Company FAQs
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 service that utilizes our proprietary qPCR (quantitative 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 is 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. MicroGenDX is also available in New York via the approval of Wadsworth Labs.
3How long has MicroGenDX been in business?
MicroGenDX was founded in 2008 as Southwest Regional PCR, LLC. In 2017 the company was acquired by Rick Martin and rebranded as MicroGen Diagnostics Laboratory.
4How many physicians use MicroGenDX?
More than 39,000 healthcare providers have utilized MicroGenDX testing.
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 3-5 days
- Cost reduction and avoidance: Reduced antibiotic utilization and better Antibiotic Stewardship
- Increased patient satisfaction
- Greater clinical value - by reducing the subjectivity of identification associated with conventional culture technology
Technology FAQs
1What is PCR?
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% of microbes within an infection site
- Fast results in 3-5 business days (from receipt)
- Simultaneous identification of bacteria, fungi, and antibiotic resistance genes
- Detection of bacteria in the presence of antibiotics
- Increased sensitivity
- Simple 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 gastrointestinal infections:
- Respiratory Viral Test Service
- Gastrointestinal (GI) Panel
5Why does MicroGenDX send out two separate lab reports instead of both LEVEL I and LEVEL II at the same time?
- The PCR PART I delivers the detection of microbes on the chosen panel and the presence of 17 antibiotic resistance genes within 24 hours of receipt. This report will also give “bacterial load,” ie the quantity of bacteria found in the sample.
- The NGS PART II is generally delivered within 3-5 business days of receipt of sample. The complex processing and verification associated with Next-Generation Sequencing typically takes us 3-5 days. The superior data delivered in the Level II report provides all the detected microbes within the sample and their relative abundances.
6Does MicroGenDX test for antibiotic susceptibilities?
- No, however, we do test for the following resistance genes via genotypic sensitivities:
- Quinolone Level
- Methicillin Level
- Vancomycin Level
- Beta-lactam Level
- Carbapenem Level
- Macrolide Level
- Aminoglycoside Level
- Tetracycline
- Bactrim
- 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. However, your local antibiogram, which tracks local resistance patterns, should also be referenced.
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.
FedEx® Shipping FAQs
1How many lab bags can I put in one FedEx® box?
You may fill the box with as many lab bags as possible to still allow the box to close well.
2How do I schedule a FedEx® Pick-Up?
- It’s easy! Just click on the FedEx Schedule a pick-up button located bottom bar of our website.
- Call FedEx at 1-800-GOFEDEX (1-800-463-3339). When calling say "agent" twice to speak to an agent. Let them know it's billable stamp prepaid pick-up.
There is also the option to drop off at any FedEx/Kinkos location and drop off at the 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 being handed to an agent at the counter. Drop package into drop box only. 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 cannot 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. Our packages are shipped via FedEx shipments, FedEx Ground drivers will not accept FedEx Express shipment.
Supplies FAQs
1What options are available to sending in supply orders?
You can find an order at www.microgendx.com. In the top right corner, you will see a Place Order tab, click Request Kits, 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. Alternatively call 1-855-208-0019.
2What if I did not receive enough supplies - or the wrong supplies?
Please contact Customer Care at 1-855-208-0019
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 shipping will result in an additional charge.
4What volume of supplies will I receive?
You can request an amount of supplies based on your need but that may be adjusted by your usage volume.
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.
6What should I do if I have not received my test results?
If you have not received your results within 48 hours (about 2 days), 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.
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.
Clinical Diagnosis FAQs
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 because NGS can detect organisms 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. In the case of a urine sample, it is recommended the patient be off antibiotics for 48 hours prior to taking the sample, however, the sample can still be processed if antibiotics are unavoidable.
Testing FAQs
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.
2Does MicroGenDX test for parasites?
Yes. The Gastrointestinal Panel includes Giardia lamblia and Cryptosporidium parvum.
3When ordering the UTI Panel will I receive a list of antibiotic resistances?
Yes.
Lab Report FAQs
1How do I retrieve my lab reports?
3 ways to retrieve your lab reports:
- MDX labs Secure Portal (Click Here)
- MDX Secure Email
- Secure FAX
2How can I better understand my PCR level I and NGS Level II lab reports?
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. Your local antibiogram should also be referenced.
4Why do some species show up in Level II but not Level I?
- In general: Level I will detect panel organisms at a lower concentration than Level I (level I is more sensitive). However, Level II will detect many more organisms than Level I. The value of NGS over PCR is that NGS can still identify a bacteria that has had a strain mutation when the narrow range of PCR will not identify them.
- For Example: A strain of E. coli or Klebsiella pneumoniae will have a mutation at the primer binding site for the Level I PCR assay. The mutation will cause it to not be detected by the Level I PCR. However, since Level II, uses a completely different primer binding site, and technology (NGS), the test will be able to detect those strains.
Specimen Collection FAQs
1What specimens are acceptable?
We accept urine, blood, fluid, bone, tissue, hardware, mucus, fecal matter, semen, sputum, nail clipping and scrapings. Each test and respective samples will have its own guidelines. Please refer to the “How to Collect a Sample” Sheet prepared for each specialty.
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 ?
Yes.
4Is the eye an appropriate source for an infection site?
Yes.
5When swabbing a wound should I swab some of the area or all of it?
Thoroughly swab the entire area of the 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.
7Is urine an acceptable specimen for the Bacterial Vaginosis and Candidiasis Panels?
Yes.
8What is the proper amount of urine for a specimen?
Approximately 8 milliliters of urine.
9Does Urine have to be on ice?
No.
10If 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 the last pick up on Friday, ship the sample the next business day.
- Samples should be shipped as soon as possible for best quality, and patient experience, and to take into account variation in shipping times. However, MicroGenDX stability testing shows samples as viable at room temperature for at least 21 days after collection.
- Always check sample collection instructions for more information on the maximum time a sample can be held.
Negative or Inconclusive Lab Report
1Why did I receive a "negative report"?
- Sample was collected from a site where there were no microbial species.
- Biocides or Lidocaine at 4% or higher came into contact with the sample, this can degrade the DNA in the sample.
- Sample contained an overabundance of host DNA.
- Sample contained only non-viable material – ie, pus, mucus.
- In the case of urine an antibiotic active metabolite was in the sample vial and degraded the DNA. This can occur if the patient is on antibiotics.
Antibiotic Sensitivities & Viable vs Non-viable bacteria
1Can NGS technology replace traditional culture if it doesn’t provide antibiotic sensitivities?
MicroGenDX offers genotypic detection of antibiotic resistance for 17 different antibiotic genes, a crucial service considering that culture sensitivities are limited by the necessity to successfully cultivate the microbe first. However, the ability to culture a microbe doesn't determine its significance as a pathogen, as only 1% of known microorganisms can be cultured. Traditional microbiology labs face limitations in providing sensitivities for species they cannot detect. MicroGenDX can detect over 57,000 species. In addition, ECSMID guidelines emphasize the limited clinical value of antibiotic sensitivities in treating biofilm infections, for which breakpoints haven't been established. While breakpoints exist for planktonic bacteria, they don't apply to biofilm or communities of microorganisms, underscoring the complexity of antibiotic resistance in clinical settings.
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 will take weeks 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 for a significant length of time.
- 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.
- For a detailed breakdown of your report please visit the corresponding our medical specialty: https://microgendx.com/microgen-diagnostics-specialties/
4Questions on species detected:
- 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.
- 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 provide 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.