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The PREMIER™ TYPE SPECIFIC HSV-1 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 1 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-2 IgG ELISA Test in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection. For example, this test can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-1 infection.

The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV-1 associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method.

The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items:

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

When the Premier™ Type Specific HSV-1 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 1 glycoprotein (gG1) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 1 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 1 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

Here's a breakdown of the acceptance criteria and study information for the Premier™ Type Specific HSV-1 IgG ELISA Test, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the document frames "substantial equivalence" as the primary criterion, supported by acceptable agreement, relative sensitivity, and relative specificity when compared to a Western Blot Method (which is considered the reference standard in these studies) and the predicate device. For the "substantial equivalence performance data," the overall agreement, sensitivity, and specificity are reported.

Note: The document presents results from several studies. The table above focuses on the largest prospective study for the "Reported Device Performance."

Study Information:

2. Sample Size and Data Provenance:

• Initial Clinical Laboratory Study:
  • Sample Size: 193 frozen sequential sera from patients.
  • Data Provenance: Clinical laboratory in the Pacific Northwest Region of the US. Retrospective.
• CDC Serum Panel Study:
  • Sample Size: 100 clinical specimens (50 paired sera).
  • Data Provenance: Centers for Disease Control (CDC) (characterized previously by CDC EIA and Western Blot testing). The origin country is likely the US. Retrospective.
• Archived HSV-1 Culture-Documented Samples:
  • Sample Size: 49 archived serum samples from patients with culture-documented HSV-1 infection.
  • Data Provenance: Not explicitly stated, but implies a retrospective collection from culture-positive patients.
• Prospective STD Clinics Study:
  • Sample Size: 756 serum samples from unduplicated individuals.
  • Data Provenance: Prospectively collected from two STD Clinics in the Pacific Northwest Region of the US. Prospective.
• Low Prevalence Populations Studies:
  • Pediatric Patients: 199 serum samples. Northeast Region of the US.
  • University Student Health Clinic: 209 serum samples. Pacific Northwest Region of the US.
  • Blood Bank Donors: 100 serum samples. Northeast Region of the US.
  • Data Provenance: All three are from the US. Implied retrospective but collected from specific low prevalence populations. (The method for their initial selection is not detailed beyond "low prevalence.")

3. Number of Experts and Qualifications:

• No information provided. The document describes comparisons to "Western Blot Method" and "CDC results" or "CDC EIA and Western Blot testing" as the ground truth, but does not specify the number or qualifications of experts involved in establishing these reference standards.

4. Adjudication Method:

• For the Main Prospective Study (STD Clinics): Western Blot results were based on initial testing. Specimens with initial atypical results were reanalyzed by Western Blot, and these repeat results were used for patients returning for repeat analysis. Patients not returning were presumed negative. Premier™ ELISA equivocal specimens were retested, and the second test result was used. This implies a form of retesting and a decision rule for ambiguous cases.
• For Low Prevalence Studies: Similar adjudication for Western Blot (reanalysis of atypical results) and ELISA (retesting equivocal samples) was applied.
• No explicit "2+1" or "3+1" expert adjudication is mentioned. The Western Blot itself, when performed and interpreted, serves as the comparison method, and its interpretation would encompass an "adjudication" (e.g., whether it's positive, negative, or atypical/equivocal requiring reanalysis).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not done. The studies described compare the device's performance to a laboratory reference method (Western Blot or CDC characterized panels), not directly measuring the improvement of human readers with or without AI assistance. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance:

• Yes, a standalone performance was done. All the reported studies assess the performance of the Premier™ Type Specific HSV-1 IgG ELISA Test as a standalone diagnostic tool, comparing its results (qualitative detection of IgG antibody) directly against the established reference methods (Western Blot or CDC characterized results). There is no "human-in-the-loop" component described for the device's operation.

7. Type of Ground Truth Used:

• Expert Consensus/Reference Method: The primary ground truth for comparison across most key studies is the Western Blot Method for detection of HSV type specific antibody. For the CDC serum panel, the ground truth was "characterized previously by CDC EIA and Western Blot testing." For a smaller study, clinical culture-documented HSV-1 infection was used.

8. Sample Size for the Training Set:

• Not applicable / Not specified. As an ELISA test, this device is a laboratory assay with reagents; it's not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" in the manufacturing process would be related to quality control and standardization of the assay components.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not specified. (See point 8.) The performance characteristics are established via clinical validation studies against recognized reference methods.

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