MicroGen FAQs

Company FAQs

1How is MicroGen DX different from other reference laboratories?
MicroGen DX is an innovative, CAP accredited, CLIA licensed, molecular diagnostic laboratory utilizing proprietary PCR (Polymerase Chain Reaction) technology. But what sets us apart in delivering truly superior molecular diagnostics is our Proprietary Bioinformatics System and our process in using NGS (Next Generation Sequencing) for precise detection of infectious diseases at high levels of sensitivity and specificity.
2What certifications does MicroGen DX have?
MicroGen DX 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 MicroGen DX been in business?
MicroGen DX 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 MicroGen DX Laboratory. Collectively this laboratory has been used by more than 8,000 doctors and delivered over 200,000 NGS lab results.
4How many physicians use MicroGen DX?
More than 8,000 doctors have relied on our Next-Gen Sequencing Laboratory.
5What are the key benefits of utilizing MicroGen DX’s service?
  • 24 hour turn-around for PCR Lab results (determined by sample receipt) for PCR reports
  • Detection of Resistance Genes

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

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 distinctions does MicroGen DX’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 infections, Level I and II.

For Respiratory Viral and Bacterial infections:

  • Respiratory Panel
  • Gastrointestinal Panel
5Why does MicroGen DX send out 2 lab reports instead of both LEVEL I and LEVEL II at one time?

Rapid PCR Level I delivers detection of microbes within the chosen panel within 24 hours. We also deliver the bacterial load and qualitative information as well as 8 gene resistances detected for immediate antibiotic therapy.

NGS Level 2 is delivered within 3-5 business days of receipt. A Next-Gen Comprehensive Report matching the sequence codes for 25,000+ microbes in the data base. The complexity and validation process currently takes 3-5 days. The superior data delivered in Level 2 report all the detected microbes within the sample by their percentage found. With this next level of data physicians can target the major contributor of the disease state in 99% more depth than any other test available for microbial detection.

6Does MicroGen DX test for antibiotic susceptibilities?

No, however we do test for the following resistance genes:

  • Vancomycin
  • Methicillin
  • Beta-lactam
  • Carbapenem
  • Macrolide
  • Aminoglycoside
  • Tetracycline

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 MicroGen DX perform gram stains?
No. MicroGen DX 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?
  1. It’s easy! Just click on the FedEx Schedule a pick-up button located in the top right corner of our website.
  2. 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.
5I am out of FedEx® UN3373 Clinical Paks, can I still send the shipment?
A FedEx® UN3373 Clinical Pak is required to ship a specimen to MicroGen DX. This type of packaging is not available at FedEx® locations and must be shipped to you from MicroGen DX. If you have run out of Clinical Paks, please call the MicroGen DX Customer Care Department at 877-820-8047 to request an overnight shipment.
6How can I verify that my package arrived at MicroGen DX?
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.
7What 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.
8Can 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.

Supplies FAQs

1What options are available to sending in supply orders?
You have the option to call 1-855-208-0019 or email your order [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?
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 Priority Overnight® delivery. Supply orders must be received by 6:00 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 do not receive 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. MicroGen DX Customer Care is located in Orlando Florida. You should receive your orders within 2 days maximum.
6What should I do if I do not receive my test results?
If you have not received your results within 48 hours, please call Customer Care at 1-855-208-0019
7Who do I call if I am having FedEx issues?
Please call your MicroGen DX 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.

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 MicroGen DX 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 MicroGen DX 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.
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 MicroGen DX 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.
3Does molecular detection quantitate the number of microorganisms in the specimen?
Although quantitation is important for certain infections such as determining viral load in Hepatitis C and HIV to adjust antiviral dosing, quantitation in bacterial infections can vary with the particular infection and the patient involved. In effect, the number of organisms infecting one patient may not be the same with another. Establishing some arbitrary threshold to determine whether someone is infected would not be accurate or practical.
4What 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 MicroGen DX 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.
5How does the clinician use the results of multiplex screening when test results are negative?
There are multiple reasons for a negative result. First, not all potential pathogens are tested on our panels. Our panels are designed to capture the most common causes of infection at a particular anatomic site. The value of a negative result provides the information that the most common pathogens for that particular site could be excluded. Second, infections in sterile sites such as the bloodstream or synovial fluid have a very low number of organisms, and could be below the limit of detection of our test for a particular target. Lastly, the collection of the specimen is key in obtaining an accurate result. For example, if a lower respiratory infection is suspected, then the specimen source should be from lower airway secretions instead of a nasopharyngeal (NP) swab.
6What 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.
7Can other laboratory tests detect H1N1?
Laminar flow immunoassays that are in place in most hospitals and physician offices detect the hemagglutinin (H) only and not only lack sensitivity but, also, lack the ability to determine the specific neuraminidase (N) component. In that regard, we are currently the only laboratory in the country that can accurately determine both the hemagglutinin and the neuraminidase of the H1N1 strain.
8If MRSA is detected, does that mean the patient is a carrier or has active MRSA disease and should be treated?
MRSA often colonizes the external nares, the axilla, and the perineum of a growing number of people. When the organism produces disease, it is often mechanically introduced into healthy tissue by self-inoculation (scratching mosquito bites, contact with cuts or scratches, etc.), or during surgical procedures when patients are not effectively decolonized before the surgery is performed. Whether a patient has MRSA disease and is in need of treatment is a clinical decision and is based upon whether the specimen is properly collected and if the patient is symptomatic.

