Combined Testing for Chlamydia, Gonorrhea, and Trichomonas by Use of the BD Max CT/GC/TV Assay with Genitourinary Specimen Types.

The BD Max CT/GC/TV (MAX) assay is a true multiplex assay for simultaneous detection of chlamydia (CT), gonorrhea (GC), and trichomonas (TV). We evaluated assay performance for women using endocervical and vaginal swabs as well as urine specimens. A total of 1,143 women were tested for CT, GC, and TV and, subsequently, another 847 (1,990 total women) for CT and GC only, with positivity rates for CT, GC, and TV of 7.

Improved Diagnosis of Acute Pulmonary Histoplasmosis by Combining Antigen and Antibody Detection.

Background: Acute pulmonary histoplasmosis can be severe, especially following heavy inoculum exposure. Rapid diagnosis is critical and often possible by detection of antigen, but this test may be falsely negative in 17% of such cases. Antibody detection by enzyme immunoassay (EIA) may increase sensitivity and permit the measurement of immunoglobulin M (IgM) and immunoglobulin G (IgG) classes of antibodies separately.

Multicenter evaluation of Candida QuickFISH BC for identification of Candida species directly from blood culture bottles.

Candida species are common causes of bloodstream infections (BSI), with high mortality. Four species cause >90% of Candida BSI: C. albicans, C.

Multicenter clinical evaluation of the Xpert GBS LB assay for detection of group B Streptococcus in prenatal screening specimens.

Neonatal infection with Streptococcus agalactiae (group B Streptococcus [GBS]) is a leading cause of sepsis and meningitis in newborns. Recent guidelines have recommended universal screening of all pregnant women to identify those colonized with GBS and administration of peripartum prophylaxis to those identified as carriers to reduce the risk of early-onset GBS disease in neonates. Enriched culture methods are the current standard for prenatal GBS screening; however, the implementation of more sensitive molecular diagnostic tests may be able to further reduce the risk of early-onset GBS infection.

Rapid detection of Enterococcus spp. direct from blood culture bottles using Enterococcus QuickFISH method: a multicenter investigation.

The performance of a diagnostic method for detection and identification of Enterococcus spp. directly from positive blood culture was evaluated in a clinical study. The method, Enterococcus QuickFISH BC, is a second-generation peptide nucleic acid (PNA) fluorescence in situ hybridization (FISH) test, which uses a simplified, faster assay procedure.

Detection of Trichomonas vaginalis DNA by use of self-obtained vaginal swabs with the BD ProbeTec Qx assay on the BD Viper system.

Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection worldwide, and improved diagnostic methods are critical for controlling this pathogen. Diagnostic assays that can be used in conjunction with routine chlamydia/gonorrhea nucleic acid-based screening are likely to have the most impact on disease control. Here we describe the performance of the new BD T.

Clinical evaluation of a new Pap test-based method for screening of Chlamydia trachomatis and Neisseria gonorrhoeae using liquid-based cytology media.

Objectives: The majority of chlamydial and gonococcal infections in women are asymptomatic and, if left untreated, may result in serious sequelae. Simple and accurate testing of men and women at risk for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) is the single most effective strategy for control of sexually transmitted infections. New tests using easy-to-acquire samples, such as the Papanicolaou (Pap) test, need to be validated in an effort to expand and improve detection.

Multicenter evaluation of the Staphylococcus QuickFISH method for simultaneous identification of Staphylococcus aureus and coagulase-negative staphylococci directly from blood culture bottles in less than 30 minutes.

A novel rapid peptide nucleic acid fluorescence in situ hybridization (FISH) method, Staphylococcus QuickFISH, for the direct detection of Staphylococcus species from positive blood culture bottles was evaluated in a multicenter clinical study. The method utilizes a microscope slide with predeposited positive- and negative-control organisms and a self-reporting 15-min hybridization step, which eliminates the need for a wash step. Five clinical laboratories tested 722 positive blood culture bottles containing gram-positive cocci in clusters.

Clinical evaluation of the BD ProbeTec™ Neisseria gonorrhoeae Qx amplified DNA assay on the BD Viper™ system with XTR™ technology.

Background: The excellent sensitivity and specificity of commercially available nucleic acid amplification tests (NAATs) for the identification of Neisseria gonorrhoeae have been demonstrated. This study evaluated the performance of the BD ProbeTec™ N. gonorrhoeae Q (GCQ) Amplified DNA Assay on the BD Viper™ System with XTR™ Technology in a multicenter study.

