scholarly journals Assignment of Additional Anticapsular Antibody Concentrations to the Neisseria meningitidis Group A, C, Y, and W-135 Meningococcal Standard Reference Serum CDC1992

2002 ◽  
Vol 9 (3) ◽  
pp. 725-726 ◽  
Author(s):  
Cheryl M. Elie ◽  
Patricia K. Holder ◽  
Sandra Romero-Steiner ◽  
George M. Carlone

ABSTRACT We assigned additional enzyme-linked immunosorbent assay antibody concentrations (immunoglobulin G [IgG], IgM, and IgA, and total) to the Neisseria meningitidis standard reference serum CDC1992 for groups Y and W-135 to 12 Centers for Disease Control and Prevention quality control sera. These assignments will supplement previous assignments and will aid in the evaluation of present and developing vaccines.

1999 ◽  
Vol 37 (11) ◽  
pp. 3718-3721 ◽  
Author(s):  
Maria E. Aguero-Rosenfeld ◽  
Janet Roberge ◽  
Carol A. Carbonaro ◽  
John Nowakowski ◽  
Robert B. Nadelman ◽  
...  

This study presents the effects of OspA vaccination on two-step testing for Borrelia burgdorferi antibodies. Although vaccinees developed enzyme-linked immunosorbent assay reactivity, immunoblots did not fulfill Centers for Disease Control and Prevention criteria for positivity. Furthermore, OspA reactivity did not interfere with interpretation of immunoblots with sera from patients who developed early Lyme disease despite vaccination.


2000 ◽  
Vol 124 (7) ◽  
pp. 1066-1073
Author(s):  
Tina M. St. John ◽  
Harvey B. Lipman ◽  
John M. Krolak ◽  
Thomas L. Hearn

Abstract Background.—In 1986 and 1989, the Centers for Disease Control and Prevention sponsored institutes on Critical Issues in Health Laboratory Practice. It was noted during the institutes that physician's office laboratories were a rapidly emerging site for clinical laboratory testing, yet no comprehensive data were available regarding the practice of clinical laboratory medicine in physician's office laboratories. As a mechanism to begin addressing this void, the Centers for Disease Control and Prevention added questions on clinical laboratory practice to the National Ambulatory Medical Care Survey, a national probability sample of ambulatory care provided by office-based physicians. Data were collected for survey years 1989, 1991, 1993, and 1994. Methods.—Each survey was conducted among a nationally representative, random sample of office-based physicians who provide ambulatory patient care. Sample physicians were enlisted using both mail and telephone contacts. Clinical laboratory data were obtained via telephone by trained field representatives. Weighted univariate and multivariate analyses were performed on responses from each of the 4 survey years. Analyses were repeated after combining survey responses from years 1989 and 1991 and 1993 and 1994 as representative of physician's office laboratory practices before and after implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) final rule in 1992. Results.—Quality laboratory practice indicators showed significant increases during the study interval, with implementation of the CLIA ’88 final rule in 1992 playing a pivotal role. Relative to 1992, enrollment in proficiency testing programs increased from 32.4% to 52.7% (P < .001), use of daily quality control samples increased from 79.2% to 89.0% (P < .001), and use of daily quality control with written instructions for action following a questionable quality control result (quality control with action step documentation) increased from 62.6% to 77.2% (P < .001). The presence of a medical technologist or technician in the office laboratory was also significantly and independently associated with each of the quality indicators. Although the percentage of physician's offices performing on-site testing decreased from 56% to 45% during the survey interval, overall testing volume appeared unchanged. Conclusions.—The quality of clinical laboratory practice in physician's office laboratories improved during the study interval (1989–1994) as measured by the quality indicators used in the study. The association of this improvement with implementation of the CLIA ‘88 final rule and the presence of a trained laboratory professional in the testing site indicate the importance of minimum practice standards and professional expertise in ensuring use of quality laboratory practices. Overall test volume appeared to be stable despite a decreased proportion of physician's offices at which on-site testing was performed.


2004 ◽  
Vol 11 (5) ◽  
pp. 924-929 ◽  
Author(s):  
Elena Mogilyansky ◽  
Chien Chang Loa ◽  
Martin E. Adelson ◽  
Eli Mordechai ◽  
Richard C. Tilton

ABSTRACT Three commercial Lyme disease Western immunoblotting (WB) kits and the C6 Borrelia burgdorferi (Lyme) enzyme-linked immunosorbent assay (ELISA) kit were compared using two commercially available performance panels from the Centers for Disease Control and Prevention (CDC) and Boston Biomedica (BBI). Combined, the panels consisted of 52 characterized specimens. Immunoglobulin G (IgG) sensitivity was similar for the three WB products. The BBI and Marblot WBs were more specific for IgG antibodies, while the Virablot was the most sensitive for IgM antibody. The BBI WB was 100% specific for IgM, while Marblot was 97% and Virablot was 77% specific for IgM. The C6 ELISA was found to be 100% sensitive. Four false-positive C6 results were identified in patients that had clinically and microbiologically confirmed Lyme disease but were not detected by the CDC reference methods. No one WB product showed overall superiority. The C6 ELISA shows promise as the first ELISA for Lyme disease that would not require a supplemental test such as a WB.


