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HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections

  • Barbara Suligoi EMAIL logo , Vincenza Regine , Mariangela Raimondo , Anna Rodella , Luigina Terlenghi , Arnaldo Caruso , Patrizia Bagnarelli , Maria Rosaria Capobianchi , Nadia Zanchetta , Valeria Ghisetti and Claudio Galli
Published/Copyright: June 24, 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 12

Abstract

Background:

Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections.

Methods:

We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=<6 months from seroconversion) and established (EI) infections. The diagnostic accuracy was evaluated by receiver operating characteristic (ROC) curve analysis. The proportion of samples misclassified as recent (FRR) was calculated.

Results:

In total, 647 samples were collected: 455 in group A (51.6% RI and 48.4% EI) and 192 in group B. Among these, sixteen samples were from elite controllers, 294 from treated patients, 328 from patients infected with non-B subtypes. Samples before antiretroviral initiation showed a mean AI significantly lower among RI compared to EI (0.66+0.28 vs. 1.00±0.12; p<0.000). The FRR was 0% using a cut-off of ≤0.70. An extremely low FRR was observed among elite controllers, samples with low VL or CD4. HIV subtype had no impact on AI misclassifications. All individuals in group A reached the AI threshold of 0.80 within 24 months after seroconversion.

Conclusions:

The AI is an accurate serological marker for discriminating recent from established HIV infections and meets WHO requirements for HIV incidence assays.

Keywords: avidity; enzyme immunoassay; epidemiology; HIV; incidence; recent infection
Corresponding author: Barbara Suligoi, MD, Department of Infectious Diseases,Istituto Superiore di Sanità, Viale Regina Elena 299 – 00161 Rome, Italy, Phone: +39 0649906123, Fax: +39 0649902755

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: This study was partly funded by the Italian Ministry of Health, Ricerca Corrente.

  3. Employment or leadership: Claudio Galli is currently employed by Abbott Diagnostics as the Associate Medical Director for Europe.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplemental Material:

The online version of this article (https://doi.org/10.1515/cclm-2016-1192) offers supplementary material, available to authorized users.

Received: 2016-12-29
Accepted: 2017-5-5
Published Online: 2017-6-24
Published in Print: 2017-10-26

©2017 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2016-1192
Keywords for this article
avidity; enzyme immunoassay; epidemiology; HIV; incidence; recent infection

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Tumor microenvironment and systemic disease: a dual target in medical oncology (also in the case of biomarkers)
  4. Reviews
  5. Sample types applied for molecular diagnosis of therapeutic management of advanced non-small cell lung cancer in the precision medicine
  6. The impact of pneumatic tube system on routine laboratory parameters: a systematic review and meta-analysis
  7. Opinion Paper
  8. How to reduce scientific irreproducibility: the 5-year reflection
  9. EFLM Paper
  10. Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference
  11. General Clinical Chemistry and Laboratory Medicine
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  13. Separate patient serum sodium medians from males and females provide independent information on analytical bias
  14. Are admission procalcitonin levels universal mortality predictors across different medical emergency patient populations? Results from the multi-national, prospective, observational TRIAGE study
  15. Biochemical testing in a laboratory tent and semi-intensive care of Ebola patients on-site in a remote part of Guinea: a paradigm shift based on a bleach-sensitive point-of-care device
  16. Efficient reporting of the estimated glomerular filtration rate without height in pediatric patients with cancer
  17. Evaluation of thyroid test utilization through analysis of population-level data
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  19. Impact of a single oral dose of 100,000 IU vitamin D3 on profiles of serum 25(OH)D3 and its metabolites 24,25(OH)2D3, 3-epi-25(OH)D3, and 1,25(OH)2D3 in adults with vitamin D insufficiency
  20. Automated antinuclear immunofluorescence antibody analysis is a reliable approach in routine clinical laboratories
  21. Infrared analyzers for breast milk analysis: fat levels can influence the accuracy of protein measurements
  22. Hematology and Coagulation
  23. A new approach to define acceptance limits for hematology in external quality assessment schemes
  24. The effects of transport by car on coagulation tests
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