HIV Diagnostic Tests Research Articles

Surveillance of recent HIV infections among newly diagnosed HIV cases in Germany between 2008 and 2014

BackgroundThe HIV surveillance system in Germany is based on mandatory, anonymous notification of newly diagnosed HIV cases by laboratories. Because the time between HIV infection and the diagnosis of HIV varies widely between persons, it is difficult to determine the number of cases of recent HIV infection among newly diagnosed cases of HIV. In Germany, the BED-capture-enzyme immunoassay (BED-CEIA) has been used to distinguish between recent and long-standing HIV infection. The aim of this analysis is to report the proportion of cases of recent HIV infection among newly diagnosed cases in Germany between 2008 and 2014 and to identify factors associated with recent infections.MethodsA sample of voluntary laboratories among all HIV diagnostic laboratories was recruited. Residual blood from HIV diagnostic tests was spotted on filter paper as dried serum or dried plasma spots and was sent along with the notification form of the HIV cases. The BED-CEIA test was performed. A case was defined as recent HIV infection with a BED-CEIA test result of less than 0.8 normalized optical density, with the exclusion of CDC stage C. The proportion of recent newly diagnosed HIV infections among different groups (such as transmission groups, gender or age groups) was calculated. We used logistic regression to identify factors associated with recent HIV infection and to identify subpopulations with high proportions of recent HIV infections.ResultsApproximately 10,257 newly diagnosed cases were tested for recency using the BED-CEIA. In total, 3084 (30.4%) of those were recently infected with HIV. The highest proportion of recent HIV infections was found among men who had sex with men (MSM) (35%) and persons between 18 and 25 years of age (43.0%). Logistic regression revealed that female German intravenous drug users with a recent HIV infection had a higher chance of being detected than German MSM (OR 2.27).ConclusionsSurveillance of recent HIV infection is a useful additional tool to monitor the HIV epidemic in Germany. We could observe ongoing HIV transmission in Germany in general and in different subgroups, and we could identify factors associated with recent HIV infection in Germany.

Performance of the HIV diagnosis screening algorithm using two immunoassays and a molecular test

Abstract Advances in HIV diagnostic testing have improved detection of HIV infections. HIV can be detected earlier so patients benefit from treatment and negative results reassure uninfected patients. Because first line immunoassays lack specificity, positive results need to be confirmed. The aim of this study was to evaluate the algorithm used at The Ohio State Wexner Medical Center for the diagnosis of HIV infection. The algorithm begins with a combination immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen [ADVIA Centaur® HIV Ag/Ab Combo (CHIV), Siemens]. All positive specimens are confirmed with an immunoassay that differentiates HIV-1 from HIV-2 antibodies [Geenius HIV-1/HIV-2 Confirmatory assay (GHIV), Bio-Rad]. Specimens that are positive by CHIV and negative or indeterminate by GHIV proceed to HIV-1 nucleic acid testing for resolution. A total of 14,994 patients were evaluated using CHIV assay, of these 99.7% were negative (n= 14,950) and 0.3% were positive (n=44). The 44 positive specimens were tested by GHIV, only 4 confirmed positive and 40 were negative. Of the 40 that tested negative, only 32 had enough serum left to be tested by RNA HIV molecular test and all tested negative. Of the 8 that there was not enough serum left, 6 patients had a follow up viral load and they were all negative. In summary, of the 44 CHIV positive, only 4 were confirmed by GHIV, and 38 confirmed negative by the molecular tests, questioning the utility of the additional molecular step.

Comparison of turnaround time and total cost of HIV testing before and after implementation of the 2014 CDC/APHL Laboratory Testing Algorithm for diagnosis of HIV infection

