Yes! Health Canada requires prior registration, regulatory review, and approval for medical devices marketed in Canada. Rapid tests are a kind of medical device (Class II, III, or IV), and approved tests are registered in the Medical Devices Active Licence List (MDALL). As a Canadian company serving the Canadian market, we are required to sell authentic licenced tests from approved manufacturers who have gone through Health Canada’s rigorous registration process.

Rapid tests earn their moniker by providing human-legible results within minutes. With paper-based lateral flow technology that doesn't require complex laboratory equipment or processing, rapid tests deliver results in 1-20 minutes. Colloidal gold nanoparticle chemistry makes their test lines a visible purple-red to the human eye.

Most rapid tests use paper, water, and a targeted mixture of reagents. Think of a pregnancy test: the sample flows along the strip, and if the target substance is present, it creates a visible line or other indicator as a result. A wide range of chemistries and reactions can have this outcome. A lateral flow immunoassay is the technical name for a device that detects the presence of a target substance in a liquid sample by flowing through a membrane like paper.

No, rapid tests exist for many different health conditions. While Covid-19 made rapid tests widely known, they're available for various conditions including vitamin D levels, HIV, influenza, strep throat, and many other biomarkers. There are also many rapid tests for other purposes: veterinary health, foodborne contaminants, environmental toxins, and drugs (for harm reduction, substance analysis, and compliance assessment purposes).

Compared directly against lab tests for regulatory quality certification, rapid tests are highly accurate, often 95% or higher. Accuracy in this case is usually calculated from a combination of sensitivity (false positives), specificity (false negatives), and concordance (overall consistency with reference system).

Rapid lateral flow immunoassay tests are typically categorized as in-vitro diagnostics (IVD) devices. Rapid tests are also known as lateral flow tests (LFTs), point-of-care tests (POCTs), rapid diagnostic tests (RDTs), chemiluminescence assays, or immunochromatographic tests. Many use colloidal gold nanoparticles to produce the familiar reddish colour of the control and test lines. Other tests which may be described as rapid include colorimetric tests, such as enzymatic urinalysis tests, which produce specific colours in response to the presence of specific compounds in a urine sample.

These three terms are used to describe the accuracy of in-vitro diagnostics (IVD) like rapid tests.
• Sensitivity: Of all the times the test results were positive, how many were positive when tested by the reference system. A higher number means fewer false positives, where the reference system result was negative but the test was positive.
• Specificity: Like sensitivity, but for negatives. Of all the times the test results were positive, how many were negative when tested by the reference system. Higher specificity means fewer false negatives, where the reference system result was positive but the test was negative.
• Accuracy: Depending on the manufacturer or marketer, this number is calculated differently; sometimes, it is the only number on the packaging. Generally, it represents a combination of sensitivity and specificity, but an accuracy number alone is not enough for a professional to trust a test.
• Concordance: The degree of agreement between rapid test results and reference system test results. Sensitivity and specificity are both measures of concordance, focused on positive and negative result concordance, respectively.

Yes! No requisitions are required for any of the rapid tests we sell, since they are approved by Health Canada specifically for usage by individuals.

It depends, like most things in our system! Generally, rapid tests for personal use are not covered by the government or insurers, but they are significantly more affordable than other options and so make sense for people who are seeking agency in their own care. However, certain healthcare facilities and organizations use or provide rapid tests of various kinds for specific populations. In Toronto, UHN Emergency and Unity Health use HIV rapid tests, Community Health Centres use Strep A rapid tests, and province-covered Covid tests remain available for certain immunocompromised people (if they want to or can go to a pharmacy while they’re sick).

Yes, rapid tests and laboratory tests often look for the same biomarkers, and yes, rapid tests and labs are both approved to do what they do by stringent regulations. However, they use different methodologies to analyze different samples. Rapid tests are made for indicative purposes, providing quick qualitative or semi-quantitative results. Lab tests typically use high-volume equipment and can provide more detailed quantitative results; in general, lab tests are considered the “gold standard” for confirmatory testing. Specialized rapid tests for professionals, combined with reader devices, can provide quantitative results by detecting result intensity. Indicative results, such as those from rapid tests, may or may not warrant further investigation via lab tests.

This is a great question, and something we want to learn more about as well. We ask our test-takers to share the result with their providers, and to share what happened next in an after-test survey. Generally, because these are Health Canada-approved medical devices, most providers are open to them as indicators for further clinical evaluation, potentially leading to confirmatory lab testing.

Technically, rapid tests are not supposed to be interpreted after a certain read window, because they dry out, and that can create changes in their appearance. Each test has a different read window, depending on the complexity of the chemistry and physics at play in the analysis. Anecdotal experience suggests rapid tests look about the same to the naked eye after the read window.

We suggest taking two pictures on your phone: 1, when you apply the sample, and 2, once enough time has passed and the test reaches its read window. This is the minimum amount of information to show that you documented the result while it was still most accurate, during its read window, since the difference between timestamps would indicate how many minutes passed.