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 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.

scholarly journals Diagnostic Pitfalls in Newborns and Babies with Blisters and Erosions

2009 ◽  
Vol 2009 ◽  
pp. 1-10 ◽  
Author(s):  
Elke Nischler ◽  
Alfred Klausegger ◽  
Clemens Hüttner ◽  
Gabriele Pohla-Gubo ◽  
Anja Diem ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Correct Diagnosis ◽  
Molecular Genetic ◽  
Diagnostic Algorithm ◽  
Skin Lesions ◽  
Molecular Genetic Analysis ◽  
Inherited Disorders ◽  
Clinical Appearance ◽  
Transmission Electron ◽  
Disease Entities

Establishing the correct diagnosis in newborns presenting with blisters and erosions is not always a straightforward process. Many different disease entities including acquired (i.e., infectious, immunobullous, traumatic) and inherited disorders have to be taken into consideration. Similarities in clinical appearance, colonization and/or superinfections of preexisting skin lesions, as well as the absence of late changes in the neonate often pose significant diagnostic challenges. In this paper we discuss by giving examples the process of making an accurate diagnosis of blistering skin diseases in the neonatal period on the basis of a diagnostic algorithm. In addition, we provide an overview of the rational use and the limitations of laboratory procedures such as microbial testing, routine light microscopy, immunofluorescence antigen mapping, transmission electron microscopy, and molecular genetic analysis.

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 To the Problem of Comorbidity of HIV Infection and Tuberculosis

Medicina ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 91-98
Author(s):  
A. V. Safronenko ◽  
◽  
E. V. Gantsgorn ◽  
L. F. Chernigovets ◽  
E. A. Sklyanaya ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Primary Care Physicians ◽  
Molecular Genetic ◽  
Molecular Genetic Analysis ◽  
Economic Significance ◽  
Current State ◽  
Close Cooperation ◽  
Level Of Knowledge ◽  
Medico Economic ◽  
Tuberculosis Therapy

The problem of combined HIV infection and TB has a high medico-biological, medico-social and medico-economic significance, which has been steadily growing lately. At the same time, this variant of infectious comorbidity is an interdisciplinary problem of international dimension. This analytical article summarizes both the data presented in the literature and the results of our own research. To improve the current state of this problem, in our opinion, it is extremely important to take measures to increase the alertness of primary care physicians to the possibility of such comorbidity, the level of knowledge in the field of phthisiology, epidemiology, clinical pharmacology, the active use of methods for determining the sensitivity of mycobacteria to anti-tuberculosis therapy, including express molecular genetic analysis, increased patient compliance. Only close cooperation of health professionals and their coordinated activities can help to reduce the spread of HIV infection and tuberculosis and reduce epidemiological tension.

Laboratory Diagnosis and Monitoring of HIV Infection

2019 ◽  
Author(s):  
Anna Jeffery- Smith ◽  
C. Y. William Tong
Keyword(s):  
Hiv Infection ◽  
Sensitivity And Specificity ◽  
Point Of Care ◽  
Fourth Generation ◽  
Third Generation ◽  
Window Period ◽  
P24 Antigen ◽  
Exposure Risks ◽  
Positive Results ◽  
Hiv 1

In the majority of UK laboratories initial testing for HIV is now performed using a fourth generation test, which is a combination test for antibody to HIV and p24 antigen. These tests should be able to detect antibody to both HIV-1 and HIV-2. In addition, due to the heterogeneity of the virus they should be able to reliably detect antibody to the main circulating subtypes of HIV-1, i.e. group M (Major), O (Outlier), and N (non-M, non-O). The p24 antigen is an HIV capsid protein which is produced in large quantities during initial infection, prior to seroconversion. The sensitivity and specificity of fourth generation tests is typically > 99%. However, all positive results need further confirmation tests, as discussed below. Third generation laboratory assays only test for the presence of antibody to HIV. Though it includes the detection of IgM (which is not included in second generation assays), they do not detect early infection with isolated HIV antigen prior to seroconversion. Point-of-care testing for HIV is performed in the clinic or at bedside. Like laboratory based assays these tests can be either third or fourth generation. The sensitivity and specificity of point-of-care tests is considered lower than that of laboratory tests, and all positive results require confirmation with a laboratory assay. The window period is the length of time following infection with HIV until the appearance of laboratory markers of HIV infection in the blood. This period varies depending on which marker, i.e. antibody or antigen, is being tested for. The window period for fourth-generation tests is between eleven days and one month. Patients being counselled prior to this testing should be advised that a negative result does not cover risk exposures in the preceding month. These patients should be advised to have repeat testing if they have any further exposure risks in the preceding month prior to testing. For third-generation tests the window period is up to three months, correlating with the amount of time it may take for antibodies to HIV to develop.

