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What Does CLIA Waived Mean?

CLIA Waived FDA HHS

Almost all point of care drug tests are advertised as CLIA waived. Customers often want to know what does CLIA waived mean, and why is it so important?

CLIA stands for Clinical Laboratory Improvement Amendments. CLIA is a set of guidelines and regulations that are jointly enforced by the CDC (Center for Disease Control), CMS (Centers for Medicare and Medicaid Services) and FDA (Food and Drug Administration).

In its most basic form the FDA categorizes all diagnostic tests according to complexity. There are 3 levels of complexity:

  • High Complexity
  • Moderate Complexity
  • Waived

CLIA Waived Drug Tests

For a test to be waived it must :

  1. Require minimal scientific and technical knowledge to perform the test and the knowledge must be easily obtained through on the job instruction with minimal training.
  2. Regeants must be pre-packaged, reliable, stable and require no special handling, precautions, or storage.
  3. Operational is automatic or easily controlled.
  4. Calibration, Quality Control & external proficiency testing materials must be readily available and stable.
  5. Test system troubleshooting is automatic or self correcting, or clearly described and requires minimal judgement.
  6. Minimal interpretation and judgement are required to analyze results.
  7. Have been issued a CLIA waiver and number by the FDA.

Basically a CLIA waived test is a test that can be performed by anyone at home or in any setting without special raining or certification. Besides the requirements for being fool proof, a test must apply and receive a CLIA waiver or be amended onto an existing CLIA waiver with updated inserts and labeling. Someone can build a drug test identical to our CLIA waived 12 Panel Test and it wouldn’t be considered CLIA waived until they were issued the waiver by the FDA.

CLIA Enforcement

For a multi-panel drug test each strip and the device must be covered under the waiver, however enforcement is carried out at the state level and many states do not strictly enforce this. Every strip on the test must be CLIA waived for the test to be CLIA waived. Most states have employees within their state health departments that are contracted directly with the CMS as CLIA surveyors.

Some states have their own licensure and infrastructure for enforcing CLIA. Their regulations are usually more stringent, but at the very least meet the federal requirements.

At the time of this publication the only two states with independent licensure are Washington and New York. Washington’s program is run by the Office of Laboratory Quality Assurance and New York’s program is called the Clinical Laboratory Evaluation Program under the State of New York Department of Health.

For a test to be CLIA waived the FDA must inspect the facility where it is manufactured. During the Coronavirus pandemic the FDA suspended drug and medical device inspections. For the majority of drug tests an existing CLIA waiver is amended for slight changes to labeling and recently waived tests are produced by facilities that are already producing CLIA waived drug tests.

False Advertising

Just because a drug test is advertised or labeled as CLIA waived does not mean it really is. The only sure way to check is to see if the test and all its component strips are listed correctly in the FDA CLIA medical device database.

According to Alicia Williams, a CLIA Surveyor for the state of Oklahoma, many drug test cups that are re-labeled do not file the appropriate paperwork with the FDA and even though they are advertised as CLIA waived they do not meet the guidelines. Suppliers often sell these tests for months and potentially thousands of labs, healthcare facilities and other businesses are using tests that they believe are CLIA waived but aren’t.

Reasons You May Need a CLIA Waiver

You will need a CLIA waiver if you plan on charging someone for testing and do not have an employee that is properly certified in conducting moderate or high complexity tests.

You will need a CLIA waiver if you charge insurance for drug testing at a medical practice.

You will need a CLIA waiver to test employees if you do not have staff properly certified in conducting moderate or high complexity tests.

CLIA waivers are not available for all types of drugs and it can take years for a facility to get new drugs issued for existing or new waivers. In this case tests can be used “for forensic use only”. For example it currently isn’t possible to get a fentanyl test that is CLIA waived, but the drug is becoming more popular. Some professionals will order a single panel fentanyl strip in addition to a CLIA waived 12 panel cup so they can send a sample for laboratory confirmation if it fails for fentanyl, but for all other purposes their testing is covered by CLIA.

For a laboratory to perform high complexity tests the Executive Director has to be a certified pathologist or have a P.H.D. with related board certification and each technician has to have an Associates Degree minimum.

Even though a test is very simple if the distributor does not complete the required filings and their tests are not listed on the FDA’s CLIA medical device database you still need the infrastructure and certifications that a high complexity lab would need.

 

“Oklahoma CLIA surveyors can be contacted through email and cell phone.  We encourage laboratories or potential laboratory personnel to ask questions.  We believe in a partnership between the laboratory and the CLIA State Agency to deliver accurate laboratory test results.”  

Alicia Williams, BS, MS, MLS (ASCP)
Clinical Health Facility Surveyor
Oklahoma State Department of Health

 

The personnel on staff in your state are usually happy to help with any questions you have. According to Alicia Williams, a clinical health facility surveyor for the state of Oklahoma, “Oklahoma CLIA surveyors can be contacted through email and cell phone.  We encourage laboratories or potential laboratory personnel to ask questions.  We believe in a partnership between the laboratory and the CLIA State Agency to deliver accurate laboratory test results.”.

CLIA Resources

CMS Website for CLIA Services

CLIA Medical Device Database

For information on the CLIA status of any of our products please Contact Us with your questions.