BackgroundUpdated recommendations for HIV diagnostic laboratory testing published by the Centers for Disease Control and Prevention and the Association of Public Health Laboratories incorporate 4th generation HIV immunoassays, which are capable of identifying HIV infection prior to seroconversion. ObjectivesThe purpose of this study was to compare turnaround time and cost between 3rd and 4th generation HIV immunoassay-based testing algorithms for initially reactive results. Study DesignThe clinical microbiology laboratory database at Mayo Clinic, Rochester, MN was queried for 3rd generation (from November 2012 to May 2014) and 4th generation (from May 2014 to November 2015) HIV immunoassay results. All results from downstream supplemental testing were recorded. Turnaround time (defined as the time of initial sample receipt in the laboratory to the time the final supplemental test in the algorithm was resulted) and cost (based on 2016 Medicare reimbursement rates) were assessed. ResultsA total of 76,454 and 78,998 initial tests were performed during the study period using the 3rd generation and 4th generation HIV immunoassays, respectively. There were 516 (0.7%) and 581 (0.7%) total initially reactive results, respectively. Of these, 304 (58.9%) and 457 (78.7%) were positive by supplemental testing. There were 10 (0.01%) cases of acute HIV infection identified with the 4th generation algorithm. The most frequent tests performed to confirm an HIV-positive case using the 3rd generation algorithm, which were reactive initial immunoassay and positive HIV-1 Western blot, took a median time of 1.1 days to complete at a cost of $45.00. In contrast, the most frequent tests performed to confirm an HIV-positive case using the 4th generation algorithm, which included a reactive initial immunoassay and positive HIV-1/-2 antibody differentiation immunoassay for HIV-1, took a median time of 0.4 days and cost $63.25. Overall median turnaround time was 2.2 and 1.5 days, and overall median cost was $63.90 and $72.50 for 3rd and 4th generation algorithms, respectively. ConclusionsBoth 3rd and 4th generation HIV immunoassays had similar total numbers of tests performed and positivity rates during the study period. A greater proportion of reactive 4th generation immunoassays were confirmed to be positive, and the 4th generation algorithm identified several cases of acute HIV infection that would have been missed by the 3rd generation algorithm. The 4th generation algorithm had a more rapid turnaround time but higher cost for confirmed positive HIV infections and overall, compared to the 3rd generation algorithm.

Clinical validation of a novel diagnostic HIV-2 total nucleic acid qualitative assay using the Abbott m2000 platform: Implications for complementary HIV-2 nucleic acid testing for the CDC 4th generation HIV diagnostic testing algorithm

BackgroundThe 2014 CDC 4th generation HIV screening algorithm includes an orthogonal immunoassay to confirm and discriminate HIV-1 and HIV-2 antibodies. Additional nucleic acid testing (NAT) is recommended to resolve indeterminate or undifferentiated HIV seroreactivity. HIV-2 NAT requires a second-line assay to detect HIV-2 total nucleic acid (TNA) in patients’ blood cells, as a third of untreated patients have undetectable plasma HIV-2 RNA. ObjectivesTo validate a qualitative HIV-2 TNA assay using peripheral blood mononuclear cells (PBMC) from HIV-2–infected Senegalese study participants. Study designWe evaluated the assay precision, sensitivity, specificity, and diagnostic performance of an HIV-2 TNA assay. Matched plasma and PBMC samples were collected from 25 HIV-1, 30 HIV-2, 8 HIV-1/-2 dual-seropositive and 25 HIV seronegative individuals. Diagnostic performance was evaluated by comparing the outcome of the TNA assay to the results obtained by the 4th generation HIV screening and confirmatory immunoassays. ResultsAll PBMC from 30 HIV-2 seropositive participants tested positive for HIV-2 TNA including 23 patients with undetectable plasma RNA. Of the 30 matched plasma specimens, one was HIV non-reactive. Samples from 50 non-HIV-2 infected individuals were confirmed as non-reactive for HIV-2 Ab and negative for HIV-2 TNA. The agreement between HIV-2 TNA and the combined immunoassay results was 98.8% (79/80). Furthermore, HIV-2 TNA was detected in 7 of 8 PBMC specimens from HIV-1/HIV-2 dual-seropositive participants. ConclusionsOur TNA assay detected HIV-2 DNA/RNA in PBMC from serologically HIV-2 reactive, HIV indeterminate or HIV undifferentiated individuals with undetectable plasma RNA, and is suitable for confirming HIV-2 infection in the HIV testing algorithm.

