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Evaluation of the Bio-Rad Geenius HIV 1/2 Confirmation Assay as an Alternative to Western Blot in the Korean Population: A Multi-Center Study.

Moon HW, Huh HJ, Oh GY, Lee SG, Lee A, Yun YM, Hur M - PLoS ONE (2015)

Bottom Line: The Geenius HIV1/2 is simple and time-saving compared with WB.It has an excellent performance and can be a reliable alternative to WB.HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.

View Article: PubMed Central - PubMed

Affiliation: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.

ABSTRACT
Recently updated recommendations for diagnosis of HIV infection suggest a new diagnostic algorithm including HIV-1/HIV-2 antibody differentiation immunoassay instead of western blot (WB) as a confirmatory testing. We evaluated Bio-Rad Geenius HIV1/2 confirmation assay as a simple and reliable alternative to WB in the Korean population with low HIV prevalence. The Geenius HIV1/2 was performed in a total of 192 serum specimens (140 reactive and 52 nonreactive specimens by ARCHITECT HIV Ag/Ab Combo assay) that were prospectively collected from five institutions. HIV-1 nucleic acid amplification test (NAT) was performed in negative or indeterminate specimens by Geenius HIV1/2 or WB. Among 140 reactive specimens by HIV Ag/Ab assay, 82 (58.6%) were positive for HIV-1 Ab by Geenius HIV1/2. Among 58 negative or indeterminate specimens by Geenius HIV1/2, four specimens (6.9%) were positive by HIV-1 NAT. The sensitivity and specificity of Geenius HIV1/2 were 95.3% and 100.0%, respectively. When we considered only WB, the sensitivity and specificity of Geenius HIV1/2 were 100.0% and 99.1%, respectively. Agreement between Geenius HIV1/2 and WB was excellent (weighted Kappa = 0.89). The Geenius HIV1/2 is simple and time-saving compared with WB. It has an excellent performance and can be a reliable alternative to WB. HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.

No MeSH data available.


Related in: MedlinePlus

Distribution of results based on new HIV diagnostic algorithm.*The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required in the new recommendation.
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pone.0139169.g001: Distribution of results based on new HIV diagnostic algorithm.*The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required in the new recommendation.

Mentions: The results of this study based on new recommendations are presented in Fig 1. According to the new recommendations, 140 reactive specimens by HIV Ag/Ab assay were tested by HIV-1/HIV-2 differentiation assay (Geenius HIV-1/2), and 82 (58.6%) were positive for HIV-1 Ab. In the 58 (41.4%) specimens with negative or indeterminate results by HIV-1/HIV-2 differentiation assay, four specimens showed positive results by HIV-1 NAT. The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required for those specimens in new recommendations. Among them, two specimens showed one faint band, and the others showed nonreactive results by HIV-1/HIV-2 differentiation assay.


Evaluation of the Bio-Rad Geenius HIV 1/2 Confirmation Assay as an Alternative to Western Blot in the Korean Population: A Multi-Center Study.

Moon HW, Huh HJ, Oh GY, Lee SG, Lee A, Yun YM, Hur M - PLoS ONE (2015)

Distribution of results based on new HIV diagnostic algorithm.*The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required in the new recommendation.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4589337&req=5

pone.0139169.g001: Distribution of results based on new HIV diagnostic algorithm.*The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required in the new recommendation.
Mentions: The results of this study based on new recommendations are presented in Fig 1. According to the new recommendations, 140 reactive specimens by HIV Ag/Ab assay were tested by HIV-1/HIV-2 differentiation assay (Geenius HIV-1/2), and 82 (58.6%) were positive for HIV-1 Ab. In the 58 (41.4%) specimens with negative or indeterminate results by HIV-1/HIV-2 differentiation assay, four specimens showed positive results by HIV-1 NAT. The 52 specimens with nonreactive HIV Ag/Ab assay were additionally tested with HIV-1/HIV-2 differentiation assay, although no further testing is required for those specimens in new recommendations. Among them, two specimens showed one faint band, and the others showed nonreactive results by HIV-1/HIV-2 differentiation assay.

Bottom Line: The Geenius HIV1/2 is simple and time-saving compared with WB.It has an excellent performance and can be a reliable alternative to WB.HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.

View Article: PubMed Central - PubMed

Affiliation: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.

ABSTRACT
Recently updated recommendations for diagnosis of HIV infection suggest a new diagnostic algorithm including HIV-1/HIV-2 antibody differentiation immunoassay instead of western blot (WB) as a confirmatory testing. We evaluated Bio-Rad Geenius HIV1/2 confirmation assay as a simple and reliable alternative to WB in the Korean population with low HIV prevalence. The Geenius HIV1/2 was performed in a total of 192 serum specimens (140 reactive and 52 nonreactive specimens by ARCHITECT HIV Ag/Ab Combo assay) that were prospectively collected from five institutions. HIV-1 nucleic acid amplification test (NAT) was performed in negative or indeterminate specimens by Geenius HIV1/2 or WB. Among 140 reactive specimens by HIV Ag/Ab assay, 82 (58.6%) were positive for HIV-1 Ab by Geenius HIV1/2. Among 58 negative or indeterminate specimens by Geenius HIV1/2, four specimens (6.9%) were positive by HIV-1 NAT. The sensitivity and specificity of Geenius HIV1/2 were 95.3% and 100.0%, respectively. When we considered only WB, the sensitivity and specificity of Geenius HIV1/2 were 100.0% and 99.1%, respectively. Agreement between Geenius HIV1/2 and WB was excellent (weighted Kappa = 0.89). The Geenius HIV1/2 is simple and time-saving compared with WB. It has an excellent performance and can be a reliable alternative to WB. HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.

No MeSH data available.


Related in: MedlinePlus