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Company FAQs

How is Diatherix different from other reference laboratories?

Diatherix is an innovative, CAP accredited, molecular diagnostic laboratory utilizing proprietary TEM-PCR™ (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases at high levels of sensitivity and specificity.

What certifications does Diatherix have?

Diatherix is CAP-accredited and CLIA certified and follows the guidelines established by CAP, CLIA, and the Clinical Laboratory Standards Institute (CLSI) for validation of molecular testing technologies.

How long has Diatherix been in business?

Diatherix was founded in 2008.

How many physicians use Diatherix?

More than 13,500 physicians have ordered test panels since 2010.

What are the key benefits of utilizing Diatherix's service?

• One day results (determined by sample receipt)
• Cost reduction and avoidance
• Reduced antibiotic utilization
• Increased patient satisfaction
• Greater clinical value - by reducing the subjectivity of identification associated with conventional culture technology

Technology FAQs

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). TEM-PCR™ (Target Enriched Multiplex 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 distinctions does TEM-PCR™ technology offer?

• One day results (determined by sample receipt)
• Simultaneous identification of bacteria, viruses, parasites, Candida and antibiotic resistance
• Detection of bacteria in the presence of antibiotics
• Increased sensitivity and specificity
• Simplicity of single sample collection

Why does Diatherix only offer panels of tests versus one individual test?

Many pathogens have overlapping symptoms, making it a challenge to determine the causative organism based only on patient presentation. The true benefit of TEM-PCR™ is the ability to test for multiple organisms simultaneously in a rapid and cost-effective manner, thus providing the clinician more information to make a better informed treatment decision.

Does Diatherix test for antibiotic susceptibilities?

Diatherix tests for resistance genes that are specific to staphylococcus. When resistance genes are found in clinical specimens, the particular class of antibiotics affected by the detected resistance gene should be avoided when applying antibiotic coverage.

Does Diatherix perform gram stains?

No. Diatherix does molecular testing, not microbiological testing.

FedEx® Shipping FAQs

How do I schedule a FedEx® pickup?

Call 1-800-GO-FEDEX (1-800-463-3339) to schedule a pickup. Once in the automated system press ‘0’ for the first three prompts to speak with a customer service representative. Tell the representative that you have a “Prepaid FedEx Express® Label Pickup” and provide them with your address information. Write down the confirmation number for the pickup and retain it for your records.

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 877-820-8047 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.

I 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 Diatherix. This type of packaging is not available at FedEx® locations and must be shipped to you from Diatherix. If you have run out of Clinical Paks, please call the Diatherix Logistics Department at 877-820-8047 to request an overnight shipment.

How can I verify that my package arrived at Diatherix?

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 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.

Diatherix Supplies FAQs

How can I order more supplies?

Option #1: Complete this electronic PDF version of the Client Supply Order Form and click the submit button at the bottom and follow the steps listed to electronically submit your form.
Option #2: Print the completed Client Supply Order Form and fax it to 256-327-0984.
Option #3: Save the completed Client Supply Order Form and email it to: supplies@diatherix.com.
Option #4: Call our Diatherix Logistics Department at 877-820-8047.

What if I did not receive enough supplies or the wrong supplies?

Please contact Supplies at 877-820-8047.

Where can I locate my client number?

Your client number is a three or four digit number in parenthesis next to your office name to the right of the barcode on your requisition form.

How long does it take for supplies to be shipped?

All supply orders are shipped via FedEx Ground® and may take up to 3 business days to arrive. If you are out of supplies, please request FedEx Priority Overnight® delivery. Supply orders must be received by 3:00 p.m. (CST) to be processed on the same business day.

What volume of supplies will I receive?

Diatherix ships a 60 day supply based on your previous 30 day volume. This ensures proper rotation of stock and minimizes your time required to order.

What type of media is contained in Diatherix tubes?

Amies media in Eswab™ tubes, and guanidine thiocyanate in the Genital Health tube.

What should I do if I do not receive my supply order in the estimated time?

Please call the Supplies line at 877-820-8047 if you have not received your supplies in 2-4 days. Diatherix is located in North Alabama. The farther away you are, the longer it will take for supplies to reach you. However, you should receive your orders within four days maximum.

What should I do if I do not receive my test results?

If you have not received your results within 48 hours, please call Client Services at 877-820-8047

Who do I call if I am having FedEx issues?

Please call your Territory Manager with any issues. They will notify the Logistics Department to help resolve the issue. In most cases you will hear back from our FedEx Representative.

What if I am out of shipping boxes?

You may use any sturdy box that you can find while we are shipping you more boxes.

What option are available to sending in supply orders?

You have the option to call 877-820-8047, fax 256.327.9858, or email your order to supplies@diatherix.com. You can fi nd an order form at www.diatherix.com. In the top right corner you will see a Resources tab, from there you will select Resource Directory. There you will find, and select, the Supply Order. You can fill out the form on your computer, then email to us at supplies@diatherix.com. You may also print from here if you would to keep blank forms on hand or if you prefer fax.

Clinical Diagnosis FAQs

Is it appropriate to make treatment decisions based solely on the results of a TEM-PCR™ test?

Diagnostic tests such as TEM-PCR™ are a tool 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.

Does the information obtained with conventional culture correlate with TEM-PCR™?

Multiplex molecular technology (TEM-PCR™) is usually more sensitive than culture and can reliably detect multiple organisms in the specimen in the presence of antimicrobial therapy. TEM-PCR™ 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 TEM-PCR™ can detect organisms that are not readily grown in culture.

