HSV-1 & HSV-2 IgG

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Overview

Herpes Pathology and
Product Design
BioPlex™2200 HSV-1 & HSV-2 IgG

Herpes Pathology and Product Design

Glycoproteins that exhibit strong immunological responses in patients with herpes infection are targets for diagnostic as well as therapeutic utility. The Herpes Simplex Envelope contains at least 11 glycoproteins that exhibit significant protein and DNA (50%) homology between the two herpes immunological variants, type 1 (HSV-1) and type 2 (HSV-2).

Bio-Rad has taken advantage of some minor antigenic variation in glycoprotein G (also referred as gG) between the two subtypes in order to develop type-specific polypeptide probes for detecting IgG antibodies to HSV-1 and HSV-2. This was achieved by constructing the HSV-1 specific recombinant antigen and HSV-2* specific synthetic peptide conjugated to BSA.

* Bio-Rad BioPlex™ HSV-2 is a patented technology.


Performance Summary
BioPlex™2200 HSV-1 & HSV-2 IgG

Performance Summary

Table 1. Comparison with Immunoblot Method

Population BioPlex 2200 HSV-1 IgG BioPlex 2200 HSV-2 IgG
% Sensitivity % Specificity % Sensitivity % Specificity
Sexually Active
Individuals
(N=575)		 97.6%
(400/410)
CI 95.6% to 98.7%		 94.5%
(155/164)
CI 89.9% to 97.1%		 90.7%
(223/246)
CI 86.4% to 93.7%		 98.8%
(325/329)
CI 96.9% to 99.5%
Epectant
Mothers
(N=399)		 96.3%
(287/298)
CI 93.5% to 97.9%		 99.0%
(100/101)
CI 94.6% to 99.8%		 96.9%
(157/162)
CI 93.0% to 98.7%		 100%
(237/237)
CI 98.4% to 100%
Low Prevalence:
16–19 Years
(N=200)		 93.3%
(97/104)
CI 86.7% to 96.7%		 97.9%
(94/96)
CI 92.7% to 99.4%		 N/A 97.8%
(181/185)
CI 94.6% to 99.2%


Table 2. Comparison with ELISA Method

Population BioPlex 2200 HSV-1 IgG BioPlex 2200 HSV-2 IgG
%
Positive Agreement		 %
Negative Agreement		 %
Positive Agreement		 %
Negative Agreement
Sexually Active
Individuals
(N=575)		 98.5%
(199/202)
CI 95.7% to 99.5%		 86.2%
(75/87)
CI 77.4% to 91.9%		 94.7%
(108/114)
CI 89.0% to 97.6%		 99.4%
(171/172)
CI 96.8% to 99.9%
Epectant
Mothers
(N=399)		 96.9%
(285/294)
CI 94.3% to 98.4%		 97.1%
(102/105)
CI 91.9% to 99.0%		 96.9%
(156/161)
CI 92.9% to 98.7%		 99.6%
(237/238)
CI 97.7% to 99.9%
Low Prevalence:
16–19 Years
(N=200)		 92.3%
(96/104)
CI 85.5% to 96.1%		 96.9%
(93/96)
CI 91.2% to 98.9%		 N/A 97.3%
(182/187)
CI 93.9% to 98.9%
Precision Summary
BioPlex™2200 HSV-1 & HSV-2 IgG

Precision Summary

Intra-assay (Within-Run):
HSV-1 CV Range: 2.7%–5.8%
HSV-2 CV Range: 3.0%–5.8%

Intra-assay (Between-Run):
HSV-1 CV Range: 0.0%–5.5%
HSV-2 CV Range: 0.0%–3.6%


Note: “Between-Run” CVs are typically lower as %CV is based upon the mean across sites as opposed to single data points.


Total Precision
HSV-1 CV Range: 4.7%–7.6%
HSV-2 CV Range: 4.8%–6.8%


HSV-1 and HSV-2 IgG Precision Conclusion

The total precision near the cut-off levels for HSV-1 and HSV-2 demonstrated %CV ranges of approximately 5.2% and 4.9–6.5% respectively. Compared to competitive products that have average CVs between 10% and 11%, the BioPlex™ 2200 HSV-1 and HSV-2 assays exhibit superior performance in total precision.

The BioPlex™ 2200 HSV-1 & HSV-2 kit simultaneously detects and differentiates the two most clinically relevant IgG antibodies to Herpes Simplex Virus types 1 and 2 in serum and plasma.

BioPlex 2200 HSV-1 & HSV-2 IgG Reagent Pack
BioPlex 2200 HSV-1 & HSV-2 IgG Reagent Pack

665-3350
Reagents for 100 tests for clinically relevant IgG antibodies to HSV-1 & HSV-2 on BioPlex 2200 System; detects and differentiates Herpes Simplex Virus

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BioPlex 2200 HSV-1 & HSV-2 IgG Calibrator Set
BioPlex 2200 HSV-1 & HSV-2 IgG Calibrator Set

663-3300
Set of multiplexed standard analytes for calibration of results of HSV-1 & HSV-2 screening based on IgG antibodies on BioPlex 2200 System

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BioPlex 2200 HSV-1 & HSV-2 IgG Control Set
BioPlex 2200 HSV-1 & HSV-2 IgG Control Set

663-3330
Set of multiplexed negative and multianalyte positive controls for HSV-1 & HSV-2 screening based on IgG antibodies on BioPlex 2200 System

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Number Description Options
T-163 BioPlex 2200 HSV-1 & HSV-2 IgG Product Sheet Click to download [ Add to Cart ]
T-164 BioPlex 2200 HSV-1 & HSV-2 IgG Brochure Click to download [ Add to Cart ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart ]
T-167 BioPlex 2200 Infectious Disease Panels Brochure Click to download [ Add to Cart ]