Comparison of alternative interpretive criteria for the HIV-1 Western blot and results of the Multispot HIV-1/HIV-2 Rapid Test for classifying HIV-1 and HIV-2 infections

Nasrullah, Muazzam; Ethridge, Steven F.; Delaney, Kevin P.; Wesolowski, Laura G.; Granade, Timothy C.; Schwendemann, Joe; Boromisa, Robert D.; Heffelfinger, James D.; Owen, S. Michele; Branson, Bernard M.

doi:10.1016/j.jcv.2011.09.020

Cited by 28 publications

(30 citation statements)

References 17 publications

(20 reference statements)

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“…Further, in our study, the alternative algorithm correctly identified the HIV infection status among all HIV-1 western blotpositives, highlighting its utility in a variety of settings in the USA. In addition, even though HIV-2 is rare in the USA [26], the alternative algorithm identified HIV-2 infections that would otherwise have been misclassified as HIV-1 infections by the HIV-1 western blot, as has been noted in other studies [10,27]. With the availability of supplemental testing technologies that differentiate HIV-1 from HIV-2 and widespread use of the alternative algorithm, it is likely that more HIV-2 infections will be recognized.…”

Section: Number Of Specimensmentioning

confidence: 99%

“…In 2010, an alternative laboratory HIV diagnostic testing algorithm was proposed [6] ( Fig. 1) that is designed to detect early infections, reduce indeterminate results, and identify HIV-2 infections [7][8][9][10]. The alternative diagnostic algorithm involves screening with a sensitive fourth-generation antigen/ antibody HIV-1/2 immunoassay, or if unavailable, a third-generation HIV-1/2 immunoassay.…”

Section: Introductionmentioning

confidence: 99%

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Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm

Nasrullah

Wesolowski

Meyer

et al. 2013

Aids

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Section: Number Of Specimensmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm

Nasrullah

Wesolowski

Meyer

et al. 2013

Aids

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“…Numerous studies document that high levels of HIV-1 RNA are present in persons with acute HIV infections that are detected by sensitive immunoassays but negative or indeterminate by Western blot [43•, 44-49]. Because of cross-reactivity, the HIV-1 Western blot was interpreted as positive for HIV-1 in 46 to 85 % of specimens from persons found to be infected with HIV-2, resulting in incorrect or delayed diagnosis [50][51][52]. Although HIV-2 remains uncommon in the USA, accurate diagnosis of HIV-2 is clinically important because some antiretroviral agents effective against HIV-1 (including non-nucleoside reverse transcriptase inhibitors and some protease inhibitors) are not effective against HIV-2 [53,54].…”

Section: Clinical and Public Health Implicationsmentioning

confidence: 99%

“…New developments also occur faster than evidence-based recommendations can be written. Ample evidence demonstrated that the FDA-approved Multispot HIV-1/HIV-2 differentiation assay provided results superior to those of the HIV-1 Western blot when used as a supplemental test [45,52,[79][80][81][82][83]. However, because it was approved only for HIV antibody screening, it could not be recommended as a supplemental test in diagnostic algorithms until the manufacturer obtained FDA approval for this intended use [84].…”

Section: The Three-legged Racementioning

confidence: 99%

HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

Branson¹

2015

Curr HIV/AIDS Rep

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Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.

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“…Currently available HIV-1/2 diagnostic 3rd-generation enzyme immunoassays (EIAs) or 4th-generation EIAs and chemiluminescence microparticle immunoassays (CMIAs) do not distinguish between HIV-1 and HIV-2 antibodies and the confirmatory HIV-1 Western Blot (WB) assay may misclassify HIV-2 infection as HIV-1 due to antibody cross-reactivity [7]. Thus, an efficient and rapid supplemental orthogonal serologic method is required to differentiate HIV-2 from HIV-1 infection [8].…”

Section: Introductionmentioning

confidence: 99%

Clinical performance of the Multispot HIV-1/HIV-2 rapid test to correctly differentiate HIV-2 from HIV-1 infection in screening algorithms using third and fourth generation assays and to identify cross reactivity with the HIV-1 Western Blot

Ramos

Harb

Dragavon

et al. 2013

Journal of Clinical Virology

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Background An accurate and rapid serologic method to differentiate HIV-2 from HIV-1 infection is required since the confirmatory HIV-1 Western Blot (WB) may demonstrate cross-reactivity with HIV-2 antibodies. Objectives To evaluate the performance of the Bio-Rad Multispot HIV-1/HIV-2 rapid assay as a supplemental test to correctly identify HIV-2 infection and identify HIV-1 WB cross-reactivity with HIV-2 in clinical samples tested at an academic medical center. Study design Between August 2008 and July 2012, clinical samples were screened for HIV using either 3rd-or 4th-generation HIV-1/2 antibody or combination antibody and HIV-1 p24 antigen assays, respectively. All repeatedly reactive samples were reflexed for Multispot rapid testing. Multispot HIV-2 and HIV-1 and HIV-2-reactive samples were further tested using an HIV-2 immunoblot assay and HIV-1 or HIV-2 RNA assays when possible. The HIV-1 WB was performed routinely for additional confirmation and to assess for HIV-2 antibody cross-reactivity. Results Of 46,061 samples screened, 890 (89.6%) of 993 repeatedly reactive samples were also Multispot-reactive: 882 for HIV-1; three for only HIV-2; and five for both HIV-1 and HIV-2. All three HIV-2-only Multispot-positives along with a single dually reactive HIV-1/2 Multispot-positive were also HIV-2 immunoblot-positive; the latter was HIV-1 RNA negative and HIV-2 RNA positive. Conclusions The Multispot rapid test performed well as a supplemental test for HIV-1/2 diagnostic testing. Four new HIV-2 infections (0.45%) were identified from among 890 Multispot-reactive tests. The use of HIV-1 WB alone to confirm HIV-1/2 screening assays may underestimate the true prevalence of HIV-2 infection in the United States.

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Comparison of alternative interpretive criteria for the HIV-1 Western blot and results of the Multispot HIV-1/HIV-2 Rapid Test for classifying HIV-1 and HIV-2 infections

Cited by 28 publications

References 17 publications

Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm

Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm

HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

Clinical performance of the Multispot HIV-1/HIV-2 rapid test to correctly differentiate HIV-2 from HIV-1 infection in screening algorithms using third and fourth generation assays and to identify cross reactivity with the HIV-1 Western Blot

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