Rapid Oral Fluid Research Articles

Evaluation of three rapid oral fluid test devices on the screening of multiple drugs of abuse including ketamine

Rapid oral fluid testing (ROFT) devices have been extensively evaluated for their ability to detect common drugs of abuse; however, the performance of such devices on simultaneous screening for ketamine has been scarcely investigated. The present study evaluated three ROFT devices (DrugWipe® 6S, Ora-Check® and SalivaScreen®) on the detection of ketamine, opiates, methamphetamine, cannabis, cocaine and MDMA.A liquid chromatography tandem mass spectrometry (LCMS) assay was firstly established and validated for confirmation analysis of the six types of drugs and/or their metabolites. In the field test, the three ROFT devices were tested on subjects recruited from substance abuse clinics/rehabilitation centre. Oral fluid was also collected using Quantisal® for confirmation analysis.A total of 549 samples were collected in the study. LCMS analysis on 491 samples revealed the following drugs: codeine (55%), morphine (49%), heroin (40%), methamphetamine (35%), THC (8%), ketamine (4%) and cocaine (2%). No MDMA-positive cases were observed.Results showed that the overall specificity and accuracy were satisfactory and met the DRUID standard of >80% for all 3 devices. Ora-Check® had poor sensitivities (ketamine 36%, methamphetamine 63%, opiates 53%, cocaine 60%, THC 0%). DrugWipe® 6S showed good sensitivities in the methamphetamine (83%) and opiates (93%) tests but performed relatively poorly for ketamine (41%), cocaine (43%) and THC (22%). SalivaScreen® also demonstrated good sensitivities in the methamphetamine (83%) and opiates (100%) tests, and had the highest sensitivity for ketamine (76%) and cocaine (71%); however, it failed to detect any of the 28 THC-positive cases. The test completion rate (proportion of tests completed with quality control passed) were: 52% (Ora-Check®), 78% (SalivaScreen®) and 99% (DrugWipe® 6S).

Community-Based Rapid HIV Testing in Brazil for Vulnerable Populations: Whom are We Reaching?

Objective: Rapid HIV testing and counselling in community settings delivered by trained peers can allow easier access to and uptake of HIV testing and care. The programme 'Live Better Knowing' offers rapid HIV testing to key populations across Brazil. This cross-sectional study aims at describing the HIV prevalence in population subgroups and at assessing the association of sex work (SW) and/or drug use with a positive HIV result. Methods: Between January 2013 and April 2016, key populations were invited for HIV rapid oral fluid tests (DPP HIV- 1/2 Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil) by peers. HIV testing was offered in identified venues and areas where these populations socialize. Participants were interviewed using a brief questionnaire about their socio-demographic and risk behaviour. Multivariable logistic regression was used to assess the effect of SW and/or drug use on the risk of HIV. Results: Among the 43,358 participants, 42.9% were ciswomen, 2.9% were transvestites, 2.7% were transgender, 19.8% were men who have sex with men (MSM) and 31.9% were heterosexual men. Overall, 52.1% were first-time HIV testers. The HIV prevalence among the ciswomen, transvestites, transgender people, MSM and heterosexual men was 0.9%, 7.2%, 4%, 3.4% and 1%, respectively. Individuals who performed SW and used drugs had the highest HIV prevalence within each population group (ciswomen 1.7%, transvestites 8.1%, transgender 7.4%, MSM 5.9% and heterosexual men 2.6%). The adjusted odds ratios with 95% confidence intervals for selling sex combined with drug use were 2.90 (1.21-6.96) in ciswomen, 25.01 (2.67-234.57) in transgender people and 2.42 (1.31-4.48) in MSM. Conclusion: This outreach programme attracted persons with high risk practices who had never been tested. Our findings suggest that transvestites and transgender people (particularly those who sell sex) constitute a high risk population for HIV in urgent need of enhanced prevention, treatment and care services.

Fluorescence-based lateral flow assays for rapid oral fluid roadside detection of cannabis use.