Does 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.

What is the sensitivity and specificity for TEM-PCR™?

Both sensitivity (or the limit of detection – LoD) and specificity of TEM-PCR™ 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 Diatherix 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.

How 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.

How does the clinician interpret the information provided on antibiotic resistance gene detection?

Antibiotic resistance gene targets detected on the Diatherix panel are best interpreted when staphylococci or enterococci are also detected on the panel. Although other organisms may have the genes that we detect, most of the Gram negative bacteria that may be detected in our panels can have other resistance genes that are not included in our test menu at this time. Our technology reliably and rapidly identifies microorganisms. The selection of an appropriate antibiotic that can be used to treat a clinically apparent infection is based upon standard ‘bug-drug’ combinations as outlined by references such as the Sanford Guide, or an antibiogram from a local hospital.

What is the significance of detecting organisms in the respiratory tract?

The upper respiratory tract is heavily colonized with a variety of bacteria that are part of our natural flora; now being referred to as our microbiota. It is now recognized that several bacteria and viruses that cause infections such as otitis media, pharyngitis, and sinusitis can be found in both symptomatic and asymptomatic patients. Making a diagnosis of infection is dependent upon getting a comprehensive accounting of the organisms present, associating them with compatible clinical signs, and companion diagnostics. The identification of multiple detections may reflect a more problematic course of infection for a patient with significant symptoms.

How should I interpret the detection multiple organisms in a respiratory specimen?

While the exact significance of a given combination of detected pathogens is hard to determine, we do know that there is often synergy between pathogens. This can be between viruses and viruses, viruses with bacteria, and bacteria with bacteria. For example, at least 90% of all pneumonia cases begin with an antecedent viral illness. The interaction between multiple organisms (both viruses and bacteria) is the rule rather than the exception. As with all diagnostic reports, the provider should consider the results as indication of the presence of the pathogen(s), rather than proof of active infection. Considering the reported organism(s) with respect to the clinical presentation to arrive at the diagnosis.

What is the significance of Neisseria meningiditis detection?

A significant number of patients have, as a part of their microbiota, organisms that can cause significant disease when found in a sterile site such as the blood or spinal fluid. One such organism is Neisseria meningiditis. It is now recognized that between 10 to 20 percent of children may harbor this organism as a part of their microbiota intermittently or continually and remain asymptomatic. Detecting the presence of ‘would-be pathogens’ is important in that the patient can be a reservoir of infection for immune-compromised family members or friends. In addition, the patient’s immune competence is not always a constant and knowing that a potentially problematic organism is a part of the patient’s microflora can be important for early recognition of significant disease downstream.

What are important considerations in diagnosing urinary tract infection (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 TEM-PCR™ 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 TEM-PCR™ is not impacted by the presence of antibiotics.

How should the clinician approach specimen collection on patients suspected of having a sexually transmitted disease (STD)?

The patient’s clinical symptoms and presentation must dictate the type of specimen and collection technique used. Although urine is an acceptable method of collecting STD specimens, the selection of a specimen type should be considered based on the patient symptoms and clinical presentation. Please refer to the recommended collection techniques for STD specimen collection published by Diatherix.

C. diff: Why do you only test for Toxin B and not Toxin A?

Current research suggests that Toxin B, and not Toxin A is required for virulence. Given the evidence for the role of tcdB (not tcdA) in the pathophysiology of pseudomembranous colitis, we have excluded the Toxin A target from the panel. Some labs have chosen to combine Toxin A/B, and do not differentiate between the two.

Why do we test for B. pertussis but not B. parapertussis?

Bordetella parapertussis is similar to B. pertussis and causes a pertussis-like illness. However, B. parapertussis does not produce the pertussis toxin and therefore the infections are typically milder and often asymptomatic. The CDC estimate is that B. parapertussis produces 1%-35% of infections that are ‘pertussis-like’. Given the symptoms and prevalence, our focus is on B. pertussis.

Can 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.

If 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

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 Diatherix Viral Respiratory Panel?

HKU1, 229E, OC43 and NL63

Does the coronavirus target detect the novel MERS strain?

No.

Does Diatherix test for parasites?

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

Why 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.

Does Diatherix test for the following diseases?
• Varicella-zoster virus (chickenpox)
• Herpes zoster virus (shingles)
Tinea corposis (ringworm)
• Mold

No.

Does Diatherix test for Bactrim, Bactrim DS, and other combinations of this antibiotic class?

No.

What 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.

What is the smallest panel for Bordetella pertussis?

Atypical Pneumonia Panel

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

No.

Do we have a chain of custody for minors and STD testing?

No.

Is the Diatherix Sexually Transmitted Disease Panel acceptable for a test of cure?

Yes, under the appropriate clinical circumstances.

Specimen FAQs

Does Diatherix test spinal fluid?

No.

Does Diatherix accept tissue as a specimen source?

Tissue can be accepted as a specimen source but it is recommended that the tissue be pulverized/ground up before placing in collection tube.

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

Yes.

Can a STD panel be performed on a female that is on her menstrual cycle?

Yes.

Is the eye an appropriate source for the STD panel?

Yes.

What color tube is used for eye secretion collection for children for STD testing?

Orange.

Can urine be sent in a white cap tube for an STD test?

No, urine can only be tested for an STD in the orange cap tube.

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

Yes.

Is urine an appropriate sample for HPV?

No.

What is the proper amount of urine for a specimen?

Add approximately 1mls of urine to the 1ml of fluid already in tube.

Is colonic aspirate an acceptable specimen?

Yes.