Services aimed at making healthcare more accessible and cater to people that want to be more involved in their wellness has led to an explosion of at-home lab services. Everything from DNA tests that offer insight to ancestry, to menopause prediction tests, STI tests, and of course 2020 also ushered in the common use of home Covid-19 tests. While these types of tests, often referred to as DTC (direct to consumer) tests are convenient and enable people to be proactive about their healthcare, many healthcare providers and consumer advocates question the trade off between convenience and accuracy, privacy concerns, and the potential lack of continued care.
What are at-home lab tests?
Some of the earliest at-home tests included pregnancy tests and blood-sugar tests for diabetics. Both were game changers in providing people insight to better decide course on future care and maintaining their health. The tests helped reduce costs for patients, provided easy, accurate results, and also cut down on the need for visits to providers for basic screening. But in recent years, the popularity of at-home tests has grown to include DNA tests, completed with a saliva swab, which can give people insight into disease predispositions (for Alzheimer’s, Parkinson’s, and some cancers, for example), and can match ancestry. Some services like 23andMe (named so because there are 23 pairs of chromosomes in human cells) have gained FDA authorization, leading many people to trust their results and practices without scrutiny.
Other tests include food sensitivity tests, tests to help determine fertility, menopause predictors, STI (sexually transmitted infections) screening like HIV, and other infections like Hepatitis C and COVID-19.
Tests are completed with a saliva swab, urine collection, or a finger prick test. Most are available at neighborhood drug stores, or can easily be ordered online and often times with an accompanying service (such as 23andMe), which provide more in-depth reports about the results.
Are at-home lab tests accurate? And then what?
Some tests, such as pregnancy tests, diabetic blood tests, and even FDA permitted breast and ovarian cancer screening tests are overwhelmingly accurate. But, there are limitations to some tests, and accuracy is dependent on consumers carrying out the method of testing precisely. The battle isn’t over even then- getting the sample back to testing labs and then knowing what to do with the results are all factors to consider when deciding to use at-home lab tests.
Limitations
Many healthcare providers have raised alarms over tests like menopause predictors and even Hepatitis C and HIV screening because of their limited scope and accuracy being highly dependent on how precisely the sample was collected. Distinctions within results can only be made by a provider who can better understand the whole picture, rather than draw conclusions from one sliver of information. Take genome tests, for example, which may educate people on potential predisposition for cancers and diseases, but without an in-depth understanding of how family history and individual health co-exist with such results, the information can be misleading. A negative result may be misleading in the absence of important family or ancestral predispositions. Positive tests require further follow-up to best determine a course of care. Other limitations for specific tests include:
- HIV: When screening at home, this test is most often completed with a saliva swab. But, levels of antibody in oral fluid may be lower than it is in blood. This may lead people to think they are HIV negative, but it may mean that it has not shown up in oral fluid yet. In fact, up to 1 in 12 infected people may test negative at first, meaning that the test did not detect the antibody when it was present.
- Hepatitis C: The test shows whether you have ever contracted the hepatitis C virus, unless you were exposed in the previous 6 months, in which case it may be too early to detect the virus. However, it does not show whether the infection is active now. This must be determined by your doctor with additional testing.
- Food allergies: This screening determines whether consumers have antibodies for foods. The presence of such antibodies, however, isn’t an absolute indication of a food allergy, potentially misleading consumers. To know for certain, allergists and nutritionists often have patients keep diaries of their symptoms and diets, and then do the leg work to better understand the reason behind somebody’s experience when consuming certain foods. Lab tests are done in conjunction with such practices, not in isolation of other information.
- Pre-menopause: Menopause prediction tests use the anti-Müllerian hormone that is used to determine ovary readiness before fertility injections. Using the same technology, tests claim to be able to determine whether menopause is imminent (or not). However, people have different levels of hormones, those levels also fluctuate differently in each individual, and a low dose doesn’t mean earlier menopause, or lower fertility rates, for that matter.
- Colon cancer: There are different options for those screening for colon cancer at home, which screen blood in the stool. The most common method is using stool cards, where samples of stool are placed onto a testing area. Toilet bowl tests do not require handling of stool, but cleaning agents or toilet bowl fresheners can interfere with tests. Control pads are often provided to test the toilet conditions to avoid such issues, but there is still the chance of an inaccurate result. And, false negatives can also occur in stool tests if you take more than 250 mg of vitamin C during the testing period, or ate red meat, took ibuprofen, or other foods and vegetables. Testing for blood in the stool is not a specific test for colorectal cancer. Many people with colorectal cancer do not have positive fecal occult blood tests, and other conditions may cause blood to appear in the stool, including peptic ulcer disease, colitis, diverticulitis, hemorrhoids, and anal fissure.
