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Article ; Online: Evaluation of SAMBA II: A Qualitative and Semiquantitative HIV Point-of-Care Nucleic Acid Test.

Violette, Lauren R / Cornelius-Hudson, Andy / Snidarich, Madison / Niemann, Lisa A / Assennato, Sonny Michael / Ritchie, Allyson / Goel, Neha / Chavez, Pollyanna R / Ethridge, Steven F / Katz, David A / Lee, Helen / Delaney, Kevin P / Stekler, Joanne D

Journal of acquired immune deficiency syndromes (1999)

2022 Volume 89, Issue 5, Page(s) 537–545

Abstract: Background: Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US.: Methods: ... ...

Abstract	Background: Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US. Methods: From June 2018-March 2019, we conducted a cross-sectional evaluation of the Simple Amplification-Based Assay version II (SAMBA II) POC NAT. People with HIV (PWH) and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naive, and SAMBA II Semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared with Abbott RealTime HIV-1 polymerase chain reaction results on plasma. We calculated sensitivity, specificity, and concordance between tests. Results: SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naive participants was 91.4% [32/35, 95% confidence interval (CI): 77.6% to 97.0%] using VP WB and 100% (27/27, 95% CI: 87.5% to 100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1% to 99.4%) and 100% (30/30, 95% CI: 88.7% to 100%) using VP and FS WB, respectively. Conclusions: The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US.
MeSH term(s)	Cross-Sectional Studies ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; Humans ; Nucleic Acids/therapeutic use ; Point-of-Care Systems ; Point-of-Care Testing ; Sensitivity and Specificity ; Viral Load/methods
Chemical Substances	Nucleic Acids
Language	English
Publishing date	2022-01-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	645053-2
ISSN	1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
ISSN (online)	1944-7884 ; 1077-9450
ISSN	0897-5965 ; 0894-9255 ; 1525-4135
DOI	10.1097/QAI.0000000000002902
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Article ; Online: Time Until Emergence of HIV Test Reactivity Following Infection With HIV-1: Implications for Interpreting Test Results and Retesting After Exposure.

Delaney, Kevin P / Hanson, Debra L / Masciotra, Silvina / Ethridge, Steven F / Wesolowski, Laura / Owen, Sherry Michele

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2017 Volume 64, Issue 1, Page(s) 53–59

Abstract: Background: Understanding the period of time between an exposure resulting in infection with human immunodeficiency virus (HIV) and when a test can reliably detect the presence of that infection, that is, the test window period, may benefit testing ... ...

Abstract	Background: Understanding the period of time between an exposure resulting in infection with human immunodeficiency virus (HIV) and when a test can reliably detect the presence of that infection, that is, the test window period, may benefit testing programs and clinicians in counseling patients about when the clinician and the patient can be confident a suspected exposure did not result in HIV infection. Methods: We evaluated the intervals between reactivity of the Aptima HIV-1 RNA test (Aptima) and 20 US Food and Drug Administration-approved HIV immunoassays using 222 longitudinally collected plasma specimens from HIV-1 seroconverters from the United States. Using interval-censored survival and binomial regression approaches a multi-model framework was implemented to estimate the relative emergence of test reactivity, referred to here as an inter-test reactivity interval (ITRI). We then combined ITRI results with simulated data for the eclipse period, the time between exposure and detection of HIV virus by Aptima, to estimate the window period for each test. Results: The estimated ITRIs were shorter with each new class of HIV tests, ranging from 5.9 to 24.8 days. The 99 Conclusions: Our directly comparable estimates of the emergence of reactivity for 20 immunoassays are valuable to testing providers for interpreting negative HIV test results obtained shortly after exposure, and for counseling individuals on when to retest after an exposure.
Language	English
Publishing date	2017-01-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciw666
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Article: Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT.

Stekler, Joanne D / Violette, Lauren R / Clark, Hollie A / McDougal, Sarah J / Niemann, Lisa A / Katz, David A / Chavez, Pollyanna R / Wesolowski, Laura G / Ethridge, Steven F / McMahan, Vanessa M / Cornelius-Hudson, Andy / Delaney, Kevin P

JMIR research protocols

2020 Volume 9, Issue 1, Page(s) e16332

Abstract: 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 ... ...

