the detection of HBAg and HBAb in human serum and plasma. In the assay, sheep antibodies to HBAg, covalently linked to an insoluble carrier, highly purified 125-I labelled HBAg and the serum or plasma sample are incubated for 20 h at room ...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1975.tb00472.x
更新日期:1975-01-01 00:00:00
abstract::A pilot study for large-scale automated plasmapheresis using the Haemonetics Model 50 machine was undertaken in the Yorkshire Region of the United Kingdom to determine the viability of such a programme for national self-sufficiency in fresh plasma procurement for factor VIII concentrate production. The study was desig...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1983.tb01876.x
更新日期:1983-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The aim of this review was to summarize the properties of the commonly available resuscitation fluids and highlight where knowledge of the characteristics of individual fluids might guide their use in clinical practice. Some of the current controversies surrounding resuscitation fluids are als...
journal_title:Vox sanguinis
pub_type: 杂志文章,评审
doi:10.1046/j.1423-0410.2002.00123.x
更新日期:2002-01-01 00:00:00
abstract::Allelic subdeterminants (or splits) of the B12-Bw21 complex were characterized by the use of highly selected antisera and cell donors. The B12 antigen was separated into two major components, Bw44 and Bw45; and possibly a third. It was shown that Bw44 is primarily an antigen of whites, and Bw45 of blacks. Of the 68 pe...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1980.tb02363.x
更新日期:1980-01-01 00:00:00
abstract::Manual plasmapheresis is done worldwide on both paid donors, and to a much smaller extent on volunteer donors in order to generate source plasma to be fractionated into albumin, clotting factor concentrates, and gamma globulin. Automated technology has now been developed utilizing both centrifugal, and membrane separa...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1986.tb01992.x
更新日期:1986-01-01 00:00:00
abstract::A chromatographical study was made of eight antisera containing either anti-HL-A antibodies, cold lymphocytotoxins, or a mixture of both types of antibodies. The results vary according to the sera obtained. Usually cold lymphocytotoxins are sited in the IgM peak and anti-HL-A antibodies in the IgG peak, but there are ...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1976.tb02207.x
更新日期:1976-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Variant RHD genes associated with the weak D phenotype can result in complete or partial D-epitope expression on the red cell. This study examines the genetic classification in Australian blood donors with a weak D phenotype and correlates RHD variants associated with the weak D phenotype agai...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12488
更新日期:2017-04-01 00:00:00
abstract::Routine screening of blood donations for anti-HIV commenced in the UK during October 1985 and by the end of February 1987 approximately 3.7 million donations had been tested. Seventy-two were confirmed anti-HIV positive, i.e. 0.002%. Of the anti-HIV-positive donors interviewed to date, the majority are young homosexua...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1988.tb01609.x
更新日期:1988-01-01 00:00:00
abstract::The incidence, etiology and risk factors of posttransfusion (PT) hepatitis were evaluated in a prospective study of 297 consecutive open-heart surgery patients. PT hepatitis occurred in 63 (21.2%) patients with a significantly higher hepatitis attack rate in 51 recipients of commercial clotting factor concentrates (56...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1983.tb04099.x
更新日期:1983-01-01 00:00:00
abstract::A panel of 50 blood group antibodies covering a range of blood group antigens has been tested in the presence of 0.25% beta-propiolactone as a possible means of reducing infectivity of high-risk HTLV III/HBsAg samples. 11/50 (22%) antibodies could not be detected by the indirect antiglobulin test, and 6/40 (15%) were ...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1986.tb00207.x
更新日期:1986-01-01 00:00:00
abstract::As part of a programme to establish a panel of individuals with high titres of anticytomegalovirus (CMV) IgG for the production of CMV Ig, the CMV serostatus of 139 normal blood donors was determined by indirect haemagglutination assay, enzyme immunoassay, and complement fixation. The indirect haemagglutination assay ...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1984.tb04137.x
更新日期:1984-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Staphylococcus epidermidis is a predominant contaminant of platelet concentrates (PCs), outcompeting other skin flora bacteria such as Staphylococcus capitis. The accumulation-associated protein (Aap), encoded by the aap gene, is involved in formation of bacterial aggregates (biofilms) in S. e...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12729