With the recent worldwide changes in the legalization of marijuana, there is a significant need for rapid, roadside screening test for driving under the influence of drugs. A robust, sensitive, lateral flow assay has been developed to detect recent use via oral-fluid testing for Δ9 -tetrahydrocannabinol (THC). This proof-of-concept assay uses a fluorescent-based immunoassay detection of polymeric beads, conjugated to antibodies against native THC. The fluorescent technique allows for significantly lower limits of detection and higher precision determination of recent marijuana use without the use of urine or blood sampling-thus allowing for roadside identification. Detection levels of 0.01 ng/mL were distinguished from background and the lower limit of quantification was determined to approach 1 ng/mL.

Identification of drugged drivers using oral fluid

Several European countries have either already implemented oral fluid analysis for the detection of drugs in drivers or are contemplating its utility. In the USA, researchers involved in roadside surveys are increasingly including oral fluid collection and analysis in order to establish prevalence rates for drugs in drivers and decide whether oral fluid testing is reliable in this context. Oral fluid provides several advantages over blood, such as ease and speed of sample collection, particularly in terms of proximity to a traffic incident. Recently, several studies have been carried out with the specific aim of determining whether oral fluid, when collected simultaneously with blood provides similar information about recent drug intake. Drivers are stopped and are asked to submit voluntarily to the collection of an oral fluid and blood sample. In 2007 and 2013 over 7000 oral fluid and 3000 blood samples were collected nationally in the USA and analyzed for a wide range of drugs. In other projects, roadside instruments using oral fluid for analysis were also evaluated in conjunction with police officer observations and blood tests. Oral fluid provided similar information to blood regarding the recent intake of drugs. The overall results of several surveys will be presented, along with a discussion of the issues associated with practical aspects of saliva testing such as collection, analysis and interpretation. The outcome from several state projects, which incorporated the use of rapid oral fluid, tests using roadside instruments also provided supportive data and results will be presented. Rapid test instruments have a limited drug test panel and lack sensitivity for the detection of benzodiazepines in particular, which tend to be present in low concentrations in oral fluid compared to blood. The advantages and drawbacks of using oral fluid as a drug test specimen will be highlighted. Oral fluid is being increasingly studied for use in the area of driving under the influence of drugs. It has been shown to provide similar information to blood. Roadside instruments have been evaluated and some have been shown to be reliable, however improvements in the detection of benzodiazepines as well as extended drug test panels are necessary.

Promoting HIV testing with home self-test kit among men who have sex with men in China: a feasibility study

BackgroundIn China, the prevalence of HIV infection is high among men who have sex with men (MSM), but the HIV testing rate is rather low. HIV and sexuality stigma are the main barriers faced by Chinese MSM to testing for HIV with available testing services. The aim of this study was to assess the accuracy and acceptability of oral-based home self-testing, which might address the issue. MethodThis two-stage interventional study of HIV testing at baseline and at follow-up took place in two big cities and involved 3 clinics in Beijing and Nanning. The study population is MSM in the previous year, 18 years or older, currently living in Beijing or Nanning. The two main recruitment methods were peer-referral and disseminating testing and survey information through internet. We collected data by asking participants to fill out a questionnaire, which covers demographic characteristics, behaviour characteristics, HIV testing history, willingness to use the oral fluid rapid HIV test, and test preference. The questionnaire was pretested among five MSM and modified according to the MSM's suggestion. We also sampled blood for HIV tests and monitored oral fluid rapid self-testing. Follow-up was in the 3–12 months range after baseline study. The diagnostic accuracy of oral fluid rapid test kit for HIV infection were measured with sensitivity, specificity, and conformity by comparing oral test results with blood tests for ELISA/Western blot. The blood tests was done after the oral fluid self testing at baseline. HIV-negative MSM at the baseline were recommended to use oral testing kits as HIV home test kits to repeatedly test for HIV between baseline and follow-up. Sample size was estimated with the formula of screening. All participants provided written informed consent for voluntary rapid oral fluid testing and/or blood testing, and participation in questionnaire interview. The study protocol and informed consent form was approved by the institutional review board of Guangxi Provincial Center for Disease Control and Prevention. FindingsBetween April, 2013, and April, 2014, we enrolled 510 MSM for baseline analysis, 279 of whom were available for follow-up. The sensitivity of oral fluid HIV self-testing at baseline was 86% (95% CI 81·09–95·62); and the specificity was 98·2% (97·88–98·52). 401 (79%) MSM at baseline were willing to test for HIV with oral fluid testing kits. The associated factors were no passive unprotected anal intercourse (UAI) with male partners in the past 6 months, active UAI with regular male partners in the past 6 months, and the first choice of being tested for HIV being an oral test. 176 (35%) MSM at baseline and 125 (40%) MSM at follow-up preferred oral HIV testing. The associated factors at baseline were to grow up in urban areas and willingness to self-test for HIV using oral test kit in future. 102 (25%) MSM were willing to purchase oral fluid test kit in the following 6 months. The associated factors were 25 years of age or younger, college-level or higher education, known HIV serostatus of non-regular male sex partners through testing, and the oral test being the first choice of test. InterpretationHome HIV self-testing using oral fluid rapid testing kit of high accuracy is promising to facilitate HIV testing among MSM in China. Self-testing with oral fluid self testing kits in our study was mainly in a supervised context and the researcher could provide on-site post counseling and refer to care immediately, hence lacking data on linkage into care following a positive HIV test. FundingGuangxi Provincial Center for Disease Prevention and Control.

