Phase 1 clinical study with Bioneedles, a delivery platform for biopharmaceuticals.

Vaccination campaigns using syringes, needles, vials and refrigeration have a heavy logistic burden. A vaccination platform that circumvents these problems would improve the quality of vaccination campaigns by faster and safer vaccination of populations anywhere. A clinical phase I study in eighteen volunteers has been carried out, using biodegradable mini-implants (Bioneedles™), made of a polymer based on starch, allowing for high speed vaccination of thermostable vaccines and omitting the use of syringes, needles, vials and refrigeration.

HIV-1 antiretroviral resistance testing laboratories.

Objective: To identify and to describe the genotyping and the phenotyping testing practices of U.S. laboratories performing patient HIV-1 antiretroviral resistance testing.

Results of a physician survey on ordering viral load testing. Opportunity for laboratory consultation.

Objective: To profile physicians' practices, utilization, and understanding of human immunodeficiency virus type 1 RNA (viral load) testing and the laboratory's role in this testing.

Design: Cross sectional study using a 34-item self-report survey mailed to physicians identified as requesting viral load testing, with follow-up mailings to nonresponders.

Participants: A sampling of US physicians specializing in infectious diseases, internal medicine, and family practice associated with high, medium, and low human immunodeficiency virus/acquired immunodeficiency syndrome incidence areas.

Balanitis of Zoon: a clinicopathologic study of 45 cases.

Balanitis of Zoon is a relatively common diagnosis in elderly men, although its nature is controversial and descriptions of its histopathologic features in current textbooks of dermatopathology vary considerably. We studied 45 cases of balanitis of Zoon clinically and histopathologically. The earliest histopathologic changes in cases diagnosed clinically as balanitis of Zoon were slight thickening of the epidermis, parakeratosis, and a patchy lichenoid infiltrate of lymphocytes and some plasma cells.

Viral load test reports: a description of content from a sample of US laboratories.

Context: Human immunodeficiency virus (HIV) RNA testing (viral load testing) is increasingly important in the care of patients infected with HIV-1 to determine when to initiate, monitor, and change antiretroviral therapy. Patient viral load testing information is communicated to the clinician through the laboratory test report.

Objectives: To examine the format and information used in reporting viral load testing results and determine the clarity of the information provided in these reports.

Laboratory performance in HTLV-I/II analysis.

Background: Since 1989, the CDC's Model Performance Evaluation Program has shipped samples to voluntary participant laboratories that test for HTLV antibodies. Each laboratory tests the well-characterized samples, reports the results, and provides information about its testing practices. The data from 15 performance survey periods are reported here.

T-lymphocyte immunophenotyping blind proficiency testing: a model system for CD4+ T-cells.

Objective: To develop and evaluate methods and results for blind proficiency testing for CD4+ T-cells by T-lymphocyte immunophenotyping.

Design: A model system was developed to submit duplicate specimens for T-lymphocyte immunophenotyping as if they were routine patient specimens rather than proficiency specimens. Testing results were compared both interlaboratory and intralaboratory.

Impact of quality control on accuracy in enzyme immunoassay testing for human immunodeficiency virus type 1 antibodies.

Objective: To assess use of quality control (QC) material, supplemental to internal kit controls (calibrators), as protection against errors in enzyme immunoassay testing for human immunodeficiency virus type 1 antibodies.

Design: From August 1994 to January 1996, enzyme immunoassay testing accuracy was assessed for laboratories participating in the Centers for Disease Control and Prevention Model Performance Evaluation Program that provided information regarding their use of QC material. Error rates were examined for human immunodeficiency virus type 1 antibody-negative, strongly positive, and weakly positive samples.

Assessment of the impact of a CD4+ T-cell testing laboratory improvement program.

Objective: To evaluate the effectiveness of the Centers for Disease Control and Prevention's CD4+ T-cell laboratory testing improvement program and the influence of other laboratory improvement programs on CD4+ T-cell testing practices.

Design: Surveys asking for practice changes and factors that influenced the changes, a survey of clinicians' perceptions of laboratory quality in CD4 testing, and analysis of data from the Model Performance Evaluation Program.

Interventions: Centers for Disease Control and Prevention interventions included a series of 3-day workshops on flow cytometry, CD4+ T-cell testing guidelines published in the Morbidity and Mortality Weekly Report, the Clinical Laboratory Improvement Amendments of 1988, and the Model Performance Evaluation Program.