Evaluation of the intercept oral specimen collection device with HIV assays versus paired serum/plasma specimens

Oral fluid has many advantages over blood-based techniques: it is less invasive, eliminates the occupational risk associated with needle stick accidents and collection can be self-administrated. Each individual test is packaged with a corresponding collection device. This study tested the suitability of the Intercept Oral Specimen Collection Device for different HIV diagnostic tests: three different rapid HIV tests and two adapted ELISAs, which were evaluated and compared with a gold standard on blood. In addition a total IgG quantification was performed to demonstrate the quality of the specimen. HIV antibodies were detected with a sensitivity of 100%, 99.3%, 98.6%, 100% and 95.7% for, DPP, OraQuick, Aware, Genscreen and Vironostika respectively using the Intercept Collection Device. Respective specificities were 100%, 100%, 99.3%, 97.3% and 100%.

Avaliação do conhecimento sobre HIV/AIDS em grupo de idosos através do QHIV3I

OBJECTIVE: To investigate the knowledge of a group of elderly people about HIV / AIDS through HIV survey in old age (QHIV3I). METHODS: From the active search of researchers QHIV3I the questionnaire was applied to assessed 69 subjects aged over 60 years. RESULTS: The sample was composed mostly of women (64%), with minimum education of 4 years (69%), monthly income of less than 3 salaries (77%), catholics (57%) and singles (52%). They showed a good knowledge on the subject reaching a 82% hit rate. The vast majority (93%) had heard of HIV and AIDS diagnostic tests (84%). Most (83%) responded that the virus cannot be transmitted through towels, soap or toilet seats, as well as hugging, kissing or sharing a glass with someone who has the virus (91%). Most (91%) responded that the use of condoms could prevent AIDS. They said (83%) is still that AIDS not exclusive to homosexuals, prostitutes and drug users. Most (85%) think that the elderly should also be concerned about AIDS. Although the study population know the importance of using condoms most (40%) responded to avail erratically. CONCLUSION: This study found that the elderly population studied showed a good knowledge about HIV/AIDS.

Risk of HIV and Hepatitis B and C Over Time Among Men Who Inject Image and Performance Enhancing Drugs in England and Wales: Results From Cross-Sectional Prevalence Surveys, 1992-2013.

Infection risks among people who inject drugs (PWID) are widely recognized, but few studies have focused on image and performance enhancing drugs (IPEDs). Globally, concern about IPED injection has increased and, in the United Kingdom, IPED injectors have become the largest group using Needle and Syringe Programmes. Blood-borne virus prevalence trends among IPED injectors are explored. Data from 2 surveys of IPED injectors (2010-2011; 2012-2013) and the national bio-behavioral surveillance system for PWID (1992-1997; 1998-2003; 2004-2009) were merged. Psychoactive drug injectors and women were excluded. Logistic regression analyses explored temporal changes. Between 1992 and 2009, median age increased from 25 to 29 years (N = 1296), years injecting from 2 to 4. There were 53 men who had sex with men (MSM). Overall, 0.93% had HIV, 4.4% ever had hepatitis B (HBV), and 3.9% hepatitis C (HCV, from 1998, N = 1083). In multivariable analyses, HIV increased in 2004-2009 [adjusted odds ratio (AOR) = 10 (95% confidence interval (CI): 0.94 to 106) vs. 1992-2003], and remained elevated (AOR = 4.12, 95% CI: 0.31 to 54, 2012-2013); HBV also increased in 2004-2009 (AOR = 3.98, 95% CI: 1.59 to 9.97). HCV prevalence increase was only borderline significant (AOR = 2.47, 95% CI: 0.90 to 6.77, 2010-2011). HIV and HBV were associated with MSM and HCV with sharing needles/syringes. Uptake of diagnostic testing for HIV and HCV, and HBV vaccination increased (to 43%, 32% and 44% respectively). Condom use was consistently poor; needle/syringe sharing occurred. Blood-borne virus prevalences among IPED injectors have increased and for HIV, is now similar to that among psychoactive drug injectors. Targeted interventions to reduce risks are indicated.

Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay.