Can “Oral Fluid” be Used Instead of “Urine” for Rapid Screening of Drug of Abuse: A Prospective Pilot Study

Introduction Spot urine tests are commonly employed by emergency physicians in Hong Kong to detect recent abusive drug exposure. Spot tests utilising oral fluid are gaining its popularity in other parts of the world. There was lack of evidence about employment of rapid oral fluid test (ROFT) in the local emergency medical settings. The objective of this study is to determine the operating characteristics of ROFT, and to compare its agreement with the bedside urine immunoassay test (BUIT). Setting The emergency department and the substance abuse clinic of a regional hospital. Methods This was a single-centered cross-sectional study of diagnostic test. Patients suspected to have drug abuse were tested using either one or both of the commercially available ROFT and BUIT. The sensitivity, specificity and accuracy of both tests were calculated with reference to the laboratory urine toxicology screening results. The agreement between ROFT and BUIT was calculated. Results For the detection of ketamine and methamphetamine (the two most prevalent abusive substances), ROFT had 72-100% sensitivity and 93-100% specificity, which were comparable to that of BUIT (74-100% sensitivity and 100% specificity). The overall observed agreement of ROFT and BUIT results was at least 96%. There was good agreement between ROFT and BUIT with kappa values of 0.90-1.00. Conclusion In this pilot study, the operating characteristics of ROFT are comparable with that of BUIT, with both tests showing good agreements in the detection of ketamine and methamphetamine uses. ROFT can potentially be employed as an alternative investigation for rapid diagnosis of patients with suspected drug abuse. (Hong Kong j.emerg.med. 2015;22:265-269)

Introducing rapid oral-fluid HIV testing among high risk populations in Shandong, China: feasibility and challenges.

BackgroundThis study was conducted to ascertain the feasibility of using rapid oral fluid testing as an alternative HIV testing method in China.MethodThis is a mixed-method study among men who have sex with men (MSM), female sex workers (FSW) and VCT clients, conducted in 4 cities in Shandong Province. A pre-tested questionnaire was administered to 1137 participants through face-to-face interview to assess demographic characteristics, HIV testing histories and willingness to accept rapid oral fluid testing. VCT clients were provided with the saliva test kits for a screening test and errors in operation were recorded. Testing results were compared between oral and blood testing. Short feedback questionnaire was administered to 200 FSW who had undergone oral testing.ResultsThe rate of willingness to take oral-fluid HIV testing among MSM, FSW and VCT clients was 72.8%, 72.1% and 67.4% respectively. Common errors recorded during test kit operation by the 229 VCT clients included: unpreparedness, wrong swab sampling, wrong dilution, wrong testing and inability to read test results. Advantages of oral testing listed by participants included: less intrusive, painlessness, easy self- testing and privacy. Disadvantages included perceived unreliable results (55.5%) and not nationally recognised (9%). Comparison of saliva and the blood testing results recorded a consistency rate of 0.970 (χ2 = 153.348, P < 0.001), implying an excellent consistency.ConclusionIntroduction of oral rapid fluid testing as an alternative HIV testing method in China is highly feasible but with some challenges including low recognition and operation errors.