Abstract	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 identifier (irrid): RR1-10.2196/16332.
Language	English
Publishing date	2020-01-27
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2719222-2
ISSN	1929-0748
ISSN	1929-0748
DOI	10.2196/16332
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Article ; Online: Performance evaluation of four point-of-care HIV tests using unprocessed specimens.

Chavez, Pollyanna R / Bradley, Heather M / Wesolowski, Laura G / Violette, Lauren R / Katz, David A / Niemann, Lisa A / McMahan, Vanessa M / McDougal, Sarah / Cornelius-Hudson, Andy M / Ethridge, Steven F / Stekler, Joanne D / Delaney, Kevin P

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

2020 Volume 124, Page(s) 104282

Abstract: Background: The performance of recently approved point-of-care (POC) HIV tests should be assessed using unprocessed specimens.: Objective: To evaluate the sensitivity and specificity of four POC HIV tests using whole blood (WB) and two using oral ... ...

Abstract	Background: The performance of recently approved point-of-care (POC) HIV tests should be assessed using unprocessed specimens. Objective: To evaluate the sensitivity and specificity of four POC HIV tests using whole blood (WB) and two using oral fluid (OF) among persons recruited from health clinics in Seattle, Washington, during September 2015-September 2017. Study design: Participants were tested with the POC tests, additional plasma and serum were collected for laboratory testing, and participant- reported use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) was recorded. Participants testing negative on all tests could reenroll every 90 days. Specimens from persons previously diagnosed with HIV infection as well as from those who were newly diagnosed during the study were included in the sensitivity estimate. Sensitivity and specificity were calculated based on HIV status determined by laboratory testing. Results: Of 1,256 visits, 179 were from persons with HIV infection; 120 of these were taking ART. Among 1,077 visits from participants not diagnosed with HIV, PrEP use was reported at 155 (14.4%) visits. Sensitivity was similar among POC WB tests (95.53%-97.21%; p>0.05). Among participants on ART, sensitivity was lower for the same test performed on OF compared to WB (p<0.003). Specificity was high for all tests (99.44%- 100.00%); we did not detect specificity differences with PrEP use. Conclusions: These POC tests displayed relatively high sensitivity and specificity using unprocessed specimens, suggesting their effectiveness in identifying HIV infections whenever laboratory-based testing is not feasible. Nonetheless, clients with recent risk should retest to rule out the possibility of a false-negative result.
MeSH term(s)	Anti-HIV Agents/therapeutic use ; False Negative Reactions ; False Positive Reactions ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; HIV Testing ; Humans ; Point-of-Care Systems ; Pre-Exposure Prophylaxis ; Sensitivity and Specificity ; Specimen Handling
Chemical Substances	Anti-HIV Agents
Language	English
Publishing date	2020-01-16
Publishing country	Netherlands
Document type	Evaluation Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1446080-4
ISSN	1873-5967 ; 1386-6532
ISSN (online)	1873-5967
ISSN	1386-6532
DOI	10.1016/j.jcv.2020.104282
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Article: Group Sex Events Among Cisgender Men Who Have Sex With Men: Cross-Sectional and Longitudinal Survey Study to Explore Participation and Risk-Taking Behaviors.

Violette, Lauren R / Niemann, Lisa A / McMahan, Vanessa M / Katz, David A / Chavez, Pollyanna R / Clark, Hollie A / Cornelius-Hudson, Andy / Ethridge, Steven F / McDougal, Sarah J / Ure Ii, George / Stekler, Joanne D / Delaney, Kevin P

JMIR research protocols

2019 Volume 8, Issue 11, Page(s) e15426

Abstract: Background: Group sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking ... ...

