(203 days)
The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from
- Norovirus GI & GII
- . Rotavirus A
- . Adenovirus F40/41
- Sapovirus (genogroups I, II, IV, V)
- . Human Astrovirus (hAstro)
Testing is performed on unpreserved soft to diarrheal or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of relevant gene target DNA/RNA. The test utilizes fluorogenic gene-specific hybridization probes for the detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Norovirus GI & GII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups I, II, IV, V), and Astrovirus infections. Results of this test should not be used as for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
The BD MAX™ Enteric Viral Panel assay along with the BD MAX™ System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, nucleic acid extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors nucleic acid extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD MAX™ Enteric Viral Panel, a test result may be called as POS, NEG, or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.
The document describes the performance evaluation of the BD MAX™ Enteric Viral Panel with the Copan FecalSwab Collection, Preservation, and Transport System compared to the previously cleared Cary-Blair preserved stool specimens. The studies were conducted to demonstrate substantial equivalence for the additional specimen collection method.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides specific acceptance criteria for the "User Variability Study" and performance results for the "Multicenter Clinical Study" where the BD MAX™ Enteric Viral Panel (EVP) was compared using FecalSwab™ to Cary-Blair preserved samples.
User Variability Study Acceptance Criteria and Performance:
| Target | Panel Member | Acceptance Criteria | Assay Results | Overall Result |
|---|---|---|---|---|
| Norovirus | Low Positive | ≥ 95% POS | 100% POS | Pass |
| Moderate Pos | 100% POS | 100% POS | ||
| Negative | 100% NEG | 100% NEG | ||
| Astrovirus | Low Positive | ≥ 95% POS | 100% POS | Pass |
| Moderate Pos | 100% POS | 100% POS | ||
| Negative | 100% NEG | 100% NEG |
Multicenter Clinical Study Reported Device Performance (PPA = Positive Percent Agreement, NPA = Negative Percent Agreement) for FecalSwab™ compared to Cary-Blair results as reference:
| Target | Specimen Origin | PPA (95% CI) | NPA (95% CI) |
|---|---|---|---|
| Norovirus | Prospective | 87.0% (67.9%, 95.5%) | 99.6% (98.7%, 99.9%) |
| Retrospective | 99.0% (94.8%, 99.8%) | 94.3% (88.2%, 97.4%) | |
| Rotavirus | Prospective | 100.0% (43.9%, 100.0%) | 100.0% (99.3%, 100.0%) |
| Retrospective | 84.8% (71.8%, 92.4%) | 98.2% (94.8%, 99.4%) | |
| Adenovirus | Prospective | 100.0% (20.7%, 100.0%) | 99.5% (98.5%, 99.8%) |
| Retrospective | 100.0% (70.1%, 100.0%) | 99.0% (96.5%, 99.7%) | |
| Adenovirus | Contrived | 100.0% (93.1%, 100.0%) | 100.0% (93.2%, 100.0%) |
| Sapovirus | Prospective | 50.0% (9.5%, 90.5%) | 99.3% (98.2%, 99.7%) |
| Retrospective | 100.0% (85.1%, 100.0%) | 97.9% (94.7%, 99.2%) | |
| Astrovirus | Prospective | 100.0% (20.7%, 100.0%) | 99.3% (98.2%, 99.7%) |
| Retrospective | 96.3% (81.7%, 99.3%) | 96.7% (93.1%, 98.5%) |
Limit of Detection (LoD) Study Acceptance Criteria and Performance:
Acceptable performance was demonstrated when the detection break points between the FecalSwab and Cary-Blair Para-Pak® specimen types were within one five-fold dilution of each other. Breakpoint is defined as the highest concentration where the positivity rate is
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).