Advisory - Laboratory Testing
The Ontario Ministry of Health has contacted the College of Naturopaths of Ontario (the College) and asked that we provide some important information to Registrants about two laboratory tests that Registrants frequently order, both from In-Common Laboratories (ICL).
The first test is the GI-Map stool analysis (ICL Test GIMAP) which ICL sends to the United States (US) for processing using the Diagnostic Solutions Laboratory GI-Map Assay. The second test is Lyme Immunoblot Panel 3, Serum (ICL Test IGXIB3), which ICL sends to the US. Neither of these tests are approved for use by the US Food and Drug Administration (FDA). Additionally, these tests do not currently meet Ontario’s case definitions for various enteric pathogens and for Lyme disease.
Based on detailed information provided to the College by the Laboratory Services Branch of the Ministry of Health, Registrants are advised and reminded that laboratories and specimen collection centres are regulated under the Laboratory and Specimen Collect Centre Licensing Act (LSCCLA).
Under this Act and its regulations:
- Registrants can take blood samples in office for the purposes of performing seven specified point of care blood tests in their office/clinic.
- Registrants can take non-blood samples in office for the purposes of performing nine tests in office. The samples permitted include urine and cultures.
- Registrants can take non-blood specimens in office from their patients and send those specimens to a laboratory licensed under the LSCCLA to perform that test and that will perform that test. These include stool, urine, saliva, hair, tissue/discharge/sputum and breath specimens. Registrants are authorized to order any of 61 tests.
- Although the ICL Test GIMAP is a “comprehensive digestive stool analysis” (which is a type of test authorized to Registrants), neither ICL nor its affiliated US laboratories are licensed under the Act to perform the test. As a result, naturopaths are not permitted to collect the required specimens for the purpose of ordering these tests through ICL to obtain information for diagnosis, prophylaxis or treatment.
- Registrants can requisition an Ontario licensed specimen collection centre to collect a blood sample from a patient for the purposes of performing any of 133 tests on that blood.
- Registrants can requisition the collection of specimens from an Ontario licensed specimen collection centre for the purpose of Lyme disease testing. In Ontario, only the 11 Public Health Laboratories are licensed to perform Lyme disease testing. The specimen collection centre will forward the sample to the Public Health Laboratory.
- Registrants must perform/order tests that are for diagnosis, prophylaxis or treatment of illness or disease. Test that are not authorized for diagnostic purposes are not available to Registrants.
Under the Health Protection and Promotion Act, both laboratories licensed under the LSCCLA and Registrants of the College of Naturopaths of Ontario have a duty to report positive findings in respect of a disease of public health significance (DOPHS), to the local medical officer of health of the relevant Public Health Unit.
On July 13, 2021, Dr. Barbara Yaffe, Associate Chief Medical Officer of Health, notified each of Ontario’s Public Health Units that ICL was instructed to stop sending reports to local medical officers of health relating to the ICL Test GIMAP and ICL Test IGXIB3, as the positive laboratory findings resulting from these tests are not believed to indicate the presumptive presence or presence of a DOPHS.
Nonetheless, the College reminds all Registrants that they still have a duty to report a DOPHS to their Pubic Health Unit if they otherwise form the opinion in the course of providing care (and not solely based on previously ordering the ICL Test GIMAP and ICL Test IGXIB3) that an individual has a DOPHS, in accordance with the Health Protection and Promotion Act. The Ministry of Health has also alerted the College that reports based solely on a previously ordered ICL Test GIMAP and ICL Test IGXIB3 will likely result in the Public Health Unit liaising with you or your patient directly to ensure that patients obtain alternative testing at an Ontario licensed laboratory to perform the appropriate test(s).
If you have any questions or concerns, please do not hesitate to contact the College at firstname.lastname@example.org.
Andrew Parr, CAE
Chief Executive Officer
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