scholarly journals Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0242641
Author(s):  
Kelly A. Curtis ◽  
Donna L. Rudolph ◽  
Yi Pan ◽  
Kevin Delaney ◽  
Kathryn Anastos ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Diagnostic Test ◽  
Diagnostic Algorithm ◽  
The United States ◽  
Hiv Incidence ◽  
Test Protocol ◽  
Recent Infection ◽  
Recent Hiv Infection ◽  
Hiv 1 ◽  
Abbott Architect

Background Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States. Methods In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs. Results The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination. Conclusion Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications.

scholarly journals Evaluation of the Abbott ARCHITECT HIV Ag/Ab Combo Assay for Determining Recent HIV-1 Infection

2020 ◽  
Author(s):  
Kelly A. Curtis ◽  
Donna L. Rudolph ◽  
Yi Pan ◽  
Kevin Delaney ◽  
Kathryn Anastos ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Diagnostic Test ◽  
Diagnostic Algorithm ◽  
The United States ◽  
Hiv Incidence ◽  
Test Protocol ◽  
Recent Infection ◽  
Recent Hiv Infection ◽  
Hiv 1 ◽  
Abbott Architect

BackgroundGiven the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States.MethodsIn this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs.ResultsThe MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination.ConclusionDual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications.

Effectiveness of the algorithm for detecting cases of recent HIV-1 infection in the Russian Federation

2021 ◽  
Vol 19 (2) ◽  
pp. 37-50
Author(s):  
A.V. Shlykova ◽  
◽  
D.E. Kireev ◽  
I.A. Lapovok ◽  
D.V. Saleeva ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Sensitivity And Specificity ◽  
Molecular Genetic ◽  
Diagnostic Algorithm ◽  
Molecular Genetic Analysis ◽  
Accurate Identification ◽  
Serological Tests ◽  
Recent Infection ◽  
Duration Of Infection ◽  
Hiv 1

Objective. Accurate identification of recent HIV-1 infection cases will ensure a more effective and precise assessment of the dynamics of virus transmission, the time between infection and diagnosis, and the quality of screening and prevention programs. This study was undertaken to adjust the recent HIV-1 infection testing algorithm using a cohort of patients, in whom the time since infection was known. Materials and methods. We used blood plasma samples obtained from 264 HIV-infected patients with a known date of infection. All samples were analyzed using two serological assays aimed to differentiate between cases of recent and established HIV infection. Using the results of sequencing of the pol region, we calculated the proportion of variable positions in order to determine the duration of infection. To identify the cases of recent HIV infection, we evaluated different variants of a diagnostic algorithm that included a combination of serological tests, molecular genetic analysis of the viral genome, and other clinical and laboratory parameters. Results. The effectiveness of the DS-ELISA-HIV-AB-TERM (DS) assay for the detection of recent infection was higher than that of the Architect HIV Ag/Ab Combo assay (Abbott). The sensitivity and specificity of the DS assay were 94.4% and 96.7%, respectively. The sensitivity and specificity of the Abbott assay were 86.4% and 77,4%, respectively. The HIV-1 genome variability threshold of 0.33% allowed the differentiation between samples depending on the time since infection with a cut-off of 12 months: 82.1% of recent samples and 62.7% of established samples were correctly identified using this method. We analyzed the effectiveness of schemes of the algorithm for the detection of recent infection lasting no longer than 9 months. Conclusion. Our findings allow us to recommend the algorithm based on the Russian DS assay for the detection of recent HIV-1 cases in routine clinical practice. This algorithm will enable the detection of new HIV cases, thereby improving the disease control. Key words: HIV-1, HIV infection, genetic variability, time since infection, duration of infection, recent infection, early infection, seroconversion

scholarly journals Difficulties of Identifying the Early HIV Antibody Seroconversion Period Depending on the Confirmatory Assay

2020 ◽  
Vol 7 (5) ◽  
Author(s):  
Karl Stefic ◽  
Nadia Mahjoub ◽  
Céline Desouche ◽  
Marie Laure Néré ◽  
Damien Thierry ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Early Stage ◽  
Inclusion Criteria ◽  
Multicenter Studies ◽  
Recent Infection ◽  
Western Blots ◽  
Confirmatory Assay ◽  
Single Use ◽  
Recent Hiv Infection ◽  
Hiv 1

Abstract Background Identification of HIV infection at the early stage is valuable for patient management, for prevention, and for research purposes. In practice, identification of a recent HIV infection at diagnosis proves challenging after HIV antibody seroconversion but can be suspected using Western blots (WBs) or immunoblots (IBs) as confirmatory assays. Methods Five commercially available confirmatory assays were compared using 43 samples from recently infected individuals. This included 2 WBs (New LAV Blot I, Biorad, and HIV Blot 2.2, MP Biomedicals), 2 IBs (INNO-LIA HIV I/II, Fujirebio, and RecomLine HIV-1 & HIV-2, Mikrogen Diagnostik), and 1 immunochromatographic single-use assay (Geenius HIV1/2 supplemental assay, Biorad). Results Following the manufacturer’s recommendations for interpretation, the 2 WBs led to indeterminate results for 30% and 42% of the samples, suggesting recent infection, compared with 2%–7% for the 3 other assays. When interpreted based on the Fiebig classification, concordant stages were observed in 42% of samples, and only 49% were classified as early seroconversion by all 5 assays. For the remaining specimens, the distinction with chronic infection was highly variable depending on the assay (5%–100%). Conclusions Clinical laboratories must consider this variability, which must be kept in mind both for initial diagnosis and for multicenter studies for which inclusion criteria refer to serological profiles by confirmatory assays.

