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For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.

The SeraQuest™ HSV IqG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against type 1 or type 2 herpes simplex virus (HSV), in human serum.

The Calibrators in the SeraQuest HSV IgG test set have been assigned Index values based on an in-house standard. Test results are normalized and reported as Index values.

Diluted samples are incubated in wells coated with Type 2 herpes simplex virus. HSV antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically.

Here's a breakdown of the acceptance criteria and the studies performed for the SeraQuest™ HSV IgG device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical, predefined format. However, it presents performance metrics from two studies that implicitly serve as evidence of the device's acceptable performance in comparison to established benchmarks (CDC panel and predicate device).

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

• CDC HSV/CMV Evaluation Panel:
  • Sample Size: 72%Positive (meaning some number of positive samples) and 28%Negative samples. The total number of samples is not explicitly stated, but it's a "panel."
  • Data Provenance: The Centers for Disease Control and Prevention (CDC) provides the panel; typically, these are well-characterized, previously collected samples, implying a retrospective nature. The origin of the individual samples within the panel is not specified but is implied to be diverse for evaluation purposes.
• Comparison Testing with Predicate Device:
  • Sample Size: 207 serum specimens.
  • Data Provenance: Randomly obtained in South Florida. This suggests a prospective collection for the purpose of this comparison study.

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

• CDC HSV/CMV Evaluation Panel: The ground truth for this panel was established by the Centers for Disease Control and Prevention (CDC). The document states it was a "masked, characterized serum panel." While the number and specific qualifications of experts are not detailed in this text, the CDC's involvement implies a high level of expertise in serological testing and infectious diseases.
• Comparison Testing with Predicate Device: The ground truth for this study appears to be the results obtained from the predicate INCSTAR Herpes IgG assay. Therefore, no independent experts were explicitly used to establish a separate ground truth for these 207 South Florida samples beyond the predicate device's own established performance.

4. Adjudication Method for the Test Set:

• CDC HSV/CMV Evaluation Panel: The text states the panel was "masked" and "characterized." This implies that the CDC's established results were considered the ground truth, and device performance was directly compared against these. There is no explicit mention of an adjudication method for discrepancies between the device and the CDC's results; rather, the agreement percentages are simply reported.
• Comparison Testing with Predicate Device: The study directly compared the results of the SeraQuest™ HSV IgG test against the predicate device (INCSTAR Herpes IgG). There is no mention of an adjudication method for discordant results between the two devices; the tables simply report the agreement and disagreement between the two.

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

• No, an MRMC comparative effectiveness study was not done. The device in question is a laboratory diagnostic assay (EIA) for detecting antibodies, not an imaging or interpretative device that typically involves human readers. Therefore, the concept of human readers improving with AI assistance does not apply here.

6. Standalone Performance:

• Yes, a standalone performance study was done. Both studies presented (CDC panel evaluation and comparison with predicate device) evaluate the performance of the SeraQuest™ HSV IgG assay as a standalone algorithm/device without human intervention influencing its direct optical density readings and index value calculations. The intended use also specifies "For manual use, or for use with the HyPrep System Plus," indicating it operates independently to provide results.

7. Type of Ground Truth Used:

• CDC HSV/CMV Evaluation Panel: The ground truth was based on a "characterized serum panel" provided by the CDC. This indicates a highly reliable, expert-validated characterization of each sample's HSV IgG status, likely through a combination of definitive reference methods (e.g., Western blot, viral culture, or other highly sensitive and specific serological assays).
• Comparison Testing with Predicate Device: The ground truth for this comparison was the results obtained from the predicate device (INCSTAR Herpes IgG assay). This is a form of comparative effectiveness against an existing, cleared diagnostic.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It only describes the evaluation studies for the finished device. Diagnostic assays like this often involve internal optimization and validation during development, but the specifics of a "training set" in the machine learning sense are not provided here.

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

• Since the document does not provide information about a specific "training set" or its size, it also does not detail how its ground truth was established. For a traditional immunoassay, method development and optimization would rely on well-characterized positive and negative control samples, potentially similar to the CDC panel, but the process wouldn't typically involve a "training set" in the AI/ML context.

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