HIV-positive Samples Research Articles

Progress toward HIV epidemic control in Lesotho.

The Lesotho Population-based HIV Impact Assessment survey was conducted nationally and designed to measure HIV prevalence, incidence, and viral load suppression (VLS). A nationally representative sample of 9403 eligible households was surveyed between November 2016 and May 2017; analyses account for study design. Consenting participants provided blood samples, socio-demographic, and behavioral information. Blood samples were tested using the national rapid HIV testing algorithm. HIV-seropositive results were confirmed with Geenius supplemental assay. Screening for detectable concentrations of antiretroviral analytes was conducted on dried blood specimens from all HIV-positive adults using high-resolution liquid chromatography coupled with tandem mass spectrometry. Self-reported and/or antiretroviral biomarker data were used to classify individuals as HIV-positive and on treatment. Viral load testing was performed on all HIV-positive samples at central labs. VLS was defined as HIV RNA below 1000 copies/ml. Overall, 25.6% of adults aged 15-59 years were HIV-positive. Among seropositive adults, 81.0% (male 76.6%, female 84.0%) reported knowing their HIV status, 91.8% of people living with HIV (male 91.6%, female 92.0%) who reported knowing their status reporting taking antiretrovirals, and 87.7% (male and female 87.7%) of these had VLS. Younger age was significantly associated with being less likely to be aware of HIV status for both sexes. Findings from this population-based survey provide encouraging data in terms of HIV testing and treatment uptake and coverage. Specific attention to reaching youth to engage them in HIV-related interventions are critical to achieving epidemic control.

Seroprevalence of Human Cytomegalovirus Infection among HIV Patients in Khartoum State

Background: Human Cytomegalovirus (HCMV) is one of the opportunistic infections associated with significantly high morbidity and mortality among patients living with immunodeficiency syndrome. CMV has been reported to enhance HIV replication and accelerate the progre ssion of HIV infection to AIDS. Aim: The aim of this study was to determine the prevalence of HCMV among HIV patients in Khartoum State, Sudan, during the period April to July 2018. Methods: The study was carried out in Khartoum State, Sudan. A total of 9 2 HIV sero - positive cases were included. HCMV IgG and IgM antibodies were detected using Enzyme Linked Immune Sorbent Assay. Results: Among 92 HIV positive samples, 91 (99%) were found positive for HCMV - IgG while 3 samples (3.2%) were positive for HCMV - I gM. Conclusion: In Sudan, the existence of HCMV in patients with HIV infection was confirmed by using ELISA. These findings indicate that CMV is hyper-endemic in HIV seropositive patients in Khartoum, Sudan.

Performance evaluation of the Bio-Rad Geenius HIV 1/2 supplemental assay

BackgroundIn the US, the HIV diagnostic algorithm for laboratory settings recommends the use of an HIV-1/HIV-2 differentiation supplemental assay after an initial reactive antigen/antibody (Ag/Ab) assay result. Since the discontinuation of the Multispot HIV-1/HIV-2 Rapid Test (MS), the Geenius HIV-1/2 Supplemental assay (Geenius) is the only FDA-approved supplemental differentiation test. ObjectiveWe compared the performance of Geenius to MS and Western Blot (WB). Study designThe relative seroconversion plasma reactivity of Geenius and MS was assessed using a 50% cumulative frequency analysis from 17 HIV-1 seroconverters. In addition, previously characterized plasma specimens, 186 HIV-1 positive, 100 HIV-2 positive, and 93 Ag/Ab-positive/HIV-1 RNA-negative, were tested with Geenius v1.1 software. McNemar’s test was used for paired comparison analysis. A subset of 48 specimens were retested with the upgraded Geenius v1.3 software. ResultsIn HIV-1 seroconverters, the relative seroconversion reactivity was 2.5 and 2 days before the first positive HIV-1 WB for Geenius and MS, respectively. In HIV-1 positive samples, Geenius performed similarly to HIV-1 WB (p=0.1687) and MS (p=0.8312). In HIV-2 positive samples, Geenius underperformed compared to HIV-2 WB (p=0.0005) and MS (p=0.0012). When using the upgraded software among the HIV-1 positive and Ag/Ab-reactive/HIV-1 RNA-negative samples, gp140 reactivity decreased without affecting characterization of HIV-2 samples. ConclusionsWith HIV-1 samples, Geenius, WB and MS performance was similar as supplemental tests. The updated Geenius software reduced false gp140 reactivity, but had no impact on identifying true HIV-2 infections. Further evaluation will assess the impact of the Geenius software update on final diagnostic interpretations

HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors.

