(290 days)
The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state.
The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum.
The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window.
When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit.
The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2). The study compared the device's performance to the HSV-2 Western Blot method and also tested it against the CDC serum panel for HSV-2 serology assays.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to show substantial equivalence to the Western Blot method. Therefore, the "acceptance criteria" can be inferred as achieving high agreement, sensitivity, and specificity in comparison to the Western Blot.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Whole Blood) | Reported Device Performance (Serum) |
|---|---|---|---|
| Performance | High agreement with Western Blot | Evaluated across 1193 samples | Evaluated across 1220 samples |
| Sensitivity | High | Not explicitly quantified in text | Not explicitly quantified in text |
| Specificity | High | Not explicitly quantified in text | Not explicitly quantified in text |
| Comparison Panel | Agreement with CDC serum panel for HSV-2 serology assays | Tested with CDC serum panel | Tested with CDC serum panel |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Whole blood samples: 1193
- Serum samples: 1220
- Data Provenance: Not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the "CDC serum panel for HSV-2 serology assays" suggests a US-based dataset for part of the evaluation.
3. Number of Experts and their Qualifications for Establishing Ground Truth
- The document implies that the Western Blot method served as the reference standard (ground truth). The number of experts and their qualifications involved in establishing the ground truth for the Western Blot results are not provided in this document.
- Similarly, for the CDC serum panel, the method of establishing ground truth (e.g., expert consensus, other reference methods) and the number/qualifications of experts are not specified.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The comparison appears to be a direct evaluation against the Western Blot and CDC panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study focuses on the standalone performance of the device against established methods. There is no information provided regarding human readers or improved performance with AI assistance.
6. Standalone Performance
- Yes, a standalone performance study was conducted. The "Performance Data" section describes the evaluation of the POCkit™ HSV-2 Rapid Test "relative to the HSV-2 Western Blot method" and states that the "CDC serum panel for HSV-2 serology assays was tested with this device." This indicates an assessment of the algorithm's (device's) performance purely on its own.
7. Type of Ground Truth Used
- The primary ground truth used was the HSV-2 Western Blot method.
- Additionally, a CDC serum panel for HSV-2 serology assays was used as a reference. This panel would typically have known or well-characterized HSV-2 status, serving as another form of ground truth.
8. Sample Size for the Training Set
- The document does not provide any information regarding a distinct training set sample size. This suggests that if machine learning was involved (which is unlikely given the stated nature of the device as a membrane immunoassay), the training details are not disclosed. More likely, the device is a fixed immunoassay, and what is described is its analytical validation against reference methods.
9. How Ground Truth for the Training Set Was Established
- As no training set is described for this device, the method for establishing its ground truth is not applicable/not provided. The device's mechanism is a membrane immunoassay, which does not typically involve a "training" phase in the context of machine learning. The "ground truth" discussed in the context of performance evaluation refers to the reference standard for validating the device's accuracy.
§ 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).