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.
2What are the Human coronavirus targets that are included in the MicroGen DX Viral Respiratory Panel?
HKU1, 229E, OC43 and NL63
3Does MicroGen DX 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?
Yes.
5Does MicroGen DX test for Sexually Transmitted Diseases?
No. We currently do not test for STDs but we will be adding those panels in the near future.
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 MicroGen DX Viral Respiratory Panel?
HKU1, 229E, OC43 and NL63
3Does MicroGen DX test for parasites?
Yes. The Gastrointestinal Panel includes Giardia lamblia and Cryptosporidium parvum.
4Why do we test for Toxin B gene and not Toxin A with our C. difficile panel?
Recommendations from both the CDC and the IDSA conclude that toxin B is the primary toxin responsible for disease produced by Clostridium difficile.
5What is the smallest panel for Streptococcus Pyogenes or Group A Strep?
With the understanding that pharyngitis is most often caused by viruses, the Pharyngitis Panel includes Group A Strep as well as other organisms that either cause or contribute to the severity of symptoms.
6When ordering the UTI Panel will I receive a list of Antibiotic Resistances?
Yes.
7Does MicroGen DX test for Sexually Transmitted Diseases?
No. We currently do not test for STDs but we will be adding those panels in the near future.

Lab Report FAQs

1How do I retrieve my lab reports?

3 ways to retrieve your lab reports:

  1. MDX labs Secure Portal (Click Here)
  2. MDX Secure Email
  3. Secure FAX
3What is the antibiotic Recommendation sheet?
We provide an 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. Click Here to View Example

Specimen Collection FAQs

1What specimens are acceptable for collecting the specimen source?
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. (build out the library)
2Does MicroGen DX 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.
3Client 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.
5What color tube cap is used for Sinus and Ear Infection collection for testing?
Orange.
6What color tube cap is used for Wound collection for testing?
Red.
7When 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.
8Do I collect the sluff in my collection process?
Yes. Sluff will carry DNA of microbes.
9What color tube cap is used for Vaginal collection for testing?
Red.
10Can urine be sent in a white cap container?
No, urine must be transferred to the yellow capped 60ml Vial.
11Is urine an acceptable specimen for the Bacterial Vaginosis and Candidiasis Panels?
Yes.
12What is the proper amount of urine for a specimen?
Add approximately 10mls of urine.
13Does Urine have to be on ice?
No.
14If 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.

Negative or Inconclusive Lab Report

1Why did I receive a "negative report"?

5 reasons your sample may have been compromised

  1. Sample was collected from a site where there was no microbial species.
  2. Biocides or Lidocaine at 4% or higher was on the sample.
  3. Sample contained an overabundance of host DNA.
  4. Sample contained only non-viable material – ie, pus, mucus.
  5. 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

1NGS technology can’t replace traditional culture because it doesn’t provide Antibiotic Sensitivities.
  1. We do provide antibiotic resistance by detection of the resistant gene for the antibiotic classes.
  2. Culture sensitivities can only be performed if you can “grow” the microbe.
  3. Being able to culture “grow” a microbe is not the determining factor to verify if the species is a problem for the host.
  4. 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.
  5. We currently know the sequence codes for more than 25,000 species.
  6. You will not get from your micro lab the sensitivities of the more than 4,000 species we have detected in human samples.
  7. ECSMID guidelines make the point that antibiotic sensitivities have no clinical value when treating a biofilm infection.
  8. 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.

  1. 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.
  2. 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.
  3. 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.

  1. When treating a chronic infection you are dealing with biofilm phenotype.
  2. CDC and NIH “have estimated that biofilm infections now constitute 65% to 80% (respectively) of bacterial infections treated by physicians in the developed world.
  3. All bacteria / microorganisms will move to a biofilm phenotype.
  4. 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 don’t the % of species add up to 100%?
We only report species that make up greater than 2% of the DNA detected.