BackgroundRapid tests for HIV testing are essential tools to achieve the 90-90-90 target of the World Health Organization. Many tests are available, some directly from websites. Evaluation of the performance of rapid tests, under close to real-life usage, is therefore needed to ensure accurate diagnosis in the context of the recommendation for their more widespread use.MethodNine third- (3G) or fourth-generation (4G) rapid screening tests or self-tests (two bought on websites), were evaluated on an extensive panel of 200 HIV-negative and 312 HIV-positive samples, representative of a wide variety of clinical situations and HIV genetic diversity. A whole blood reconstitution protocol was designed to simulate real-life usage of these tests in community-based and private settings.FindingsThe specificity was high (98.5–100%) and sensitivity excellent (100%) for samples from patients chronically infected with the pandemic strains. The performance for infrequent situations with a major epidemiological and clinical impact, such as infection with divergent viruses or primary infection, was highly variable, depending on the test. One of the two 4G tests allowed detection of additional positive samples from early stages of infection, whereas the second (sold as a 4G test on a website) corresponded in reality to a 3G test.InterpretationOur study showed that not all tests are equal for the detection of major HIV variants or early stages of HIV infection; adding the detection of specific p24Ag improved the latter point. This study also showed, for the first time, that buying through web-based vendors can be risky, due to the varying performance of the tests and questionable sales practices. Our results are of particular importance in the context of the increasing use of rapid tests in an “outside laboratory” settings.FundSanté Publique France, COREVIH – Normandie, and Rouen University Hospital.

Evaluation of the vitros hiv combo 4th generation test for the identification of HIV infections

BackgroundSimultaneous detection of HIV 1 and 2 antibodies and HIV-1 p-24 antigen in the 4th generation tests is particularly effective for the identification of early acute HIV infections while maintaining accurate detection of long-established infections. ObjectivesThe aim of this study was to evaluate the new 4th generation VITROS HIV Combo test from Ortho-Clinical Diagnostics by comparing its results with those obtained using a 3rd generation HIV 1/2 antibody test (VITROS Anti HIV 1 + 2 from Ortho-Clinical Diagnostics) and a 4th generation test (LIAISON XL HIV Ab/Ag, DiaSorin) currently used in the Microbiology Unit of Legnano Hospital. Study designOne thousand and three samples of the normal daily routine (Group 1) were analyzed simultaneously with the three systems. The concordant and discordant sample results were further tested using Western blot and HIV-RNA assay (Roche). One hundred samples (Group 2) of known HIV positive subjects (63 of subtype B, 37 subtype non-B, and 51 with positive viraemia) and 50 samples (Group 3) with indeterminate Western blot were also examined using the three systems. From Group 3, 24 samples were collected from patients diagnosed with acute infection. ResultsThe overall agreement between the three systems was 99.4% (99.5% in group 1, 100% in group 2 and 96.6% in group 3) with a coefficient Fleiss Kappa of 0.9814. Notably, the VITROS HIV Combo test was positive in all known HIV positive samples of group 2 without any statistically significant difference in the values of the sample/cut off ratios between the B and non-B subtypes and between the positive and negative viraemia samples in established infections. The VITROS HIV Combo test was also positive in all samples of patients with acute infection in group 3. ConclusionsThe VITROS HIV Combo test has shown comparable performance to the other two assays in use of 3rd and 4th generation tests and is able to correctly identify both acute and established HIV infections independently of viraemia and HIV subtype.

Elevated soluble CD23 level indicates increased risk of B cell non-Hodgkin's lymphomas: evidence from a meta-analysis.