BackgroundUse of rapid diagnostic tests for HIV and syphilis has increased remarkably in the last decade. As new rapid diagnostic tests become available, there is a continuous need to assess their performance and operational characteristics prior to use in clinical settings.ObjectivesIn this study, we evaluated the performance of the Chembio Dual Path Platform (DPP®) HIV–Syphilis Assay to accurately diagnose HIV, syphilis, and HIV/syphilis co-infection.MethodIn 2013, 990 serum samples from the Georgia Public Health Laboratory in Atlanta, Georgia, United States were characterised for HIV and syphilis and used to evaluate the platform. HIV reference testing combined third-generation Enzyme Immunoassay and Western Blot, whereas reference testing for syphilis was conducted by the Treponema pallidum passive particle agglutination method and the TrepSure assay. We assessed the sensitivity and specificity of the DPP assay on this panel by comparing results with the HIV and syphilis reference testing algorithms.ResultsFor HIV, sensitivity was 99.8% and specificity was 98.4%; for syphilis, sensitivity was 98.8% and specificity was 99.4%. Of the 348 co-infected sera, 344 (98.9%) were detected accurately by the DPP assay, but 11 specimens had false-positive results (9 HIV and 2 syphilis) due to weak reactivity.ConclusionIn this evaluation, the Chembio DPP HIV–Syphilis Assay had high sensitivity and specificity for detecting both HIV and treponemal antibodies. Our results indicate that this assay could have a significant impact on the simultaneous screening of HIV and syphilis using a single test device for high-risk populations or pregnant women needing timely care and treatment.

Impact of naturally occurring amino acid variations on the detection of HIV-1 p24 in diagnostic antigen tests.

BackgroundThe detection of HIV-1 p24 antigen in diagnostic tests relies on antibodies binding to conserved areas of the protein to cover the full range of HIV-1 subtypes. Using a panel of 43 different virus-like particles (VLPs) expressing Gag from clinical HIV-1 isolates, we previously found that some highly sensitive tests completely failed to detect p24 of certain VLPs, seemingly unrelated to their subtype. Here we aimed to investigate the reason for this failure, hypothesising that it might be due to single amino acid variations in conserved epitopes.MethodsUsing amino acid alignment, we identified single amino acid variations at position 16 or 170 of p24, unique to those VLPs that failed to be detected in certain diagnostic tests. Through DNA-mutagenesis, these amino acids were changed to ones more commonly found at these positions. The impact of these changes on p24 detection was tested in commercial diagnostic tests as well as by Western Blot and ELISA, using epitope-specific antibodies.Results and ConclusionsChanging positions 16 or 170 to consensus amino acids restored the detection of p24 by the investigated diagnostic tests as well as by epitope-specific antibodies in Western Blot and ELISA. Hence, single amino acid changes in conserved epitopes can lead to the failure of p24 detection and thus to false-negative results. To optimise HIV diagnostic tests, they should also be evaluated using isolates which harbour less-frequent epitope variants.

The Global Fund and global goals: the role of implementation and operational research.

