The Multispot rapid HIV-1/HIV-2 differentiation assay is comparable with the Western blot and an immunofluorescence assay at confirming HIV infection in a prospective study in three regions of the United States

Pandori, Mark; Westheimer, Emily; Moss, Nicholas J.; Fu, Jie; Hightow-Weidman, Lisa; Craw, Jason; Hall, Laura; Giancotti, Francesca R.; Mak, Mae Ling; Madayag, Carmela; Tsoi, Benjamin; Louie, Brian; Patel, Pragna; Owen, S. Michele; Peters, Philip J.

doi:10.1016/j.jcv.2013.10.006

Cited by 28 publications

(11 citation statements)

References 11 publications

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“…who reported the difficulty to confirm the dual infection with HIV-1 and HIV-2 in a population of pregnant women in Abidjan [7]. Currently, HIV screening strategies in France [28] and in the United States [29, 30] are based on algorithms using a fourth generation assay which accurately detects early HIV infection but is unable to differentiate between HIV-1 and HIV-2. A Western Blot or a Multispot rapid HIV-1/HIV-2 differentiation assay is then used for the differentiation and in case of discordance a supplemental nucleic acid test (HIV-1 RNA) is performed [31].…”

Section: Discussionmentioning

confidence: 99%

Re‐testing and misclassification of HIV‐2 and HIV‐1&2 dually reactive patients among the HIV‐2 cohort of The West African Database to evaluate AIDS collaboration

Tchounga¹,

Inwoley²,

Coffie³

et al. 2014

Journal of the International AIDS Society

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IntroductionWest Africa is characterized by the circulation of HIV-1 and HIV-2. The laboratory diagnosis of these two infections as well as the choice of a first-line antiretroviral therapy (ART) is challenging, considering the limited access to second-line regimens. This study aimed at confirming the classification of HIV-2 and HIV-1&2 dually reactive patients followed up in the HIV-2 cohort of the West African Database to evaluate AIDS collaboration.MethodA cross-sectional survey was conducted from March to December 2012 in Burkina Faso, Côte d’Ivoire and Mali among patients classified as HIV-2 or HIV-1&2 dually reactive according to the national HIV testing algorithms. A 5-ml blood sample was collected from each patient and tested in a single reference laboratory in Côte d’Ivoire (CeDReS, Abidjan) with two immuno-enzymatic tests: ImmunoCombII® (HIV-1&2 ImmunoComb BiSpot – Alere) and an in-house ELISA test, approved by the French National AIDS and hepatitis Research Agency (ANRS).ResultsA total of 547 patients were included; 57% of them were initially classified as HIV-2 and 43% as HIV-1&2 dually reactive. Half of the patients had CD4≥500 cells/mm3 and 68.6% were on ART. Of the 312 patients initially classified as HIV-2, 267 (85.7%) were confirmed as HIV-2 with ImmunoCombII® and in-house ELISA while 16 (5.1%) and 9 (2.9%) were reclassified as HIV-1 and HIV-1&2, respectively (Kappa=0.69; p<0.001). Among the 235 patients initially classified as HIV-1&2 dually reactive, only 54 (23.0%) were confirmed as dually reactive with ImmunoCombII® and in-house ELISA, while 103 (43.8%) and 33 (14.0%) were reclassified as HIV-1 and HIV-2 mono-infected, respectively (kappa= 0.70; p<0.001). Overall, 300 samples (54.8%) were concordantly classified as HIV-2, 63 (11.5%) as HIV-1&2 dually reactive and 119 (21.8%) as HIV-1 (kappa=0.79; p<0.001). The two tests gave discordant results for 65 samples (11.9%).ConclusionsPatients with HIV-2 mono-infection are correctly discriminated by the national algorithms used in West African countries. HIV-1&2 dually reactive patients should be systematically investigated, with a standardized algorithm using more accurate tests, before initiating ART as at least 4 out of 10 of them could initiate an effective first-line ART for HIV-1 and optimize their second-line treatment options.

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Section: Discussionmentioning

confidence: 99%

Re‐testing and misclassification of HIV‐2 and HIV‐1&2 dually reactive patients among the HIV‐2 cohort of The West African Database to evaluate AIDS collaboration

Tchounga¹,

Inwoley²,

Coffie³

et al. 2014

Journal of the International AIDS Society

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“…This multispot assay detects and differentiates HIV-1 and HIV-2 antibodies in serum and plasma and was reported to confirm HIV infections at a proportion similar to that of the Western blot assay (9,10). The Bio-Rad Geenius HIV 1/2 confirmatory assay is a newer test which can also be used for the confirmation and differentiation of HIV-1 and HIV-2 infection.…”

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confidence: 99%

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as an Alternative to the INNO-LIA HIV 1/2 Assay for Confirmation of HIV Infection

et al. 2014

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The Bio-Rad Geenius HIV 1/2 assay was evaluated as an alternative to the INNO-LIA HIV 1/2 assay for the confirmation of HIV infection in 198 serum samples reactive to 4th-generation HIV enzyme immunoassays (EIAs). The Geenius assay correctly identified 85% of the samples, compared to 75% identified by the INNO-LIA assay, reduced the number of indeterminate results, and shortened the overall turnaround time.

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“…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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The Multispot rapid HIV-1/HIV-2 differentiation assay is comparable with the Western blot and an immunofluorescence assay at confirming HIV infection in a prospective study in three regions of the United States

Cited by 28 publications

References 11 publications

Re‐testing and misclassification of HIV‐2 and HIV‐1&2 dually reactive patients among the HIV‐2 cohort of The West African Database to evaluate AIDS collaboration

Re‐testing and misclassification of HIV‐2 and HIV‐1&2 dually reactive patients among the HIV‐2 cohort of The West African Database to evaluate AIDS collaboration

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as an Alternative to the INNO-LIA HIV 1/2 Assay for Confirmation of HIV Infection

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

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