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Advancing HIV Diagnostics: Evaluating the Emerging Multisure HIV1/2 Rapid Confirmatory Test as an Alternative to the Traditional Gold Standard Assays
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  • Ahmed Ismail,
  • Israa M. Salameh,
  • Nadin Younes,
  • Parveen B. Nizamuddin,
  • Salma Younes,
  • Sara Abdelmohsen,
  • Mazen N. Abouassali,
  • Manal Elshaikh,
  • Ibrahim W. Karimeh,
  • Mohammed A. Ibrahim,
  • Mutaz M. Ali,
  • Ibrahim Al-Shaar,
  • Haris Ong,
  • Çiğdem S. Zhmurov,
  • HADI YASSINE,
  • Laith Abu-Raddad,
  • Houssein H. Ayoub,
  • Gheyath Nasrallah
Ahmed Ismail
Ministry of Public Health Qatar
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Israa M. Salameh
Qatar University
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Nadin Younes
Qatar University
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Parveen B. Nizamuddin
Qatar University
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Salma Younes
Qatar University
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Sara Abdelmohsen
Qatar University College of Health Sciences
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Mazen N. Abouassali
Ministry of Public Health Qatar
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Manal Elshaikh
Ministry of Public Health Qatar
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Ibrahim W. Karimeh
Ministry of Public Health Qatar
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Mohammed A. Ibrahim
Ministry of Public Health Qatar
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Mutaz M. Ali
Ministry of Public Health Qatar
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Ibrahim Al-Shaar
Ministry of Public Health Qatar
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Haris Ong
MP Biomedicals Asia Pacific Pte Ltd
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Çiğdem S. Zhmurov
TC Uskudar Universitesi
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HADI YASSINE
Qatar University
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Laith Abu-Raddad
Weill Cornell Medicine - Qatar
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Houssein H. Ayoub
Qatar University College of Arts and Sciences
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Gheyath Nasrallah
Qatar University

Corresponding Author:[email protected]

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Abstract

Background: HIV remains a significant global health challenge, demanding routine testing for early detection. CLIA screening assay, particularly Architect HIV, followed by immunoblot confirmation assay such as INNO-LIA™, is the standard procedure. However, due to indeterminate results and limitations of immunoblot assays, the CDC recommended utilizing Geenius HIV1/2 assay for confirmatory testing. This study compares two advanced HIV1/2 rapid tests as efficient alternatives for HIV confirmation. Method: 224 Architect HIV positive and HIV negative samples were utilized. These included true positives ( n=38; Architect positive & INNO-LIA™ positive), true negatives ( n=139; Architect negative & INNO-LIA™ negative), false positives ( n=20; Architect positive & INNO-LIA™ negative) and INNO-LIA™ indeterminate ( n=27). Samples were screened with Architect HIV and confirmed by INNO-LIA™ and PCR. All samples were re-tested by Multisure HIV1/2 and Geenius HIV1/2. Assessment performed via performance evaluation metrics. Results: Both rapid tests showed 100% sensitivity and specificity compared to INNO-LIA™. For IND cases, Multisure HIV1/2 classified 81.5% as negative, while Geenius HIV1/2 classified 55.6%. Multisure had higher specificity (89.2%) and PPV (89.5%) than Geenius (82.9% and 84.6%) when compared to PCR. Conclusion: Multisure HIV1/2 is a reliable potential addition to the CDC algorithm as an alternative to immunoblot assays.
13 Feb 2025Submitted to Journal of Medical Virology
14 Feb 2025Submission Checks Completed
14 Feb 2025Assigned to Editor
14 Feb 2025Review(s) Completed, Editorial Evaluation Pending
20 Feb 2025Reviewer(s) Assigned