The Global Fund to Fight AIDS, Tuberculosis and Malaria has transformed the financing and delivery of health interventions in countries to meet Millennium Development Goal (MDG) 6, to combat human immunodeficiency virus/acquired immunedeficiency syndrome (HIV/AIDS), malaria and other diseases (mainly tuberculosis [TB]). At the United Nations General Assembly in New York, 25–27 September 2015, governments are due to adopt the new Sustainable Development Goals (SDGs) for 2016–2030. One of the proposed 17 goals is on health (Goal 3). This goal comprises 13 targets, including HIV/AIDS, malaria and tuberculosis, among a broader array of health problems. Leaving aside the important question as to whether the mission of the Global Fund may embrace a broader health agenda in the future, it is useful at this turning point to review the role of implementation and operational research in reducing the burden of HIV/AIDS, malaria and tuberculosis, looking back at the MDG era and looking forward towards the SDG era. Science and technology have generated tools to address HIV/AIDS, malaria and tuberculosis, and implementation and operational research have taken these tools out of the research and development laboratories and into communities. The development of HIV tests and drugs counts as one of the greatest modern achievements in health science and technology. Implementation and operational research have contributed to the global scale-up of access to antiretroviral drugs. By June 2014, 13.6 million people living with HIV infection were receiving antiretroviral therapy (ART) globally, an increase from just 800 000 in 2003. Successful scale-up of ART has had a dramatic impact on the estimated number of people dying of HIV-related illnesses: the number of HIV deaths declined by 35% from a peak of 2.4 million in 2005 to 1.5 million people in 2013.1 Despite a lack of progress for many years in developing new TB diagnostics, drugs and vaccines, implementation and operational research have maximised the impact of the available tools. The data systematically collected by national TB programmes on people diagnosed with TB and the outcomes of their treatment have not only enabled evaluation of programme performance, they have also fuelled operational research, which has been the hallmark of effective TB control in a wide variety of settings. Globally, the TB mortality rate fell by 45% between 1990 and 2013.1 The prospects for large-scale access to new diagnostic tests, such as nucleic acid amplification tests, and new drugs, such as delamanid and bedaquiline, depend on implementation research to realise their potential to contribute to a further decrease in the TB burden. Implementation research has taken the technologies for malaria control, including indoor residual spraying, long-lasting insecticidal nets, point-of-care diagnostic tests and artemisinin-based combination therapies, into communities and contributed to a significantly decreased burden of malaria: between 2000 and 2015, the global malaria mortality rate has decreased by 58%.1 The SDGs are to build on the lessons learned from progress towards the MDGs and setbacks. Progress towards the SDG years depends on maximising the gains from the health interventions that are currently available and from those that will become available (undoubtedly including new drugs and potentially new vaccines against HIV, TB and malaria). For HIV, extending access to ‘test and treat’ using currently available HIV diagnostic tests and treatment, and in the future making an effective HIV vaccine widely available, both depend on implementation research to bring these interventions to scale. For TB, the dramatic increase in the rate of decline of TB incidence that is needed to realise the ultimate goal of TB elimination will depend not only on science and technology for the development of new drugs and vaccines but also on implementation research to make these widely available. Finally, for malaria, the use of mass drug administration in the contribution to malaria elimination raises the question of how effective and feasible methods of delivery through community engagement can be developed. In the SDGs era, we need to maximise the potential of implementation and operational research to make the benefits of science and technology available to at-risk individuals and communities and to help achieve the ambition of ending the epidemics of TB, HIV and malaria. Implementation and operational research involve modest costs, but they have the potential for a huge magnifier effect in extending the impact of health interventions delivered by programmes supported by the Global Fund. The challenge arises for the Public Health Action community: how can we engage with the wide range of stakeholders involved in Global Fund grant activities to promote the inclusion of implementation and operational research as a key activity for funding under a Global Fund grant?

Implementation and Operational Research: Expedited Results Delivery Systems Using GPRS Technology Significantly Reduce Early Infant Diagnosis Test Turnaround Times.

The objective of this study was to quantify the impact of a new technology to communicate the results of an infant HIV diagnostic test on test turnaround time and to quantify the association between late delivery of test results and patient loss to follow-up. We used data collected during a pilot implementation of Global Package Radio Service (GPRS) printers for communicating results in the early infant diagnosis program in Mozambique from 2008 through 2010. Our dataset comprised 1757 patient records, of which 767 were from before implementation and 990 from after implementation of expedited results delivery system. We used multivariate logistic regression model to determine the association between late result delivery (more than 30 days between sample collection and result delivery to the health facility) and the probability of result collection by the infant's caregiver. We used a sample selection model to determine the association between late result delivery to the facility and further delay in collection of results by the caregiver. The mean test turnaround time reduced from 68.13 to 41.05 days post-expedited results delivery system. Caregivers collected only 665 (37.8%) of the 1757 results. After controlling for confounders, the late delivery of results was associated with a reduction of approximately 18% (0.44 vs. 0.36; P < 0.01) in the probability of results collected by the caregivers (odds ratio = 0.67, P < 0.05). Late delivery of results was also associated with a further average increase in 20.91 days of delay in collection of results (P < 0.01). Early infant diagnosis program managers should further evaluate the cost-effectiveness of operational interventions (eg, GPRS printers) that reduce delays.

The Uptake of Prevention of Mother-to-Child HIV Transmission Programs in China: A Systematic Review and Meta-Analysis.

