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Home Test Kits 101 - How to Choose a Reliable Test Kit
Home test kits are becoming increasingly popular because they offer some advantages over traditional laboratory
testing, but before choosing a kit is important to make sure that the one you select yields accurate and reliable
A variety of CLIA-waived, FDA cleared and FDA approved tests kits are available including those that test for
illegal drug use, pregnancy, fertility, the diagnosis of sexually-transmitted diseases including AIDS, paternity,
wellness, early disease detection and exposure to various environmental toxins such as heavy metals.
CLIA, which is an acronym for Clinical Laboratory Improvement Amendments, was established in 1988 and implemented
in 1992 to develop quality control standards for the entire laboratory industry to ensure the accuracy, reliability
and consistency of test results regardless of where the test is performed. The Food and Drug Administration (FDA),
which is responsible for assigning testing devices to one of three categories based on the complexity of the test
methodology and the potential risk to public health by the devices. It designates the simplest category of home
test kits as CLIA-waived tests, which means that the methodologies employed in conducting the tests are so simple
and accurate so as to render the likelihood of erroneous results negligible and to pose no reasonable risk of harm
to a consumer if the test is performed incorrectly. Many of the home test kits and even some of the kits for
professional use are CLIA-waived, but to ensure accuracy of test result it is always advisable to check the
certification of any test kit before purchasing it to determine if it is CLIA-waived and manufactured by a
reputable company. The most popular CLIA-waived devices are some of the home drug test kits.
If the kit is not CLIA-waived and involves more complex methodology, it is important to make sure that it is FDA
cleared or FDA approved. FDA clearance is different from FDA approval in the sense that for a device to obtain FDA
clearance the manufacturer must demonstrate to the FDA prior to marketing that the device is substantially
equivalent to a similar device already on the market and that it does not require pre-market FDA approval. If the
submission is successful FDA clearance is granted for marketing of the product. FDA approval on the other hand
applies to a new device which requires that prior to marketing evidence including clinical data be submitted to the
FDA constituting reasonable evidence that new device is safe and effective. If the submission is successful FDA
approval status is granted, but the process for obtaining FDA approval is much more stringent than that for
obtaining FDA clearance. Since FDA approval applies primarily to devices that are life-sustaining and that can
carry significant risks, the FDA approval label for home testing kits is a misnomer, and the FDA cleared label is a
more appropriate one. An exception however is The Home Access HIV-One Test System and The Home Access Expressed
HIV-1 Test System. These are the only HIV home test kits which are FDA approved.
Depending on the complexity of the methodology of the testing process and the immediacy of test results, there
basically two types of test kits. The first type which is oftentimes CLIA-waived is that which provides immediate
test results in the home or other setting in which the specimen was obtained. The other type is that which requires
shipment of the collected specimen(s) to a reference laboratory for analysis and interpretation of the test result
which is then reported to the consumer, usually by mail. In the case of the latter type of kit an additional
variable that affects the accuracy and quality of the test device is the reference lab that analyzes sample and
interprets the test result. Therefore, in doing your due diligence before choosing a home test kit it is advisable
to make sure that the reference laboratory is CLIA-certified or has other certification and accreditation vouching
for its proficiency as a testing center.
It should be noted that many testing kits are bogusly marketed and sold as FDA approved when in fact they have not
even been FDA cleared. Although these products may have a certain degree of appeal to the consumer because they are
sold at a cheaper price than those that are not FDA unapproved, it stands to reason that they should be
In summary, in selecting a kit for home testing it is of utmost importance to make sure that the kit you choose is
an accurate one which produces proven reliable results. This can be best accomplished making sure that it meets the
CLIA and FDA standards as they apply and that if a reference laboratory is involved in analyzing a sample and
interpreting the test result it has the proper accreditation and certification credentials. It is also important
that the test is manufactured by a reputable company.
Victor E. Battles, M.D.
August 27, 2009
As a board-certified internist and am well aware of the role that laboratory testing plays in evaluating patients
and providing appropriate health care.
To learn more about home test kits and how you can use them as a supplement to
your health care and improving your health and to choose from a variety of quality kits visit www.proactivehealthoutlet.com.
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