Abstract	Background: Group sex events (GSEs) are common among cisgender men who have sex with men (MSM), pose a unique risk profile for HIV and sexually transmitted disease (STD) transmission, and may be on the rise, in part because of Web-based networking platforms. However, collecting data on GSEs can be challenging, and many gaps exist in our knowledge about GSE participation among MSM. Objective: The objective of this study was to develop survey questions addressing aggregate and partner-specific group sex behaviors to measure prevalence of GSEs and associated risks in persons participating in Project Diagnostic Evaluation To Expand Critical Testing Technologies (DETECT), including MSM seeking HIV and STD testing at a public clinic in Seattle, Washington. Methods: We developed a computer self-assisted survey that included questions about participant demographics, sexual history, and risk behaviors, including group sex, as a part of Project DETECT, a Centers for Disease Control and Prevention-funded study evaluating point-of-care HIV tests. Aggregate and partner-specific questions asked about participation in all GSEs, threesomes, and four-or-more-somes including questions about number and HIV status of sex partners and condom use during the events. To evaluate question performance, we assessed the discrepancies in reporting between the aggregate and partner-specific questions, quantified question refusal rates, and calculated the additional time required to answer the GSE questions. Information about network density (number of partnerships of overlapping duration) was estimated and compared for MSM who did and did not report GSEs. Results: Among 841 visits by 690 MSM who were asked any group sex survey question, participation in a GSE of any type in the past 3 months was reported at 293 visits (293/841, 34.8%). We found that 9.0% (76/841) of MSM in the sample reported ≥1 four-or-more-some in the partner-specific questions but did not report in the aggregate. The proportion of refusals on any given aggregate GSE-related question ranged from 0% (0/273) to 10.6% (15/141) (median 2.6%) and partner-specific questions ranged from 0% (0/143) to 22% (5/23) (median 3.0%), with questions about four-or-more-somes having the highest proportions of refusals. Completing the aggregate group sex questions added 1 to 2 minutes and the partner-specific questions added an additional 2 to 4 minutes per partner to the total survey length. As expected, the partner-specific GSE questions documented higher density of sexual networks that was not captured by asking about total partner counts and overlap of specific partnerships. Conclusions: We found that the Project DETECT survey was able to obtain nuanced information about GSEs. The question skip patterns and consistency checks were effective, and survey fatigue was minimal. More research is needed on GSEs, and our survey represents a promising data collection tool to help fill gaps in knowledge about the subject.
Language	English
Publishing date	2019-11-27
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2719222-2
ISSN	1929-0748
ISSN	1929-0748
DOI	10.2196/15426
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Article ; Online: Evaluation of pooling strategies for acute HIV-1 infection screening using nucleic acid amplification testing.

Sullivan, Timothy J / Patel, Pragna / Hutchinson, Angela / Ethridge, Steven F / Parker, Monica M

Journal of clinical microbiology

2011 Volume 49, Issue 10, Page(s) 3667–3668

Abstract: A 128-member specimen pooling scheme for acute HIV infection (AHI) detection was evaluated using 21 AHI specimens (range, 1,520 to 500,000 copies/ml) previously identified by RNA testing of 16-member plasma pools. HIV-1 RNA was detectable in 128-member ... ...

Abstract	A 128-member specimen pooling scheme for acute HIV infection (AHI) detection was evaluated using 21 AHI specimens (range, 1,520 to 500,000 copies/ml) previously identified by RNA testing of 16-member plasma pools. HIV-1 RNA was detectable in 128-member pools for all 21 specimens; however, one pool created from a specimen with 1,827 copies/ml was nonreactive in one of three replicates.
MeSH term(s)	HIV Infections/diagnosis ; HIV Infections/virology ; HIV-1/genetics ; HIV-1/isolation & purification ; Humans ; Mass Screening/methods ; Molecular Diagnostic Techniques/methods ; Plasma/virology ; RNA, Viral/blood ; RNA, Viral/genetics ; Specimen Handling/methods ; Virology/methods
Chemical Substances	RNA, Viral
Language	English
Publishing date	2011-08-10
Publishing country	United States
Document type	Evaluation Study ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.00650-11
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Article ; Online: HIV screening practices and hospital characteristics in the US, 2009-2010.