The aim of the present study was to determine whether circulating soluble CD23 (sCD23) was associated with B cells non-Hodgkin's lymphomas (B-NHL). PubMed, EMBASE, and ISI Web of Science were extensively searched without language restriction. Data was extracted in a standardized data collection sheet after two reviewers scanned studies independently. The association between sCD23 and NHL was indicated as odds ratio (OR) along with its related 95% confidence interval (95% CI). Meta-analysis was conducted via RevMan 5.3. A total of five studies, which included 964 B-NHL patients and 1243 matched controls without B-NHL, among which 257 were HIV-positive donors and 986 were general controls, were included in our study. Meta-analysis revealed a significant association between peripheral sCD23 level and B-NHL in HIV-positive samples (OR 1.66, 95% CI 1.25, 2.20; P = 0.0005) as well as the general population (OR 2.51; 95% CI 1.71, 3.86; P < 0.00001). Meta-analysis, stratified by sampling time prior to diagnosis, indicated potential HIV-NHL patients are 2.34-folds more likely to have higher blood sCD23 level, although this association is statistically meaningful only during 3-5years prior to diagnosis (95% CI 1.27, 4.33). Subgroup analysis based on B-NHL type demonstrated a significant association between sCD23 level and diffuse large B cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), and follicular lymphoma (FL). The findings of our study indicate a positive association of circulating sCD23 level and B-NHL risks and highlight the possibility of sCD23 as a predictive marker of B-NHL. However, to better understand the underlying mechanism, further studies are needed.

Torque Teno Virus in HIV-infected transgender in Surakarta, Indonesia

Torque Teno Virus (TTV) is a circular single-stranded DNA virus that may co-infected with human immunodeficiency virus (HIV), especially in the high-risk community e.g. the transgender performing high-riskbehavior. TTV shows an increased viremia in HIV patients and maybe influence the HIV clinical progression. Blood samples collected from transgender performing high-riskbehavior in Surakarta were tested by serological and molecular assays to detect the presence of HIV infection. The blood samples with HIV positive status were then tested by a nested polymerase chain reaction (PCR) to detect the presentation of TTV DNA. The amplified PCR products were molecularly cloned and subjected to sequence analysis. TTV DNA was detected in 40.0% HIV-positive samples. The molecular characterization revealed that the most prevalent was genogroup 3, followed by genogroup 2 and 1, respectively. TTV was detected in HIV-infected transgender performing high-riskbehavior in Surakarta with high infection rate.

Psychometric Properties of the Relational Self-Esteem Scale in a Community-Based Sample in China

Abstract. This study examines the psychometric properties of the Relational Self-Esteem scale (RSE; Du, King, &amp; Chi, 2012 ) in a community sample in rural China. The RSE was developed to measure one’s sense of self-worth in relationships with significant others (i.e., family and friends). The study draws upon data from 754 rural residents (42.4% HIV-positive) in a county in central China with a high prevalence of HIV infection. Factor structure and measurement invariance were examined using confirmatory factor analyses (CFAs). Concurrent validity was tested by correlating the RSE with a set of previously developed measures of psychological well-being and social support. The data supported a two-factor family-friend model for both HIV-positive and HIV-negative samples. Multiple-group tests showed measurement invariance across two samples. Concurrent validity was confirmed with correlations in the expected direction between the RSE and psychological well-being and social support. Implications for mental health research and practice are discussed.

P-E3 Assessment of internationally-available HIV test kits for their suitability to meet manufacturers' claims

Background: HIV test kits, particularly rapid HIV tests, are used throughout the world as a primary measure to protect the blood supply and provide diagnosis to save lives. The US government purchases large numbers of HIV tests at considerable expense, and expects them to perform adequately. Objective: To assess a large number and variety of HIV test kits to determine if they meet the claims of the manufacturers. Methods: From September 2010 through July 2017, a total of 1,123 lots of HIV test kits from 14 manufacturers and representing 11 different tests from 26 countries, were received for evaluation at the INSTITUTE OF HUMAN VIROLOGY. Each test kit was assessed for performance characteristics using panels of sera (n=30 or 160) that included positives for HIV-1 and HIV-2 (n=8 or 80), and negatives (n=22 or 80). Several HIV-1 positive samples were weak positives derived from seroconversion panels (SeraCare). Test kits were also assessed for precision using several HIV-1 weak positive samples tested in replicate. Results: Of the HIV test kit lots evaluated, 99.2% successfully passed the evaluation with perfect performance. Of the 9 lots that did not pass, 3 were found to produce high background that interfered with reading, 2 performed inadequately with high-temperature testing, and 4 exhibited greater than one false-positive result. In one assessment, a country had reported poor performance of a test kit, but the test kit passed the evaluation; this resulted in a visit to the country to assess the laboratory's activities. Conclusion: In our evaluation of a large number and variety of HIV test kit lots from 14 manufacturers, nearly all performed as expected and met the manufacturers' claims.