 

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Home Drug Test vs. Lab Drug Test: What’s the Difference?

home drug test vs. lab drug test

What is the difference between a home drug test vs. a lab drug test? A lot of customers assume that when a they go to a physical location to take a drug test that it’s more accurate. That’s not always the case, but there are some differences between a home drug test vs. lab drug test.

Home Drug Test vs. Lab Drug Test

Many organizations use home drug testing kits that are CLIA waived because lab costs are so high and so any employee can administer the test. They are relatively accurate and give results within a couple minutes. Usually positive tests are then sealed and sent to a lab for confirmation. Laboratories charge by the drug so it is much cheaper to confirm the presence of 1 drug than it is to test for 12 drugs using complex laboratory equipment.

Other organizations that run a lot of drug tests and have a high rate of failure send all their tests to a lab. Some facilities will even build their own lab.  Usually the cost of lab testing is subsidized in some way (either the customer pays for it or insurance pays part of the cost). Medicare and most insurances will only pay for 1 type of drug test per visit so they will not pay for a standard 12 panel cup test and a confirmation.

Home Drug Testing

Drug Testing you do at home will generally use a cup or cassette with different strips for each drug. The strip contains reagents which is the scientific term for compounds that react to metabolites produced by the drug in your body.

When you perform a drug test with a cup like our 12 Panel drug test at home you are testing for a chemical reaction between the reagent on your strips and a known quantity of metabolites in the subject urine. It’s almost like a small science lab in your house!

The biggest difference between a test that is sold to the public is whether or not it is CLIA waived.

CLIA waived means that the FDA has determined that the test is simple and accurate enough to be performed by an untrained person with a simple set of printed instructions.

Drug tests that you can use at home are considered qualitative and presumptive, meaning that they cannot tell you exactly how much drugs are present in the sample and that a positive result means that the donor likely used drugs recently.

Lab Drug Testing

Drug testing at a lab can be accomplished a number of different ways. In some cases a lab may used the same type of reagents that are used in home drug tests to do testing. They may or may not use CLIA waived tests because their technicians are likely certified in forensic drug test analysis.

Usually it is assumed that if someone sends a sample to be tested at a lab that they will at the very minimum use a presumptive drug testing method that is interpreted with the use of an instrument. This usually means they are using a drug test much like ours that is inserted into a machine that reads the results. This step takes out human error and subjectivity.

The primary reason to send a sample to a lab is to get a confirmation that uses imunoassay, mass spectrometry or chromatography. Some of these instrument chemistry analyzers are capable of detailing the quantity of metabolite in the sample. You can make deductions with this information (such as the subject is a light user or the subject had not used that day).

Imunoassay

Immunoassay is basically the same method used by a home drug test. A reagent that binds to the analyte is mixed with the sample and the contents are measured. A home drug test has the reagents configured in a manner that is easy to use and it’s calibrated to variables determined at the time of manufacture.

An immunoassay run in a lab can be much more detailed. The sample can have its components separated to make the reagents bind to the analytes easier. The reagents can be added multiple times to make sure nothing is missed. Each test is calibrated at the time of testing to a control solution to account for variables.

 

Imunoassay
A typical Immunoassay test.

 

In the home drug test the reagent uses a control and detection line as a signal. In a lab performed immunoassay the signal can be a number of things. The most common is linking a chemical that changes color when the reaction takes place. Other more accurate tests use radio isotopes that can be measured precisely with additional instrumentation.

 

Chromatography & Mass Spectrometry

With mass spectrometry a sample is bombarded with electrons which separate the sample into ionized fragments. The components sometimes separate, but even if they do not they can still be measured by an instrument capable of detecting charged particles. The instrument cycles through an intensity spectrum which correlates to mass; the results are recorded on a graph and correlated to known masses of molecules that are being detected.

Chromatography makes use of a fluid to separate a substance into its components. Various constituents travel through the liquid at different speeds causing them to separate. This is called the mobile phase of chromatography. A structure or chemical is used to stop the component particles in a stationary position. Chromatography got its name from the different colors created by the constituent particles of plants.

 

Lab Drug Testing Instrument
This Gas Chromatography / Mass Spectrometry instrument combines the two techniques to give the most accurate analysis of a urine sample. By Polimerek – Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=425348

 

 

The most definitive laboratory test for drug testing uses a combination of gas chromatography with mass spectrometry to first separate and then accurately measure the metabolites present in a sample. By combining gas chromatography with mass spectrometry a lab technician can get a definitive measurement on the quantity of metabolites in a sample. While this testing is more accurate, it’s also very costly especially if testing for multiple drugs. Most confirmations a lab will only test for drugs that were indicated positive by presumptive testing.

Which is Better?

The bottom line is that testing done with experienced technicians using expensive equipment in a controlled laboratory is more accurate. You just need to make sure than when you pay hundreds of dollars for complex testing using expensive tools that that’s the kind of testing you’re getting.

The accuracy of a CLIA waived test cup is so good though that the added cost isn’t justified in most cases. When it comes to a home drug test vs. a lab drug test, in most cases a home drug test is the right tool for the job. Laboratory drug tests are always available though if you need a confirmation, need the presence of drugs quantified or need the most accurate option. The cost of most drug tests is so little that they make a great option for a transport container, so even if you opt to have all drug tests sent to a lab you could have an immediate presumptive result with a drug test cup.

For most uses a home drug test is the best option considering price, accuracy, purpose and immediacy.