Note: if you have been clinically diagnosed with Lyme disease or just got back a positive blood result (by IGeneX in the U.S. or the Public Health Lab in Canada) and don’t know where to turn, you can get in touch with Lyme Ontario or the Canadian Lyme Disease Foundation (CanLyme) for further information, help and support.
If you’d like to get right to the tutorial on how to send away a blood sample to IGeneX, skip to the next section entitled “IGeneX Testing Process” – but if you live in Ontario, be sure to read the important update six paragraphs below.
Before I get into the tutorial, I just want to make everyone aware that blood testing – no matter where you have it done – is not a foolproof method to determine whether one has Lyme disease. There currently isn’t a reliable blood culture test that can detect LIVE bacteria; the best we can do is to test for antibodies and sometimes (depending on when you may have been exposed to the bacteria) a person will unfortunately not have made detectable antibodies at the time of testing.
In Canada, an ELISA screening test is done first, but is not sensitive enough to screen for Lyme – according to a Health Canada newsletter outlining the limitations of our test kits. You should be aware that if you do not test positive on the initial screening, your blood will not undergo further testing with a Western Blot (the most accurate antibody test currently available). A negative blood test does not mean you don’t have Lyme disease.
There are several reasons that IGeneX provides a better test, but the two that resonated with me were: a) I could order the Western Blot and, b) it tested for two stains instead of one. In my own case, the blood testing I had done in Canada came back negative, yet I had close to 50 symptoms that my GP was unable to diagnose. That’s when I decided to send my blood for testing to IgeneX and seek out a Lyme Literate Medical Doctor (LLMD) in the U.S. who was familiar with diagnosing Lyme disease.
Because on my clinical symptoms and the picture below of an Erythema Migrans rash that appeared on my shin while vacationing in Naples Florida, my LLMD diagnosed me with Lyme disease. You can click on this link to fill out a symptom questionnaire to take into your own doctor to determine if you could have Lyme disease and here are some other examples of EM rashes. When my IGeneX blood results came back positive, it supported the clinical diagnosis of Lyme disease (like I mentioned earlier, blood tests are not the be-all and end-all when it comes to diagnosing Lyme disease).
IMPORTANT UPDATE (ONTARIO ONLY): In Ontario, some Naturopaths were previously providing a service to patients by conducting the blood draw blood and taking care of shipping to IGeneX on behalf of their patients. New regulations now prevent Ontario-based Naturopaths from directly ordering out of country tests, which unfortunately includes Igenex.
However, if you have a Naturopath or are planning on finding one, all is not lost. Your Naturopath can contact a company by the name of In-Common Laboratories (or ICL). ICL is a private not-for-profit lab. As long as your Naturopath is registered with ICL, he or she can order the test kit directly from ICL and sign the requisition for you. The test kit is then given to you, the patient, and all you have to do is take the kit into an affiliated Laboratory to get your blood drawn (ICL takes care of the shipping too).
ICL, has partnered with Alpha Laboratories in Ontario and Biotest Labs in Ottawa. As long as you go into one of these two labs to have your blood drawn, they will take care of the rest. When results are in, ICL will then forward them on to your Naturopath for interpretation.
Information to Pass Along to Your Naturopath
Alpha and Biotest Labs may have restricted hours at some locations, print out and take this pdf with you to your Naturopath if you are planning on doing the IGeneX testing through ICL: 2016-ILS Specimen Collection Hours for Naturopathic Doctors.
For registration with ICL and access to ICL’s test menu, you can pass these links onto your Naturopath: http://ils.iclabs.ca/portal/client-registration/ AND http://ils.iclabs.ca/test-menu/ or provide them with the following contact info for further information: Telephone: 416-422-3000 x 300 E-Mail: firstname.lastname@example.org
If you live outside of Ontario (and don’t have access to a Naturopath), you can follow the instructions in my tutorial below for how to send your own blood sample to IGeneX.
IGeneX Testing Process
In May of 2013 I sent my own bloodwork off to IGeneX. In this post, I’ll share what I learned to make it easier for anyone else in Canada wanting to undergo better testing for Lyme Disease by sending blood samples to IGeneX. Below is an itemized list of the process, followed by a detailed explanation and samples for each step.
