The rapid diagnosis and management of bacterial infection are heavily dependent upon clinical assessment. Blood culture may take up to 2 days for results and may be suspect. Surface neutrophil CD64 expression has been shown to be upregulated in cases of bacterial infection. Recently, a standardized kit for the CD64 index was used in neonatal intensive care units, showing high sensitivity and specificity for bacterial infections. Our study was designed to confirm and extend these results to adult hospital patients and to determine the impact of this testing on a clinical laboratory's finances and staffing. CD64 indices were performed with peripheral blood drawn in tandem with blood cultures from 109 patients over a 2-month period. We found that a CD64 index of <1.19 was predictive of "no growth" blood culture results. An index of >1.19 was predictive of an ultimate clinical and/or culture diagnosis of infection with a sensitivity and specificity of 94.6% and 88.7%, respectively. Positive and negative predictive values were 89.8% and 94%, respectively. The CD64 index was easily performed using our flow cytometer and staff, producing minimal alteration in clinical workflow. A 7-day-a-week testing schedule will result in some additional expense but will be more than offset by the expected cost savings. The CD64 index is a useful and inexpensive test for improving the diagnosis and management of hospital patients with bacterial infection. It can be readily performed by clinical laboratories and could result in considerable savings for the institution.
BACKGROUND: Extending existing research on the relationship between predonation fear of having blood drawn and risk for vasovagal reactions among young donors, this study assessed the predictive power of specific donation-related fears. STUDY DESIGN AND METHODS:After the health screening, high school whole blood donors (59.5% female) were randomly assigned into one of three groups. Group 1 (n = 881) answered a control question about their prior night's sleep. Group 2 (n = 911) answered the sleep question and a question about fear of having blood drawn. Group 3 (n = 924) answered the sleep question, the fear of having blood drawn question, and four questions about specific donation-related fears (seeing blood, needles, pain, and fainting).From the
Iron depletion is high in frequent whole-blood donors. It is of interest to blood centres to develop ways to mitigate this risk while maintaining the current blood supply. Our feasibility study shows that blood collection agencies can measure iron stores and safely offer iron replacement in frequent blood donors with low ferritin to reduce the risk of iron depletion and future donor deferrals for low haemoglobin.
BACKGROUND: Use of nucleic acid testing (NAT) in donor infectious disease screening improves transfusion safety. Advances in NAT technology include improvements in assay sensitivity and system automation, and real-time viral target discrimination in multiplex assays. This article describes the sensitivity and specificity of cobas MPX, a multiplex assay for detection of human immunodeficiency virus (HIV)-1 Group M, HIV-2 and HIV-1 Group O RNA, HCV RNA, and HBV DNA, for use on the cobas 6800/8800 Systems. STUDY DESIGN AND METHODS:The specificity of cobas MPX was evaluated in samples from donors of blood and source plasma in the United States. Analytic sensitivity was determined with reference standards. Infectious window periods (WPs) before NAT detectability were calculated for current donor screening assays. RESULTS:The specificity of cobas MPX was 99.946% (99.883%-99.980%) in 11,203 blood donor samples tested individually (IDT), 100% (99.994%-100%) in 63,012 donor samples tested in pools of 6, and 99.994% (99.988%-99.998%) in 108,306 source plasma donations tested in pools of 96. Seven HCV NAT-yield donations and one seronegative occult HBV infection were detected. Ninety-five percent and 50% detection limits in plasma (IU/mL) were 25.7 and 3.8 for HIV-1M, 7.0 and 1.3 for HCV, and 1.4 and 0.3 for HBV. The HBV WP was 1 to 4 days shorter than other donor screening assays by IDT. CONCLUSION: cobas MPX demonstrated high specificity in blood and source plasma donations tested individually and in pools. High sensitivity, in particular for HBV, shortens the WP and may enhance detection of occult HBV. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. ABBREVIATIONS: CASThe studies described in this article were sponsored by Roche Molecular Systems, Inc.Received for publication May 25, 2017; revision received November 13, 2017; and accepted November 17, 2017. doi:10.1111/trf.14457 (HIV, HBV, or HCV) during the primary multiplex screen, eliminating the need for a second round of discriminatory testing.Assays used for testing blood donations require a high level of sensitivity to assure detection of infectious blood units but at the same time must also have high specificity to avoid wastage of safe donations and unnecessary donor deferral. The cobas MPX test for use on the cobas 6800/8800 Systems (Roche Molecular Systems, Inc.[RMS]) is a qualitative in vitro nucleic acid screening test (NAT) for the direct detection of HIV Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, HIV Type 2 (HIV-2) RNA, HCV RNA, and HBV DNA in human plasma and serum. Results are simultaneously detected and discriminated for HIV, HCV, and HBV. This article describes the results of preclinical and clinical performance studies evaluating the sensitivity and specificity of this new donor screening test. MATERIALS AND METHODS Assays and syste...
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