BackgroundNo systematic review of prevention of mother to child transmission (PMTCT) in China has been performed. We aimed to estimate the uptake of PMTCT programs services in China.MethodsWe searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang (Chinese) to identify research studies. Only descriptive epidemiological studies were eligible for this study.ResultsA total of 57 eligible cross-section studies were finally included. We estimated that the mean HIV-positive rate of exposed infants was 4.4% (95% CI = 3.2–5.5), and more than 33% of exposed infants had not undergone HIV diagnostic testing. The percentage of initiating antiretroviral therapy (ART) in HIV-positive women was 71.0% (95% CI = 66.3–75.8), and that for initiating antiretroviral prophylaxis (ARP) in exposed infants was 78.3% (95% CI = 74.9–81.8); also, 31.3% (95% CI = 15.5–47.0) of women with HIV and < 1% of exposed infants received the combination of three antiretroviral drugs. There were bigger gap of uptake of PMTCT programs between income levels, and cities with a low income level had a higher percentage of initiating ART in HIV-positive women (80%) and ARP in exposed infants (85%) compared to cities with high-middle income (57% and 65%, respectively) (P<0.05).ConclusionsThis paper highlights the need to further scale up PMTCT services in China, especially in regions with the lowest coverage, so that more women can access and utilize them. However, some estimated outcome should be interpreted with caution due to the high level of heterogeneity and the small number of studies.

P189 “… giving something back to the gay community by taking part”: gay and bisexual men’s understandings of participation in behavioural research

<h3>Background/introduction</h3> Studies exploring public participation in health research have not, to date, included the perspectives of gay and bisexual men taking part in behavioural surveillance research. Understanding factors which motivate men to participate in behavioural research, and their perceptions of feedback on anonymous HIV antibody tests are important in the design of future studies. <h3>Aim(s)/objectives</h3> The aim of this qualitative study was to gain insight into men’s motivations for participation in the Gay Men’s Sexual Health Survey (GMSHS), and their understandings of, and views on, HIV testing as part of the survey. <h3>Methods</h3> Semi-structured telephone interviews were conducted with 29 gay and bisexual men who participated in the 2011 GMSHS. Men were recruited in 13 licensed premises on the commercial ‘gay scene’ in Edinburgh and Glasgow. Data were analysed thematically, focusing on motives for participation and perceptions of not receiving individual feedback on HIV status. <h3>Results</h3> Most men expressed sophisticated understandings of the purpose of behavioural research and distinguished between this and individual diagnostic testing for HIV. Men’s accounts suggested a shared understanding of participation in research as a means of contributing to ‘community’ HIV prevention efforts. Among the men interviewed feedback on HIV status was not deemed crucial. <h3>Discussion/conclusion</h3> Continuing to engage with gay and bisexual men, and practitioners working within these communities, is vital to engendering trust in, and support for, future behavioural research. This is particularly important during the process of developing new and innovative research strategies. Further research is needed to explore men’s perceptions of participation in research, and their perspectives on receiving feedback on testing, within wider contexts.

Brief Report: Health-Seeking Behavior and Symptoms Associated With Early HIV Infection: Results From a Population-Based Cohort in Southern Malawi.

HIV transmission is most likely to occur during the first few months after infection, yet few cases are identified during this period. Using a population-based cohort of young Malawian women, we identify the distinct symptomology and health-seeking behavior marking early HIV infection by comparing it with periods of seronegativity and chronic infection. During early HIV infection, women are more likely to report malaria-like symptoms and visit clinics for malaria care. In malaria-endemic contexts, where acute HIV symptoms are commonly mistaken for malaria, early diagnostic HIV testing and counseling should be integrated into health care settings where people commonly seek treatment for malaria.

Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria

ObjectiveTo determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis. MethodsThree dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed. ResultsAll three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%–99.6% for HIV and 98.3%–99.0% for syphilis, and a combined specificity ranging from 97.9%–99.0% for HIV and 97.2%–99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98. ConclusionsAll the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed.

HIV testing updates and challenges: when regulatory caution and public health imperatives collide.

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.

