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The BioPlex™ 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.

The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

The BioPlex 2200 HSV-1 & HSV-2 IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube.

Two different populations of dyed beads are each coated with antigens associated with herpes simplex virus, types 1 and 2. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum. Refer to the BioPlex 2200 System Operation Manual for more information.

The instrument is calibrated using a set of 4 distinct calibrator vials, supplied separately by Bio-Rad Laboratories.

Here's a breakdown of the acceptance criteria and the study details for the BioPlex 2200 HSV-1 and HSV-2 IgG kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents performance metrics. Thus, I've interpreted the "acceptance criteria" as the performance levels demonstrated by the predicate device (implicitly accepted by the FDA) and the "reported device performance" as the BioPlex 2200's performance as measured against a commercially available immunoblot.

Assumed "Acceptance Criteria" (based on predicate performance and FDA clearance of similar devices): High sensitivity and specificity, typically above 90% in relevant populations, to reliably detect and differentiate HSV-1 and HSV-2 IgG antibodies. Precision and reproducibility should also be high (low CV).

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