- Contact IGeneX for Kit (free of charge): 1.800.832.3200
- Decide on which blood tests you want in discussion with IGeneX: 1.800.832.3200
- Find a Lab in advance: check ahead to see which lab in your area can draw blood (charge is generally $25 – $35 and should be drawn on a Monday or Tuesday).
- Arrange a FedEx Account online, then fill out Waybill and Commercial Invoice for customs once you have your kit. If you prefer not to set up an account, you will need to find a drop off location (visit a FedEx World Service Centre® or FedEx Authorized ShipCentre®)
- Find a Doctor or Naturopathic Doctor (ND) to sign the Test Requisition Form and fill out the rest.
- Have blood drawn at the lab. Be sure to bring the bright lime green instruction sheet included with the Kit so the lab technician knows what to do once blood is taken. Pack the vials according to the packing procedure found on the same instruction sheet.
- Arrange pick-up with FedEx. Pick-up can be arranged at your house or in some cases you may be able to drop off at a depot. Call FedEx at 1.800.463.3339 for assistance. You also have the option to ship without setting up an account by dropping your package off at a drop-off location: to ship without an account number, visit a FedEx World Service Centre® or FedEx Authorized ShipCentre®.
Contact IGeneX for Kit
IGeneX is a lab in California that specializes in testing for Lyme disease and other tick-borne diseases – or ‘co-infections’ – such as Babesia, Bartonella, Erlichia. More often than not, the tick leaves you with more that just a Lyme infection so it’s best to test for co-infections too. You can contact IGeneX at 1.800.832.3200 to order a test kit free of charge and to ask questions about which tests may be appropriate for you.
It will generally take up to two weeks for the kit to arrive, as it is sent by snail mail. As an alternative, some Lyme support groups and naturopathic doctors keep kits on-hand. If you can find one close to you, it may save you time to pick it up locally.
Decide on Blood Tests
Personally, I ordered #188 and #189 – Lyme Western Blot IgM and Lyme Western Blot IgG, as well as #5090 – the complete co-infection panel. Please see full pricing below for all the tests available (this lime sheet also has the test requirements for the lab technician and shipping requirements on it and comes with the IGeneX kit). My Lyme tests were $100 each and the co-infection panel was $660. Keep in mind that these prices may have changed since 2013 and you will have to factor in the Canadian dollar exchange rate.
Finding a Lab to Draw Your Blood
Have your blood drawn on Monday or Tuesday at the latest. I was going to have it done on Monday, but it was Memorial day in the States and nothing gets through customs on a holiday. Rather than have my blood sitting for a day in customs, I decided to postpone drawing blood until Tuesday. Any later than that and you run the risk of running into shipping delays and having your blood spoil before it can be tested (IGeneX does not work on the weekends).
A blood draw for IGeneX testing will cost around $25 – $35 if you can find a local lab to do it. Not all labs in Canada will draw blood for you, so call ahead to labs in your own area before you show up to ensure they’ll do it.
Initially I called LifeLabs’ head office and they said No. They said that IGeneX would have to call them to pre-arrange a contract first, so perhaps at some point in the future somebody will arrange that.
Then I called my local Gamma-Dynacare lab and they said they would do it if I came some time after 11:00 when they’re not as busy. When I got there, the clinician had to call head office to check and she got the ok to proceed.
I also heard that some locations of CML are familiar with the process, but again, you must call ahead to check the lab in your particular area.
FedEx Packaging and Procedures
The kit will come in a FedEx clinical pak (UN 3373) which is specially designated for shipping of biological substances such as blood. Also included will be a FedEx International Air Waybill. Please see the picture below for a sample Waybill for help on how to fill out the information that is required. I checked off ‘FedEx Intl. Priority” under item #4 (Express Package Services) – depending on where you’re located, it will get the package there the next morning by 10:30 and is the best option for shipping to IGeneX.
IGeneX filled out their own address information on the waybill, but the Recipients Tax ID Number was missing on mine. IGeneX’s ID number is 943147701 – note that you will also need this number for the Commercial Invoice that has to be printed and included with your Waybill (see further info below).