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:A disposable set for platelet concentrate (PC) preparation by the buffy coat method allows pooling of buffy coats, centrifugation and cell separation with in-line leucocyte filtration. This study compares three commercially available pooling sets in combination with INTERCEPT pathogen inactivation (PI). MAT...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12668
更新日期:2018-05-24 00:00:00
abstract:BACKGROUND:Aggregates often appear during apheresis. Sometimes, these persist throughout storage, causing product wastage. This study assessed product quality of apheresis concentrates containing persistent aggregates (PA) and aimed to identify the factors that contribute to their formation. METHODS:Donation (n = 180)...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12243
更新日期:2015-05-01 00:00:00
abstract::An example of a cold-reacting IgM anti-K2 is described. The patient has a history of blood transfusion and two pregnancies. It is, therefore, not possible to differentiate between natural occurrence or immune stimulation as an explanation of this antibody's presence. In 1966, Thomas and Konugres reported an unusual ex...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1985.tb00189.x
更新日期:1985-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The aim of this study was to assess potentially relevant clinical characteristics which influence the decision to transfuse red cells in critically ill patients with low haemoglobin concentrations (6.0-10.0 g/dl). MATERIALS AND METHODS:This was a retrospective observational cohort study of pa...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12831
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Inaccuracy of fingerstick haemoglobin compromises donor's health and losses blood donations. We evaluated the benefit of double haemoglobin screening with HemoCue. STUDY DESIGN AND METHODS:Blood donors underwent fingerstick screening by HemoCue and were driven for donation if capillary haemog...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12165
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Although transfusion-transmitted infections are rare, non-infectious complications occur relatively frequently. Solvent/detergent-treated fresh-frozen plasma (SD-FFP) has been shown to reduce the frequency of both types of complication, although previous economic evaluations failed to consider...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1046/j.1423-0410.2003.00329.x
更新日期:2003-08-01 00:00:00
abstract::A combined immunoassay for the simultaneous detection of antibodies to HIV-1/2 and HTLV-I/II (Bioelisa, Launch Diagnostics) has been evaluated to determine its suitability for routine use in blood screening. 84,222 donations were tested from 76,452 donors. One HIV- and 1 HTLV-1-positive donor were identified. The spec...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1995.tb02576.x
更新日期:1995-01-01 00:00:00
abstract::The functional antibacterial activity of an intravenous immunoglobulin preparation (Swiss Red Cross Immunoglobulin, SRK-Ig) was tested both in vitro and in vivo. Using type III group B streptococci as a model system, the intravenous immunoglobulin preparation was shown to enhance phagocytosis and killing of the bacter...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1983.tb04485.x
更新日期:1983-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Revised Icelandic guidelines proposed a restrictive haemoglobin (Hb) threshold of 70 g/l for red blood cell (RBC) transfusions in general, but 100 g/l for malignancies/bone marrow suppression. Chronic lymphocytic leukaemia (CLL) is frequently complicated by anaemia. The objective was to invest...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12775
更新日期:2019-07-01 00:00:00
abstract::To obtain red cell populations of increasing mean age erythropoiesis was arrested through continuous actinomycin treatment or maintained transfusion polycythemia in mice and rats respectively. The parameters studied included cell indices, enzyme activities and rheological characteristics. Further, the life-span of age...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1976.tb02809.x
更新日期:1976-01-01 00:00:00
abstract::Recently, the polymorphism of a new human platelet antigen, Ca/Tu, was shown to be derived from a G-A nucleotide substitution at base 1564 of GPIIIa cDNA, which leads to a single amino acid difference, Arg/Gln at amino acid 489 of GPIIIa. We developed a PCR-RFLP method to determine the genotypes of Ca/Tu and their fre...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/j.1423-0410.1996.tb00995.x
更新日期:1996-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Our post-thaw cell recovery rates differed substantially in interlaboratory comparisons of identical samples, potentially due to different temperatures during cell staining. MATERIALS AND METHODS:Viable CD34(+) cells and leucocyte (WBC) subtypes were quantified by multiparameter single-platfo...
journal_title:Vox sanguinis
pub_type: 杂志文章
doi:10.1111/vox.12398
更新日期:2016-08-01 00:00:00