Rapid Oral Fluid HIV Antibody Testing in Exposed Babies: A Diagnostic Study

Aims: The usefulness of rapid oral fluid HIV antibody tests has rarely been evaluated in exposed babies. Study Design: A diagnostic survey comparing the performance of oral fluid HIV antibody test and the routine rapid blood screening test. Place and Duration of Study: University College Hospital, Ibadan and Nigerian Institute of Medical Research, Lagos, between May 2010 and April 2011. Methodology: The study involved children aged less than 18 months referred for screening in two large HIV care programmes in Nigeria using rapid antibody tests - an oral fluid test (Test A) and the routine blood test (Test B). The testing was blinded and HIV status was confirmed using DNA PCR. Results: A total of 94 children were studied with ages ranging from 0.13 to less than 18months. Out of the 94 parallel tests, when compared with DNA PCR, there were 7 (7.5%) discordant results. Test A gave one false positive, one false negative and no indeterminate result. Test B gave four false positive, one false negative and two indeterminate results. Test A had a sensitivity of 93.3%, specificity of 98.7%, positive

Feasibility of implementing rapid oral fluid HIV testing in an urban University Dental Clinic: a qualitative study

BackgroundMore than 1 million individuals in the U.S. are infected with HIV; approximately 20% of whom do not know they are infected. Early diagnosis of HIV infection results in earlier access to treatment and reductions in HIV transmission. In 2006, the CDC recommended that health care providers offer routine HIV screening to all adolescent and adult patients, regardless of community seroprevalence or patient lifestyle. Dental providers are uniquely positioned to implement these recommendations using rapid oral fluid HIV screening technology. However, thus far, uptake into dental practice has been very limited.MethodsThe study utilized a qualitative descriptive approach with convenience samples of dental faculty and students. Six in-depth one-on-one interviews were conducted with dental faculty and three focus groups were conducted with fifteen dental students.ResultsResults were fairly consistent and indicated relatively high levels of acceptability. Barriers and facilitators of oral fluid HIV screening were identified in four primary areas: scope of practice/practice enhancement, skills/knowledge/training, patient service/patient reactions and logistical issues.ConclusionsOral fluid HIV screening was described as having benefits for patients, dental practitioners and the public good. Many of the barriers to implementation that were identified in the study could be addressed through training and interdisciplinary collaborations.

Adolescents’ agreement to test for HIV when different testing methods are offered

Offering rapid HIV testing improves rates of testing in adults, but little is known about whether offering adolescents a choice of testing methods increases rates of testing. The aims of the study were to determine rates of HIV testing in adolescents when different testing methods were offered and explore factors associated with agreement to be tested for HIV. Participants (n= 200, sexually experienced 13-22 year olds) were recruited from an urban adolescent clinic, completed a 99-item theory-based survey and were offered their choice of venipuncture, rapid fingerstick or rapid oral fluid HIV testing. Approximately half (49.5%) agreed to HIV testing. Male gender, parental completion of high school, intention to test for HIV if offered by clinician and higher perceived likelihood of current HIV infection were independently associated with agreement to test. Combining new strategies, such as opt-out testing, with routine testing may be needed to improve rates of adolescent HIV testing.

