The following are answers to Frequently Asked Questions we typically receive from physicians, patients and the general public who are interested in the tests we offer. If you have a question that is not addressed here, we would greatly appreciate it if you would take a few minutes to send it to us via the "Contact Us" box on the home page.
What is T Lab Inc?
T Lab Inc (TLab) is a CLIA-approved high complexity lab providing both clinical tests and RUO (Research Use Only) tests to physicians and qualified, licensed health practitioners.
Are TLab tests, “Lyme” tests, and how are these tests related to Lyme disease?
Lyme disease, medically defined, is an infection with Borrelia burgdorferi. If this infection persists for any reason, then it may cause a wide range of symptoms. These symptoms can not usually be used to make a medical diagnosis. The symptoms are often vague and can be caused by many other things, ranging from other infections to other causes of inflammation.
Non medical people may often refer to the set of symptoms (that are not specific for Lyme Disease) as “lyme disease” or “Lyme’s disease” only because the vague symptoms sometimes seen with persistent Borrelia infections may be more easily described using this term in social communications. However, this is a major reason for the confusion and controversies. This is sometimes referred to as “#lymedisease’ as it is more of a social definition rather than a medical definition.
Actual medically defined Lyme disease, caused by Borrelia, is often complicated by co-occurring infections often seen together with Borrelia, such as Bartonella or Babesia. Thus, patients who don’t improve with Borrelia-directed treatment for Lyme disease, may have persistent symptoms.
TLab develops tests to help provide molecular evidence of these various infections to help inform better treatment strategies. A Bartonella test is not a ‘lyme’ test and a Babesia test is not a ‘lyme’ test, but these tests may be important to do in a patient suspected of having medically defined Lyme disease caused by Borrelia.
These other microbes can also cause their own diseases that may resemble Lyme disease even though, medically speaking with precision, these are not causes of Lyme disease as it is medically defined.
This complicated and confusing set of issues is the reason why TLab was founded - to help provide molecular images of pathogens and the host inflammatory response, to help accurately detect the appropriate microbial targets of treatment for diagnosis and to monitor the success of therapies.
Hopefully, soon, better clinical studies using molecular diagnostics will provide solutions for patients with these complex chronic conditions.
What is the BNR test, and what is it for?
The BNR test examines specially prepared whole blood samples under high-resolution microscopy to identify the presence of biofilm (B), neutrophil lysis/degranulation (N), and red blood cell inclusions (R).
RBC inclusions may, but do not always represent intracellular pathogens. This may help the clinician develop a better differential diagnosis and direct additional diagnostic testing by the clinician.
This is NOT a standard blood smear review and it is NOT developed to detect protozoa, such as Malaria- or Babesia-like organisms.
What are "Molecular Imaging" tests?
We use a technology known as “FISH” (which is an acronym for Fluorescence in Situ Hybridization) to detect the presence of a pathogen’s genetic (DNA or RNA) specific signature in blood and skin specimens. In FISH testing, highly specific molecules targeting the molecular sequence of interest (called probes) are used to attach to specific sections of a pathogen’s RNA or DNA, bind with it, and then fluorescent tags (that emit light when struck by a laser of a specific frequency) are examined and images produced using a confocal laser microscope. The combination of methods enhances sensitivity while maintaining specificity. They can be developed for finding almost any DNA or RNA sequence in blood and other tissues.
Why RNA probes?
RNA is thought to have a shorter half-life in the blood, therefore, a positive RNA FISH result is more likely to reflect an active infection.
Why ribosomal RNA (rRNA) probes?
rRNA is an important constituent of ribosomes, the ‘factory’ where proteins are synthesized by living organisms. rRNA is among the most abundant RNA in cells, allowing probes of rRNA the ability to more efficiently detect microorganisms. rRNA also reflects the level of metabolic activity of the cell, therefore, in the detection of rRNA the probe signal strength is increased with metabolic activity of the cell. Therefore, rRNA probes have the advantages of higher sensitivity, reflect metabolic activity, and thus are able to demonstrate metabolically active infections.
What does an ‘Indeterminate’ result mean on the molecular imaging (RNA probe) tests?
An ‘indeterminate’ result means that the signal is comparable to a background level of signal and can not, therefore, be interpreted as either positive or negative. If a previous test was positive and a follow up test is Indeterminate, then it suggests that the burden of the microbe is being reduced BUT only if ongoing testing shows this to be part of a trend. Levels may fluctuate considerably during treatment but over time, a high rate of indeterminate results leading to negative results will be seen as a trend. Consecutive negative results may indicate full suppression of the microbe and with further research and experience, together with other clinical and lab data, may become a helpful marker for determining when the course of treatment has succeeded.
What is confocal scanning laser microscopy?
Confocal scanning laser microscopy is a technique that uses a laser to scan multiple layers in the sample. These layers can then be collapsed or merged to make a 3D image of the sample. It allows for quantifiable imaging of samples that are thicker than samples could be in a conventional microscope. By cutting out background light and imaging one section at a time the confocal gives a more accurate image.
Will insurance pay for these tests? Medicare? Medicaid?
Reimbursement for these tests is highly variable and up to your plan and coverage. TLab does not submit claims to private insurance companies. At your request, we will provide you a copy of your test requisition form along with proof of payment and CPT code information for the test(s) ordered. This is all the information you will need to submit a claim to your insurance company on your own behalf.
How do I order TLab tests?
Please speak with your practitioners, and inform them of TLab's test offerings. If you are interested in having TLab tests, practitioners must set up a TLab account by filling out the Contact form on this website. TLab will follow-up with them by providing specimen collection kits and giving them secure access to our requisition forms reports portal. At a practitioner’s request, we can ship specimen collection kits directly to patients (in most states) when tests are ordered.
Where do I go for the tests?
That depends on your practitioner. Many practitioners will draw your blood or perform a skin biopsy in their offices. Others will send their patients to commercial laboratories or other practitioners for these services. TLab provides all of the necessary forms and instructions to your practitioner for specimen collection and shipping. If requested, TLab will provide the kits directly to patients to take with themselves to commercial labs or other providers to obtain specimens. Specimens can only be collected and shipped on Monday through Thursday.
How are tests shipped?
Using the special kits provided by TLab, specimens must be shipped to TLab via FedEx on the same day as collected, and only on Monday through Thursday if within the United States. All forms must be included in the kit with the specimens when they are shipped.
Are TLab tests available to international patients?
When requested by your physician TLab will send you all the necessary specimen kits and forms for obtaining you specimens and shipping them to us. We will need from you your kit shipping information in the following format split between different fields: Street Number: Street Name: City: State/Province: Postal Code: Country: Phone Number
Due to the increased cost of international shipments, we must bill you for the shipping costs. The shipping cost will be added to the cost of the test(s) ordered and charged using the credit card provided on the TLab payment form.
Note: Specimens from outside the United States can ONLY be shipped on Monday.
How long does it take to get results?
Turnaround time for blood and skin test results is 4 to 6 weeks.
Who can I talk to about my results?
TLab provides test results directly to the ordering physician/practitioner. Patients must consult with their provider to discuss the findings and meaning (for their care) of these test results and also to discuss the implications the results may have for their treatment or further testing.
Do you have a question?
Please let us know if you have any questions about our services that you think would be good additions to these Frequently Asked Questions. We look forward to hearing from you!