Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.

Background: Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs.

A new trend in the HIV epidemic among men who have sex with men, San Francisco, 2004-2011.

Background: In San Francisco, men who have sex with men (MSM) have historically comprised 90% of the HIV epidemic. It has been suggested that given the ongoing HIV transmission among this population, there is the possibility of a high-level endemic of HIV into the future. We report on the possibility of another phase in the HIV epidemic among MSM in San Francisco.

Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma.

Background: A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations.

Objectives: The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay.

Study Design: The evaluation included testing 9150 samples at four U.

Infections missed by urethral-only screening for chlamydia or gonorrhea detection among men who have sex with men.

In a retrospective analysis of asymptomatic men who have sex with men visiting an urban municipal sexually transmitted disease clinic, 83.8% of chlamydial and gonococcal infections would have been missed by urethral screening, compared with 9.8% by screening the rectum and pharynx.

Disentangling screening and diagnostic Chlamydia test positivity among females testing at title x-funded and adolescent health clinics, san francisco 2009.

By using a reason-for-test code, we compared positivity for female chlamydia and gonorrhea. At family planning clinics, there were no statistically significant differences in screening versus diagnostic positivity for either chlamydia or gonorrhea among women. However, at adolescent health clinics, diagnostic positivity was higher than screening positivity for chlamydia and gonorrhea.

Evaluation of an IgM/IgG sensitive enzyme immunoassay and the utility of index values for the screening of syphilis infection in a high-risk population.

Background: Increasing interest in the use of enzyme immunoassays (EIA) for syphilis screening has generated a considerable need for data on the performance of such tests.

Methods: We compared the performance of 1 EIA, the TREP-SURE EIA to that of the Venereal Disease Research Laboratory (VDRL) and Treponema pallidum particle agglutination assay (TPPA) in the detection of infection with Treponema pallidum. In total, 674 specimens were tested by VDRL and EIA (356 VDRL-nonreactive and 318 VDRL-reactive).

Reduction in unnecessary Chlamydia screening among older women at title X-funded family planning sites following a structural intervention--San Francisco, 2009.

A structural intervention designed to reduce unnecessary chlamydia screening among older women resulted in a 24.4% reduction in test volume and an associated cost savings of nearly $40,000.

Sentinel surveillance of rectal chlamydia and gonorrhea among males--San Francisco, 2005-2008.

Rectal gonorrhea cases among males remained stable in San Francisco during 2005-2008, but rectal chlamydia increased 38 percent. While testing increased, rectal gonorrhea positivity declined at the STD clinic, and both infections remained stable elsewhere. Sentinel surveillance provides a better understanding of disease trends than case reporting alone.

Prevalence and correlates of Trichomonas vaginalis among incarcerated persons assessed using a highly sensitive molecular assay.

We describe the epidemiology of Trichomonas vaginalis (TV) among San Francisco County Jail inmates using APTIMA TV analyte-specific reagents on remnant urine. We detected TV in 15/713 (2.1%) men and 95/297 (32.

Chlamydia trachomatis and Neisseria gonorrhoeae transmission from the oropharynx to the urethra among men who have sex with men.

Background: Limited data exist on the risk of Chlamydia trachomatis and Neisseria gonorrhoeae transmission from oropharynx to urethra. We examined urethral C. trachomatis and N.

Mosaic penicillin-binding protein 2 in Neisseria gonorrhoeae isolates collected in 2008 in San Francisco, California.

Using a real-time PCR assay specific for a mosaic penA allele that has been associated with oral cephalosporin resistance in Asia, 54 available Neisseria gonorrhoeae isolates collected in San Francisco, CA, from January to October 2008 were analyzed. Five isolates tested positive for the mosaic penA gene by real-time PCR. DNA sequencing revealed two mosaic penA alleles (SF-A and SF-B).

Assessment of the ability of a fourth-generation immunoassay for human immunodeficiency virus (HIV) antibody and p24 antigen to detect both acute and recent HIV infections in a high-risk setting.

An immunoassay (IA) that simultaneously detects both antibody to human immunodeficiency virus (HIV) and HIV p24 antigen (Architect HIV Ag/Ab Combo) was evaluated for its ability to detect HIV infection by using a panel of specimens collected from individuals recently infected with HIV type 1 (HIV-1). This IA was found to be capable of detecting the majority (89%) of infections, including 80% of those considered acute infections based on the presence of HIV RNA and the lack of detectable antibody to HIV. Substantial improvements in detection of recent infections by the Architect HIV Ag/Ab Combo relative to previous generations of IAs as well as the capacity to detect acute infections have important implications for HIV prevention strategies.

Assessment of sensitivity and specificity of first, second, and third generation EIA for the detection of antibodies to HIV-1 in oral fluid.

The performances of three blood-based immunoassays test kits were compared with regard to their ability to detect HIV-1 antibody in oral fluid. It was found that these three kits differ in their ability to detect HIV-1 antibody. Notably, a third generation EIA which has been shown to possess superior sensitivity for antibody detection in plasma appears to possess no sensitivity advantage for detecting HIV-1 antibody in oral fluid.

Evaluation of self-collected glans and rectal swabs from men who have sex with men for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of nucleic acid amplification tests.

Self-collected glans and rectal swab specimens from men who have sex with men (MSM) may be appropriate, convenient specimens for testing. We evaluated the use of self-collected swabs for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae by a transcription-mediated amplification test (AC2; Aptima Combo 2; Gen-Probe Inc.) and a strand displacement amplification test (SDA; ProbeTec; Becton Dickinson Co.

Screening and confirmation of human immunodeficiency virus type 1 infection solely by detection of RNA.