HIV Screening in an Urban Emergency Department: Comparison of Screening Using an Opt-In Versus an Opt-Out Approach

We compare outcomes of opt-in and opt-out HIV screening approaches in an urban emergency department. This was a 1-year prospective observational study comparing 2 6-month screening approaches. Eligibility for opt-in and opt-out screening was identical: aged 15 years or older, medically stable, and able to complete general consent. During the opt-in phase, triage nurses referred patients to HIV testers stationed at triage, who obtained separate opt-in written consent and performed rapid oral fluid tests. During the opt-out phase, registration staff conducted integrated opt-out consent and then referred patients to HIV testers. We assessed the proportion of potentially eligible patients who were offered screening (screening offer rate), the proportion offered screening who accepted (screening acceptance rate), the proportion who accepted screening and subsequently completed testing (test completion rate), and the proportion of potentially eligible patients who completed testing (overall screening rate) during each phase. For the opt-in versus the opt-out phases, respectively, there were 23,236 potentially eligible patients versus 26,757, screening offer rate was 27.9% versus 75.8% (P<.001), screening acceptance rate was 62.7% versus 30.9% (P<.001), test completion rate was 99.8% versus 74.6% (P<.001), and overall screening rate was 17.4% versus 17.5% (P = .90). A significantly higher proportion of patients were offered HIV screening with an opt-out approach at registration. However, this was offset by much higher screening acceptance and test completion rates with the opt-in approach at triage. Overall screening rates with the 2 approaches were nearly identical.

Acceptability of rapid oral fluid HIV testing among male injection drug users in Taiwan, 1997 and 2007

Rapid oral fluid HIV testing (rapid oral testing) is in the process of being adapted in Taiwan and elsewhere given its advantages over prior HIV testing methods. To guide this process, we examined the acceptability of rapid oral testing at two time points (i.e., 1997 and 2007) among one of the highest risk populations, male injection drug users (IDUs). For this purpose, an anonymous self-administered survey was completed by HIV-negative IDUs involved in the criminal justice system in 1997 (N 1=137 parolees) and 2007 (N 2=106 prisoners). A social marketing model helped guide the design of our questionnaire to assess the acceptability of rapid oral testing. This included assessing a new product, across four marketing dimensions: product, price, promotion, and place. Results revealed that in both 1997 and 2007, over 90% indicated that rapid oral testing would be highly acceptable, particularly if the cost was under US$6, and that a pharmacy would be the most appropriate and accessible venue for selling the rapid oral testing kits. The vast majority of survey respondents believed that the cost of rapid oral testing should be federally subsidized and that television and newspaper advertisements would be the most effective media to advertise for rapid oral testing. Both the 1997 and 2007 surveys suggested that rapid oral HIV testing would be particularly accepted in Taiwan by IDUs after release from the criminal justice system.

Rapid Oral Fluid Testing for HIV in Veterans With Mental Health Diagnoses and Residing in Community-Assisted Living Facilities

Veterans with a history of mental health and substance abuse diagnoses, residing in assisted living facilities, are more likely to have an undiagnosed HIV infection related to high-risk behaviors. We determined (a) the cross-sectional prevalence of HIV infection among 65 veterans of unknown HIV serostatus with mental health diagnoses who resided in 11 community-assisted living facilities, and (b) whether patients who had not consented to standard physician-initiated blood testing in the previous 5 years would consent to rapid oral fluid HIV testing by nurses familiar to the subjects. We found an HIV prevalence of 3.1% in the subjects who agreed to be tested (n = 64, 98%). High test acceptance, especially in a group with little HIV screening experience, and the identified high prevalence of disease, suggest that this diagnostic method is effective. Patients' familiarity with the nurses who conducted the testing most likely supported the success of the procedure.