Another concern when considering the accuracy of the test is the method of sample collection. With saliva tests, viral load in saliva significantly impacts the accuracy of the result (as with COVID_19 and HIV tests, for example). Nasal swabs, as used with other COVID tests, highly depend on self-swabbing the nose as instructed- some are as specific as swabbing 1 inch into the nasal passage. When using blood, finger prick tests can impact results due to several factors, including whether a finger prick test produces enough of a sample (versus being able to screen from a larger sample collected at a medical lab). Squeezing the finger, or scraping the finger on the side of the tube can lead to blood cells bursting, the haemoglobin escaping and spoiling the sample, known as a haemolysed sample. That occurrence can skew the levels of several markers, throwing off results. Studies have found that blood drop variation from a single finger prick can lead to inaccurate results, and that 6-9 drops combined are needed to achieve the most accurate results. Studies have repeatedly shown when it comes to finger-prick versus veinous sample collection, results are significantly more accurate when drawn directly from a vein, at a lab.
Shipment and stability of the sample after testing is done
Once people complete testing at home, even if it is done exactly to specifications, in ideal conditions, there is no guarantee that samples won’t still be compromised. Sending samples back to labs for testing can present significant obstacles, including the time in transport and temperature during transport. The stability of the sample is also often questioned. The FDA has recently shared that preliminary data suggests that it appears nasal swabs remain stable (this statement was made in reference to either foam or polyester swabs, shipped using a dry tube or saline solution). Data on other types of tests and their stability are still being researched, but this is one variable that should be considered when deciding whether to test or screen using at-home products.
Benefits
At-home laboratory testing has its obvious advantages. One can have multiple important tests without even leaving their home. Depending on the privacy and data practices of the company, it’s (relatively) private, and, such tests can remove a serious burden off the shoulders of healthcare systems. The past two years also provided another example of their benefit- during a pandemic when people want to avoid situations that could lead to infection from COVID-19, at-home testing provided an alternative to testing in facilities and potentially being exposed to the virus.
Some argue that in the U.S., DTC tests can also become the first step for uninsured Americans to finally access healthcare. But, many people also argue that the results of such tests could potentially be used against patients as lacking regulations could also mean life insurance agencies, health insurance companies, and others use information to restrict coverage. Direct to consumer testing does present a lower cost option for initial testing- but as we’ve outlined, the next step after receiving results is ideally meeting with a medical provider to best understand the results and plan any necessary future care or follow-up.
Though the debate wages on for how to cover America, these types of startups present a wider range of options for the healthcare industry and could help lower the cost and ease of access for service workers and others who don’t work regular hours or don’t typically have insurance coverage. Companies that manufacture DTC tests also say there are benefits beyond their convenience, including more transparency of prices. Customers know how much they will pay for the test when they order it, which is not often the case in today’s health system where even patients with insurance can be hit with expensive bills they weren’t expecting.
Test Kit Guidelines
When using home test kits, you are self-testing, not self-diagnosing. Remember, as with all home screening, monitoring, or family planning products, you should follow up with your doctor regardless of the result.
No matter which which at-home test kit you use, certain guidelines should be followed:
- Always check the expiration date prior to using the test kit.
- Follow manufacturer’s instructions for storage.
- Read test instructions thoroughly before using the kit.
- Contact your physician to discuss your results. If your result is positive, you will need to begin treatment. If your result is negative, you may need to be retested to ensure that the home test was accurate.
There is clearly a lot to consider when choosing whether to use at-home lab tests or head to a medical facility. If you do have concerns surrounding a specific health concern, speak to a provider about the best route for screening. Some states, like Arizona, allow patients to order their own lab tests via companies like LabCorps, Sonora Quest, and others- and offer fixed rates. Provider billing offices can also provide billing codes so you can reach out to your insurance company and determine cost before making a decision with the assumption that a DTC test will be the more economic choice. You might be surprised to discover that at-home testing isn’t always the less expensive option. Not to mention that many studies have shown that tests carried out by medical providers are more accurate.
Seeking answers about any medical concern can be overwhelming and sometimes an at-home test is the way to dip your toes into addressing the issue, but please seek a provider to then help interpret results and partner with you on the road ahead.
Next week, we’ll dive into privacy concerns that surround DTC tests, the regulations that are currently in place to protect consumers (spoiler alert- there are few, and their scope is limited), as well as the potential use of all that information.
Sources:
-https://www.npr.org/sections/health-shots/2016/05/12/477644945/diy-blood-tests-theres-a-downside-to-ordering-your-own
-https://huddle.florence-health.com/discover/content/article/pros-cons-at-home-testing-what-clinicians-should-know/
-https://www.winchesterhospital.org/health-library/article?id=14169
-https://visithealth.london/home-testing-kits
-https://www.consumer.ftc.gov/blog/2017/12/dna-test-kits-consider-privacy-implications
-https://www.washingtonpost.com/health/dna-tests-privacy-risks/2020/09/11/6a783a34-d73b-11ea-9c3b-dfc394c03988_story.html
-https://www.healthline.com/health/at-home-coronavirus-test#fa-qs
-https://academic.oup.com/jlb/article/7/1/lsaa069/5910046
-https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-tests-provide-genetic-risk-information-certain-conditions
-https://health.clevelandclinic.org/home-dna-test-for-breast-cancer-risk-has-limitations/
-https://www.axios.com/trump-fda-coronavirus-response-tests-oversight-f50f4a11-7568-4228-acbe-cb706180d4ff.html