Diagnosis of human immunodeficiency virus (HIV) infection by antibody-based testing allows for some recently infected individuals to be falsely assessed as non-infected. Since such individuals often have high viral loads and are capable of transmitting HIV, it is an imperative public health need to identify these individuals. We investigated the feasibility and capability of a diagnostic algorithm which included screening and confirmation of HIV infection using only nucleic-acid-based tests.

Use of sentinel surveillance and geographic information systems to monitor trends in HIV prevalence, incidence, and related risk behavior among women undergoing syphilis screening in a jail setting.

Innovative methods are needed to systematically track the HIV epidemic and appropriately target prevention and care programs in vulnerable populations of women. We conducted sentinel surveillance among women entering the jail system of San Francisco from 1999 to 2001 to track trends in HIV incidence, HIV prevalence, and related risk behavior. Using geographic information software (GIS), we triangulated findings to examine the spatial distribution of risk and disease.

Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men.

Background: Several nucleic acid amplification tests (NAATs) are US Food and Drug Administration-cleared for detecting urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection, but they have not been adequately evaluated for the relatively common oropharyngeal or rectal CT and GC infections in men who have sex with men (MSM).

Methods: Multiple swabs were collected from the oropharynx and rectum of MSM attending a city sexually transmitted disease clinic. The specimens were tested by standard culture and the following NAATs: Roche's Amplicor (PCR), Becton Dickinson's ProbeTec (SDA), and Gen-Probe's APTIMA Combo 2 (AC2) for the detection of CT and GC.

Assessment of rapid tests for detection of human immunodeficiency virus-specific antibodies in recently infected individuals.

We have evaluated four current Food and Drug Administration-cleared rapid tests for human immunodeficiency virus (HIV)-specific antibodies with a panel of specimens from recently infected individuals. Recent infection was detected by RNA-based screening coupled with enzyme immunoassay-based testing. We found that the sensitivities of the various rapid tests vary greatly with regard to their ability to detect HIV-specific antibodies in recently infected individuals.

An evaluation of the relative sensitivities of the venereal disease research laboratory test and the Treponema pallidum particle agglutination test among patients diagnosed with primary syphilis.

Background: Because definitive methods for diagnosing primary syphilis are limited, it is important to optimize the sensitivity of serodiagnosis.

Objective: To determine the most sensitive testing approach to the diagnosis of primary syphilis, using the commonly available serologic tests: the Venereal Disease Research Laboratory (VDRL) test and the Treponema pallidum particle agglutination (TP-PA) test.

Methods: Sensitivities of 2 serologic testing strategies for primary syphilis were compared among 106 darkfield-confirmed cases treated in San Francisco from January 2002 through December 2004.

Performance of a transcription-mediated-amplification HIV-1 RNA assay in pooled specimens.

Background: Very limited data exist on the comparative performance of nucleic acid amplification tests (NATs) for the screening of pooled specimens for acute human immunodeficiency virus (HIV) infection.

Study Design: In this study, we compared a transcription-mediated-amplification assay (Procleix HIV-1 Discriminatory Assay, [TMA]) with a branched DNA assay (Bayer Versant HIV-1 RNA 3.0 assay, [bDNA]).

Real-time PCR assay for detection of quinolone-resistant Neisseria gonorrhoeae in urine samples.

A need exists for the development of applicable surveillance tools to detect fluoroquinolone-resistant Neisseria gonorrhoeae (QRNG) in urine samples. We describe here a real-time PCR assay for detecting mutations in the Ser91 codon of the gyrA gene of N. gonorrhoeae in urine specimens.

Real-Time PCR for detection of herpes simplex virus without nucleic acid extraction.

Background: The speed and sensitivity of real-time polymerase chain reaction (PCR) have made it a popular method for the detection of microbiological agents in both research and clinical specimens. For the detection and genotyping of herpes simplex virus (HSV) in clinical specimens, real-time PCR has proven to be faster, more sensitive and safer than earlier methods which included isolation of the virus in cell culture followed by immunofluorescence microscopy. While PCR-based assays for HSV detection posses clear advantages over these earlier techniques, certain aspects of the PCR method remain onerous.

Detection of acute HIV infections in high-risk patients in California.

Background: Given the strong relation between sexually transmitted diseases (STDs) and the spread of HIV infection, recent outbreaks of syphilis in the United States could lead to increased rates of new HIV infection. STD clinics serving persons at risk for syphilis would be logical sites to monitor rates of acute HIV infection. The detection of acute HIV infection, however, is not routine and requires the use of HIV RNA testing in combination with HIV antibody testing.

Use of an acute seroconversion panel to evaluate a third-generation enzyme-linked immunoassay for detection of human immunodeficiency virus-specific antibodies relative to multiple other assays.

A human immunodeficiency virus type 1 (HIV-1)/HIV-2 antibody screening assay, the Genetic Systems HIV-1/HIV-2 PLUS O EIA, was compared to several established screening or confirmatory tests using an acute HIV seroconversion panel. The HIV-1/HIV-2 PLUS O EIA showed an improved sensitivity over all tested antibody screening methods, and detected antibody in 7 of 19 specimens found to be negative by a first-generation EIA but positive for the presence of HIV RNA.

Feasibility, acceptability, and cost of tuberculosis testing by whole-blood interferon-gamma assay.

Background: The whole-blood interferon-gamma release assay (IGRA) is recommended in some settings as an alternative to the tuberculin skin test (TST). Outcomes from field implementation of the IGRA for routine tuberculosis (TB) testing have not been reported. We evaluated feasibility, acceptability, and costs after 1.