Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.
Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.We compared DHC performance (overall, by test com...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2014-01-01
|
| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC3979750?pdf=render |
| _version_ | 1811266499717890048 |
|---|---|
| author | Damian P Conway Martin Holt Anna McNulty Deborah L Couldwell Don E Smith Stephen C Davies Philip Cunningham Phillip Keen Rebecca Guy Sydney Rapid HIV Test Study |
| author_facet | Damian P Conway Martin Holt Anna McNulty Deborah L Couldwell Don E Smith Stephen C Davies Philip Cunningham Phillip Keen Rebecca Guy Sydney Rapid HIV Test Study |
| author_sort | Damian P Conway |
| collection | DOAJ |
| description | Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months.Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives.The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population. |
| first_indexed | 2024-04-12T20:44:20Z |
| format | Article |
| id | doaj.art-f9f4736740534b8aa7374e50c43a0205 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-12T20:44:20Z |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-f9f4736740534b8aa7374e50c43a02052022-12-22T03:17:20ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0194e9406210.1371/journal.pone.0094062Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.Damian P ConwayMartin HoltAnna McNultyDeborah L CouldwellDon E SmithStephen C DaviesPhilip CunninghamPhillip KeenRebecca GuySydney Rapid HIV Test StudyDetermine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months.Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives.The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.http://europepmc.org/articles/PMC3979750?pdf=render |
| spellingShingle | Damian P Conway Martin Holt Anna McNulty Deborah L Couldwell Don E Smith Stephen C Davies Philip Cunningham Phillip Keen Rebecca Guy Sydney Rapid HIV Test Study Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. PLoS ONE |
| title | Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. |
| title_full | Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. |
| title_fullStr | Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. |
| title_full_unstemmed | Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. |
| title_short | Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. |
| title_sort | multi centre evaluation of the determine hiv combo assay when used for point of care testing in a high risk clinic based population |
| url | http://europepmc.org/articles/PMC3979750?pdf=render |
| work_keys_str_mv | AT damianpconway multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT martinholt multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT annamcnulty multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT deborahlcouldwell multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT donesmith multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT stephencdavies multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT philipcunningham multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT phillipkeen multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT rebeccaguy multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation AT sydneyrapidhivteststudy multicentreevaluationofthedeterminehivcomboassaywhenusedforpointofcaretestinginahighriskclinicbasedpopulation |