Analytical evaluation of a rapid on-site oral fluid drug test

There is a need for a reliable rapid on-site oral fluid test that can be used in police controls to detect impaired drivers. We evaluated the Varian Oralab6 and collected two oral fluid samples from 250 subjects, one with the Varian Oralab6 and one with the StatSure Saliva Sampler. The Oralab6 can detect six drug types: amphetamines, methamphetamine, cocaine, opiates, delta9-tetrahydrocannabinol (THC), and phencyclidine (PCP). On-site results were obtained within 10 to 15 min. The sample collected with StatSure was analyzed using liquid chromatography-tandem mass spectrometry after liquid-liquid extraction and these results were used as a reference to determine prevalence, sensitivity, and specificity. Two cut-off values were used in the evaluation. The Varian cut-off values were: amphetamine 50 ng/mL, cocaine 20 ng/mL, opiates 40 ng/mL, and THC 50 ng/mL. The DRUID cut-offs were: amphetamine 25 ng/mL, cocaine 20 ng/mL, opiates 20 ng/mL, and THC 1 ng/mL. Applying the first cut-offs, prevalence, sensitivity, and specificity were: amphetamine 10%, 76%, 100%; cocaine 23%, 34%, 100%; opiates 38%, 83%, 94%; and THC 18%, 41%, 99%. The DRUID cut-off values gave the following results: amphetamine 14%, 56%, 100%; cocaine 28%, 34%, 100%; opiates 49%, 68%, 98%, and THC 45%, 16%, 99%. The specificity of the Oralab6 is generally good. For both cut-offs, sensitivity was low for cocaine and THC. Therefore, the Varian Oralab6 test is not sensitive enough to be applied during roadside police controls.

ORAL FLUID TESTS FOR SCREENING OF HUMAN IMMUNODEFICIENCY VIRUS-EXPOSED INFANTS

In high human immunodeficiency virus (HIV) prevalence settings, routine screening of infants attending immunization visits could improve identification of HIV-exposed infants to receive an early diagnosis and appropriate interventions. This first assessment of 2 rapid oral fluid HIV tests in early infancy demonstrates a sensitivity of <90% for detection of HIV-exposure resulting in failure to detect at least 1 in 10 HIV-infected infants.

False Positive Rate of Rapid Oral Fluid HIV Tests Increases as Kits Near Expiration Date

BackgroundBecause a recent cluster of false positive results on the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test occurred in San Francisco on test kits close to their expiration date, we decided to assess the relationship between time to expiration and rate of false positive results from tests used with oral fluid.Methodology/Principal FindingsWe analyzed results of 20,904 tests with either an initial HIV-negative result (n = 20,828) or a preliminary positive result that was then negative on confirmatory tests (n = 76). We computed specificity for kits with time to expiration from ≤1 to ≥6 months, with exact binomial confidence intervals, then used logistic regression to estimate the independent association of time to expiration with false positive results, adjusting for site and technician effects. For 1,108 kits used in the last month before expiration, specificity was 98.83% (95% exact binomial confidence interval (CI) 98.00%–99.37%); the upper bound is below the claimed specificity of 99.60%. After adjustment using regression standardization for the effects of site, test lot, and technician factors, adjusted specificity in the last month before expiration was 99.18% (95% bootstrap confidence interval 98.60–99.57%).Conclusions/SignificanceWe found that specificity of the OraQuick ADVANCE® with oral fluid declined significantly with ≤1 month remaining to expiration, leaving little margin for error from other sources.

Adolescent Preferences for Human Immunodeficiency Virus Testing Methods and Impact of Rapid Tests on Receipt of Results

Rapid human immunodeficiency virus (HIV) tests may be more acceptable to adolescents and may improve receipt of test results. We conducted a study to determine (a) adolescent preferences for different HIV testing methods (rapid oral fluid vs. rapid fingerstick vs. traditional venipuncture), (b) factors associated with choice of a rapid vs. traditional test, and (c) whether those who chose a rapid method were more likely to receive test results. Participants (N=99, 13-22 years old, both genders) were recruited from an urban hospital-based adolescent primary care clinic, agreed to HIV testing with their choice of method, and completed a questionnaire assessing demographic characteristics and attitudes about HIV testing. Logistic regression modeling was used to determine factors associated with choice of a rapid versus traditional test. Half (50.5%) of participants chose rapid oral fluid testing, 30.3% traditional venipuncture testing, and 19.2% rapid fingerstick testing (p < .01). Factors independently associated with choice of a rapid versus traditional method included preference for an oral fluid versus blood test and perceived approval of HIV testing by one's healthcare provider. Participants who chose a rapid test were more likely to receive their test results within the follow-up period than participants who chose a traditional test (91.3% vs. 46.7%, p < .001). In this study, 70% of adolescents preferred rapid to traditional HIV testing, and rapid testers were more likely to receive their results within the follow-up period. Offering rapid testing may lead to improved receipt of results among adolescents in urban primary care settings.