To ship your blood back to IGeneX, you will be responsible for all shipping charges. To register for a FedEx account in Canada to ship your blood back to IGeneX, click HERE and fill out all information requested. If you have any questions, call FedEx at 1-800-463-3339. For the first two weeks of shipping, I received a 30% discount; shipping my package from Toronto to IGeneX in California cost me just under $50.
When shipping your blood, you will also need to fill out a Commercial Invoice to get the package through customs. To access the commercial invoice page, click the following link: http://www.fedex.com/ca_english/services/international/customsforms/documents/ci.html. Under the 4th title down on the page, “Where Can I Find It?”, you can then click on FedEx Document Preparation Centre™ for online completion or a PDF download of the form. Note that this used to be directly accessible, but you must now login with your User ID and Password in order to download the pdf or fill it in online.
For help on how to fill out the commercial invoice, click the following link: http://www.canadacustomer.fedex.com//ca_english/customsguide/comminvoice.html
See also below for a sample on how to fill it out for bloodwork purposes. Note that in the Description of Goods Section in the lefthand column, I wrote down the information that I found on the two vials for my bloodwork. Depending on which tests you order, your description may be different so be sure to write in what is appropriate to your own package.
Once the commercial invoice is filled out, you MUST provide one original and two copies of the form for customs. Fold them up and insert them BEHIND the Waybill in the clear WayBill Ziploc bag which you should stick onto the front of the FedEx Pak. Be sure to tear off the first page of the Waybill – the ‘Senders Copy’ so you can track your package to ensure it gets delivered in a timely manner.
Test Requistion Form – Signature Required
The kit also includes a requisition form which needs to be signed by a doctor or naturopathic doctor. You can also print a requisition from the IGeneX website if you want to do this in advance. However, the requisition included on the website is slightly different from the international form included with the kit.
My own GP refused to sign the requisition, so I went to a walk-in clinic and was able to get a signature from a doctor on-staff (a lucky break). I also discovered that my ND was able to sign the form (Note that this no longer applies in Ontario – an ND cannot sign the form unless they are registered through ICL labs as described at the beginning of this post).
Fill out the rest of the requisition form with your contact and credit card information, date and time sample was collected, and check off all the panels you are ordering (there are more panels on the back of the page). If the form is not completely filled out, it could result in delay of testing, so it’s a good idea to have someone look it over for you (and any other documentation).
Having Blood Drawn at the Lab
Other contents of the kit are a styrofoam box containing the tubes for blood collection, labels for the tubes (fill the lables out with the your first and last name, date of collection, and date of birth then stick onto the tubes) and the lime green instruction sheet shown above to take with you to the lab, which will explain to the lab technician how to treat the tubes after the blood draw. There is also a clinical history form (shown below), which isn’t mandatory to fill out but it helps IGeneX gather stats:
Once the blood was taken, one of the tubes had to clot for 15 minutes and then get spun in a Centrifuge. The technician set a timer and then the tube was spun for an additional 10 minutes. She was nice enough to put the vials into the Styrofoam holder, put the absorbent paper on top of the vials and then close the container and put an elastic around it to hold it together. The Styrofoam holder then gets placed into the clear Ziploc bag included in the box. Then the Ziploc bag along with the completed Test Requisition Form (and Clinical History Form if you chose to fill it out) are placed inside the white cardboard box.
Arrange FedEx Pickup
When all was done, I went home and placed everything into the FedEx Pak, then I called FedEx to arrange to pick up at my house (I scheduled shipment before 5:00, but pickup was dispatched when I called and the driver came at 2:00).
Click HERE to track your package at FedEx once it is shipped.
You also have the option of dropping your package off at a FedEx depot. Search online for a location near you and for payment options: FedEx World Service Centre® or FedEx Authorized ShipCentre® or call FedEx at 1.800.463.3339 for assistance.
If you live in Toronto, keep in mind that California is 3 hours behind so a 10:30 am delivery there will actually be 1:30 pm here. I monitored tracking the next day and my package got there at 10:40 am. I also called IGeneX just to ensure it got there intact but was told that it takes all day to unpack the many packages and process them into the system, so I would have to call back at 4:00 if I wanted to check.
Test results take about two weeks (but that may depend on what you’re testing) and are only sent to the doctor that signed the requisition.