The challenge of discriminating between HIV-1, HIV-2 and HIV-1/2 dual infections.

Discrimination between HIV-1 and HIV-2 is important to ensure appropriate antiretroviral treatment (ART) and epidemiological surveillance. However, serological tests have shown frequent mistyping when applied in the field. We evaluated two confirmatory tests, INNO-LIA HIV I/II Score and ImmunoComb HIV 1/2 BiSpot, for HIV type discriminatory capacity. Samples from 239 ART-naïve HIV-infected patients from the Bissau HIV Cohort in Guinea-Bissau were selected retrospectively based on the initial HIV typing performed in Bissau, ensuring a broad representation of HIV types. INNO-LIA results were interpreted by the newest software algorithm, and three independent observers read the ImmunoComb results. HIV-1/HIV-2 RNA and DNA were measured for confirmation. INNO-LIA results showed 123 HIV-1 positive samples, 69 HIV-2 positive and 47 HIV-1/2 dually reactive. There was agreement between INNO-LIA and HIV-1/HIV-2 RNA and DNA detection, although not all HIV-1/2 dually reactive samples could be confirmed by the nucleic acid results. Overall, the observers found that the ImmunoComb results differed from the INNO-LIA results, with agreements of 90.4, 91.2 and 92.5%, respectively, for HIV-1, HIV-2 and HIV-1/2. The combined kappa-score for agreement between the three observers was 0.955 (z-score 35.1; P < 0.01). Of the HIV-2 mono-reactive samples (INNO-LIA), the three observers interpreted 24.6-31.9% as HIV-1/2 dually infected by ImmunoComb. None of these samples had detectable HIV-1 RNA or DNA. There was accordance between INNO-LIA calls and nucleic acid results, whereas ImmunoComb overestimated the number of HIV-1/2 dually infected patients. Confirmatory typing is needed for patients diagnosed with HIV-1/2 dual infection by ImmunoComb.

The changing HIV-1 genetic characteristics and transmitted drug resistance among recently infected population in Yunnan, China.

Multiple human immunodeficiency virus (HIV)-1 genotypes in China were first discovered in Yunnan Province before disseminating throughout the country. As the HIV-1 epidemic continues to expand in Yunnan, genetic characteristics and transmitted drug resistance (TDR) should be further investigated among the recently infected population. Among 2828 HIV-positive samples newly reported in the first quarter of 2014, 347 were identified as recent infections with BED-captured enzyme immunoassay (CEIA). Of them, 291 were successfully genotyped and identified as circulating recombinant form (CRF)08_BC (47.4%), unique recombinant forms (URFs) (18.2%), CRF01_AE (15.8%), CRF07_BC (14.4%), subtype C (2.7%), CRF55_01B (0.7%), subtype B (0.3%) and CRF64_BC (0.3%). CRF08_BC and CRF01_AE were the predominant genotypes among heterosexual and homosexual infections, respectively. CRF08_BC, URFs, CRF01_AE and CRF07_BC expanded with higher prevalence in central and eastern Yunnan. The recent common ancestor of CRF01_AE, CRF07_BC and CRF08_BC dated back to 1983.1, 1992.1 and 1989.5, respectively. The effective population sizes (EPS) for CRF01_AE and CRF07_BC increased exponentially during 1991-1999 and 1994-1999, respectively. The EPS for CRF08_BC underwent two exponential growth phases in 1994-1998 and 2001-2002. Lastly, TDR-associated mutations were identified in 1.8% of individuals. These findings not only enhance our understanding of HIV-1 evolution in Yunnan but also have implications for vaccine design and patient management strategies.

