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The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.

The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The HSV 1+2 IgG ELISA Test is comprised of the following items: Antigen-Coated ELISA Plate, IgG Specimen Diluent, Conjugate, Substrate Buffer, p-NPP Tablets, Stopping Reagent, Positive Control and Negative Control, Reference Serum, 20X Wash Solution, ELISA Plate Sealer, Resealable Storage Bag, and ELISA Worksheet. When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" rather than explicit, pre-defined numerical acceptance criteria for absolute performance. The implied acceptance criteria are a high level of agreement, sensitivity, and specificity when compared to a legally marketed predicate device (HERPELISA II Test Kit) and a characterized serum panel from the CDC.

2. Sample Size Used for the Test Set and Data Provenance

• Comparative Study (vs. Predicate Device):

  • Sample Size: 154 donors
  • Data Provenance: The study was conducted at Gull Laboratories, Inc. The country of origin for the samples is not explicitly stated but is implied to be within the US, given the company's location. The study is prospective in the sense that the new device was evaluated against existing samples, but the samples themselves could be either prospectively collected for this study or retrospectively gathered from a bank. The text "Blood samples from 154 donors were evaluated" suggests a specific collection for this comparison.

• CDC Serum Panel Study:

  • Sample Size: 100 frozen clinical specimens (50 paired sera)
  • Data Provenance: The serum panel was obtained from the Centers for Disease Control (CDC). These were "characterized" specimens, indicating their properties were already known. The testing was conducted at three sites in the U.S.: a hospital in the Northeastern region, a clinical laboratory in the Northwestern region, and Gull Laboratories, Inc. This is a retrospective evaluation using a pre-characterized panel. The country of origin for the data is the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Comparative Study (vs. Predicate Device):

  • The ground truth was established by the HERPELISA II Test Kit, which is a legally marketed predicate device. This isn't based on human expert consensus for this specific study, but rather on the established performance of the predicate device.

• CDC Serum Panel Study:

  • The serum panel was "characterized at the CDC using both an enzyme immunoassay (EIA) and an in-house Western Blot method for HSV type specific antibody detection." While not explicitly stated as "experts," the CDC's characterization methods imply the involvement of highly qualified personnel with expertise in virology and serological testing. The number of individuals involved in the CDC's ground truth establishment is not specified.

4. Adjudication Method for the Test Set

• Comparative Study (vs. Predicate Device): Not applicable. The comparison was directly between the new device and the predicate device. Equivocal results were excluded from calculations, implying a binary (positive/negative) comparison.

• CDC Serum Panel Study:

  • The "ground truth" was already established by the CDC using EIA and Western Blot. The results from the three testing sites were then compared to this pre-established truth.
  • For the device's own internal consistency: "All three sites produced the same qualitative results for all but one sample which gave negative results at the hospital... and the clinical laboratory... but equivocal results at Gull Laboratories, Inc." This indicates a comparison across sites, but no formal adjudication process to resolve discrepancies other than noting the difference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an in vitro diagnostic (IVD) ELISA test, which is an automated or semi-automated laboratory assay, not an imaging device or AI algorithm requiring human reader interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the performance studies described are essentially standalone evaluations of the device (the HSV 1+2 IgG ELISA Test). While human technicians perform the assay, the "performance" metrics (agreement, sensitivity, specificity) reflect the device's ability to correctly classify samples based on its biochemical reactions, independent of human interpretive influence on the result itself (beyond correct assay execution).

7. The Type of Ground Truth Used

• Comparative Study (vs. Predicate Device): The ground truth was the results from a legally marketed predicate device (HERPELISA II Test Kit). This is a form of "reference standard" from another diagnostic test.
• CDC Serum Panel Study: The ground truth was established by expert-characterized reference methods (EIA and in-house Western Blot) from the CDC. This leans towards a form of "expert consensus/reference method" ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a characteristic of traditional IVD devices like ELISAs, which are developed based on biochemical principles and validation rather than machine learning algorithms that require explicit training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this type of device.

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