Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

Curtis, Kelly A.; Hanson, Debra L.; Price, Krystin Ambrose; Owen, S. Michele

doi:10.1371/journal.pone.0176593

“…Recently, Suligoi et al performed an avidity modification with the ARCHITECT and demonstrated that an avidity index, which is a measure of the binding strength between antibody and antigen, is an accurate marker for discriminating recent from long-term infection [28]. In this study, we showed that the ARCHITECT S/Co values, alone, from longitudinal seroconversion panels exhibited a biomarker maturation curve (Fig 2A) similar to other well-performing or promising incidence assays [23,29], which is suggestive of an assay's ability to effectively distinguish recent from long-term infection. Similarly, Grebe et al demonstrated comparable performance between the ARCHITECT S/Co using an unmodified protocol and HIV-1 LAg-Avidity EIA [12].…”

Section: Discussionsupporting

confidence: 74%

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

Curtis

¹

,

Rudolph²,

Pan³

et al. 2020

Preprint

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BackgroundGiven 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.MethodsIn 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.ResultsThe 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.ConclusionDual-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.

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“…Recently, Suligoi et al performed an avidity modification with the ARCHITECT and demonstrated that an avidity index, which is a measure of the binding strength between antibody and antigen, is an accurate marker for discriminating recent from long-term infection [28]. In this study, we showed that the ARCHITECT S/Co values, alone, from longitudinal seroconversion panels exhibited a biomarker maturation curve (Fig 2A) similar to other well-performing or promising incidence assays [23,29], which is suggestive of an assay's ability to effectively distinguish recent from long-term infection. Similarly, Grebe et al demonstrated comparable performance between the ARCHITECT S/Co using an unmodified protocol and HIV-1 LAg-Avidity EIA [12].…”

Section: Plos Onesupporting

confidence: 74%

“…The controls were obtained from a proficiency testing panel derived from HIV-1-seropositive serum [22]. The high and low positive controls are consistent with long-term and recent infection, respectively, as measured by a previously characterized HIV incidence assay [23].…”

Section: Architect Hiv Ag/ab Combo Assaymentioning

confidence: 99%

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Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection

Curtis

¹

,

Rudolph

²

,

Pan

³

et al. 2021

Self Cite

View full text Add to dashboard Cite

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.

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Single-Tube Multimarker Assay for Estimating the Risk to Develop Preeclampsia

Ratnik

¹

,

Rull

²

,

Hanson

³

et al. 2020

The Journal of Applied Laboratory Medicine

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Background Preeclampsia (PE) affects 2%–8% of all pregnancies worldwide. The predictive value of the currently used maternal serum fms-like tyrosine kinase-1/ placental growth factor (sFlt-1/PlGF) test is < 40% for PE onset within 4 weeks. We aimed to develop an innovative multiplex assay to improve PE prediction. Methods The 6PLEX assay combining the measurements of ADAM12, sENG, leptin, PlGF, sFlt-1, and PTX3 was developed for the Luminex® xMAP platform. Assay performance was evaluated using 61 serum samples drawn from 53 pregnant women between 180 and 275 gestational days: diagnosed PE cases, n = 4; cases with PE onset within 4–62 days after sampling, n = 25; controls, n = 32. The B·R·A·H·M·S Kryptor sFlt-1/PlGF test (Thermo Fisher Scientific, Hennigsdorf, Germany) was applied as an external reference. Alternative PE prediction formulae combining 6PLEX measurements with clinical parameters were developed. Results There was a high correlation in sFlt-1/PlGF estimated for individual sera between the 6PLEX and B·R·A·H·M·S Kryptor immunoassays (Spearman’s r = 0.93, P < 0.0001). The predictive power of the 6PLEX combined with gestational age and maternal weight at sampling reached AUC 0.99 (95% CI 0.97–1.00) with sensitivity 100.0% and specificity 96.9%. In all models, sFlt-1/PlGF derived from the B·R·A·H·M·S immunoassays exhibited the lowest AUC value (<0.87) and sensitivity (<80%) with broad confidence intervals (13%–92%). The estimated prognostic yield of the 6PLEX compared to the B·R·A·H·M·S assay was significantly higher (96.5% vs 73.7%; P = 0.0005). Conclusions The developed single-tube multimarker assay for PE risk estimation in combination with clinical symptoms reached high prognostic yield (96.5%) and exhibited superior performance compared to the sFlt-1/PlGF test.

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Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

Cited by 5 publications

References 41 publications

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

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

Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection

Single-Tube Multimarker Assay for Estimating the Risk to Develop Preeclampsia

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