Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays

Fogel, Jessica M.; Piwowar‐Manning, Estelle; Debevec, Barbara; Walsky, Tamara; Schlusser, Katherine; Laeyendecker, Oliver; Wilson, Ethan; McCauley, Marybeth; Gamble, Theresa; Tegha, Gerald; Soko, Dean; Kumwenda, Johnstone; Hosseinipour, Mina C.; Chen, Ying Qing; Cohen, Myron S.; Eshleman, Susan H.

doi:10.1097/qai.0000000000001421

Cited by 23 publications

(13 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A decrease in Ab detection after early treatment was also observed in other studies, which showed increased frequencies of false-negative results, weakly reactive HIV rapid test results, and increased numbers of indeterminate HIV-1 WB assay results (11,36). Of note, S/CO values of less than 10 by the ARC and BPX assays have frequently been associated with false-positive results (31,(37)(38)(39).…”

Section: Discussionsupporting

confidence: 71%

See 1 more Smart Citation

Decreased Seroreactivity in Individuals Initiating Antiretroviral Therapy during Acute HIV Infection

et al. 2019

View full text Add to dashboard Cite

Antiretroviral therapy (ART) during acute HIV infection (AHI) interrupts viral dynamics and may delay the emergence of serological markers targeted by current HIV screening and confirmatory assays, thus creating challenges for correctly classifying HIV infection status. The performance of three HIV antigen/antibody combination (HIV Ag/Ab Combo) assays (the Bio-Rad GS, Abbott Architect, and Bio-Rad BioPlex 2200 assays) was evaluated with samples collected from RV254/South East Asia Research Collaboration in HIV 010 (RV254/SEARCH010) study (Bangkok, Thailand) participants at weeks 12 and 24 following the initiation of ART at Fiebig stage I (FI) (n = 23), FII (n = 39), or FIII/IV (n = 22). Supplemental, confirmatory testing was performed by the Geenius HIV 1/2 and HIV-1 Western blot assays (Bio-Rad). Samples from 30 untreated, HIV-1-infected individuals demonstrated robust HIV Ag/Ab Combo assay reactivity with well-developed HIV-1 Western blotting profiles by 24 weeks after infection. In contrast, 52.2% of samples from individuals initiating ART at FI, 7.7% of samples from individuals initiating ART at FII, and 4.5% of samples from individuals initiating ART at FIII/IV were nonreactive by the HIV Ag/Ab Combo assays, with 36.4 to 39.1% of samples having low signal-to-cutoff (S/CO) results by the Architect and BioPlex assays (S/CO < 10). Seroreversion from a reactive to a nonreactive status was observed in 10 individuals initiating ART at FII and 3 individuals initiating ART at FIII/IV. The Geenius and HIV-1 Western blot assay results were negative or indeterminate for 73.9% and 69.6% of individuals, respectively, treated at FI; 50.0% and 26.3% of individuals, respectively, treated at FII; and 54.5% and 40.9% of individuals, respectively, treated at FIII/IV. Virologic suppression of HIV-1 by ART during AHI impedes seroconversion to biomarkers of infection, limiting the utility of HIV Ag/Ab Combo and supplemental, confirmatory assays for infection status determination.

show abstract

Section: Discussionsupporting

confidence: 71%

“…HIV infection (8)(9)(10)(11). Negative results on standard HIV Ab tests are common among HIV-1-infected children who initiate ART at an early age (12)(13)(14)(15).…”

mentioning

confidence: 99%

Decreased Seroreactivity in Individuals Initiating Antiretroviral Therapy during Acute HIV Infection

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Obviously, it is strictly related to different phases (for example, during sampling), and it could be avoided following the prescribed procedures in the case of viral infection [ 34 ]. Moreover, as demonstrated in other viral infections such as HIV, another important problem is related to the use of antiretroviral therapy: indeed, the viral load could be insufficient to be detected, generating false negative results [ 35 ].…”

Section: Covid-19 Laboratory-based Molecular Testingmentioning

confidence: 99%

Clinical-Forensic Autopsy Findings to Defeat COVID-19 Disease: A Literature Review