scholarly journals HIV-1 Epidemiology, Genetic Diversity, and Primary Drug Resistance in the Tyumen Oblast, Russia

2016 ◽  
Vol 2016 ◽  
pp. 1-13 ◽  
Author(s):  
Natalya M. Gashnikova ◽  
Ekaterina M. Astakhova ◽  
Mariya P. Gashnikova ◽  
Evgeniy F. Bocharov ◽  
Svetlana V. Petrova ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Risk Groups ◽  
Tyumen Oblast ◽  
Subtype B ◽  
Primary Drug Resistance ◽  
High Incidence ◽  
Duration Of Infection ◽  
Sporadic Cases ◽  
Subtype A ◽  
Hiv 1

Introduction. Specific molecular epidemic features of HIV infection in Tyumen Oblast (TO), Russia, were studied.Methods. The genome sequences encoding HIV-1 protease-reverse transcriptase, integrase, and major envelope protein were examined for 72 HIV-1 specimens isolated from the TO resident infected in 2000–2015.Results. The recorded prevalence of HIV-1 subtype A (A1) is 93.1%; HIV-1 subtype B continues to circulate in MSM risk group (1.4%). Solitary instances of HIV-1 recombinant forms, CRF63_02A1 (1.4%) and CRF03_AB (1.4%), were detected as well as two cases of HIV-1 URF63_A1 (2.8%). Phylogenetic analysis showed no HIV-1 clustering according to the duration of infection and risk groups but revealed different epidemic networks confirming that HIV infection spread within local epidemic foci. A high incidence of CXCR4-tropic HIV-1 variants and a higher rate of secondary mutations influencing the virus fitness (K20R, L10V, and I) are observed among the virus specimens isolated from newly infected individuals.Conclusions. The current HIV-1 epidemic in TO develops within the local epidemic networks. Similar to the previous period, HIV-1 subtype A is predominant in TO with sporadic cases of importation of HIV-1 recombinant forms circulating in adjacent areas.

scholarly journals Use of the method of phylogenetic analysis in an epidemiological investigation in case of HIV infection in pediatric practice

2021 ◽  
Vol 13 (1) ◽  
pp. 106-114
Author(s):  
S. P. Kruglyak ◽  
V. O. Kotova ◽  
E. I. Miroshnichenko ◽  
O. A. Skaly ◽  
E. S. Makhno ◽  
...  
Keyword(s):  
Phylogenetic Analysis ◽  
Nucleotide Sequence ◽  
Hiv Infection ◽  
Phylogenetic Trees ◽  
Comparison Group ◽  
Molecular Genetic ◽  
Molecular Genetic Analysis ◽  
Nucleotide Sequences ◽  
Likelihood Method ◽  
Epidemiological Investigation

The aim of the study is to study the main pathways and risk factors for HIV infection in a child, to establish a probable source of infection for a child, as well as to exclude the possibility of criminal or nosocomial infection.Materials and methods. At the first stage, an epidemiological investigation was conducted. Next, a molecular genetic analysis of two blood plasma samples studied (child and mother) and a comparison group were used, in which 18 nucleotide sequences of HIV-1 variants were used, obtained from patients living in the Primorsky Region, and 8 characterized nucleotide sequences additionally taken from GenBank international database. Distance calculation and phylogenetic analysis were performed by constructing phylogenetic trees using the Maximum Likelihood method using the GTR evolution model.Research results. The data obtained indicate that the nucleotide sequence from the child is most similar to the nucleotide sequence from the mother (potential source) and reliably grouped on the phylogenetic tree, forming a common cluster that is different from the samples of the comparison group. This indicates the likelihood of an epidemiological link between HIV infections in the mother and her child.Conclusion. According to the results of this study, we can conclude that the child is infected from an HIV-infected mother, approximately at the age of a child older than 4 years old, when he received the last negative test result for HIV markers.

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