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J Clin Virol. 2017 Jun;91:79-83. doi: 10.1016/j.jcv.2017.04.005. Epub 2017 Apr 6.

Comparative performance of the Geenius™ HIV-1/HIV-2 supplemental test in Florida's public health testing population.

Author information

1
Florida Bureau of Public Health Laboratories, Florida Department of Health, Jacksonville, FL, USA.
2
Florida Bureau of Public Health Laboratories, Florida Department of Health, Jacksonville, FL, USA. Electronic address: berry_bennett@doh.state.fl.us.

Abstract

BACKGROUND:

The Centers for Disease Control and Prevention (CDC) published updated guidelines in 2014 for the laboratory diagnosis of HIV in the United States, which recommend use of a supplemental immunoassay (IA) that differentiates HIV-1 from HIV-2 after a repeatedly reactive HIV-1/2 antigen/antibody "Combo" screening test. In October 2014, Bio-Rad Laboratories introduced the FDA-cleared Geenius HIV-1/HIV-2 Supplemental assay and in July 2016, it replaced the Multispot HIV-1/HIV-2 differentiation rapid test as the second test in the HIV diagnostic algorithm.

OBJECTIVE:

To compare performance of the new FDA-cleared Bio-Rad Geenius HIV-1/HIV-2 Supplemental assay and the Bio-Rad Multispot HIV-1/HIV-2 differentiation assay for use as the primary supplemental test in the 2014 CDC/APHL HIV Diagnostic Algorithm.

STUDY DESIGN:

Two sets of specimens were used to assess the performance of Geenius; 340 select retrospective specimens, obtained through routine clinical submissions from individuals seeking HIV serostatus determinations and 10 known HIV-2 antibody reactive specimens provided by Bio-Rad Laboratories. Panels were created and characterized solely by in-house laboratory results. The panels consisted of: algorithm-defined "established HIV-1 infections" (n=250), "acute HIV-1 infections" (n=20), "early HIV-1 infections" (n=10) and "false positive Combo specimens" (n=60).

RESULTS:

CONCLUSIONS: The Geenius assay provides significant advantages over Multispot as an appropriate replacement for the primary supplemental test in the HIV Diagnostic Algorithm. In this retrospective study, Geenius was highly concordant with Multispot, reclassified some acute and early algorithm-defined HIV-1 positive specimens and demonstrated a potential decrease in the number HIV-1 RNA nucleic acid amplification tests needed to complete the diagnostic algorithm.

KEYWORDS:

Algorithm; Geenius; HIV; Performance; Supplemental

PMID:
28434810
DOI:
10.1016/j.jcv.2017.04.005
[Indexed for MEDLINE]

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