2020 ◽  
Vol 41 (S1) ◽  
pp. s428-s428
Author(s):  
Joseph Lewnard ◽  
Laura King ◽  
Katherine Fleming-Dutra ◽  
Ruth Link-Gelles ◽  
Chris Van Beneden

Background: Group A Streptococcus (GAS) causes acute upper respiratory tract infections that are frequently treated with antibiotics. GAS vaccines in development may prevent both disease and outpatient antibiotic prescribing. We estimated (1) the incidences of GAS-attributable pharyngitis, sinusitis, and acute otitis media (AOM) infections in the United States; (2) the proportion of these infections resulting in antibiotic prescriptions; and (3) the incidence of infection and antibiotic prescribing potentially preventable by vaccination against GAS. Methods: We estimated annual rates of US outpatient visits and antibiotic prescriptions for pharyngitis, sinusitis, and AOM using physician office and emergency department visit data in the National Ambulatory Care Survey and National Hospital Ambulatory Medical Care Survey from 2012 to 2015. We supplemented this with visits to other outpatient settings (eg, urgent care) from the 2016 IBM MarketScan Commercial Database. We estimated the proportion of episodes attributable to GAS and to GAS emm types targeted by a 30-valent vaccine in development using data from previously conducted etiology studies. We estimated the incidence of disease and antibiotic prescribing preventable by a vaccine meeting the WHO 80% efficacy target for preventing noninvasive GAS disease, with doses administered during infancy and at age 4 years. We estimated the proportion of outpatient antibiotic prescribing preventable by vaccination by dividing estimates by total antibiotic dispensations, estimated from the IQVIA TM dataset. Results: Among individuals aged 0–64 years, GAS causes 27.3 (95% CI, 24.6–30.6) ambulatory care visits and 16.4 (95% CI, 14.5–18.6) outpatient antibiotic prescriptions per 1,000 population annually for pharyngitis, sinusitis, and AOM combined, representing 2.1% (95% CI, 1.8%–2.4%) of all outpatient antibiotic prescriptions. Among children aged 3–9 years, GAS-attributable incidence includes 124.4 (95% CI, 109.0–142.1) visits and 77.1 (95% CI, 65.7–90.6) antibiotic prescriptions per 1,000 population annually, representing 8.6% (95% CI, 7.3%–10.1%) of antibiotic prescriptions in this age group. Individual-level direct protection from a 30-valent vaccine meeting the WHO target could prevent 26.0% (95% CI, 24.0%–28.1%) of pharyngitis visits; 17.3% (95% CI, 15.5%–19.5%) of pharyngitis, sinusitis, and AOM visits; and 5.5% (95% CI, 4.7%–6.4%) of outpatient antibiotic prescriptions among children aged 3–9 years. If vaccination eliminated the need for antibiotic treatment of pharyngitis (for which GAS is the only etiology warranting antibiotic treatment), the total effects of vaccination could include the prevention of up to 17.2% (95% CI, 15.0%–19.6%) and 6.8% (95% CI, 6.3%–7.3%) of antibiotic prescriptions among persons 3–9 years and 0–64 years of age, respectively. Conclusions: In addition to preventing infections and healthcare visits, an efficacious GAS vaccine could prevent a substantial volume of outpatient antibiotic prescribing in the United States.Funding: This work was supported by the Centers for Disease Control and Prevention. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.Disclosures: Laura M. King is a contractor employed by Northrop Grumman Corporation to fulfill research needs at the Centers for Disease Control and Prevention as part of a contract covering many positions and tasks. All other authors declare no conflicts.


2019 ◽  
Vol 28 (3) ◽  
pp. 1363-1370 ◽  
Author(s):  
Jessica Brown ◽  
Katy O'Brien ◽  
Kelly Knollman-Porter ◽  
Tracey Wallace

Purpose The Centers for Disease Control and Prevention (CDC) recently released guidelines for rehabilitation professionals regarding the care of children with mild traumatic brain injury (mTBI). Given that mTBI impacts millions of children each year and can be particularly detrimental to children in middle and high school age groups, access to universal recommendations for management of postinjury symptoms is ideal. Method This viewpoint article examines the CDC guidelines and applies these recommendations directly to speech-language pathology practices. In particular, education, assessment, treatment, team management, and ongoing monitoring are discussed. In addition, suggested timelines regarding implementation of services by speech-language pathologists (SLPs) are provided. Specific focus is placed on adolescents (i.e., middle and high school–age children). Results SLPs are critical members of the rehabilitation team working with children with mTBI and should be involved in education, symptom monitoring, and assessment early in the recovery process. SLPs can also provide unique insight into the cognitive and linguistic challenges of these students and can serve to bridge the gap among rehabilitation and school-based professionals, the adolescent with brain injury, and their parents. Conclusion The guidelines provided by the CDC, along with evidence from the field of speech pathology, can guide SLPs to advocate for involvement in the care of adolescents with mTBI. More research is needed to enhance the evidence base for direct assessment and treatment with this population; however, SLPs can use their extensive knowledge and experience working with individuals with traumatic brain injury as a starting point for post-mTBI care.


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