Advancing HIV Diagnostics: Evaluating the Emerging Multisure HIV1/2
Rapid Confirmatory Test as an Alternative to the Traditional Gold
Standard Assays
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.