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<p>We evaluated the diagnostic performance and practicability of the VISITECT<sup>®</sup> CD4 Lateral Flow Assay for identifying advanced HIV disease (AHD) across 13 facilities in Nigeria. In two phases, 468 participants were tested with VISITECT<sup>®</sup> CD4 and Partec<sup>®</sup> CyFlow. VISITECT<sup>®</sup> CD4 achieved a sensitivity of 100.0% and specificity of 89.8% for detecting CD4 ≤ 200&#xa0;cells/mm<sup>3</sup>. The positive predictive value (PPV) was 91.3% (95% CI: 87.4–94.1), and the negative predictive value (NPV) was 100% (95% Cl: 98.1–100.0). Overall diagnostic accuracy was 95.1% (95% CI: 92.8–96.8). These findings support the use of VISITECT<sup>®</sup> CD4 as a complementary point-of-care tool to strengthen timely identification of advanced HIV disease within decentralized health systems. While not a substitute for flow cytometry, its high sensitivity and operational feasibility make it well suited for triage and early clinical decision-making in resource-limited settings.</p>

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Diagnostic accuracy and practicability of the VISITECT® advanced HIV disease CD4 test compared to the Partec® CyFlow Counter II for CD4 enumeration in Nigeria’s HIV program

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月28日

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  • Justin Onyebuchi Nwofe,
  • Daniel Chinenyeike Offie,
  • Izuchukwu Ibeagha,
  • Christian Okechukwu Ugwu,
  • Emmanuel Adewale Ojo,
  • David Segun Adeniyi,
  • Daniel Oguh,
  • Adeola Awolola,
  • Olabamji Samuel Osho,
  • Patrick Chike Okonkwo,
  • Adebola Mary Onyenike,
  • Isaac Onyebuchi Okohu,
  • Oyewale Oguntade,
  • Laura Madukaji,
  • Olatunde James Kehinde,
  • Anthony Ani,
  • Ada Immaculata Chinweuba,
  • Josephine Okemutie Omo-Emmanuel,
  • Daniel Ogbuagu,
  • Femi Emmanuel Owolagba,
  • Eke Ofuche

摘要

We evaluated the diagnostic performance and practicability of the VISITECT® CD4 Lateral Flow Assay for identifying advanced HIV disease (AHD) across 13 facilities in Nigeria. In two phases, 468 participants were tested with VISITECT® CD4 and Partec® CyFlow. VISITECT® CD4 achieved a sensitivity of 100.0% and specificity of 89.8% for detecting CD4 ≤ 200 cells/mm3. The positive predictive value (PPV) was 91.3% (95% CI: 87.4–94.1), and the negative predictive value (NPV) was 100% (95% Cl: 98.1–100.0). Overall diagnostic accuracy was 95.1% (95% CI: 92.8–96.8). These findings support the use of VISITECT® CD4 as a complementary point-of-care tool to strengthen timely identification of advanced HIV disease within decentralized health systems. While not a substitute for flow cytometry, its high sensitivity and operational feasibility make it well suited for triage and early clinical decision-making in resource-limited settings.