HIV rapid diagnostic testing by lay providers in a key population-led health service programme in Thailand

Introduction: Rapid diagnostic testing (RDT) for HIV has a quick turn-around time, which increases the proportion of people testing who receive their result. HIV RDT in Thailand has traditionally been performed only by medical technologists (MTs), which is a barrier to its being scaled up. We evaluated the performance of HIV RDT conducted by trained lay providers who were members of, or worked closely with, a group of men who have sex with men (MSM) and with transgender women (TG) communities, and compared it to tests conducted by MTs.Methods: Lay providers received a 3-day intensive training course on how to perform a finger-prick blood collection and an HIV RDT as part of the Key Population-led Health Services (KPLHS) programme among MSM and TG. All the samples were tested by lay providers using Alere Determine HIV 1/2. HIV-reactive samples were confirmed by DoubleCheckGold Ultra HIV 1&2 and SD Bioline HIV 1/2. All HIV-positive and 10% of HIV-negative samples were re-tested by MTs using Serodia HIV 1/2.Results: Of 1680 finger-prick blood samples collected and tested using HIV RDT by lay providers in six drop-in centres in Bangkok, Chiang Mai, Chonburi and Songkhla, 252 (15%) were HIV-positive. MTs re-tested these HIV-positive samples and 143 randomly selected HIV-negative samples with 100% concordant test results.Conclusion: Lay providers in Thailand can be trained and empowered to perform HIV RDT as they were found to achieve comparable results in sample testing with MTs. Based on the task-shifting concept, this rapid HIV testing performed by lay providers as part of the KPLHS programme has great potential to enhance HIV prevention and treatment programmes among key at-risk populations.

Seroprevalence Study of Human Immunodeficiency Virus, Hepatitis B Virus and Hepatitis C Virus in Humans and Risk Factors in Suleja, Nigeria

The study was undertaken to determine the seroprevalence of human immunodeficiency virus, hepatitis B virus (HBV) and hepatitis C Virus (HCV) infection among adults 15 years and above in Suleja, Nigeria in order to obtained the base line information on disease burden, and to assess the possible risks factors associated with these infection in the study population, A total of 360 samples were screened for the virus infection after obtaining their consent. Sera obtained from the sample were screened using rapid Immunochromatographic test kits to determine the HIV and the presences of hepatitis B surface antigen (HBs Ag) and antibody to hepatitis (Anti HCV) Respectively. The CD4+ of the entire HIV positive sample and 50 HIV negative samples were determined making use of cyslow counter according to the manufacture’s instruction. Out of the 360 sera samples tested, 58 (16.11%) were seropositive for HIV 1/2, 22 (6: 11%) were positive HBs Ag and 14(3:89%) were positive for HIV 1/2 :22 positive for both HIV and HBsAg and 5 (8:62%) were seropositive for HIV and antibody to hepatitis C (HCV) the highest prevalence of HIV 15(32:61) was in age group 35-39 results also show that the prevalence of HIV and HBV increased with age to age 35-39 and 30-34 respectively but later decrease with further increase in age. More than half of the HIV positive samples 48(69.57%) were having CD4 count &lt; 600 cell/ul. There was slight difference associated between the risk factors, history of blood transfusion, history of sexually transmitted infection use of sharp object and Injection drug user investigated in this study and infection. Universal screenings of HIV, HBsAg and anti HCV, health education to reduce the risk of infection are suggested.

Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

The point-of-care tests (POCTs) for HIV diagnosis have been widely used in Brazil in order to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. In order to guarantee the quality of HIV diagnostics based on rapid tests, the Brazilian Ministry of Health (MoH) implemented the HIV POCT Evaluation Program. This study compiles the Brazilian experience acquired over the last 13 years conducting the HIV POCT Evaluation Program.&#x0D; &#x0D; Methods and Findings&#x0D; The selection of tests was based on the interest of manufacturers to qualify for the MoH tenders. Each round was performed with fresh whole blood and oral fluid samples, always including HIV positive and negative ones. In addition to the POCT, every sample was submitted to a reference testing protocol, based on an immunoassay followed by Western blot. The POCTs were evaluated for clinical sensitivity, clinical specificity, assay operational characteristics, detection of HIV-2 antibodies, sensitivity to subtypes panels; and sensitivity to seroconversion panels. Since its implementation in 2003, the POCT evaluation protocol has undergone some modifications aiming to improve and simplify the evaluation process, to know: (i) for HIV-positive samples, perform EIA and Western blot only if the POCT is non-reactive; (ii) reduction from 800 to 600 HIV negative samples; (iii) increase from one to three subtype panels (including HIV-2 samples); and (iv) inclusion of seroconversion panel. We evaluated six tests, four of which met the sensitivity criteria of 99.5%: BD Chek™ HIV Multi-test (whole blood), HIV 1/2 Colloidal Gold (whole blood), OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (whole blood and oral fluid) and TR DPP HIV-1/2 (whole blood, plasma and oral fluid). Regarding other evaluated criteria, all assays met the requirements.&#x0D; &#x0D; Conclusions&#x0D; The successful Brazilian policy on POCT use for HIV infection diagnosis includes the evaluation of the POCT itself in addition to appropriate selection of tests to be acquired and nationwide distributed to the public health facilities, control of each test batch distributed by the MoH, proper and easily accessible training to all health professionals involved in rapid testing through distance learning tools, and continued evaluation of POCT use through external quality assessment.

Designing HIV Testing Algorithms Based on 2015 WHO Guidelines Using Data from Six Sites in Sub-Saharan Africa.

ABSTRACTOur objective was to evaluate the performance of HIV testing algorithms based on WHO recommendations, using data from specimens collected at six HIV testing and counseling sites in sub-Saharan Africa (Conakry, Guinea; Kitgum and Arua, Uganda; Homa Bay, Kenya; Douala, Cameroon; Baraka, Democratic Republic of Congo). A total of 2,780 samples, including 1,306 HIV-positive samples, were included in the analysis. HIV testing algorithms were designed using Determine as a first test. Second and third rapid diagnostic tests (RDTs) were selected based on site-specific performance, adhering where possible to the WHO-recommended minimum requirements of ≥99% sensitivity and specificity. The threshold for specificity was reduced to 98% or 96% if necessary. We also simulated algorithms consisting of one RDT followed by a simple confirmatory assay. The positive predictive values (PPV) of the simulated algorithms ranged from 75.8% to 100% using strategies recommended for high-prevalence settings, 98.7% to 100% using strategies recommended for low-prevalence settings, and 98.1% to 100% using a rapid test followed by a simple confirmatory assay. Although we were able to design algorithms that met the recommended PPV of ≥99% in five of six sites using the applicable high-prevalence strategy, options were often very limited due to suboptimal performance of individual RDTs and to shared falsely reactive results. These results underscore the impact of the sequence of HIV tests and of shared false-reactivity data on algorithm performance. Where it is not possible to identify tests that meet WHO-recommended specifications, the low-prevalence strategy may be more suitable.

High Seroprevalence of Human Herpesvirus 8 Infection in HIV-positive Homosexual Men in Jiangsu Province, China.

HIV-infected homosexual men are more frequently diagnosed with Kaposi's sarcoma. With the increase of HIV-infected homosexual men in China, we urgently need to know the KS-related human herpesvirus (KSHV/HHV-8) seroprevalence in this population. To investigate HHV-8 prevalence among HIV-positive homosexual men, we recruited 183 patients naive of antiretroviral therapy (ART) whose blood samples presented with HIV-antibody positive as confirmed by western blot. HIV viral load was tested using Cobas TaqMan HIV-1 test Version 2.0, and CD4 T cell counts were tested using a Flow cytometry instrument. All HIV-positive blood samples were collected and screened for KSHV. Immunofluorescence (IFA) test was conducted for HHV-8-Specific antibodies (anti-LANA) in the plasma. HHV-8 DNA in whole blood cells of IFA-positive subjects was quantified with Real-time polymerase chain reaction (RT-PCR). All samples showed HIV RNA positive. CD4+ T cell count was 23% cases (42/183) which showed ≤200 cells/μL, 51.3% cases (94/183) showed 201-500 cells/μL and 25.7% cases (47/183) showed ≥501 cells/μL. Immunofluorescence (IFA) test demonstrated an HHV-8 prevalence of 50.8% (93/183), among which 20.4% of the cases (19/93) were HHV-8 DNA positive. HHV-8 infection showed no difference among different age groups (p=0.96). Similarly, HHV-8 infection exhibited no significant difference among different HIV viral load groups (p=0.08). However, HHV-8 infection among different CD4+ T cell count showed significant difference (P=0.0004). This study showed a high seroprevalence of human herpesvirus 8 infection in HIVpositive homosexual men.

Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens

BackgroundThe Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens. ObjectivesWe compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens. Study designWe tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar’s and Wilcoxon signed rank tests were used for statistical analysis. ResultsOf 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p<0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or −undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p<0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p=0.008). ConclusionsIn plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion.

The performance of the Alere HIV combo point-of-care test on stored serum samples; useful for detection of early HIV-1 infections?

IntroductionThe Alere HIV-1/2 Antigen/Antibody Combo point-of-care test is a commercially available 4th-generation rapid test for the diagnosis of HIV infection, including acute infection. We evaluated the sensitivity of this test...

An Alarmingly High Proportion of HIV-1 Isolates Carrying Mutations Corresponding to Resistance to Antiretroviral Drugs among HIV-Positive High-Risk Groups in Central Vietnam: a Substudy of the National Sentinel Survey.

We studied the prevalence of HIV drug resistance among high-risk groups such as injecting drug users (IDUs), female sex workers (FSWs), and men having sex with men (MSM) in central Vietnam. We used HIV-positive blood samples from 2012-2013 sentinel surveillance surveys. Study subjects were screened for HIV infection by standardized screening assays, and the HIV-positive samples were further tested for HIV viral load and drug-resistance mutations (DRMs) by in-house assays. DRMs were identified using the Stanford University online sequence analysis tool. Their risk behaviors were also investigated. During the study period, 6,016 (high-risk) subjects were screened, and 97 tested positive for HIV infection (IDUs: n = 63, 3.0%; FSWs: n = 24, 0.9%; and MSM: n = 10, 1.0%). Ninety-two of the 97 samples (45 from 2012 and 47 from 2013) were available for further testing. HIV RNA was detected in 56 (60.9%) of the 92 samples, and drug resistance genotyping was successfully performed on 40 (71.4%) samples. All these isolates were subtype CRF01_AE, except for 1 (2.5%) IDU whose HIV belongs to subtype B. Thirteen individuals (32.5%) were carrying HIV with at least 1 DRM: 9 IDUs, 1 FSW, and 3 MSM. Thus, HIV seroprevalence among high-risk individuals in central Vietnam is low, but a high proportion of drug resistant HIV-1 isolates is observed in the high-risk group.

Viral and Host Characteristics of Recent and Established HIV-1 Infections in Kisumu based on a Multiassay Approach.

Integrated approaches provide better understanding of HIV/AIDS epidemics. We optimised a multiassay algorithm (MAA) and assessed HIV incidence, correlates of recent infections, viral diversity, plus transmission clusters among participants screened for Kisumu Incidence Cohort Study (KICoS1) (2007–2009). We performed BED-CEIA, Limiting antigen (LAg) avidity, Biorad avidity, and viral load (VL) tests on HIV-positive samples. Genotypic analyses focused on HIV-1 pol gene. Correlates of testing recent by MAA were assessed using logistic regression model. Overall, 133 (12%, 95% CI: 10.2–14.1) participants were HIV-positive, of whom 11 tested recent by MAA (BED-CEIA OD-n < 0.8 + LAg avidity OD-n < 1.5 + VL > 1000 copies/mL), giving an incidence of 1.46% (95% CI: 0.58–2.35) per year. This MAA-based incidence was similar to longitudinal KICoS1 incidence. Correlates of testing recent included sexually transmitted infection (STI) treatment history (OR = 3.94, 95% CI: 1.03–15.07) and syphilis seropositivity (OR = 10.15, 95% CI: 1.51–68.22). Overall, HIV-1 subtype A (63%), D (15%), C (3%), G (1%) and recombinants (18%), two monophyletic dyads and intrinsic viral mutations (V81I, V81I/V, V108I/V and K101Q) were observed. Viral diversity mirrored known patterns in this region, while resistance mutations reflected likely non-exposure to antiretroviral drugs. Management of STIs may help address ongoing HIV transmission in this region.