Company FAQ's

How is ImmunoGenDX different from other reference laboratories?


ImmunoGenDX 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.




What certifications does ImmunoGenDX have?


ImmunoGenDX 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.




What are the key benefits of utilizing ImmunoGenDX’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





 

Technology FAQ's

How do I retrieve my lab reports?


3 ways to retrieve your lab reports:

  • MDX labs Secure Portal (Click Here)
  • MDX Secure Email
  • Secure FAX




What 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




Why 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. In general:
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.





 

FedEx shipping FAQ's

How 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.




How do I schedule a FedEx® Pick-Up?


  • It’s easy! Just click on the FedEx Schedule a pick-up button located in the top right corner of our website.
  • 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.




Can 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.




I 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.




How can I verify that my package arrived at ImmunoGenDX?


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.




What 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.




Can 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 FAQ's

How do I retrieve my lab reports?


3 ways to retrieve your lab reports:

  • MDX labs Secure Portal (Click Here)
  • MDX Secure Email
  • Secure FAX




What 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




Why 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. In general:
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.





 

Clinical Diagnosis FAQ's

What 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.




What 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.




What distinctions does ImmunoGenDX’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.




What 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:

  • Respiratory Panel
  • Gastrointestinal Panel




Does ImmunoGenDX test for antibiotic susceptibilities?


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

  • 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. 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.




Does ImmunoGenDX 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.





 

Testing FAQ's

If 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.




What are the Human coronavirus targets that are included in the ImmunoGenDX Viral Respiratory Panel?


HKU1, 229E, OC43 and NL63




Does ImmunoGenDX test for parasites?


Yes. The Gastrointestinal Panel includes Giardia lamblia and Cryptosporidium parvum.




When ordering the UTI Panel will I receive a list of Antibiotic Resistances?


Yes




Does ImmunoGenDX 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 Result FAQ's

How do I retrieve my lab reports?


3 ways to retrieve your lab reports:

  • MDX labs Secure Portal (Click Here)
  • MDX Secure Email
  • Secure FAX




What 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




Why 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. In general:
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.





 

Specimen Collection FAQ's

What 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.




Does ImmunoGenDX 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.




Client has a bronchial aspirate specimen that is clotted. Can the specimen be submitted for respiratory panel testing ?


Yes




Is the eye an appropriate source for an infection site?


Yes




When 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.




Do I collect the sluff in my collection process?


Yes. Sluff will carry DNA of microbes.




Can urine be sent in a white cap container?


No, urine must be transferred to the yellow capped 8ml Vial.




Is urine an acceptable specimen for the Bacterial Vaginosis and Candidiasis Panels?


Yes




What is the proper amount of urine for a specimen?


Add approximately 8mls of urine.




Does Urine have to be on ice?


No




If 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

What 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.




Does ImmunoGenDX 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.




Client has a bronchial aspirate specimen that is clotted. Can the specimen be submitted for respiratory panel testing ?


Yes




Is the eye an appropriate source for an infection site?


Yes




When 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.




Do I collect the sluff in my collection process?


Yes. Sluff will carry DNA of microbes.




Can urine be sent in a white cap container?


No, urine must be transferred to the yellow capped 8ml Vial.




Is urine an acceptable specimen for the Bacterial Vaginosis and Candidiasis Panels?


Yes




What is the proper amount of urine for a specimen?


Add approximately 8mls of urine.




Does Urine have to be on ice?


No




If 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

NGS technology can’t replace traditional culture because 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.




How 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.




Interpretation 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.




Questions 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.




What 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.




Why don’t the % of species add up to 100%?


We only report species that make up greater than 2% of the DNA detected.