Quality assessment activities in Latin America and the Caribbean.

The Pan American Health Organization (PAHO) supports performance evaluation programs in clinical chemistry, Caribbean. Much more work remains to be done before many labs in this part of the world can be certified as providing accurate results, but PAHO has taken an important first step toward establishing benchmarks and rallying for labs to improve test quality.

Quality of laboratory performance in testing for human immunodeficiency virus type 1 antibody. Identification of variables associated with laboratory performance.

To identify factors that may affect the quality of laboratory performance of human immunodeficiency virus type 1 (HIV-1) antibody testing, the Centers for Disease Control and Prevention Model Performance Evaluation Program surveyed laboratories in 1989 that performed enzyme immunoassay (EIA) and Western blot tests for HIV-1 antibody. Panels of 10 HIV-1-antibody-positive and antibody-negative plasma samples, some of which were duplicates, were mailed to program-participating laboratories. Laboratories were also mailed survey questionnaires to ascertain their laboratory characteristics and testing practices.

Variability of reporting and lack of adherence to consensus guidelines in human T-lymphocyte immunophenotyping reports: results of a case series.

Percentages and absolute counts of CD4+ lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagnostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneumonia prophylaxis and antiretroviral therapy. In December 1990, we requested that a nonrandom sample of 17 laboratories provide us with typical reports of their TLI results from an immunodeficient patient and from a patient whose TLI results were within the laboratory's normal reference ranges. We also searched published literature and documents proposed by professional organizations for recommendations regarding T-lymphocyte testing and reporting.

Use of a modified nominal group process for improving laboratory performance in human immunodeficiency virus type 1 antibody testing. Reaching consensus on three questions concerning HIV-1 testing.

Using expert panels of medical technologists and public health microbiologists, a modified nominal group process was used to reach a consensus on three questions concerning current human immunodeficiency virus type 1 (HIV-1) testing methods. The questions related to important sources of error, improving the testing process, and improving proficiency testing. The modified nominal group process proved to be effective in developing lists of errors in laboratory testing; it provided a fast, economic means of identifying possible areas for improving laboratory quality assurance and training programs.

Analytic sensitivity and specificity of enzyme immunoassay results in testing for human immunodeficiency virus type 1 antibody.

In 1986, a performance evaluation program at the Centers for Disease Control was implemented to assess the quality of performance of laboratories testing for human immunodeficiency virus type 1 antibody and to identify problems that occur during the testing process. Laboratories participating in the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 antibody testing furnished enzyme immunoassay results after they tested performance evaluation panels that were sent to them in August and November 1989. The panels consisted of 10 individual samples containing antibody-negative and antibody-positive samples, some of which were duplicates.

Human T-lymphotropic virus type I/II. Status of enzyme immunoassay and western blot testing in the United States in 1989 and 1990.

In three performance evaluation surveys, panels that consisted of human T-lymphotropic virus type I or type II (HTLV-I/II) antibody-positive and -negative plasma samples were mailed to laboratories that voluntarily participated in the Centers for Disease Control Model Performance Evaluation Program. Donor samples were identical among surveys. In each survey, more than 98% of the laboratories reported enzyme immunoassay (EIA) test results; about 11% also reported results of Western blot (WB) testing.

Identification of nonanalytic issues in HIV-1 antibody testing using blind proficiency testing.

Blind proficiency testing was used to examine nonanalytic performance indicators for human immunodeficiency virus type 1 (HIV-1) antibody testing. Physician offices, clinics, and hospitals located throughout Southern California submitted simulated patient specimens to laboratories as routine test requests. A total of 32 laboratories were involved during five blind proficiency testing surveys.

Analytic results of HIV-1 testing using blind proficiency testing.

The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California.

Potency assessment of topical corticoids in the vasoconstrictor assay and on tuberculin-induced inflammation.

The topical anti-inflammatory activity of potent and very potent corticoids was studied in normal and inflamed skin using the vasoconstriction assay and tuberculin-induced inflammation in four double-blind intraindividual comparison trials. Instrumental techniques in addition to visual scores and several time points were applied to get better insight into the reliability of the models and the sensitivity of the different variables. Beta-methasone-17-valerate and two concentrations of prednicarbate were used as potent corticoids, clobetasol-17-propionate, betamethasone-17,21-dipropionate and different biopharmaceutical forms of desoximetasone (DOM) as very potent corticoids.

