(87 days)
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.
The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro PCR assay for the qualitative detection and differentiation of nucleic acids encoding the Glycoprotein D and UL30 genes isolated from HSV-1 and HSV-2 DNA present in genital or oral lesions from male and female patients. Samples are extracted and prepared for PCR using the QIAsymphony SP/AS instrument with the QIAsymphony DSP Virus/Pathogen Mini Kit. Amplification and detection are carried out using the artus HSV-1/2 QS-RGQ MDx Kit with the Rotor-Gene O MDx (RGO MDx) and Rotor-Gene AssayManager software. The presence of a HSV-1 or HSV-2 target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the RGQ MDx is inversely proportional to the HSV-1 and/or HSV-2 target concentration present in the original specimen. A plasmid construct containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as a process control, to demonstrate that sample preparation has proceeded correctly during the run.
The provided documentation describes the performance characteristics and clinical study results for the artus® HSV-1/2 QS-RGQ MDx Kit, an in vitro real-time PCR assay for the detection and differentiation of HSV-1 and HSV-2 DNA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative for this type of diagnostic device, revolving around achieving sufficient sensitivity and specificity compared to a predicate device or established methods. The reported device performance is detailed in the tables under "Performance Characteristics - Clinical Studies."
| Acceptance Criteria (Implied) | Reported Device Performance (artus® HSV-1/2 QS-RGQ MDx Kit) |
|---|---|
| Analytical Sensitivity (LoD) at ≥ 95% detection | HSV-1 MacIntyre: 4.42 x 100 TCID50/mL (95% CI: 2.81 x 100 - 9.14 x 100) |
| HSV-1 Isolate 15: 1.82 x 101 TCID50/mL (95% CI: 0.96 x 101 - 5.47 x 101) | |
| HSV-2 MS: 9.78 x 10-1 TCID50/mL (95% CI: 0.66 x 10-1 - 2.01 x 100) | |
| HSV-2 Isolate 2: 1.91 x 102 TCID50/mL (95% CI: 1.26 x 102 - 3.55 x 102) | |
| Analytical Reactivity (Detection of various HSV strains) | Detected intended HSV-1 or HSV-2 in all 39 strains (20 HSV-1, 19 HSV-2) tested at 2-3X LoD. |
| Cross-Reactivity/Microbial Interference (No interference from common microorganisms) | None of the 45 tested microorganisms (bacteria, fungi, viruses) cross-reacted or interfered with HSV detection. |
| Precision (Repeatability & Reproducibility of results) | Within-Laboratory Repeatability: Low %CV for CT values (mostly |
§ 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).