Performance of the BioPlex 2200 Multiplexing Immunoassay Platform for the Detection of Herpes Simplex Virus Type 2 Specific Antibodies in African Settings

Goff, Jérôme Le; Grésenguet, Gérard; Gody, Chrysostome; Longo, Jean De Dieu; Khonde, Nzambi; Weiss, Helen A.; Mayaud, Philippe; Bélec, Laurent

doi:10.1128/cvi.05003-11

“…The second panel consisted of 100 serum aliquot specimens from adult individuals (31 males; 69 female, mean age, 30.6 years) attending the Centre National des Maladies Sexuellement Transmissibles et du SIDA of Bangui, CAR, between the year 2000 and year 2011 28–30 . Among those, 54 were HIV‐1‐seropositive, 5 were hepatitis C virus (HCV) antibodies‐positive and 35 were positive for antigen HBs (AgHBs)‐positive; 33 were coinfected by HIV and hepatitis B virus and 3 by HIV and HCV.…”

Section: Methodsmentioning

confidence: 99%

Unexpected high frequency of unspecific reactivities by testing pre‐epidemic blood specimens from Europe and Africa with SARS‐CoV‐2 IgG–IgM antibody rapid tests points to IgM as the Achilles heel

Bouassa

¹

,

Péré

²

,

Tonen‐Wolyec

³

et al. 2020

Journal of Medical Virology

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We aimed to evaluate the rates of false‐positive test results of three rapid diagnostic tests (RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2)‐specific immunoglobulin G (IgG) and IgM detection. Two serum panels from patients hospitalized in Paris, France, and from patients living in Bangui, Central African Republic, acquired before the 2019 COVID‐19 outbreak, were tested by 3 CE IVD‐labeled RDTs for SARS‐CoV‐2 serology (BIOSYNEX® COVID‐19 BSS [IgG/IgM]; SIENNA™ COVID‐19 IgG/IgM Rapid Test Cassette; NG‐Test® IgG–IgM COVID‐19). Detectable IgG or IgM reactivities could be observed in 31 (3.43%) of the 902 IgG and IgM bands of the 3 RDTs used with all pre‐epidemic sera. The frequencies of IgG/IgM reactivities were similar for European (3.20%) and African (3.55%) sera. IgM reactivities were observed in 9 European and 14 African sera, while IgG reactivity was observed in only 1 African serum (15.1% vs. 0.66%). The test NG‐Test® IgG–IgM COVID‐19 showed the highest rates of IgG or IgM reactivities (6.12% [18/294]), while the test BIOSYNEX® COVID‐19 BSS (IgG/IgM) showed the lowest rate (1.36% [4/294]). Some combinations of 2 RDTs in series allowed decreasing significantly the risk of false‐positive test results. Our observations point to the risk of false‐positive reactivities when using currently available RDT for SARS‐CoV‐2 serological screening, especially for the IgM band, even if the test is CE IVD‐labeled and approved by national health authorities, and provide the rational basis for confirmatory testing by another RDT in case of positive initial screening.

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“…17 Similarly, the last large-scale comparisons of the Bio-Rad HSV-1 and HSV-2 IgG assays to other HSV serologic diagnostic methods were published in 2010-11. 18,19 A strength of this study includes comparing automated HSV serology assays using samples not only measured by HSV WB, but also with virologic confirmation of HSV infection. The VRC cohort provides a set of samples with a high degree of confidence in their diagnosis that serve as an excellent cohort for determining the optimal performance characteristics for these assays.…”

Section: Discussionmentioning

confidence: 99%

“…17 Similarly, the last large-scale comparisons of the Bio-Rad HSV-1 and HSV-2 IgG assays to other HSV serologic diagnostic methods were published in 2010-11. 18,19…”

Section: Discussionmentioning

confidence: 99%

Performance characteristics of highly automated HSV-1 and HSV-2 IgG testing

Crawford,

Selke,

Pepper

et al. 2024

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Herpes simplex virus (HSV) infections are one of the most common and stigmatized infections of humankind, affecting more than 4 billion people around the world and more than 100 million Americans. Yet most people do not know their infection status and antibody testing is not recommended, partly due to poor test performance. Here, we compared the test performance of the Roche Elecsys HSV-1 IgG and HSV-2 IgG, DiaSorin LIAISON HSV-1/2 IgG, and Bio-Rad BioPlex 2200 HSV-1 & HSV-2 IgG assays with the gold-standard HSV western blot in 1994 persons, including 1017 persons with PCR or culture-confirmed HSV-1 and/or HSV-2 infection. Across all samples, the Bio-Rad and Roche assays had similar performance metrics with low sensitivity (<85%), but high specificity (>97%) for detecting HSV-1 IgG and both high sensitivity (>97%) and high specificity (>98%) for detecting HSV-2 IgG. The DiaSorin assay had a higher sensitivity (92.1%) but much lower specificity (88.7%) for detecting HSV-1 IgG and comparatively poor sensitivity (94.5%) and specificity (94.2%) for detecting HSV-2 IgG. The DiaSorin assay performed poorly at low-positive index values with 60.9% of DiaSorin HSV-1 results and 20.8% of DiaSorin HSV-2 results with positive index values <3.0 yielding false positive results. Based on an estimated HSV-2 seroprevalence of 12% in the United States, positive predictive values for HSV-2 IgG were 96.1% for Roche, 87.4% for Bio-Rad, and 69.0% for DiaSorin, meaning nearly 1 of every 3 positive DiaSorin HSV-2 IgG results would be falsely positive. Further development in HSV antibody diagnostics is needed to provide appropriate patient care.

