(506 days)
OMNIgene. GUT Dx is intended for the non-invasive collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene GUT Dx.
The OMNIgene . GUT Dx device consists of a collection tube with a tube top and pusher cap with a screw seal, along with a spatula or spoon for transferring fecal specimen into the collection tube. The tube contains 2 mL of the stabilizing liquid and a stainless-steel mixing ball. These components are intended to stabilize bacterial DNA in human fecal specimens. notably to preserve the relative abundances of bacterial organisms, for potential downstream analysis of the fecal microbiome. The collection device is designed for storage of fecal specimens at room temperature (20-26°C/68-79°F) for up to 30 days.
Here's a breakdown of the acceptance criteria and the studies conducted to prove the OMNIgene.GUT Dx device meets these criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
The device's performance was evaluated through several analytical studies focusing on DNA yield, microbial community neutrality (preservation of relative abundances), and stability at room temperature, as well as reproducibility.
Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Study Section |
|---|---|---|---|
| DNA Yield | ≥ 120 ng (0.12 µg) per extraction aliquot in ≥ 95% of samples (Neutrality Study) | 100% of specimens met the DNA yield acceptance criteria of 120 ng (0.12 µg) for both adult and pediatric cohorts. (Neutrality Study Results) | L.1.b, Neutrality results; L.1.c, Reproducibility results |
| ≥ 120 ng (0.12 µg) per extraction aliquot in ≥ 95% of samples (Room Temperature Storage Stability Study) | 100% of specimens met the DNA yield acceptance criteria of 120 ng (0.12 µg) for both adult and pediatric cohorts. (Room Temperature Storage Stability Results) | ||
| ≥ 120 ng (0.12 µg) per extraction aliquot in ≥ 95% of samples (Reproducibility Study) | 100% of specimens for both lot-to-lot and aliquot-to-aliquot reproducibility met the DNA yield acceptance criteria of 120 ng (0.12 µg). | ||
| Microbial Community Neutrality (Relative Abundance Preservation) | Per donor, each Microbiome Panel species in the stored sample has read counts within the TeSaRCol (Test Sample Read Count Limit) range as calculated using the unstabilized Control Baseline. Neutrality demonstrated in ≥ 90% of donors that were successfully screened to contain that species. | All species examined as part of the Microbiome Panel demonstrated neutrality in ≥ 90% of donors between unstabilized and OMD-200 fecal samples. Whole Microbiome Analysis: Group wise comparison of Aitchison distance showed change in microbial profile was significantly lower between OMD-200 collected fecal samples at baseline and unstabilized control fecal samples than observed donor-to-donor differences (P 0.1). PCA and hierarchical clustering showed intra-donor clustering. | L.1.b, Neutrality Acceptance Criteria; Neutrality Results; L.1.e, Neutrality (Whole Microbiome) Results |
| Room Temperature Storage Stability | Per donor, each Microbiome Panel species in the stored sample has read counts within the TeSaRCol range as calculated using the OMD Baseline. Stability demonstrated in ≥ 90% of donors that were screened to contain that species. | All species examined as part of the Microbiome Panel demonstrated stability in ≥ 90% of donors when stored at room temperature for up to 30 days either with or without the addition of OM-LQR. Whole Microbiome Analysis: Group wise comparison of Aitchison distance showed no difference between stability time points (P > 0.05) and change was significantly lower than observed donor-to-donor differences (P 0.1). | L.1.b, Room Temperature Storage Stability Acceptance Criteria; Stability Results; L.1.e, Stability (Whole Microbiome) Results |
| Reproducibility | CV of classified read counts post-rarefaction |
N/A