Sessa

Bertozzi

Cipolloni

et al. 2020

JCM

View full text Add to dashboard Cite

The severe acute respiratory syndrome (SARS)-CoV-2 was identified for the first time in China, in December 2019. Confirmed cases of COVID-19 have been reported around the world; indeed, this infection has been declared a pandemic. Consequently, the scientific community is working hard to gain useful information about the history of this virus, its transmission, diagnosis, clinical features, radiological findings, research and development of candidate therapeutics as well as vaccines. This review aims to analyze the diagnostic techniques used to ascertain the COVID-19 infection, critically reviewing positive points and criticism for forensic implications, obviously including autopsy. Finally, this review proposes a practical workflow to be applied in the management of corpses during this outbreak of the COVID-19 infection, which could be useful in cases of future infectious disease emergencies. Analyzing the diagnostic methods, to date, virus nucleic acid RT-PCR represents the standard method used to ascertain the COVID-19 infection in living subjects and corpses, even if this technique has several criticisms: mainly, the staff should be highly specialized, working in high-throughput settings, able to handle high workloads and aware of health risks and the importance of the results. Thus, IgG/IgM serological tests have been developed, overcoming RT-qPCR duration, costs, and management, not requiring highly trained personnel. Nevertheless, serological tests present problems; the WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. Furthermore, nothing has yet been published regarding the possibility of applying these methods during post-mortem investigations. In light of this scenario, in this review, we suggest a flow chart for the pathologist called on to ascertain the cause of death of a subject with historical and clinical findings of COVID-19 status or without any anamnestic, diagnostic, or exposure information. Indeed, the literature data confirmed the analytical vulnerabilities of the kits used for laboratory diagnosis of COVID-19, particularly during postmortem examinations. For these reasons, autopsy remains the gold standard method to ascertain the exact cause of death (from or with COVID-19 infection, or other causes), to consequently provide real data for statistical evaluations and to take necessary measures to contain the risks of the infection. Moreover, performing autopsies could provide information on the pathogenesis of the COVID-19 infection with obvious therapeutic implications.

show abstract

“…Among the 90 pieces of evidence that were identified through country survey and systematic review and that met the inclusion criteria, 65 (88%) 1,4,5,[7][8][9][10][11][12][13][14][15]20, focused on assay performance, algorithm performance, or methodological descriptions of incidence estimation.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…Factors that can affect assay performance include natural variability in individual immune responses (in particular, elite control of HIV or natural viral suppression), variability in biomarker progression for different HIV-1 subtypes, the types of specimens collected and storage methods, advanced HIV disease, and treatment with antiretroviral therapy (ART) or use of pre-exposure prophylaxis (PrEP). [5][6][7][8][9][10] The effect of ART on increasing the FRR of recency assays appears to be more pronounced when a person receives treatment very early after initial infection; 11,12 which is complicated by rapid improvements in treatment coverage worldwide, as well as uptake of pre-exposure prophylaxis (PrEP). Other factors that may impact assay performance but are not yet well-characterised include sex, pregnancy status and the presence of co-morbidities.…”

Section: Introductionmentioning

confidence: 99%

Use of HIV Recency Assays for HIV Incidence Estimation and Non-Incidence Surveillance Use Cases: A systematic review

Facente

Agyei²,

Maher

et al. 2021

Preprint

View full text Add to dashboard Cite

IntroductionHIV assays designed to detect recent infection, also known as “recency assays,” are often used to estimate HIV incidence in a specific country, region, or subpopulation, alone or as part of recent infection testing algorithms (RITAs). Recently, many countries and organizations have become interested in using recency assays within case surveillance systems and routine HIV testing services, and in measuring other indicators beyond incidence, generally referred to as “non-incidence surveillance use cases.”MethodsTo identify best methodological and field implementation practices for the use of recency assays to estimate HIV incidence and trends in recent infections for key populations or specific geographic areas, we undertook: 1) a global Call for Information released from WHO/UNAIDS; and 2) a systematic review of the literature to: (a) assess the field performance characteristics of commercially available recency assays, (b) understand the use of recency testing for surveillance in programmatic and laboratory settings, and (c) review methodologies for implementing recency testing for both incidence estimation and non-incidence use cases.Results and discussionAmong the 90 documents ultimately reviewed, 65 (88%) focused on assay/algorithm performance or methodological descriptions, with high-quality evidence of accurate age- and sex- disaggregated HIV incidence estimation at national or regional levels in general population settings, but not at finer geographic levels for prevention prioritization. The remaining 25 documents described field-derived incidence (n=14) and non-incidence (n=11) use cases, including integrating RITAs into routine surveillance and assisting with molecular genetic analyses, but evidence was generally weaker or only reported on what was done, without validation data or findings related to effectiveness of recency assays when used for these purposes.ConclusionsHIV recency assays have been widely validated for estimating HIV incidence in age- and sex-specific populations at national and sub-national regional levels; however, there was a lack of evidence validating the accuracy and effectiveness of using recency assays for non-incidence surveillance use cases. The evidence identified through this review will be used in forthcoming technical guidance on the use of HIV recency assays for surveillance use cases by WHO and UNAIDS; further evidence on methodologies and effectiveness of non-incidence use cases is needed.

show abstract

Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays

Cited by 23 publications

References 29 publications

Decreased Seroreactivity in Individuals Initiating Antiretroviral Therapy during Acute HIV Infection

Decreased Seroreactivity in Individuals Initiating Antiretroviral Therapy during Acute HIV Infection

Clinical-Forensic Autopsy Findings to Defeat COVID-19 Disease: A Literature Review

Use of HIV Recency Assays for HIV Incidence Estimation and Non-Incidence Surveillance Use Cases: A systematic review

Contact Info

Product

Resources

About