Where does NGS (Next Generation Sequencing) Sampling Fit into my Orthopedic Practice?
ASPIRATION IN THE OFFICE
Culture is Negative
Other Lab values indicate infection
- There is still a high percentage of aspirations that will be “inconclusive” with NGS. Microbes form biofilms on the tissue and hardware. The biofilm will shed fragments off the community. We need to have those microbes in the fluid.
- The more fluid volume we receive, the higher the probability we will find enough DNA reads.
- Minimum volume required is 2ml.
- Maximum volume (3) 10ml vials.
NGS provides more accurate identification of multiple species.
- Allowing for more targeted antimicrobial selection post op.
- Provides the species identification to use if a revision is required. Antibiotic selection for cement spacer is targeted to the correct species detected.
- Sample from as much surface area as possible.
- Avoid pus and nonviable material.
- Samples taken for NGS provide species identification to make targeted post op antibiotic selection.
- During revision, antimicrobial selection for spacers is based on accurate species detected in prior sample collection (washout or aspiration sample reports).
"First, NGS was found to be capable of identifying an organism in almost 90 percent of patients with PJI (as determined by the MSIS criteria) compared to culture that had a sensitivity of 60.7%. Second, and perhaps more importantly, NGS detected a potentially infecting organism in more than 80% of culture negative PJIs."
- 82% of culture negative infections detected is among the highest reported in the literature.
- Multiple organisms were detected in the vast majority of cases, which may indicate the presence of multiple bacteria in the joint. These organisms would not have been detected by the majority of available PCR technologies and cultures.
- The false positive rate displayed by NGS is much lower than that of other PCR based technology.
Traditional Culture Labs vs Next Generation Sequencing (NGS)
Traditional Culture Labs
- Samples must follow strict guidelines of being at the lab within 2 hours and kept at room temperature.
- Less than 1% of known microbes will grow in traditional culture methods.
- Cultures have a high probability of returning with “no growth” results.
- Anaerobes are extremely difficult to grow in culture.
- Fungi can take over 20 days to get a result.
- It takes several diagnostic tests to identify anaerobes, aerobes, and fungi, costing the patient for each test.
Next Generation Sequencing
- Samples are not easily affected by time and temperature.
- We do not grow microbes. Our technology Extracts the Microbial DNA from each sample. Similar to lifting finger prints at a crime scene.
- We can identify 100% of the microbes within a sample with 99.9% accuracy.
- We return NGS results in 3-5 days. Lab results deliver all detected microbes against a data base of 25,000 known microbes.
- All microbes and fungi can be tested within one test at one price.
- We also detect Antibiotic resistance genes for 7 antibiotic classes and deliver an antibiotic recommendations sheet.
Other PCR Labs
- PCR is limited to the microbial species in the panel.
- PCR panel are often 8-20 species or less.
- PCR has no clinical value when the panel returns negative.
- PCR will only confirm what you ask it to identify.
Our PCR & Next Generation Sequencing
- Within 24 hrs we provide Quantitative PCR with bacterial load.
- We also detect 8 known antibiotic resistance genes.
- We can detect the Sequence codes of more than 25,000 species.
- Complete screening of the entire known microbial universe with 99.9% accuracy.
Specificity You Deserve for Precise Treatment Decisions.
MicroGen DX offers Orthopedics Next-Gen Sequencing, a superior diagnostic tool over culture and PCR detection methods. Our High Complexity Laboratory extracts the DNA of all the microbes within a sample and matches those sequence codes to all 25,000+ known microbial species with a 99.9% accuracy rate. When you get precise data of the causative microbes you can have confidence in your clinical treatment plan while raising your level of care with a higher standard of antibiotic stewardship. Truly targeted antimicrobial treatments can clear the infection faster.
It’s not New Technology to us.
MicroGen DX Laboratory Next-Gen Sequencing is far superior to culture, PCR techniques, and other NGS platforms due to the complexity of our proprietary bioinformatics processes that have been delivering accurate microbial data 6 years consistent precision certified by CAP and CLIA down to species level. We have identified over 6,500 species of microbes in human samples to date.
Our laboratory has been trusted by over 8,000 doctors and has delivered over 200,000 NGS test results.
We look forward to assisting you with the most accurate and dependable data in microbial identification for your confident clinical decision-making and the successful treatment of your patients.
5 Simple Steps to Better Patient Outcomes
Operating Room Kit Contents
- Lab Requisition and Specimen Label
- One 10 ml Sample Vial
- One 60 ml Sample Container
- Four Sterile Pack Swabs
- Biohazard Lab Bag
- Prepaid FedEx Shipping Box
- FedEx Tracking Slip
Doctor's Office Kit Contents
- Lab Requisition and Specimen Label
- Three 10 ml Sample Vials
- One 60 ml Sample Container
- Two Sterile Pack Swabs
- Lab Bag
- Prepaid FedEx Shipping Box
- FedEx Tracking Slip
Please use the form below to order kits. Feel free to call with any questions: 1-855-208-0019
Sample Collection Instructions
Prepare the shipping box
- To assemble the Category B shipping box, begin to fold the top up.