Is HIV Screening in the Labor and Delivery Unit Feasible and Acceptable in Low-Income Settings?

Despite the downward revision of the estimated national prevalence of HIV infection in India from 5.7 million to 2.5 million in UNAIDS' December 2007 report, the burden faced in providing national HIV prevention and care remains massive [1]. The National AIDS Control Organization (NACO) of India estimated that some 60% of cases of HIV infection are found in rural areas, where about half of India's citizens live [2]. In rural and urban areas, women of reproductive age are principally at risk for HIV acquisition through marriage—this risk reflects their husband's premarital behavior and sexual concurrency during marriage [3,4]. Therefore, NACO has focused on the expansion of voluntary counseling and testing (VCT) services to increase early case-finding, in large part through antenatal care in conjunction with the prevention of mother-to-child transmission (PMTCT) of HIV during labor and delivery [2]. What is the impact of these national policies on HIV testing during pregnancy in India? Sinha and colleagues found that out of a random sample of 400 recently pregnant women in rural Maharashtra State, where sentinel surveillance suggested an antenatal HIV rate of at least 1%, only 3.3% of women reported receiving VCT during pregnancy [5]. This exceptionally low rate of antenatal testing for HIV was attributed to two identified barriers: (1) lack of discussion of HIV testing by antenatal care providers; and (2) women's lack of awareness of HIV testing, including VCT. Interestingly, of the 13 participants reporting VCT during antenatal care, 12 received it through the private sector—thus, only one woman (in 400) reported receiving the Indian standard of care for HIV testing during pregnancy through a government clinic. In this issue of PLoS Medicine, Nitika Pant Pai and colleagues evaluated the uptake of 24-hour rapid HIV testing of women in a labor and delivery center in a rural, tertiary teaching hospital in Sevagram, Maharashtra State, India [6]. The research team wanted to determine if offering round-the-clock rapid HIV testing would be feasible, lead to increased uptake of testing, and identify women in labor who could be provided optimal PMTCT. Linked Research Article This Perspective discusses the following new study published in PLoS Medicine: Pai NPP, Barick R, Tulsky JP, Shivkumar PV, Cohan D, et al. (2008) Impact of round-the-clock, rapid oral fluid HIV testing of women in labor in rural India. PLoS Med 5(5): e92. doi:10.1371/journal.pmed.0050092 Nitika Pant Pai and colleagues report the results of offering a round-the-clock rapid HIV testing program in a rural labor ward setting in India.

Impact of Round-the-Clock, Rapid Oral Fluid HIV Testing of Women in Labor in Rural India

BackgroundTesting pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India.Methods and FindingsAfter they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%–1.8%). Of the 15 HIV test–positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery.ConclusionsIn a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries.

Circumcision status and HIV infection among Black and Latino men who have sex with men in 3 US cities.

To examine characteristics of circumcised and uncircumcised Latino and black men who have sex with men (MSM) in the United States and assess the association between circumcision and HIV infection. Using respondent-driven sampling, 1154 black MSM and 1091 Latino MSM were recruited from New York City, Philadelphia, and Los Angeles. A 45-minute computer-assisted interview and a rapid oral fluid HIV antibody test (OraSure Technologies, Bethlehem, PA) were administered to participants. Circumcision prevalence was higher among black MSM than among Latino MSM (74% vs. 33%; P < 0.0001). Circumcised MSM in both racial/ethnic groups were more likely than uncircumcised MSM to be born in the United States or to have a US-born parent. Circumcision status was not associated with prevalent HIV infection among Latino MSM, black MSM, black bisexual men, or black or Latino men who reported being HIV-negative based on their last HIV test. Further, circumcision was not associated with a reduced likelihood of HIV infection among men who had engaged in unprotected insertive and not unprotected receptive anal sex. In these cross-sectional data, there was no evidence that being circumcised was protective against HIV infection among black MSM or Latino MSM.