Herrin, Jeph / Wesolowski, Laura G / Heffelfinger, James D / Bostick, Nathan / Hall, H Irene / Ethridge, Steven F / Branson, Bernard M

Public health reports (Washington, D.C. : 1974)

2013 Volume 128, Issue 3, Page(s) 161–169

Abstract: Objectives: The Centers for Disease Control and Prevention recommends HIV screening in U.S. health-care settings unless providers document a yield of undiagnosed HIV infections of <1 per 1,000 population. However, implementation of this guidance has not ...

Abstract	Objectives: The Centers for Disease Control and Prevention recommends HIV screening in U.S. health-care settings unless providers document a yield of undiagnosed HIV infections of <1 per 1,000 population. However, implementation of this guidance has not been widespread and little is known of the characteristics of hospitals with screening practices in place. We assessed how screening practices vary with hospital characteristics. Methods: We used a national hospital survey of HIV testing practices, linked to HIV prevalence for the county, parish, borough, or city where the hospital was located, to assess HIV screening of some or all patients by hospitals. We used multivariate logistic regression analysis to assess the association between screening practices and hospital characteristics that were significantly associated with screening in bivariate analyses. Results: Of 376 hospitals in areas of prevalence ≥0.1%, only 25 (6.6%) reported screening all patients for HIV and 131 (34.8%) reported screening some or all patients. Among 638 hospitals included, screening some or all patients was significantly (p<0.05) more common at teaching hospitals, hospitals with higher numbers of annual admissions, and hospitals with a high proportion of Medicaid admissions. In multivariable analysis, screening some or all patients was independently associated with admitting more than 15% of Medicaid patients and receiving resources or reimbursement for screening tests. Conclusion: We found that few hospitals surveyed reported screening some or all patients, and failure to screen is common across all types of hospitals in all regions of the country. Expanded reimbursement for screening may increase compliance with the recommendations.
MeSH term(s)	Black or African American/statistics & numerical data ; Centers for Disease Control and Prevention, U.S. ; Cross-Sectional Studies ; Guideline Adherence ; HIV ; HIV Infections/diagnosis ; HIV Infections/epidemiology ; Health Surveys ; Hospitals/classification ; Hospitals/standards ; Hospitals/statistics & numerical data ; Humans ; Logistic Models ; Mass Screening/standards ; Mass Screening/statistics & numerical data ; Medicare/statistics & numerical data ; Practice Guidelines as Topic ; Prevalence ; United States/epidemiology
Language	English
Publishing date	2013-03-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	120953-x
ISSN	1468-2877 ; 0033-3549
ISSN (online)	1468-2877
ISSN	0033-3549
DOI	10.1177/003335491312800306
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Article ; Online: Acute infections, cost and time to reporting of HIV test results in three U.S. State Public Health Laboratories.

Nasrullah, Muazzam / Wesolowski, Laura G / Ethridge, Steven F / Cranston, Kevin / Pentella, Michael / Myers, Robert A / Rudrik, James T / Hutchinson, Angela B / Bennett, Spencer B / Werner, Barbara G

The Journal of infection

2016 Volume 73, Issue 2, Page(s) 164–172

Abstract: Objective: In three U.S. State Public Health Laboratories (PHLs) using a fourth-generation immunoassay (IA), an HIV-1/HIV-2 differentiation antibody IA and a nucleic acid test (NAT), we characterized the yield and time to reporting of acute infections, ... ...

