Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2021
2021
Historique:
received:
05
11
2020
accepted:
02
06
2021
entrez:
1
7
2021
pubmed:
2
7
2021
medline:
3
11
2021
Statut:
epublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 34197451
doi: 10.1371/journal.pone.0242641
pii: PONE-D-20-34878
pmc: PMC8248699
doi:
Substances chimiques
HIV Antibodies
0
HIV Antigens
0
Reagent Kits, Diagnostic
0
Types de publication
Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0242641Subventions
Organisme : CDC HHS
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI103397
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI031834
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI035004
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI034989
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI034994
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI103401
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL146202
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI103408
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI103390
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI034993
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD032632
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI042590
Pays : United States
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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