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HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.

The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.

Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2

Here's a breakdown of the acceptance criteria and study information for the HerpeSelect Express IgG device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance characteristics presented in comparison to the predicate device (HerpeSelect 1 and 2 Immunoblot IgG). The document does not explicitly state a pre-defined numerical "acceptance criteria" for sensitivity and specificity. Instead, it presents the device's performance, indicating that these achieved results were deemed acceptable for market clearance.

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

• Pregnant Women: 401 samples (n=161 from Southeastern US, n=120 from Mid-Atlantic US, n=120 from Mid-Atlantic US). Prospective.
• Sexually Active Adults: 575 samples (n=195 from Southeastern US, n=190 from Rocky Mountain Region US, n=190 from Southeastern US). Prospective.
• Non-Sexually Active Adults (Low Prevalence): 104 samples (n=46 from Southeastern US, n=58 from Pacific Northwest US). Prospective.
• CDC HSV/CMV Panel: 100 samples (65 HSV-2 negative, 35 HSV-2 positive). Provenance is CDC (likely mixed origin, characterized serum panel).

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

The ground truth for the primary studies (Pregnant Women, Sexually Active Adults, Non-Sexually Active Adults) was established by the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG. This is a reference method/predicate device, not a panel of human experts. Therefore, the number and qualifications of experts are not applicable for establishing the ground truth directly for these studies as it refers to a laboratory assay.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was based on a reference laboratory assay (Immunoblot) and not on expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the device against a reference method and not on human reader performance with or without AI assistance. The "Inter-Operator & Inter-Site Reproducibility" section mentions different sites and operators, but this evaluates the device's consistency under various conditions, not the comparative effectiveness of human readers using the device versus not using it.

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

Yes, the studies presented are for the standalone performance of the HerpeSelect Express IgG device. It is a rapid diagnostic test, and its performance (sensitivity and specificity) is reported independently against a reference method.

7. The Type of Ground Truth Used

The primary ground truth used for the sensitivity and specificity analysis was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG, which is a reference laboratory method/predicate device. Additionally, agreement with the HerpeSelect 2 ELISA IgG (another cleared predicate device) was evaluated. For the CDC panel, the ground truth was a characterized serum panel from the CDC.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The HerpeSelect Express IgG is an immunochromatographic test, meaning it's a biochemical assay, not an algorithm that requires a training set in the typical sense of AI/ML. The samples mentioned were for performance evaluation (test sets).

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

Not applicable, as the device is not an AI/ML algorithm requiring a training set with established ground truth in that manner.

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