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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 Calibrator Set is intended for the calibration of the BioPlex® 2200 HSV-1 & HSV-2 IgG Reagent Pack.

The BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® HSV-1 & HSV-2 IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set has not been established with any other HSV-1 and HSV-2 antibody assays.

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 (2) 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 reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, antihuman IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37℃. 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 are 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 or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex® 2200 System Operation Manual for more information.

The instrument is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. The four (4) vials representing four (4) different antibody concentrations are used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).

The BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set includes a negative control as well as multi-analyte positive control. The Positive Control is manufactured to give positive results, with values above the cut-off for each specific analyte. The Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte.

This document describes the BioPlex® 2200 HSV-1 & HSV-2 IgG kit for qualitative detection and differentiation of IgG antibodies to HSV-1 and HSV-2. The primary acceptance criteria provided relate to comparative testing against a predicate device and a CDC panel, as well as precision studies and interference testing.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical "acceptance criteria" independently, but rather presents the performance of the modified device in comparison to a predicate device and a CDC panel. The comparisons effectively serve as the standard for acceptance, implying that the modified device should perform comparably or better.

2. Sample size used for the test set and the data provenance

• Comparative Testing (Predicate Device):
  • Test Set Size: 399 samples for HSV-1, 399 samples for HSV-2.
  • Data Provenance: Samples from sexually active individuals where an HSV-1 or HSV-2 test was ordered. The country of origin is not explicitly stated but is implied to be within the jurisdiction of the Bio-Rad Laboratories, Inc. (Benicia, CA). The data is retrospective, as it involves comparison to an already marketed predicate device and characterization of existing samples.
• Comparative Testing (CDC HSV Panel):
  • Test Set Size: 80 samples.
  • Data Provenance: A "well characterized HSV serum panel from the CDC." This suggests existing, well-defined samples. The country of origin is the United States (CDC). This data is retrospective.
• Precision Studies:
  • Test Set Size: 8 panel members for each analyte (HSV-1 and HSV-2), each tested 20 times (2 replicates x 2 runs x 5 days).
  • Data Provenance: Prepared by Bio-Rad Laboratories, tested at Bio-Rad Laboratories. Retrospective/internal data.
• Interference Testing:
  • Test Set Size: Samples prepared by blending negative human serum with positive samples. Evaluated in replicates of ten. Specific number of donor samples not provided, but the interference substances are well-defined.
  • Data Provenance: Internal studies by Bio-Rad Laboratories. Retrospective.
• Matrix Comparison:
  • Test Set Size: >40 matched serum and plasma (EDTA and heparin sodium) samples for each assay (47 for HSV-1, 44 for HSV-2).
  • Data Provenance: Matched serum and plasma drawn from the same donor, acquired from commercial sources. Retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the test sets (comparative testing with predicate and CDC panel) was established through existing reference methods.

• Predicate Device Comparison: The "predicate method" served as the reference standard. The document does not specify the number or qualifications of experts involved in the initial determination by the predicate method.
• CDC HSV Panel: The panel is described as "well characterized," implying its status as a reference standard. The document does not specify the number or qualifications of experts involved in characterizing the CDC panel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe an adjudication method for disagreements. The comparisons rely on agreement with the predicate device results or the CDC panel's established status.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) kit that directly measures antibody levels, not an AI-assisted diagnostic tool that interprets images or other complex data requiring human reader interaction. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance studies presented are for the standalone device (BioPlex® 2200 HSV-1 & HSV-2 IgG kit on the BioPlex® 2200 Multi-Analyte Detection System) without human interpretation as part of the primary diagnostic output. The results (antibody index) are objectively measured by the automated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was based on:

• Reference Method/Predicate Device: For the comparative testing against the predicate device, the results obtained from the legally marketed predicate device served as the reference standard.
• Reference Panel: For the CDC HSV Panel, the "well-characterized" status of the panel served as the established ground truth. This type of panel typically undergoes extensive testing and validation, often using a combination of methods and expert consensus to establish the definitive status of each sample.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is an IVD kit, and studies focus on analytical and clinical performance. The studies performed are validation studies, not training studies for an algorithm.

9. How the ground truth for the training set was established

As there is no "training set" in the context of an AI/ML algorithm for this IVD device, this question is not applicable. The development and validation of the device are based on laboratory testing and comparisons to established reference methods and panels.

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