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The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD), For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection.

The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method.

The Premier™ Type Specific HSV-2 IgG ELISA Test is comprised of the following items:

1. Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-2 glycoprotein G (gG-2).
2. IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide.
3. Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
4. Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide.
5. p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP).
6. Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH).
7. Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide.
8. Reference Serum: One vial containing 400 ul of serum (human) with sodium azide.
9. 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
10. ELISA Plate Sealer: One acetate sheet with contact adhesive.
11. Resealable Storage Bag: One plastic sealable bag.
12. ELISA Worksheet: One worksheet for recording data.

When the Premier™ Type Specific HSV-2 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 2 glycoprotein (gG2) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 2 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 the herpes simplex virus type 2 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of X% and specificity of Y%"). Instead, it presents performance metrics from various studies and implies that these "acceptable agreement" and "relative sensitivity and relative specificity" values demonstrate substantial equivalence to a predicate device, particularly noting "improved specificity" over the predicate.

Given the lack of explicit acceptance criteria, the table below reports the performance metrics achieved in the primary clinical studies.

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

• Study 1 (STD Clinics):
  • Sample Size: 756 serum samples.
  • Data Provenance: Prospectively collected from unduplicated individuals attending two STD Clinics in the Pacific Northwest Region of the US.
• Study 2 (Clinical Laboratory):
  • Sample Size: 193 patients (sequential sera), with 179 included in calculations after exclusions.
  • Data Provenance: Frozen samples from patients submitted to a clinical laboratory in the Pacific Northwest Region of the US.
• Study 3 (CDC Panel):
  • Sample Size: 100 clinical specimens (50 paired sera).
  • Data Provenance: Serum panel obtained from the Centers for Disease Control (CDC).
• Study 4 (Culture Documented HSV-2 Infection):
  • Sample Size: 335 archived serum samples.
  • Data Provenance: Archived serum samples from patients with culture documented HSV-2 infection (retrospective, pre-selected).
• Study 5 (Low Prevalence Populations for Specificity):
  • Sample Size:
    • 199 pediatric patients (Northeast Region, US).
    • 209 individuals (University Student Health Clinic, Pacific Northwest Region, US).
    • 100 Blood Bank donors (Northeast Region, US).
  • Data Provenance: Prospectively collected (implied by "pediatric patients," "individuals attending," "Blood Bank donors" in specific regions of the US).

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

The ground truth for most studies was established using the Western Blot Method for type specific IgG antibody to HSV-2.

• For Study 1 (STD Clinics), it states, "Western Blot results were based on initial testing with the exception of specimens with initial atypical results which were reanalyzed."
• For Study 2 (Clinical Laboratory), it states, "Tested for IgG antibodies to HSV-2 using... a Western Blot Method."
• For Study 3 (CDC Panel), the specimens were "characterized previously by CDC EIA and Western Blot testing."
• For Study 5 (Low Prevalence Populations), the ground truth was also "a Western Blot Method for type specific IgG antibody to HSV-2."

The document does not specify the number of experts or their qualifications who interpreted these Western Blot results. However, Western Blot is typically considered a highly reliable, gold-standard method for HSV-2 serology.

For Study 4 (Culture Documented HSV-2 Infection), the ground truth was prior culture documentation of HSV-2 infection. This does not require expert interpretation of a secondary diagnostic test.

4. Adjudication Method for the Test Set

The document details the following adjudication methods:

• Study 1 (STD Clinics) and Study 5 (Low Prevalence Populations):
  • Western Blot: Initial atypical results were reanalyzed. Patients not returning for repeat testing were presumed negative.
  • Premier™ Type Specific HSV-2 IgG ELISA Test: Specimens initially reported as equivocal were retested, and the second test result was used.
• Study 2 (Clinical Laboratory): "There were ten specimens which demonstrated either equivocal ELISA results or atypical Western Blot results and four specimens that could not be typed by Western Blot which were not included in the above calculations." This implies exclusion rather than a specific re-adjudication protocol for these excluded cases.
• Study 4 (Culture Documented HSV-2 Infection): "Based on repeat testing of equivocal samples."

No explicit "2+1" or "3+1" expert adjudication scheme is mentioned, but rather a protocol for handling equivocal or atypical results with repeat testing or re-analysis.

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

This is an in vitro diagnostic (IVD) device, specifically an ELISA test, which is read by an automated ELISA plate reader to produce a color endpoint reaction that is then quantitatively measured. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or AI assistance in the way typically discussed in MRMC studies. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable and not performed.

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

Yes, the studies presented are standalone performance studies for the Premier™ Type Specific HSV-2 IgG ELISA Test. The device provides a quantitative result (color endpoint) which is then interpreted qualitatively (positive/negative/equivocal) based on pre-defined cut-offs without human interpretive "readings" in the sense of image analysis. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (the ELISA test's) ability to correctly classify samples against the ground truth.

7. The Type of Ground Truth Used

The primary type of ground truth used across most studies was:

• Expertly Interpreted Gold Standard Test: The Western Blot Method for type specific IgG antibody to HSV-2. This is considered the reference standard for HSV type-specific serology.
• Outcomes Data/Validated Diagnosis: For one study (Study 4), culture documented HSV-2 infection was used as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the Premier™ Type Specific HSV-2 IgG ELISA Test. The studies described are performance evaluations of the completed device. For IVDs like ELISA tests, the "training" analogous to machine learning often involves optimizing reagent concentrations, incubation times, and optical density cut-offs during product development, typically using characterized clinical samples (development panels), but this is not typically referred to as a "training set" in the same way as for AI/ML models. No sample size for such a set is provided.

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

Since no explicit training set is mentioned, this information is not provided. If the question implies how the inherent parameters (like cut-offs) of the ELISA test were established during development, it would have been based on characterized samples, likely against a gold standard like Western Blot or culture results, but the document does not detail this process or the ground truth establishment for such a developmental phase.

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