- The side with 4 holes is the bottom.
- Fold small flaps in (2) so they are hovering over the holes.
- Next, fold the side up and into the box (3) to hold the small flaps in place.
- Press the sides down slightly (4) so there are 2 folded edges (inside top and outer top); the notches go into the four holes in the bottom.
Packing the sample and shipping
- Place the prepared specimen bag containing the sample and order form (5) into the box.
- Fold the side into the interior of the box (6).
- Push the top down (7).
- Finally, hold the tabs into the box and push the front in (8). *Please tape the front shut for extra security.
Note: More than one specimen transport bag can be placed in one shipping container. However, only one sample and one order form should be placed in a sample bag.
Understanding Your Lab Results and Antibiotic Recommendations Sheet
MicroGen DX delivers easy-to-understand results, quickly. Within 24 hours you receive PCR level 1 and within 5 days you receive NGS Level 2 with exact percentage, type of bacteria and fungi present in patient sample. We also provide a complete list of applicable antibiotics to let doctors decide best care for patients.
PCR Rapid Screening: Panel Results
It starts with PCR PCR Rapid Screening, often with a turnaround time of only 24 hours from receipt of sample. The specimen is examined for the most commonly identified microbes of interest within the field of medicine serviced. Approximately 80% of PCR Rapid Screening samples are positive for at least one pathogenic microbe.
Our PCR Level I for wound and nail detects the microbes listed on the lab request form. Scope is specific to 7 bacterial species, Candida albicans, MRSA, VanA and total bacterial load. Quantitative results on tissue and fluid samples. Semi-quantitative results on swab samples.
We primer our tests to identify these microbes in our 24 hour Rapid Results:
- Pseudomonas aeruginosa
- Streptococcus pyogenes (GAS)
- Streptococcus agalactiae (GBS)
- Staphylococcus aureus
- Enterococcus faecalis
- Enterococcus faecium
- Serratia marcescens
- Candida albicans
- Trichophyton rubrum
PCR Rapid Screening Results are a Quantitative PCR panel of 8 microbes. The PCR panel tells you the total bacteria load: Low, Medium, or High. Providing the numerical value of the bacteria, such as 10 to the fifth power. PCR Rapid Screening PCR will also detect bacteria resistance for MRSA; mech A positive or Van A – Vancomycin resistant enterococci.
Next-Generation Sequencing Comprehensive Results
Decodex Microbial Genetic Identfication is the first universally comprehensive bacterial and fungal diagnostic test. It provides a comparative DNA sequencing analysis that determines with DNA-level accuracy which microbes are present and in what relative abundance.
Scope is comprehensive (all known bacteria, yeast, and fungi). While PCR Rapid Screening is rapid, Level 2 is comprehensive, critical for polymicrobial specimens of high diversity (chronic wounds, prosthetic joint, etc.). Both are free of cultivation limitations. Results are typically reported within 3-5 business days of receipt. Our Level 2 testing identifies genetic signatures and the estimated percentage of bacteria and fungal organisms present in the specimen. All detected bacteria are listed first, in order of prominence. To the right of each bacteria you can review the percentage detected. If detected, fungi is listed next.Once identified, medications can be selected to specifically address the infection for a precise treatment… and expedite healing.
The final column on Page One is Resistance Information. Here we list other detections that impact treatment. For example, our test detects when the mecA or VanA gene is present – these strains allow bacteria to be resistant to certain antibiotics. Resistance information is also provided below these three columns and includes the undetected PCR Rapid Screening microbes, and undetected antibiotic resistance markers. When the bacterial species is one that can be grown in traditional culture, e-coli for example, you should take into consideration local resistance patterns. These local resistance patterns can be obtained from your hospital anti-biogram. Remember this is only applicable to the 25 to 30 species that are reported in culture.
Determine Treatment Plan
Targeted antibiotic recommendations allow doctors to make informed, targeted decisions for treatment. Targeted treatment results in faster healing. And faster healing means less expense. These are the Better Outcomes you can expect from MicroGen DX.
Treatment recommendations are listed in order of IV, PO or topical for personalized treatment solutions. Many antibiotics classified as “IV Only” can still be used in customized topical compounds. Please note, the list of antibiotics is not all-inclusive. It is only there to provide you with options. Page Two of your Diagnostic Results is the Antibiotics Recommendations. The top column lists the identified bacteria and fungi in the specimen by percentage of DNA – and if the microbes are gram negative, positive, aerobic, anaerobic or facultative anaerobes. On the far left is the list of antibiotics recommended. The antibiotic recommendations are based on clinical studies where the antibiotic has been shown to be effective against that specific species.
Better Patient Outcomes
With a 100% accuracy rate in identification for the past 6 years by CAP and CLIA, MicroGen DX looks forward to hearing your success stories and becoming your reliable partner in finding superior diagnostics, determining targeted treatment, and providing physicians and patients with better outcomes.
Our Dedication to Delivering Dependable Data
First, we apologize for any inconvenience due to receiving a negative report.
Please click the button below to see why you may have received a Negative Report, our 3 run promise of your sample and details of our free sample run guarantee.