CD4 results with a bias larger than hundred cells per microliter can have a significant impact on the clinical decision during treatment initiation of HIV patients

Géraldine Daneau, Jozefien Buyze, Djibril Wade, Papa Alassane Diaw, Tandakha Ndeye Dieye, S Thai, Eric Florence, Lutgarde Lynen, Luc Kestens

Research output: Contribution to journalA1: Web of Science-article

Abstract

BACKGROUND: CD4 counts are currently used to assess HIV patients for treatment eligibility and to monitor antiretroviral response to treatment. The emerging point-of-care devices could fill an important gap in resource-limited settings. However, the accuracy of CD4-counting instruments is diverse and data on how CD4 measurement errors have an impact on clinical decisions are lacking.

METHODS: Clinicians were queried on the use of CD4 results in their clinical setting. Subsequently, the effect of CD4 measurement errors on treatment initiation was put in a statistical model. Based on clinical CD4 databases from Belgium, Cambodia, and Senegal, the percentage of unchanged clinical decisions was calculated (treatment initiation should start within a 3-month delay [one visit]) for escalating CD4 measurement errors, taking into account the strict or preventive application of CD4 thresholds at 350 or 500 cells/µl used by clinicians.

RESULTS: To ensure that the treatment was initiated appropriately for at least 95% of patients, an error of 5-10 cells/µl was allowed. This is significantly smaller than the bias of ±50 cells/µl most clinicians considered acceptable. For limits of agreement (LOA, 1.96 x error) of 100 cells/µl, corresponding to most CD4 instrument evaluations, the misclassification rate of patients was found to be 3-28% at the threshold of 350 cells/µl (strict or flexible), and 13-20% at 500 cells/µl.

CONCLUSIONS: The maximum allowed CD4 bias on results from new CD4 technologies should not exceed 50 cells/µl (LOA 100 cells/µl) when applied for treatment initiation, to ensure at least 72% of correct clinical decisions. This article is protected by copyright. All rights reserved.

Original languageEnglish
JournalCytometry Part B Clinical Cytometry
Volume92
Issue number6
Pages (from-to)476-484
Number of pages9
ISSN1552-4949
DOIs
Publication statusPublished - 2017

Keywords

  • CD4 count
  • accuracy
  • bias
  • clinical decision
  • ART initiation
  • EXTERNAL QUALITY ASSESSMENT
  • RESOURCE-POOR SETTINGS
  • ANTIRETROVIRAL THERAPY
  • FLOW-CYTOMETRY
  • PIMA CD4
  • LYMPHOCYTE COUNTS
  • INFECTED PATIENTS
  • CARE
  • POINT
  • ENUMERATION

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