(281 days)
The Premier HSV is a qualitative enzyme immunoassay designed for detection of herpes simplex virus (HSV) . The test is intended to be used for direct detection from genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens to rapidly confirm the presence of HSV. The test can also be used in conjunction with cell cultures inoculated with these specimens.
The Premier HSV Plus assay system is a microwell-based sandwich EIA for the detection of herpes simplex virus. Each kit contains the following components: Capture Antibody-coated microwells, Positive Control, Negative Control, Extraction Buffer, Enzyme Conjugate, 20X Wash Buffer, Substrate, Stop Solution, Transfer Pipet, Microwell Strip Holder, Microwell Strip Sealer. The assay is performed by adding Extraction Buffer, then positive and negative control or sample, incubating, washing, adding enzyme conjugate, incubating, washing, adding substrate, incubating, adding Stop Solution, waiting, and reading at 450/630nm.
Here's a breakdown of the acceptance criteria and study information for the Premier HSV Plus device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the device's performance in comparison to a gold standard (Culture with FA Confirmation) across various specimen types. I will present the "Resolved" performance metrics as these represent the final, adjudicated results.
| Metric (Acceptance Criteria) | Reported Device Performance (Premier HSV Plus Direct EIA - Resolved) | Reported Device Performance (Premier HSV Plus Spin-Amp EIA - Resolved) |
|---|---|---|
| Relative Sensitivity (Genital Symptomatic) | 93.1% (161/173) | 99.4% (173/174) |
| Relative Specificity (Genital Symptomatic) | 100% (220/220) | 99.5% (218/219) |
| Relative Sensitivity (Genital Asymptomatic) | 83.3% (5/6) | 100% (6/6) |
| Relative Specificity (Genital Asymptomatic) | 100% (72/72) | 100% (72/72) |
| Relative Sensitivity (Oral) | 92.9% (13/14) | 92.9% (13/14) |
| Relative Specificity (Oral) | 100% (28/28) | 100% (28/28) |
| Relative Sensitivity (Others) | 92.3% (12/13) | 100% (13/13) |
| Relative Specificity (Others) | 100% (30/30) | 100% (30/30) |
| Overall Relative Sensitivity | 92.7% (191/206) | 99.0% (205/207) |
| Overall Relative Specificity | 100% (350/350) | 99.7% (348/349) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Total: 556 specimens
- Breakdown by Specimen Type:
- Genital Symptomatic: 393
- Genital Asymptomatic: 78
- Oral: 42
- Others: 43
- Data Provenance: The document does not specify the country of origin of the data. It appears to be a retrospective analysis or a prospective collection for this specific study, but the exact nature (retrospective/prospective) is not explicitly stated. It is presented as a "Clinical Trial Results."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the ground truth was established by "Culture with FA Confirmation" (Fluorescent Antibody Confirmation). This typically involves laboratory technicians or clinical microbiologists. The number of such experts and their specific qualifications (e.g., years of experience) are not provided in the given text.
4. Adjudication Method for the Test Set
The term "Resolved" in the performance tables indicates that there was some form of adjudication process for discrepancies between the initial EIA results and the culture results. However, the specific adjudication method (e.g., 2+1, 3+1, independent expert review) is not described in the provided text.
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 section is not applicable as the Premier HSV Plus is an in-vitro diagnostic (IVD) assay for direct detection of HSV antigens, not an AI-powered human-in-the-loop diagnostic aid. It does not involve human "readers" in the context of interpretation of images or complex data where AI assistance would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the principal clinical study described is a standalone performance evaluation of the Premier HSV Plus device (both Direct EIA and Spin-Amp EIA) against a gold standard (Culture with FA Confirmation). The device itself is an automated or semi-automated Enzyme Immunoassay; its performance is reported directly without human interpretation in the loop that would modify its output.
7. The Type of Ground Truth Used
The type of ground truth used was Culture with FA Confirmation. This is considered a gold standard for viral detection in many clinical microbiology settings.
8. The Sample Size for the Training Set
The document describes the clinical performance evaluation of the final device. It does not provide information about a separate "training set" for the development of the assay. This is typical for traditional IVDs like ELISAs, where the assay design is based on known immunological principles rather than machine learning models that require distinct training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described (as per point 8), this information is not applicable/provided.
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).