• Who Needs to Use CLIA Waived Drug Test?

    CLIA-waived-drug-testWhat is CLIA Waived Drug Testing?

    CLIA or Clinical Laboratory Improvement Amendments are a set of regulations set out in 1988 to establish and regulate the quality of laboratory testing. These amendments help tests to be accurate, reliable and timely. The Centers for Medicare and Medicaid Services supervises these regulations. In order for something to be waived by CLIA it needs to be so basic and precise that there is no way for the test to be inaccurate. It may also be waived if it poses no threat to the health of a human being such as a test that has already been cleared by the FDA for home use.

    CLIA certification has to be renewed every two years by testing in a controlled environment. Generally this testing is conducted without monitoring unless a compliant has been made about the company.

    Which Tests are CLIA Waived?

    Most home tests are CLIA waived and considered safe for the home use they were intended for but some of these are used by physicians to evaluate the health of patients.

    The following tests are waived:

    • Fecal Occult blood tests
    • Urine Pregnancy Tests
    • Tests for Ovulation
    • Dipstick or tablet reagents which are non-automated
    • Erythrocyte Sedimentation Rate Tests
    • Hemoglobin-Copper Sulfate Testing
    • Spun Microhemacrit
    • Home Tests for Blood Glucose Monitoring
    • Hemoglobin Testing That use Self-Contained Testing Devices and Readout Results

    If a test does not fall under these qualifications, it can still apply for certification through monitored clinical trials.

    Who Needs CLIA Waived Tests?

    The people who are most likely to need and use these tests are people who must monitor things that relate to their health and reproduction in their home.

    • Women Seeking to Conceive: Women who are trying to become pregnant might use an ovulation test and/or a pregnancy test to evaluate her ability to conceive or to verify if conception has occurred. These tests help her to better monitor the condition of her hormonal state and how that state affects her reproduction.
    • Those With Blood Sugar Issues: People who must monitor their blood sugar levels might use these tests. This includes those with diabetes and those who suffer from low levels of blood sugar. Evaluating the level of glucose in these people’s systems can mean the difference between life and death.  The level of glucose in a person’s body must be in the right balance with other factors in the body, if that level is too high or too low it can cause illness and even degradation of the body over time.
    • Those at Risk for Cancer: These tests evaluate the level of blood present in the fecal matter dictating the presence of cancers like colorectal cancer in the body.
    • Those Who Deal With Arthritis: These tests test for the level of swelling in the body to evaluate the presence and severity of diseases such as arthritis.
    • Those Whose Blood Must be Evaluated: The level of hemoglobin in the blood must be evaluated to determine if anemia is present and causing health problems for the patient.
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