1How is MicroGenDX different from other reference laboratories?
MicroGenDX is an innovative, CAP accredited, CLIA licensed, molecular diagnostic laboratory. What sets us apart is our 2-Part DNA testing services that utilize our proprietary PCR (Polymerase Chain Reaction) and our NGS (Next Generation Sequencing) technology. Our process uses our Proprietary Bioinformatics System and curated database that provides precise detection of infectious diseases at high levels of sensitivity and specificity.
2What certifications does MicroGenDX have?
MicroGenDX We are CAP and CLIA certified. College of American Pathologists (CAP) is a laboratory accreditation program that is widely recognized as the ‘gold standard’ and has served as a model for various federal, state, and private laboratory accreditation programs throughout the world. The Clinical Laboratory Improvement Amendments (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.
3How long has MicroGenDX been in business?
MicroGenDX was founded in 2008 under the DBA Pathogenius by Randy Wolcott, MD of Southwest Regional PCR. In 2017 the company was acquired and rebranded as MicroGenDX Laboratory. Collectively this laboratory has been used by more than 10,000 doctors and delivered over 400,000 NGS lab results.
4How many physicians use MicroGenDX?
More than 10,000 doctors have relied on our Next-Gen Sequencing Laboratory.
5What are the key benefits of utilizing MicroGenDX’s service?
24 hour turn-around for PCR Lab results (determined by sample receipt) for PCR reports
Detection of Resistance Genes
“NGS” results in just 3-5days
Cost reduction and avoidance
Reduced antibiotic utilization and better Antibiotic Stewardship
Increased Heal rates
Increased patient satisfaction
Greater clinical value - by reducing the subjectivity of identification associated with conventional culture technology
Polymerase chain reaction (PCR) is a molecular biology technique that amplifies a DNA base pair sequence up to several orders of magnitude (billions and trillions of copies). PCR (Polymerase Chain Reaction) is a proprietary technology that accomplishes the task of DNA amplification in a multiplex format; e.g. amplifying the DNA of multiple organisms in a single reaction.
2What is Next Generation Sequencing (NGS)?
Next Generation Sequencing (NGS), also known as high-throughput sequencing, Next Generation Sequencing refers to non-Sanger-based high-throughput DNA sequencing technologies. Millions or billions of DNA strands can be sequenced in parallel, yielding substantially more throughput and minimizing the need for the fragment-cloning methods that are often used in Sanger sequencing of genomes.
3What distinct advantages does MicroGenDX’s NGS technology offer?
Superior specificity of 99.9% microbes within an infection site
Fast results in 3-5 business days (determined by sample receipt)
Simultaneous identification of bacteria fungus, viruses, parasites, Candida and antibiotic resistance
Detection of bacteria in the presence of antibiotics
Increased sensitivity and specificity
Simplicity of sample collection
We do not need to follow the same guidelines for transportation as culture samples, as DNA is not easily affected by time and temperature.
4What panel should I order?
For bacterial and fungal infection choose the infection type that applies to the infection in PART I and check the box for PART II.
For Respiratory Viral and Bacterial infections:
5Why does MicroGenDX send out two separate lab reports instead of both LEVEL I and LEVEL II at the same time?
Rapid PCR PART 1 delivers detection of microbes on the chosen panel within 24 hours. Also, bacterial load and 8 gene resistances for immediate antibiotic therapy are delivered.
NGS PART 2 is delivered within 3-5 business days of receipt typically. The complex processing and verification associated with Next-Gen Sequencing typically takes 3-5 days. The superior data delivered in the Comprehensive report provides all the detected microbes within the sample and their relative abundances. With this next level of data, physicians can target therapy to over 25,000 major contributors of the disease state in great depth regardless of aerobic or anaerobic state.
6Does MicroGenDX test for antibiotic susceptibilities?
