The Clinical Laboratory Improvement Amendments
Laboratories that perform tests on human specimens for health assessment purposes, diagnosis, treatment of diseases, or prevention of diseases in the United States must obtain and maintain a valid Clinical Laboratory Improvement Amendments (CLIA) Certificate. In adherence with the 1988 CLIA statute amendment to the Public Health Services Act. CLIA reexamined the federal certification program and associated regulations for clinical laboratory testing for any lab that conducts human specimen tests for practical assessment purposes (research only labs are exempt from the CLIA certificate program), since 1988 there have been 2 more amendments to the oversight program, but the industry standard name and regulatory understanding is under the CLIA title. CLIA regulates practices and policies for any clinical laboratory that reports human specimen testing to patients or people for anything beyond pure research-based findings.
CLIA Waived Test
If a human specimen test is deemed CLIA waived that means the United States Food and Drug Administration (FDA) has approved the test system for home use based on CLIA criteria satisfaction. In this case, home use refers to use outside of a CLIA certified lab, meaning that a person or entity that is not federally certified to test and report on human specimen testings may report on the results of human specimen tests if the test is a CLIA waived test. CLIA waived approval by the FDA requires that the test system maintain a low risk of error or erroneous results and that the test be simple and easy to understand. CLIA waived tests are not 100% error-free, but the test system to be deemed CLIA-Waived must satisfy the FDA standards set forth by the CLIA statute.
Benefits of CLIA Waived Testing Kits
CLIA waived tests and testing kits may be utilized by anyone. With a CLIA waived test system, the operator and test subject do not need to be in a certified lab, nor does the administrator need medical or clinical licensing to perform the test. This means that businesses or people in need of test results may perform the tests themselves and read/report on the results themselves without the need to visit or send the test system to a clinical lab for analysis and results. This saves time, money, and effort, which makes human specimen testing more accessible to a greater amount of people, systems, and processes.
Drawbacks of CLIA Waived Testing Kits
CLIA waived testing kits are tests performed by individuals outside of clinical lab environments and training. The very functions that make CLIA waived tests beneficial are also their drawbacks. If the person performing the test is a layman or does not follow the manufacturer’s guidelines and instructions then the test may yield inaccurate and potentially dangerous outcomes if considered to be accurate or relied upon (other situations may arise based on different circumstances as well – please consult test guidelines or industry professionals for guidance and advice when choosing and performing waived testing if you are unclear on how to proceed). CLIA waived tests may be obtained and used by an adult without the interference of a certified agency or laboratory. The potential dangers presented by CLIA waiver or test systems is the possibility for the incorrect understanding of the test results, incorrect reporting or recounting of the test results, incorrect handling of the human specimens for the test, incorrect administration of the test process, or any other error encounter by either human or test system error. These mistakes, test system failures, or any other factors that may occur outside of a clinical lab setting are the potential dangers of CLIA waived testing kits.
A person or administrator of CLIA waived tests may equip themselves with the necessary knowledge to safely perform and report the results of testing kits by learning how to use and read test results through manufacturer and distributor sources such as DrugTestsInBulk.com’s extensive library of training programs, quizzes, and videos. Every CLIA waived product available on DrugTestsInBulk.com offers training guides and quizzes on the training, as to ensure that the end-users of the testing systems are well-equipped and knowledgeable when it comes to using, administering, and reporting on the results of DrugTestsInBulk test kits and systems.
Types of CLIA Tests
Waived tests collectively are simple tests that are deemed safe for home use. Tests systems that are easy to operate and understand if the user follows the manufacturers’ instructions. While moderate to high complexity level tests are non-waived test systems that require clinical settings and certified labs and clinicians. The types of tests that are frequently CLIA waived are the following:
Drug tests (urine, hair, saliva)
Alcohol tests (urine, breathalyzer, salvia)
Pregnancy tests (urine)
Virus/disease tests (COVID-19 and various other diseases)
Blood glucose monitors
Health screening (urinanalyse)
See the full list of testing systems with FDA approved CLIA Waived status here: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf
Testing kits designated for home use are testing kits that can be performed and reviewed by the person performing the test. The majority of CLIA waived testing kits are rapid tests, meaning that the person performing the test will be able to read the test results soon after finishing the test preparations. CLIA waiver is for tests that involve human specimens and can significantly impact the lives of the people utilizing the tests so they should be handled with care and concern for accuracy. Home use is the broadly applied term for anywhere outside of a clinical laboratory, home in this definition may be an office building, a testing tent, a residence, or any other appropriate location that allows the people taking the test to maintain test integrity.
How to Use CLIA Waived Tests
Every test is slightly different and comes with its own set of guidelines and instructions. The most vital aspect to safely performing and administering CLIA waived tests is to follow the instructions closely and accurately. Interpretation of test results also differs based on the type of test and the type of human specimen sample (whether it is urine, saliva, or something else). Again, test results interpretation must follow the manufacturer’s guidelines and instructions. DrugTestsInBulk.com provides detailed instructions about the use of each of our drug tests as well as providing manufacturer instructions and guidelines to taking the test and reading the results.
CLIA waived tests open the ability of instant and accurate test results over a broad range of specific and general testing options for the wellbeing of individuals and organizations.