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“…To our knowledge, this is the first large-scale comparison of a Roche HSV-1 IgG assay and the first comparison of any Roche HSV-2 IgG assay since 1999 ( 17 ). Similarly, the last large-scale comparisons of the Bio-Rad HSV-1 and HSV-2 IgG assays to other HSV serologic diagnostic methods were published in 2010–2011 ( 18 , 19 ).…”

Section: Discussionmentioning

confidence: 99%

Performance characteristics of highly automated HSV-1 and HSV-2 IgG testing

Crawford,

Selke,

Pepper

et al. 2024

J Clin Microbiol

4

0

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Herpes simplex virus (HSV) infections are one of the most common and stigmatized infections of humankind, affecting more than 4 billion people around the world and more than 100 million Americans. Yet, most people do not know their infection status, and antibody testing is not recommended, partly due to poor test performance. Here, we compared the test performance of the Roche Elecsys HSV-1 IgG and HSV-2 IgG, DiaSorin LIAISON HSV-1/2 IgG, and Bio-Rad BioPlex 2200 HSV-1 and HSV-2 IgG assays with the gold-standard HSV western blot in 1,994 persons, including 1,017 persons with PCR or culture-confirmed HSV-1 and/or HSV-2 infection. Across all samples, the Bio-Rad and Roche assays had similar performance metrics with low sensitivity (<85%) but high specificity (>97%) for detecting HSV-1 IgG and both high sensitivity (>97%) and high specificity (>98%) for detecting HSV-2 IgG. The DiaSorin assay had a higher sensitivity (92.1%) but much lower specificity (88.7%) for detecting HSV-1 IgG and comparatively poor sensitivity (94.5%) and specificity (94.2%) for detecting HSV-2 IgG. The DiaSorin assay performed poorly at low-positive index values with 60.9% of DiaSorin HSV-1 results and 20.8% of DiaSorin HSV-2 results with positive index values <3.0 yielding false positive results. Based on an estimated HSV-2 seroprevalence of 12% in the United States, positive predictive values for HSV-2 IgG were 96.1% for Roche, 87.4% for Bio-Rad, and 69.0% for DiaSorin, meaning nearly one of every three positive DiaSorin HSV-2 IgG results would be falsely positive. Further development in HSV antibody diagnostics is needed to provide appropriate patient care. IMPORTANCE Serological screening for HSV infections is currently not recommended in part due to the poor performance metrics of widely used commercial HSV-1 and HSV-2 IgG assays. Here, we compare three Food and Drug Administration (FDA)-cleared automated HSV-1 and HSV-2 IgG assays to the gold-standard western blot across nearly 2,000 samples. We find that not all commercially available HSV assays are created equal, with comparably low sensitivities for HSV-1 IgG across platforms and high false positivity rates for DiaSorin on HSV-2 IgG. This study is the first large-scale comparison of performance metrics for the Bio-Rad and Roche assays in over 10 years. Our study confirms that there remains room for improvement in HSV serological diagnostic testing—especially in regard to low sensitivities for HSV-1 IgG detection—and highlights that some previously less-studied assays may have better performance metrics than previously considered typical of commercially available HSV-2 IgG assays.

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Performance of the BioPlex 2200 Multiplexing Immunoassay Platform for the Detection of Herpes Simplex Virus Type 2 Specific Antibodies in African Settings

Cited by 7 publications

References 18 publications

Unexpected high frequency of unspecific reactivities by testing pre‐epidemic blood specimens from Europe and Africa with SARS‐CoV‐2 IgG–IgM antibody rapid tests points to IgM as the Achilles heel

Unexpected high frequency of unspecific reactivities by testing pre‐epidemic blood specimens from Europe and Africa with SARS‐CoV‐2 IgG–IgM antibody rapid tests points to IgM as the Achilles heel

Performance characteristics of highly automated HSV-1 and HSV-2 IgG testing

Performance characteristics of highly automated HSV-1 and HSV-2 IgG testing

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