A multicenter evaluation of tests for diagnosis of histoplasmosis.

Background: The sensitivity of the MVista Histoplasma antigen enzyme immunoassay (MiraVista Diagnostics) has been evaluated in disseminated histoplasmosis in patients with AIDS and in the "epidemic" form of acute pneumonia. Moreover, there has been no evaluation of the sensitivity of antigenemia detection in disseminated histoplasmosis after the implementation of methods to dissociate immune complexes and denature released antibodies. The goal of this study was to determine the sensitivity of the current antigen assay in different categories of histoplasmosis.

Clinical evaluation of the BD ProbeTec™ Chlamydia trachomatis Qx amplified DNA assay on the BD Viper™ system with XTR™ technology.

Background: This study evaluated the performance of the BD ProbeTec Chlamydia trachomatis Q (CTQ) Amplified DNA Assay on the BD Viper System with XTR Technology in a multicenter study.

Methods: Specimens were collected at 7 geographically diverse clinical sites from 1538 women and men attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. There were 1465 evaluable participants, 993 women and 472 men.

Multicenter evaluation of the LightCycler methicillin-resistant Staphylococcus aureus (MRSA) advanced test as a rapid method for detection of MRSA in nasal surveillance swabs.

The rate of methicillin-resistant Staphylococcus aureus (MRSA) infection continues to rise in many health care settings. Rapid detection of MRSA colonization followed by appropriate isolation can reduce transmission and infection. We compared the performance of the new Roche LightCycler MRSA advanced test to that of the BD GeneOhm MRSA test and culture.

Diagnosis of histoplasmosis by antigen detection in BAL fluid.

Background: Detection of antigen in BAL is useful for diagnosis of histoplasmosis. The MVista Histoplasma antigen enzyme immunoassay has been modified to permit quantification. The purpose of this study is to compare the sensitivity of the quantitative antigen detection assay with cytopathology and culture of BAL specimens.

Detection of Histoplasma capsulatum antigenuria by ultrafiltration of samples with false-negative results.

Patients with histoplasmosis may test falsely negative for Histoplasma capsulatum antigenuria. In some cases antigen is present at levels below the assay's detection limit, and ultrafiltration could improve sensitivity. Antigen was detected following ultrafiltration in 73.

Histoplasmosis as a cause for a positive Fungitell (1 --> 3)-beta-D-glucan test.

We evaluated the Fungitell beta-glucan (BG) test with specimens from patients with presumed histoplasmosis. The sensitivity of the test was 87% in histoplasmosis cases and had a specificity of 68% with controls. Histoplasmosis should be considered as a possible cause for a positive BG test, but such results may be found with many other conditions that are clinically similar to this fungal disease.

Diagnosis of pulmonary histoplasmosis and blastomycosis by detection of antigen in bronchoalveolar lavage fluid using an improved second-generation enzyme-linked immunoassay.

Antigen detection is a useful adjunct for the diagnosis of histoplasmosis. The purpose of this study was to evaluate antigen detection in bronchoalveolar lavage (BAL) fluid using an improved second-generation Histoplasma antigen assay. Antigen was detected in 16 of 19 (84%) cases of histoplasmosis and 5 of 6 (83.

Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections.

Background: Self-collected specimens can be used to screen asymptomatic women for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). We surveyed women's opinions on ease and preferences as to sampling after collecting their own vaginal swab and urine and a physician collection of vaginal swab and cervical swab.

Methods: In 7 North American cities, a questionnaire was used for women after they participated in a clinical trial of nucleic acid amplification testing of various specimens.

Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections.

Background: Vaginal swabs were recently U.S. Food and Drug Administration-cleared for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) using Gen-Probe Incorporated's APTIMA COMBO2 Assay (AC2).

Clinical evaluation of affirm VPIII in the detection and identification of Trichomonas vaginalis, Gardnerella vaginalis, and Candida species in vaginitis/vaginosis.

Objective: To compare the Affirm VPIII Microbial Identification Test for detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis to clinical and microscopic criteria commonly used to diagnose vaginitis.

Methods: Women that were symptomatic for vaginitis/vaginosis and asymptomatic women being seen for routine obstetric or gynecological care were included in this study. Women treated with antibiotics or antifungals within one week or women who had douched within 24 hours were excluded.