No, however we do test for the following resistance genes:
Extended Spectrum Beta Lactamase CTX-M
We also provide the antimicrobial recommendation for each species detected. These recommendations are research based, similar to an antimicrobial guide reference. When a more typical bacteria is detected that is easily grown in the micro lab, like e-coli, your local antibiogram which tracks local resistance patterns should be referenced. This will only apply to 20-25 microbial species that are easily grown in culture.
7Does MicroGenDX perform gram stains?
No. MicroGenDX does molecular testing, not microbiological testing. However, we deliver the class of antibiotics per species found from the National Library of Microbiology.
Call FedEx at 1-800-GOFEDEX (1-800-463-3339) and give them the tracking number (12 digit number under the barcode). When calling say "agent" twice to speak to agent. Let them know it's biohazard prepaid pick-up.
Option to drop off at any FedEx/Kinkos location and drop inside at front of the store.
3Can I take the FedEx® package to a FedEx® location?
Our packages are accepted at FedEx® main facility locations and FedEx® Drop Boxes. FedEx® Office locations WILL NOT accept this type of package. Visit FedEx.com to find a location near you.
4I am out of FedEx® labels, what can I do?
Call and request that more labels be shipped to you. If you require a label for a same day shipment, one can be emailed to you. FedEx® labels can not be faxed due to the poor reproduction quality of fax machines.
5How can I verify that my package arrived at MicroGenDX?
Always retain the *Keep for your records* shipping label copy from your FedEx Express® shipping label. Go to FedEx.com and type in the tracking number of your package to check the delivery status.
6What is the latest time I can call for a FedEx® pickup?
FedEx® routes may vary from location to location. Call 1-800-GO-FEDEX (1-800-463-3339) to obtain a pickup schedule for your area. Only request a FedEx Express® pickup schedule, as other FedEx® methods do not apply.
7Can I give the package to any FedEx® driver?
Only FedEx Express® drivers will accept UN3373 Clinical Paks. FedEx Ground® drivers will not accept packages classified as such.
1What options are available to sending in supply orders?
You have the option to call 1-855-208-0019 or email your order to [email protected] . You can find an order form at www.microgendx.com. In the top right corner you will see a Request Kits tab, from there you will select fill out the digital form. There you will find, and select, the Supply Order. You can fill out the form on your computer, then simply submit your order.
2What if I did not receive enough supplies - or the wrong supplies?
3How long does it take for supplies to be shipped?
All supply orders are shipped via FedEx Flat Rate 2 Business day delivery. Supply orders requesting Overnight deivery must be received by 1:00 p.m. (EST) to be processed on the same business day.
4What volume of supplies will I receive?
You have the ability to choose the amount of supplies you need based on your need.
5What should I do if I have not received my supply order in the estimated time?
Please call the Supplies line at 1-855-208-0019 if you have not received your supplies in 2 days. MicroGenDX Customer Care is located in Orlando Florida. You should receive your orders within 2 days maximum.
6What should I do if I have not received my test results?
If you have not received your results within 48 hours, please call Customer Care at 1-855-208-0019
7Whom do I call if I am having FedEx® issues?
Please call your MicroGenDX Customer Care Department at 1-855-208-0019 with any issues or click here to contact us. They will help resolve the issue. In most cases you will hear back from our FedEx Representative.
8What if I am out of shipping boxes?
You may use any sturdy box that you can find while we are shipping you more boxes.
1Is it appropriate to make treatment decisions based solely on the results of PCR or the NGS test?
Diagnostic tests such as PCR and NGS are tools used in conjunction with patient symptoms, history, and other appropriate companion diagnostic tests (complete blood count, inflammatory markers, etc) that the provider deems appropriate to properly diagnose and treat.
2Does the information obtained with conventional culture correlate with MicroGenDX lab results?
Multiplex and comprehensive molecular technology is more sensitive than culture and can reliably detect multiple organisms in the specimen in the presence of antimicrobial therapy. NGS removes the human bias and variation of culture from microbiology laboratories, and does not require organism viability. Results may not always correlate due to the fact that NGS can detect organisms that are not readily grown in culture.