scholarly journals Risk Factor Detection as a Metric of STARHS Performance for HIV Incidence Surveillance Among Female Sex Workers in Kigali, Rwanda

2012 ◽  
Vol 6 (1) ◽  
pp. 112-121 ◽  
Author(s):  
Sarah L Braunstein ◽  
Janneke H van de Wijgert ◽  
Joseph Vyankandondera ◽  
Evelyne Kestelyn ◽  
Justin Ntirushwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Hiv Infection ◽  
Sex Workers ◽  
Female Sex Workers ◽  
Hiv Incidence ◽  
Recent Infection ◽  
Female Sex ◽  
Hiv Seroconversion ◽  
Recent Hiv Infection

Background: The epidemiologic utility of STARHS hinges not only on producing accurate estimates of HIV incidence, but also on identifying risk factors for recent HIV infection. Methods: As part of an HIV seroincidence study, 800 Rwandan female sex workers (FSW) were HIV tested, with those testing positive further tested by BED-CEIA (BED) and AxSYM Avidity Index (Ax-AI) assays. A sample of HIV-negative (N=397) FSW were followed prospectively for HIV seroconversion. We compared estimates of risk factors for: 1) prevalent HIV infection; 2) recently acquired HIV infection (RI) based on three different STARHS classifications (BED alone, Ax-AI alone, BED/Ax-AI combined); and 3) prospectively observed seroconversion. Results: There was mixed agreement in risk factors between methods. HSV-2 coinfection and recent STI treatment were associated with both prevalent HIV infection and all three measures of recent infection. A number of risk factors were associated only with prevalent infection, including widowhood, history of forced sex, regular alcohol consumption, prior imprisonment, and current breastfeeding. Number of sex partners in the last 3 months was associated with recent infection based on BED/Ax-AI combined, but not other STARHS-based recent infection outcomes or prevalent infection. Risk factor estimates for prospectively observed seroconversion differed in magnitude and direction from those for recent infection via STARHS. Conclusions: Differences in risk factor estimates by each method could reflect true differences in risk factors between the prevalent, recently, or newly infected populations, the effect of study interventions (among those followed prospectively), or assay misclassification. Similar investigations in other populations/settings are needed to further establish the epidemiologic utility of STARHS for identifying risk factors, in addition to incidence rate estimation.

scholarly journals Transmitted drug resistance to Tenofovir/Emtricitabine among persons with newly diagnosed HIV infection in Shenyang city, Northeast China from 2016 to 2018

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhen Wang ◽  
Bin Zhao ◽  
Minghui An ◽  
Wei Song ◽  
Xue Dong ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Hiv Infection ◽  
Northeast China ◽  
Transmitted Drug Resistance ◽  
Newly Diagnosed ◽  
Resistance Mutations ◽  
Shenyang City ◽  
Subtype B ◽  
Recent Hiv Infection ◽  
Hiv 1

Abstract Background To assess transmitted drug resistance (TDR) to tenofovir (TDF)/emtricitabine (FTC), using as pre-exposure prophylaxis, among newly diagnosed human immunodeficiency virus-1 (HIV-1)-infected residents in Shenyang city, northeast China. Methods Demographic and epidemiological information of all newly diagnosed HIV-1 infected residents in Shenyang city from 2016 to 2018 were anonymously collected from the local HIV epidemic database. HIV-1 pol sequences were amplified from RNA in cryopreserved plasma samples and sequenced directly. Viral subtypes were inferred with phylogenetic analysis and drug resistance mutations (DRMs) were determined according to the Stanford HIVdb algorithm. Recent HIV infection was determined with HIV Limiting Antigen avidity electro immunoassay. Results A total of 2176 sequences (92.4%, 2176/2354) were obtained; 70.9% (1536/2167) were CRF01_AE, followed by CRF07_BC (18.0%, 391/2167), subtype B (4.7%, 102/2167), other subtypes (2.6%, 56/2167), and unique recombinant forms (3.8%, 82/2167). The prevalence of TDR was 4.9% (107/2167), among which, only 0.6% (13/2167) was resistance to TDF/FTC. Most of these subjects had CRF01_AE strains (76.9%, 10/13), were unmarried (76.9%, 10/13), infected through homosexual contact (92.3%, 12/13), and over 30 years old (median age: 33). The TDF/FTC DRMs included K65R (8/13), M184I/V (5/13), and Y115F (2/13). Recent HIV infection accounted for only 23.1% (3/13). Most cases were sporadic in the phylogenetic tree, except two CRF01_AE sequences with K65R (Bootstrap value: 99%). Conclusions The prevalence of TDR to TDF/FTC is low among newly diagnosed HIV-infected cases in Shenyang, suggesting that TDR may have little impact on the protective effect of the ongoing CROPrEP project in Shenyang city.

