(271 days)
The Genetic Signatures EasyScreen™ Gastrointestinal Parasite Detection Kit is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR, detects the nucleic acid of the following organisms:
- · Cryptosporidium spp.
- · Giardia intestinalis
- Dientamoeba fragilis
- · Entamoeba histolytica
- Blastocystis hominis
- · Enterocytozoon bieneusi
- · Encephalitozoon intestinalis
- · Cyclospora cayetanensis
The kit is compatible with stool specimens that are unpreserved or frozen or in transport media including Cary Blair or C&S media from symptomatic patients with suspected gastroenteritis. It is required that the stool is first processed using the EasyScreen™ Sample Processing Kit. Nucleic acid extraction and real-time PCR set up are performed on the automated Genetic Signatures GS1 platform.
This device is an in vitro diagnostic (IVD) intended to be used by trained personnel in clinical, pathology or hospital laboratories as an aid in the diagnosis of gastrointestinal illness. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of infections by Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon bieneusis, Entamoeba histolytica, Encephalitozoon intestinalis, Cryptosporidium spp. (including C. parvum), and Giardia intestinalis. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not indicate the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis and/or colitis 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 EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005) is designed to simultaneously identify 8 potential pathogens of the gastrointestinal tract, from human stool samples. The device is only compatible with nucleic acids prepared using an EasyScreen™ Sample Processing Kit (SP008B).
A stool sample from a patient suspected of having gastroenteritis (usually liquid or soft stool) is collected and transported to the testing laboratory. A portion of the stool material is taken using a swab or pipette and processed with the EasyScreen™ Sample Processing Kit (SP008B), which lyses cells and converts the nucleic acid to a 3base™ form.
An aliquot of purified eluate is then added to the PCR reagents supplied in the EP005 kit, which selectively amplify the genetic targets of Cryptosporidium spp., Giardia intestinalis, Entamoeba Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon histolytica. bieneusi. Encephalitozoon intestinalis and Cyclospora cayetanensis. The reaction mix is manufactured to detect an Extraction Control (EC) and features an incorporated Internal Positive Control (IPC) to determine the reliability of the extracted nucleic acid and to detect the presence of any inhibitors after extraction from the primary sample.
Amplified targets are detected with probes labeled with fluorophores as detected by the real-time PCR platform. The PCR amplification takes approximately 150 minutes, depending on the PCR platform used. A positive control is included to ascertain that the detection reagents and analyzer are functioning correctly.
The amplified nucleic acid targets are detected by probes labeled with fluorophores, as detected by the real-time PCR platform. If no amplification occurs for a given target, then there will not be any significant increase in fluorescence. Each probe fluoresces at a given wavelength and the signals are measured and distinguished from each other by the real-time PCR platform. The realtime PCR software interprets all data collection and provides the information for automated or manual result analysis. The assay is semi-automated.
The provided text describes the performance of the Genetic Signatures EasyScreen™ Gastrointestinal Parasite Detection Kit. This device is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from human stool samples.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a consolidated table of acceptance criteria for all aspects of the study alongside the reported performance in a single, clear format. However, acceptance criteria are stated within each section of the performance studies, and the results are then presented against those criteria. Below is a reconstructed table based on the explicit statements regarding acceptance and observed performance.
Acceptance Criteria and Reported Device Performance
| Study Aspect | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LoD) | ≥95% detection of the specified target AND 1 sites (excluding C. cayetanensis) was expected to be high. | For targets evaluated at >1 sites, overall site-to-site qualitative reproducibility percent agreement was 100% for all targets at 2x LoD (Low Positive) and for all targets except C. parvum at 4x LoD (Medium Positive). C. parvum at 4x LoD showed 98.9% (95% CI: 93.8-99.9). Within-site reproducibility for C. cayetanensis was 97.1% for LP and 100% for MP. All True Negative samples were 100% correctly identified. Concluded as "acceptably consistent performance." |
| Analytical Specificity (Cross-Reactivity) | No detection for any given target for whole organism/genome wet testing. For in silico analysis, potential cross-reactivity was categorized. | Wet Testing: No cross-reactivity observed with 94 organisms and 7 media, except for three congeneric protozoa (C. muris, E. cuniculi, E. hellem) that showed positive signals. In Silico Analysis: Identified several targets with high/moderate potential for cross-reactivity. Confirmatory wet testing of synthetic RNA targets from clinically relevant protozoa showed that C. meleagridis, C. tyzzeri, C. canis, C. felis, C. muris, E. cuniculi, and E. hellem cross-reacted. (Note: Chilomastix mesnili and Entamoeba dispar did not cross-react in wet testing despite in silico prediction). |
| Analytical Reactivity (Inclusivity) | All isolates detected at all tested concentrations (1X-3X LoD). | Eighty-two isolates representing eight target parasites were tested. The kit detected all isolates at all tested concentrations. |
| Interfering Substances | No interference if 15% change in average Ct values in test (with interferent) samples relative to control (no interferent). | Two substances showed potential interference: Whole Blood at >0.63% (v/v) and Mucin at >0.75 mg/mL. All other 21 substances showed no interference. |
| Microbial Interference | No reportable interference if 100% (10/10) target positivity with test Ct changes at or below 10%. | All targets showed ** |
§ 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).