Nucleic acid testing by public health referral laboratories for public health laboratories using the U.S. HIV diagnostic testing algorithm

BackgroundMany public health laboratories adopting the U.S. HIV laboratory testing algorithm do not have a nucleic acid test (NAT), which is needed when the third- or fourth-generation HIV screening immunoassay is reactive and the antibody-based supplemental test is non-reactive or indeterminate. ObjectivesAmong public health laboratories utilizing public health referral laboratories for NAT conducted as part of the algorithm, we evaluated the percentage of screening immunoassays needing NAT, the number of specimens not meeting APTIMA (NAT) specifications, time to APTIMA result, the proportion of acute infections (i.e., reactive APTIMA) among total infections, and screening immunoassay specificity. Study designFrom August 2012 to April 2013, 22 laboratories enrolled to receive free APTIMA (NAT) at New York or Florida public health referral laboratories. Data were analyzed for testing conducted until June 2013. ResultsSubmitting laboratories conducted a median of 4778 screening immunoassays; 0–1.3% (median 0.2%) needed NAT. Of 140 specimens received, 9 (6.4%) did not meet NAT specifications. The median time from specimen collection to reporting the 11 reactive NAT results was ten days, including six days from receipt in the submitting laboratory to shipment to the referral laboratory. Acute infections ranged from 0 to 12.5% (median 0%) of total infections. Third- and fourth-generation immunoassays met package insert specificity values. ConclusionsPublic health referral laboratories provide a feasible option for conducting NAT. Reducing the time from specimen collection to submission of specimens for NAT is an important step toward maximizing the public health impact of identifying acute infections.

1581Laboratory Evaluation of three HIV and Syphilis Combination Rapid Diagnostic Tests

1581Laboratory Evaluation of three HIV and Syphilis Combination Rapid Diagnostic Tests

Expedited Results Delivery Systems Using SMS Technology Significantly Reduce Early Infant Diagnosis Test Turnaround Times

The objective of this study was to quantify the impact of a new technology to communicate the results of an infant HIV diagnostic test on test turnaround time and to quantify the association between late delivery of test results and patient loss to follow-up. We used data collected during a pilot implementation of Global Package Radio Service (GPRS) printers for communicating results in the early infant diagnosis program in Mozambique from 2008 through 2010. Our dataset comprised 1757 patient records, of which 767 were from before implementation and 990 from after implementation of expedited results delivery system. We used multivariate logistic regression model to determine the association between late result delivery (more than 30 days between sample collection and result delivery to the health facility) and the probability of result collection by the infant's caregiver. We used a sample selection model to determine the association between late result delivery to the facility and further delay in collection of results by the caregiver. The mean test turnaround time reduced from 68.13 to 41.05 days post-expedited results delivery system. Caregivers collected only 665 (37.8%) of the 1757 results. After controlling for confounders, the late delivery of results was associated with a reduction of approximately 18% (0.44 vs. 0.36; P < 0.01) in the probability of results collected by the caregivers (odds ratio = 0.67, P < 0.05). Late delivery of results was also associated with a further average increase in 20.91 days of delay in collection of results (P < 0.01). Early infant diagnosis program managers should further evaluate the cost-effectiveness of operational interventions (eg, GPRS printers) that reduce delays.

Clinical Image: Clubbed with a Reminder to Test for HIV

A previously healthy 34-year-old man was evaluated for two years of progressive digital clubbing. He denied fevers, night sweats, cardiopulmonary symptoms, travel, or unusual exposures. Physical examination demonstrated no pathologic lymphadenopathy, genital lesions or penile discharge. The patient had dramatic clubbing of all digits and erythematous nail beds (Figs. 1 and ​and22). Figure 1 Digital clubbing. Figure 2 Digital clubbing. There are many different diseases associated with clubbing. Pulmonary diseases are most commonly associated, but cardiac conditions, gastrointestinal diseases, and various infections are also found with clubbing. The patient’s evaluation included unremarkable labs for systemic diseases such as malignancy, liver disease, and inflammatory bowel disease. His cardiopulmonary evaluation included echocardiography, pulmonary function testing, polysomnography and chest computed tomography. These were also unrevealing. The patient’s PPD test and RPR were nonreactive. His HIV antibody test (with Western blot) returned positive. CD4+ lymphocyte count was 401/μL and viral load was 205,000 copies/mL.1 Digital clubbing is associated with HIV. Among one convenience sample of 76 HIV-infected patients, 28 (36 %) had objectively confirmed clubbing—thus, HIV testing is recommended as part of a diagnostic algorithm.1,2 While HIV screening is now recommended for all patients aged 15–65 years, this case highlights the need for HIV diagnostic testing in patients with digital clubbing.3