(85 days)
The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System.
The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.
The ARCHITECT HSV-2 IgG assay is an automated, two-step immunoassay for the qualitative detection of IgG antibodies to HSV-2 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.
The kit contains different components: Reagent (microparticles, conjugate and assay diluent), Calibrator, and external Controls (reactive and nonreactive).
The document describes the ARCHITECT HSV-2 IgG assay, a diagnostic device for detecting specific IgG antibodies to herpes simplex virus type 2 (HSV-2). The study aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.
While the document does not explicitly state "acceptance criteria" in the format of a separate table setting thresholds beforehand, the performance summary sections detail the studies and the observed performance. The key performance metrics demonstrated are:
- Clinical Performance (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA): This is the primary measure of the device's accuracy in correctly identifying positive and negative samples for HSV-2 IgG antibodies.
- Precision (Within-Laboratory and Reproducibility): These studies evaluate the consistency and reliability of the assay results across different runs, days, and sites.
- Analytical Specificity (Interference and Cross-reactivity): These studies assess the device's ability to accurately measure HSV-2 IgG without being affected by other substances or related conditions.
- Specimen Collection Types: This confirms the assay's performance across various accepted sample types.
- Carry-Over: Verifies that prior samples do not affect subsequent sample results.
Here's an interpretation of the implied acceptance criteria and reported performance based on the provided document:
Acceptance Criteria and Reported Device Performance
| Performance Metric | Implicit Acceptance Criteria (Inferred from study design/general diagnostic device standards) | Reported Device Performance |
|---|---|---|
| Clinical Performance | High Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a composite comparator, indicating strong diagnostic accuracy. | Sexually Active Population: |
- PPA: 96.54% (223/231) with 95% CI: 93.32% to 98.24%
- NPA: 96.90% (375/387) with 95% CI: 94.66% to 98.22%
Pregnant Population:
- PPA: 95.12% (78/82) with 95% CI: 88.12% to 98.09%
- NPA: 98.60% (212/215) with 95% CI: 95.98% to 99.52%
CDC Panel Agreement:
- PPA (Reactive samples): 100% (30/30)
- NPA (Nonreactive samples): 97.14% (68/70) |
| Precision (Within-Laboratory) | Low %CV for different panels and controls, demonstrating consistent results within the laboratory. | 20-Day Within-Laboratory Precision: - Positive Control: Mean S/CO 3.01, Within-Laboratory %CV 3.9
- Serum Panel 2: Mean S/CO 1.60, Within-Laboratory %CV 6.8
- Serum Panel 3: Mean S/CO 2.47, Within-Laboratory %CV 11.6
- Plasma Panels: %CVs ranging from 3.3 to 5.7
12-Day Within-Laboratory Precision (Higher Analyte Levels):
- Serum Panel 4: Mean S/CO 7.14, Within-Laboratory %CV 5.2
- Serum Panel 5: Mean S/CO 14.73, Within-Laboratory %CV 4.6
- Plasma Panel 4: Mean S/CO 7.85, Within-Laboratory %CV 4.5
- Plasma Panel 5: Mean S/CO 14.90, Within-Laboratory %CV 5.0 |
| Precision (Reproducibility) | Low %CV across multiple sites/instruments, demonstrating consistent results regardless of testing location. | Reproducibility (3 testing sites): - Positive Control: Mean S/CO 2.98, Reproducibility %CV 5.2
- Serum Panel 2: Mean S/CO 1.56, Reproducibility %CV 4.0
- Serum Panel 3: Mean S/CO 2.52, Reproducibility %CV 4.3
- Plasma Panels: %CVs ranging from 5.2 to 5.4 |
| Analytical Specificity (Interference) | Minimal impact (
§ 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).