Binding of S protein by Neisseria gonorrhoeae and potential role in invasion.

An agglutination assay was used to examine the binding of purified human S protein (vitronectin, serum spreading factor) to 201 clinical isolates of Neisseria gonorrhoeae. Strains belonging to the protein IA serovars were significantly (P less than 0.001) more reactive in agglutination tests with human S protein and were more serum resistant than strains belonging to the protein IB serovars.

Indirect immunofluorescence test performance and questionnaire results from the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 testing.

Results from laboratories performing indirect immunofluorescence (IIF) testing for human immunodeficiency virus type 1 antibody and participating in the Centers for Disease Control Model Performance Evaluation Program in 1988 are presented. Approximately 90% of all laboratories receiving specimen panels or questionnaires furnished results to the Centers for Disease Control. In September 1988, 111 reports were received from IIF laboratories from 34 states and nine countries; most of these laboratories did IIF testing in conjunction with other antibody tests.

CDC's Model Performance Evaluation Program: assessment of the quality of laboratory performance for HIV-1 antibody testing.

In 1986, the Centers for Disease Control (CDC) implemented the Model Performance Evaluation Program (MPEP) to evaluate the performance of laboratories that test for antibody directed against human immunodeficiency virus type 1 (HIV-1). The impetus for developing this program came from the recognition of a need to assess the quality of existing and changing laboratory technology and to ensure that the quality of testing was sufficient to meet medical and public health needs. To develop the program, CDC chose HIV-1 antibody testing as the first specific application for assessing the quality of laboratory performance because (a) of the importance of accurate and reproducible test results for acquired immunodeficiency syndrome (AIDS) surveillance, prevention, and treatment programs; (b) HIV-1 testing technology is new to many laboratories; and (c) HIV-1 testing practices and applications continue to evolve.

Centers for Disease Control perspective on quality assurance for human immunodeficiency virus type 1 antibody testing. Model Performance Evaluation Program.

Ensuring high quality in human immunodeficiency virus type 1 (HIV-1) antibody testing is an essential component of the organized public health response to epidemic HIV-1 infection. In 1986, the Centers for Disease Control designed the Model Performance Evaluation Program to assess and improve the analytic quality of HIV-1 antibody testing. In addition, the program was designed to gather information about HIV-1 antibody testing practices.

Comparison of isolates of Neisseria gonorrhoeae causing meningitis and report of gonococcal meningitis in a patient with C8 deficiency.

We studied a previously healthy 20-year-old woman who presented with gonococcal meningitis. The gonococcal isolate, HT-1, was prototrophic by auxotyping, was protein I serovar IB-1, and agglutinated with wheat germ lectin. This isolate differed from the proline-requiring, serovar IA-1 and IB-4, wheat germ-agglutination-negative gonococcal isolates recovered from three patients during a recent outbreak of gonococcal meningitis in Philadelphia.

Characteristics of toxic shock syndrome toxin 1-induced lectin-like activity and inhibitor(s) in rabbit serum.

In adult rabbits intravenously injected with toxic shock syndrome toxin 1 (TSST-1) or staphylococcal enterotoxin B, serum lectin-like activity (detectable by cation-dependent agglutination of bacteria) developed. This activity was sensitive to heat, trypsin, and formaldehyde but resistant to neuraminidase or galactose oxidase. Formaldehyde-fixed Propionibacterium acnes or Escherichia coli cells reactive with plant lectins provided sensitive targets for titration of serum agglutination activity that was competitively blocked with D-galactose, D-glucose, D-mannose, and alpha-L-fucose.

Randomized comparative study of 0.5 and 1 g of cefodizime (HR 221) versus 1 g of cefotaxime for acute uncomplicated urogenital gonorrhea.

Uncomplicated urogenital and concomitant oropharyngeal gonorrhea in 424 male and female patients was treated in a randomized comparative study with 0.5 g of cefodizime (89 men and 54 women), 1 g of cefodizime (87 men and 52 women), or 1 g of cefotaxime (86 men and 56 women). The cure rates were 100% for men and women in the group given 0.