Abstract	Objective: In three U.S. State Public Health Laboratories (PHLs) using a fourth-generation immunoassay (IA), an HIV-1/HIV-2 differentiation antibody IA and a nucleic acid test (NAT), we characterized the yield and time to reporting of acute infections, and cost per positive specimen. Methods: Routine HIV testing data were collected from July 1, 2012-June 30, 2013 for Massachusetts and Maryland PHLs, and from November 27, 2012-June 30, 2013 for Michigan PHL. Massachusetts and Michigan used fourth-generation and differentiation IAs with NAT conducted by a referral laboratory. In Maryland, fourth-generation IA repeatedly reactive specimens were followed by a Western blot (WB), and those with negative or indeterminate results were tested with a differentiation IA and HIV-1 NAT, and if positive by NAT, confirmed by a different HIV-1 NAT. Specimens from WB-positive persons at risk for HIV-2 were tested with a differentiation IA and, if positive, with an HIV-2 WB and/or differential HIV-1/HIV-2 proviral DNA polymerase chain reaction. Results: Among 7914 specimens from Massachusetts PHL, 6069 from Michigan PHL, and 36,266 from Maryland PHL, 0.10%, 0.02% and 0.05% acute infections were identified, respectively. Massachusetts and Maryland PHLs each had 1 HIV-2 positive specimen. The median time from specimen receipt to laboratory reporting of results for acute infections at Massachusetts, Michigan and Maryland PHLs was 8, 11, and 7 days respectively. The laboratory cost per HIV positive specimen was $336 (Massachusetts), $263 (Michigan) and $210 (Maryland). Conclusions: Acute and established infections were found by PHLs using fourth-generation IA in conjunction with antibody tests and NAT. Time to reporting of acute HIV test results to clients was suboptimal, and needs to be streamlined to expedite treatment and interrupt transmission.
MeSH term(s)	Acute Disease ; Algorithms ; Blotting, Western ; Clinical Laboratory Services ; HIV Antibodies/blood ; HIV Infections/epidemiology ; HIV Infections/virology ; HIV-1/genetics ; HIV-1/immunology ; HIV-1/isolation & purification ; HIV-2/genetics ; HIV-2/immunology ; HIV-2/isolation & purification ; Humans ; Immunoassay ; Mass Screening ; Nucleic Acid Amplification Techniques/methods ; RNA, Viral/blood ; Sensitivity and Specificity ; Time Factors ; United States/epidemiology ; United States Public Health Service/statistics & numerical data
Chemical Substances	HIV Antibodies ; RNA, Viral
Language	English
Publishing date	2016-05-26
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	424417-5
ISSN	1532-2742 ; 0163-4453
ISSN (online)	1532-2742
ISSN	0163-4453
DOI	10.1016/j.jinf.2016.05.006
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Article ; Online: Prospective Evaluation of HIV Testing Technologies in a Clinical Setting

JMIR Research Protocols, Vol 9, Iss 1, p e

Protocol for Project DETECT

2020 Volume 16332

Abstract: BackgroundHIV 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 ... ...

Abstract	BackgroundHIV 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. ObjectiveThis paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. MethodsProject 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. ResultsBetween September 2015 and March ...
Keywords	Medicine ; R ; Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	310
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	JMIR Publications
Document type	Article ; Online
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Article ; Online: Rapid human immunodeficiency virus test quality assurance practices and outcomes among testing sites affiliated with 17 public health departments.

Wesolowski, Laura G / Ethridge, Steven F / Martin, Eugene G / Cadoff, Evan M / MacKellar, Duncan A

Journal of clinical microbiology

2009 Volume 47, Issue 10, Page(s) 3333–3335

Abstract: Rapid human immunodeficiency virus testing is often conducted in nonclinical settings by staff with limited training, so quality assurance (QA) monitoring is critical to ensure accuracy of test results. Rapid tests (n = 86,749) were generally conducted ... ...

Abstract	Rapid human immunodeficiency virus testing is often conducted in nonclinical settings by staff with limited training, so quality assurance (QA) monitoring is critical to ensure accuracy of test results. Rapid tests (n = 86,749) were generally conducted according to manufacturers' instructions, but ongoing testing competency assessments and on-site QA monitoring were not uniformly conducted.
MeSH term(s)	HIV/isolation & purification ; HIV Infections/diagnosis ; Health Services Research ; Humans ; Medical Laboratory Science/methods ; Medical Laboratory Science/standards ; Public Health ; Quality Assurance, Health Care/methods ; Virology/methods
Language	English
Publishing date	2009-08-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01504-09
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