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The Epstein-Barr Virus Viral Capsid-p18 Antigen (EBV VCA-p18) IgG ELISA is for the qualitative detection of IgG antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV VCA-p18 IgG ELISA should be used in conjunction with other EBV serologies.

The EBV VCA-p18 IgG ELISA is an Enzyme Linked Immunosorbent Assay for the qualitative detection of IgG antibodies in human serum to EBV VCA antigen.

Here's a summary of the acceptance criteria and the study details for the PANBIO EBV VCA-p18 IgG ELISA, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it presents the performance characteristics as a comparison to an equivalent device (DiaSorin EBV VCA IgG ELISA) and established EBV serological status. The study aims to demonstrate that the device performs comparably and effectively identifies different EBV infection states.

However, based on the results and the context of a 510(k) submission, we can infer that the observed performance values for sensitivity, specificity, and agreement, particularly in relation to the predicate device and the known EBV status, were considered acceptable by the manufacturer for regulatory clearance.

Table of Reported Device Performance for PANBIO EBV VCA-p18 IgG ELISA (Study Site 1):

Table of Reported Device Performance for PANBIO EBV VCA-p18 IgG ELISA (Study Site 3):

2. Sample Sizes and Data Provenance

Study Site 1 (Primary Performance Study):

• Sample Size (Test Set): 342 sera
  • Seronegative: 45
  • Acute IM: 41
  • Past Exposure to EBV: 256
• Data Provenance: Prospective sera collected from a private pathology laboratory in Queensland, Australia.

Study Site 3 (Confirmatory Performance Study):

• Sample Size (Test Set): 148 sera
  • Seronegative: 25
  • Acute IM: 23
  • Past Exposure to EBV: 100
• Data Provenance: Frozen retrospective sera submitted to a state health laboratory in Maryland, USA.

3. Number of Experts and their Qualifications (for Ground Truth)

The document does not explicitly mention the use of "experts" for establishing the ground truth in the traditional sense of clinicians or radiologists reviewing cases. Instead, the ground truth for the EBV status of the test sets was established by the results of other standard EBV serological assays.

The "EBV Status" was defined based on a combination of different assay results:

• Seronegative: VCA IgG (-), VCA IgM (-), EBNA IgG (-)
• Acute IM: VCA IgM (+), EBNA IgG (-)
• Past Infection: VCA IgG (+), VCA IgM (-), EBNA IgG (+)

This implies that the "experts" were the laboratory personnel and clinicians who interpreted these existing serological results to categorize the samples. No specific number or qualifications for individual experts interpreting these criteria are provided.

4. Adjudication Method

The document does not describe an adjudication method in the context of multiple expert readers. The ground truth was established by comparing the device's results to the serological EBV status determined by a panel of other EBV serologies. For the study at Site 3, it is noted that re-testing of equivocal samples was not conducted because the samples were unavailable. This suggests that there was no specific adjudication process for discordant results against the "EBV Status" ground truth, beyond the initial classification based on the serological panel.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of an in vitro diagnostic device (ELISA) against serological ground truth and a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done. The PANBIO EBV VCA-p18 IgG ELISA is an automated/semi-automated test that provides a quantitative result (absorbance) which is then interpreted qualitatively (Positive/Negative/Equivocal) based on a cut-off ratio. The reported sensitivity, specificity, and agreement values are for the device itself.

7. Type of Ground Truth Used

The ground truth used was expert consensus derived from other EBV serological assays. The "EBV Status" for each sample was determined by a panel of a priori defined serological markers for VCA IgG, VCA IgM, and EBNA IgG, which are established indicators of different stages of EBV infection.

The study explicitly states: "Note: "Serological" sensitivity and specificity refers to the comparison of the PANBIO assay results to that of other assays normally used to diagnose EBV associated IM. There was not an attempt to correlate the assay's results with disease presence or absence. No judgement can be made on the comparison's accuracy to predict disease." This clarifies that the ground truth is based on laboratory-defined serological status, not direct clinical outcomes or pathology reports.

8. Sample Size for the Training Set

The document does not provide information about a distinct "training set." The studies described are performance evaluations of the finalized device (test sets). For an ELISA, development typically involves optimization using a set of samples, but these are not explicitly called out as a "training set" with specific numbers.

9. How Ground Truth for the Training Set Was Established

As no specific training set is detailed, information on how its ground truth was established is not provided. Typically, in the development of such assays, candidate samples would be characterized using established reference methods for the target analyte (EBV VCA IgG antibodies).

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