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

Curtis, Kelly A.; Rudolph, Donna L.; Pan, Yi; Delaney, Kevin P.; Anastos, Kathryn; DeHovitz, Jack; Kassaye, Seble; Hanson, Carl V.; French, Audrey L.; Golub, Elizabeth T.; Adimora, Adaora A.; Ofotokun, Igho; Bolívar, Héctor; Kempf, Mirjam-Colette; Peters, Philip J.; Switzer, William M.

doi:10.1101/2020.11.09.374017

Cited by 2 publications

(3 citation statements)

References 32 publications

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“…Since the literature lacks a clear value to define what a high CMIA is, a more conservative definition was assumed based on our tested cases, in which the cutoff was defined as a CMIA value above the median of volunteers lacking previous negative test, i.e., 821 units. This value is above the 400 units used in some previous studies as a proxy for chronic cases 13,14 .…”

Section: Methodsmentioning

confidence: 54%

“…The recency cutoffs used were as suggested by the literature, such as defining recent infections by an avidity index below 40% 9 and a cut-off below 0.5% of the ambiguous positions 12 . For CMIA, although a signal/cut-off (S/CO) limit of 400 13 or 418 (IQR25-75 384-449) 14 units was used by some studies as a proxy for recent infection, a stringent cutoff of an S/CO below 200 units 15 was chosen.…”

Section: Methodsmentioning

confidence: 99%

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Recent HIV infections: evaluation of a simple identification score for newly diagnosed patients

Matsuda¹,

Ahagon

Coelho

et al. 2022

Rev. saúde pública

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OBJECTIVE: Recognize incident infection to better characterize the groups that fuel HIV epidemic. We propose a simple score to identify recent infections among newly diagnosed patients as a HIV surveillance tool. METHODS: Newly diagnosed patients were defined as recent infections when a negative serological test in the previous year was available. Laboratory tests, such as the avidity index (Bio-Rad, according to the CEPHIA protocol), chemiluminescent intensity (CMIA, architect, Abbott), and the nucleotide ambiguity index of partial pol sequences were used as proxies of recency. A simple score based on clinical symptoms of acute retroviral syndrome during the previous year, CD4+ T cell count, and viral load at admission was tested to assess the predictive power, using receiver operating characteristic (ROC) curves, to identify recent cases of infection. RESULTS: We evaluated 204 recently diagnosed patients who were admitted to the Ambulatório de Referência em Moléstias Infecciosas de Santo André (Santo André Reference Infectious Diseases Outpatient Clinic), in the metropolitan region of São Paulo, Brazil, recruited between 2011 and 2018. An HIV-negative test in the year prior to enrollment was documented in 37% of participants. The proportion of cases classified as recent infections (less than one year), according to the laboratory proxies were: 37% (67/181) for an avidity index < 40%, 22% (30/137) for a CMIA < 200, and 68% (124/181) for an ambiguity index < 0.5%. Using different combinations of recency definitions, our score showed an area under the ROC curve from 0.66 to 0.87 to predict recency. CONCLUSIONS: Using data from patients’ interviews and routine laboratory tests at admission, a simple score may provide information on HIV recency and thus, a proxy for HIV incidence to guide public policies. This simple for the Brazilian public health system and other low- and middle-income countries.

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Section: Methodsmentioning

confidence: 54%

Section: Methodsmentioning

confidence: 99%

Recent HIV infections: evaluation of a simple identification score for newly diagnosed patients

Matsuda¹,

Ahagon

Coelho

et al. 2022

Rev. saúde pública

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“…Use of testing history alone could be a pragmatic approach to correct for seroconversion in countries lacking detailed clinical or serological information. Where collected, information from diagnostic tests could also provide a useful proxy for recency, recent studies have shown correlation between a ‘recent’ LAg result and a signal-to-cutoff ratio <250 in the widely-used Abbott Architect Ag/Ab assay [ 44 , 45 ].…”

Section: Discussionmentioning

confidence: 99%

Re‐assessing the late HIV diagnosis surveillance definition in the era of increased and frequent testing

Kirwan

Croxford²,

Aghaizu³

et al. 2022

HIV Medicine

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Objectives Late HIV diagnosis (CD4<350 cells/mm 3 ) is a key public health metric. In an era of more frequent testing there is greater likelihood of HIV diagnosis occurring during seroconversion, when CD4 counts may dip below 350. We apply a correction, considering markers of recent infection and reassess one-year mortality following late diagnosis. Methods We used national epidemiological and laboratory surveillance data on all persons diagnosed with HIV in England, Wales, and Northern Ireland (EW&NI). Persons with a baseline CD4<350 were reclassified as “not-late” if they had evidence of recent infection (recency test and/or negative test within 24 months). A correction factor (CF) was the number reclassified divided by the number with CD4<350. Results Of the 32,227 people diagnosed with HIV in EW&NI between 2011-2019 with a baseline CD4 (81% of total), 46% had a CD4<350 (uncorrected late diagnosis rate): 34% of gay and bisexual men (GBM), 65% of heterosexual men, and 56% of heterosexual women. Accounting for recency test and/or prior negative tests gave a “corrected” late diagnosis rate of 39% and corresponding CF of 14%. The CF increased from 10% to 18% during 2011-2015, then plateaued, and was larger among GBM (25%) than heterosexual men and women (6% and 7%, respectively). One-year mortality among persons diagnosed late was 329 per 10,000 after reclassification (an increase from 288/10,000). Conclusions The case-surveillance definition of late diagnosis increasingly over-estimates late presentation, the extent of which differs by key populations. Adjustment of late diagnosis is recommended, particularly for frequent testers such as GBM.

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

Cited by 2 publications

References 32 publications

Recent HIV infections: evaluation of a simple identification score for newly diagnosed patients

Recent HIV infections: evaluation of a simple identification score for newly diagnosed patients

Re‐assessing the late HIV diagnosis surveillance definition in the era of increased and frequent testing

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