scholarly journals Detection of IgG3 antibodies specific to the human immunodeficiency virus type 1 (HIV-1) p24 protein as marker for recently acquired infection

2018 ◽  
Vol 146 (10) ◽  
pp. 1293-1300 ◽  
Author(s):  
I. F. T. Viana ◽  
D. F. Coêlho ◽  
M. L. Palma ◽  
E. J. M. Nascimento ◽  
G. Gu ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Human Immunodeficiency Virus Type ◽  
Virus Type ◽  
Control Strategies ◽  
Hiv Incidence ◽  
Recent Infection ◽  
Immunodeficiency Virus ◽  
P24 Protein ◽  
Hiv 1

AbstractReducing the risk of human immunodeficiency virus type 1 (HIV-1) transmission is still a public health priority. The development of effective control strategies relies on the quantification of the effects of prophylactic and therapeutic measures in disease incidence. Although several assays can be used to estimate HIV incidence, these estimates are limited by the poor performance of these assays in distinguishing recent from long-standing infections. To address such limitation, we have developed an assay to titrate p24-specific IgG3 antibodies as a marker of recent infection. The assay is based on a recombinant p24 protein capable to detect total IgG antibodies in sera using a liquid micro array and enzyme-linked immunosorbent assay. Subsequently, the assay was optimised to detect and titrate anti-p24 IgG3 responses in a panel of sequential specimens from seroconverters over 24 months. The kinetics of p24-specific IgG3 titres revealed a transient peak in the 4 to 5-month period after seroconversion. It was followed by a sharp decline, allowing infections with less than 6 months to be distinguished from older ones. The developed assay exhibited a mean duration of recent infection of 144 days and a false-recent rate of ca. 14%. Our findings show that HIV-1 p24-specific IgG3 titres can be used as a tool to evaluate HIV incidence in serosurveys and to monitor the efficacy of vaccines and other transmission control strategies.

scholarly journals Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT (Preprint)

2019 ◽  
Author(s):  
Joanne D Stekler ◽  
Lauren R Violette ◽  
Hollie A Clark ◽  
Sarah J McDougal ◽  
Lisa A Niemann ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Prospective Study ◽  
Hiv Testing ◽  
Transmitted Disease ◽  
The United States ◽  
Test Results ◽  
Cross Sectional ◽  
Hiv Test ◽  
Hiv Acquisition ◽  
Hiv 1

BACKGROUND HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. OBJECTIVE This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. METHODS Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. RESULTS Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. CONCLUSIONS Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. INTERNATIONAL REGISTERED REPORT RR1-10.2196/16332

scholarly journals ESTIMATES OF RECENT HIV INFECTION IN THE POPULATION BY FREQUENCY OF OCCURRENCE P24 ANTIGEN AND IN THE KIT DISTINGUISH RECENT FROM LONGSTANDING INFECTION

2020 ◽  
Vol 12 (1) ◽  
pp. 68-74
Author(s):  
D. A. Neshumaev ◽  
E. M. Meirmanova ◽  
O. N. Kuntsevich ◽  
S. E. Skudarnov ◽  
V. L. Stasenko
Keyword(s):  
Hiv Infection ◽  
Correlation Coefficient ◽  
Statistical Processing ◽  
Diagnostic Algorithm ◽  
Close Correlation ◽  
Test System ◽  
Frequency Of Occurrence ◽  
True Value ◽  
P24 Antigen ◽  
Recent Hiv Infection

Aim: to compare the incidence of recent cases of HIV infection in the population, recorded by the presence of p24 antigen and in thekit distinguish recent from longstanding infection.Materials and methods. Evaluation of recent HIV infection was carried out through studies of two cohorts of patients: 1) persons with negative / undetermined result of an immune blot and p24 antigen; 2) individuals with positive immune blot who were additionally studied using a test system to determine the duration of infection. Randomly in 2011, 2013, 2014 and 2015, 22%, 17%, 44% and 6% of all newly identified patients with a positive immune blot, respectively, were examined. Statistical processing, correlation coefficient and confidence intervals were calculated using Student’s t-test.Results. There is a close correlation between the detection rate of the p24 antigen of HIV and the frequency of occurrence of recent cases of infection registered among newly identified individuals with positive immune blot (the period of probable infection is less than 9 months). Correlation coefficient =0,91, p<0,05.Conclusion. The established dependence allows one to estimate the recent cases of infection in the population by a calculated method using only the frequency of occurrence of the p24 antigen included in the standard diagnostic algorithm of HIV infection. A formula is proposed in accordance with which it is necessary to add 0,6±0,2 to the frequency of occurrence of the p24 antigen expressed per 1000 individuals covered by screening. With a probability of 95%, the true value of the frequency of occurrence of recent cases of infections in a population will be in the calculated confidence interval.

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