3What is the sensitivity and specificity for NGS
Both sensitivity (or the limit of detection – LoD) and specificity of NGS testing is determined as a part of our validation protocol. The steps outlined by the Clinical Laboratory Standards Institute are summarized in a document prepared by MicroGenDX and is available for circulation to our clients and their staff. Additional information about the sensitivity and specificity of a particular target on any one of the panels is also available upon request.
4What are important considerations in diagnosing urinary tract infections (UTI)?
Recurrent or chronic UTIs are sometimes the result of more than just a single infectious organism. Urine culture is biased towards a single infectious organism based on CFU (colony-forming unit) count, possibly leading to inappropriate therapy. Some problematic organisms are not readily grown in culture which may lead to incorrect treatment or non-treatment. The advantage of NGS is the ability to test and detect multiple organisms simultaneously, including those that may not grow readily in culture. And if the patient is currently on antibiotic therapy or has a recent history of antibiotic therapy, detection of pathogens by NGS is not impacted by the presence of antibiotics.
1If a patient is on anti-herpes medication, will it interfere with the test results?
Anti-herpes medications disrupt the process by which the virus makes copies of itself and spreads to new cells. The antiviral works by inhibiting an enzyme that the virus has, but human cells do not, and therefore interrupts the virus’ ability to synthesize its DNA. By reducing the replication of the Herpes virus, the number of virus particles shed by the host is reduced and tests (even molecular assays) may not always be able to detect viral shedding.
2What are the Human coronavirus targets that are included in the MicroGenDX Viral Respiratory Panel?
HKU1, 229E, OC43 and NL63. For SARS-CoV-2 testing, click here
3Does MicroGenDX test for parasites?
Yes. The Gastrointestinal Panel includes Giardia lamblia and Cryptosporidium parvum.
4When ordering the UTI Panel will I receive a list of antibiotic resistances?
5Does MicroGenDX test for Sexually Transmitted Diseases?
Yes. We currently offer multiple options for STI testing. Click here.
3What do the “antimicrobials for consideration” sections indicate?
We provide antimicrobials for consideration for each species detected. These antimicrobial options are based on the Sanford Guide and Johns Hopkins Guides. When a more typical bacteria like E. coli is detected that is easily grown in the micro lab, your local antibiogram which tracks local resistance patterns should be referenced – though this will only apply to 20-25 microbial species that are easily grown in culture. Click Here to View Example
4Why do some species show up in Level II but not Level I?
This sometimes happens when a strain of E coli or Kleb has a mutation at our primer binding site for our Level 1 assay. The mutation will cause it to not be detected by the Level 1. However, since Level 2, using a completely different site and technology, will be able to detected those strains.
Level 1 will be able to detect panel organisms at a lower concentration than level 2 (level 1 is more sensitive) However, Level 2 will detect numerous more organisms than Level 1.
Value of NGS over PCR is that we can still identify that’s had a strain mutation when the narrow range of PCR will not identify them.
We accept urine, blood, fluid, bone, tissue, hardware, mucus, fecal matter, semen, sputum, nail clipping and scrapings. Each sample will have its own guidelines. Please refer to the “How to Collect a Sample” Sheet prepared for each specialty. Click HERE to see the full library of “How to Collect a Sample” sheets.
2Does MicroGenDX accept tissue as a specimen source?
Tissue can be accepted as a specimen source but it is recommended that the tissue be no larger than the size of a pea.
3A client has a bronchial aspirate specimen that is clotted. Can the specimen be submitted for respiratory panel testing ?
4Is the eye an appropriate source for an infection site?
5When swabbing a wound should I swab some of the area or all of it?
Be Thorough swabbing the entire area of suspected infection site. Detailed instructions are in the how-to video and PDF found on the Wound Care specialty page.
6Do I collect the sluff in my collection process?
Yes. Sluff will carry DNA of microbes.
7Can urine be sent in a white cap container?
No, urine must be transferred to the yellow capped 8ml Vial.
8Is urine an acceptable specimen for the Bacterial Vaginosis and Candidiasis Panels?
9What is the proper amount of urine for a specimen?
Add approximately 8mls of urine.
10Does Urine have to be on ice?
11If I missed the last pick up from FedEx®, can I ship the following day or will I need to recollect the sample?
The next day, or week is just fine. DNA is not easily affected by time and temperature. If you weren’t able to ship out the same day or even missed last time of Friday ship the sample the next business day.
Antibiotic Sensitivities & Viable vs Non-viable bacteria
1Can NGS technology replace traditional culture if it doesn’t provide antibiotic sensitivities?
We do provide antibiotic resistance by detection of the resistant gene for the antibiotic classes.
Culture sensitivities can only be performed if you can “grow” the microbe.
Being able to culture “grow” a microbe is not the determining factor to verify if the species is a problem for the host.
Only 1% of all known microorganisms can be grown in culture. Most physicians have only seen 30-50 species on C&S reports their entire medical career.
We currently know the sequence codes for more than 50,000 species.
You will not get from your micro lab the sensitivities of the more than 4,000 species we have detected in human samples.
ECSMID guidelines make the point that antibiotic sensitivities have no clinical value when treating a biofilm infection.
Breakpoints to determine S-I-R have been established for planktonic bacteria however, breakpoints haven’t been established for the biofilm or community of microorganisms.
2How do you determine if the bacteria species are Viable?
Dead or Non Viable bacteria DNA degrades within 24 hours within the host environment.
Viable or Live bacteria once removed from the host environment it will take about 5 days for the DNA to die or degrade and become non-viable.
If you refrigerate the sample it will be good for weeks. If you freeze the sample, the DNA will not degrade, and will be good forever.
Due to the rapid degradation of DNA in dead bacterial cells it becomes extremely challenging for the technology to reach the threshold of DNA reads. If we don’t achieve enough DNA reads we can not detect the species.
If the bacterial species is listed in our report it has met our criteria for DNA reads.
3Interpretation of the lab report - what does all this mean?
Detecting multiple species in a sample may be overwhelming, especially seeing species that you do not recognize. We are providing a complete picture of the microorganisms at the site the sample was taken from. If the sample was taken from an area of the host which has an established microbiome, (sinus cavity, mouth) interpretation can be more of a challenge. The following are points you should consider when reviewing our report.
When treating a chronic infection you are dealing with biofilm phenotype.
CDC and NIH “have estimated that biofilm infections now constitute 65% to 80% (respectively) of bacterial infections treated by physicians in the developed world.
All bacteria / microorganisms will move to a biofilm phenotype.
If we detect multiple species from a host site that is normally sterile, there is a high probability you are dealing with a Biofilm.
4Questions on species detected:
A: What do I treat? Answer: Treatment decisions are based on multiple diagnostic criteria. Our report is not to be used in isolation. A common approach is to treat the dominant species when there is a concern for using multiple antimicrobials.
B. Is there a cut off of which species to treat? Answer: No. Multiple species identified could be interpreted as a biofilm. In the case of biofilm infections the microorganisms are a “collaborative community” and are highly synergistic. When the sample is taken from a site other than the mouth, sinus cavity, gut, or areas in the body where we have an established microbiome, there are no commensal bacteria (Good Bacteria). Commensals need specific host related mechanisms and those host dependent processes are not possible in wounds, RTI, UTI, or joint infections.
5What is found in non-infected patients?
You will find microorganism DNA in healthy people BUT you are going to have other diagnostic information to indicate infection. We give you precise information on what was detected at the site.
6Why doesn't the combined % of species add up to 100%?
We only report species that make up greater than 2% of the DNA detected.