What Is CLIA?
Often we are asked by distributors why it is important for a test to be CLIA-Waived. Well to answer that question it is first best to explain what CLIA stands for. The Clinical Laboratory Improvement Amendments of 1988 specifies that laboratory requirements must be based on the complexity of the test performed. As a result, they established provisions for categorizing a test as Waived.
If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.
Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.
ALFA’s CLIA-waived products
ALFA’s CLIA-waived product line makes rapid IVD testing as easy as can be. Interested to place an order? Let us help. Just click the ‘contact us’ button to reach out to our dedicated customer service team who are happy to help you.
|Test Type: Drugs of Abuse|
|Buprenorphine Test||Instant-View BUP Urine Test, cut off: 10 ng/ml||Dip Cassette||25 Tests||03-2842QW|
|Oxycodone Test||Instant-View OXY 100 Urine Test, cut off: 100 ng/ml||Dip Cassette||25 Tests||03-2862QW|
|Ecstasy (MDMA) Test||Instant-View MDMA (XTC) Urine Test, cut off: 500 ng/ml||Dip Cassette||25 Tests||03-2952QW|
|Tricyclic Antidepressants Test||Instant-View TCA Urine Test, cut off: 1000 ng/ml||Dip Cassette||25 Tests||03-2972QW|
|Amphetamine Test||Instant-View AMP Urine Test, cut off: 1000 ng/ml||Dip Cassette||25 Tests||03-3012QW|
|Methamphetamine 1000 Test||Instant-View MET1000 Urine Test, cut off: 1000 ng/ml||Dip Cassette||25 Tests||03-3032QW|
|Cocaine 300 Test||Instant-View COC Urine Test, cut off: 300 ng/ml||Dip Cassette||25 Tests||03-3052QW|
|Marijuana Test||Instant-View THC Urine Test, cut off: 50 ng/ml||Dip Cassette||25 Tests||03-3072QW|
|Morphine/Opiate 2000 Test||Instant-View MOR/OPI2000 Urine Test, cut off: 1000 ng/ml||Dip Cassette||25 Tests||03-3092QW|
|Morphine/Opiate 300 Test||Instant-View MOR/OPI300 Urine Test, cut off: 300 ng/ml||Dip Cassette||25 Tests||03-3093QW|
|Phencyclidine Test||Instant-View PCP Urine Test, cut off: 25 ng/ml||Dip Cassette||25 Tests||03-3112QW|
|Benzodiazepine Test||Instant-View BZD Urine Test, cut off: 300 ng/ml||Dip Cassette||25 Tests||03-3132QW|
|Barbiturate Test||Instant-View BAR Urine Test, cut off: 200 ng/ml||Dip Cassette||25 Tests||03-3152QW|
|Methadone Test||Instant-View MTD Urine Test, cut off:300 ng/ml||Dip Cassette||25 Tests||03-3172QW|
|Multi Drug M4 Urine Test||Instant-View M4 (BZD COC MOR MTD) Dip Test||Panel||25 Tests||03-3427QW|
|Multi Drug M5 Urine Test||Instant-View M5 (BZD COC MET MOR THC) Dip Test||Panel||25 Tests||03-3571QW|
|Multi Drug M5 Urine Test||Instant-View M5 (AMP COC MOR PCO THC) Dip Test||Panel||25 Tests||03-3576QW|
|Multi Drug M5 Urine Test||Instant-View M5 (AMP BAR BZD MTD OXY) Dip Test||Panel||25 Tests||03-5050|
|Multi Drug M5 Urine Test||Instant-View M5 (BZD COC MOR300 MTD THC) Dip Test||Panel||25 Tests||03-5051|
|Multi Drug M6 Urine Test||Instant-View M6 (AMP BZD COC MET MOR THC) Dip Test||Panel||25 Tests||03-3635QW|
|Multi Drug M8 Urine Test||Instant-View M8 (AMP BAR BZD COC MOR MTD OXY TCA) Dip Test||Panel||20 Tests||03-3862QW|
|Multi Drug M9 Urine Test||Instant-View M9 (AMP BAR BZD COC MET MOR MTD PCP THC) Dip Test||Panel||20 Tests||03-3997QW|
|Multi Drug M10 Urine Test||Instant-View M10 (AMP BAR BZD COC MET MOR MTD PCP TCA THC) Dip Test||Panel||20 Tests||03-3910QW|
|Multi Drug M11 Urine Test||Instant-View M11 (AMP BAR BZD COC MET MOR MTD PCP TCA THC XTC) Dip Test||Panel||20 Tests||03-3940QW|
|Multi Drug M12 Urine Test||Instant-View M12 (AMP BAR BZD COC MET MOR300 MTD OXY100 PCP TCA THC XTC) Dip Test||Panel||20 Tests||03-3965QW|
|Test Type: Health|
|IFOB Cassette Test||Instant-View FOB Fecal Test, Cut off: 50 ng/ml||Cassette||25 Tests||05-7602|
|Test Type: Fertility|
|Menopause Cassette Test||Instant-View FSH Urine Test, Cut-off: 40 mIU/ml||Dip Strip||50 Tests||02-2567|
|Menopause Cassette Test||Instant-View FSH Urine Test, Cut-off: 40 mIU/ml||Cassette||25 Tests||02-2562|
|Ovulation Strip Test||Instant-View LH Urine Test, Cut-off: 20 mIU/ml||Dip Strip||50 Tests||02-2547|
|Ovulation Cassette Test||Instant-View LH Urine Test, Cut-off: 20 mIU/ml||Cassette||25 Tests||02-2542|
|Pregnancy Strip Test||Instant-View HCG Urine Test, Cut-off: 25 mIU/m||Dip Strip||50 Tests||02-2487|
|Pregnancy Cassette Test||Instant-View HCG Urine Test, Cut-off: 25 mIU/m||Cassette||25 Tests||02-2482|
Do I Need A CLIA-Waived Test?
CLIA requirements do apply to entities that perform test on …”materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program. In these instances, the advantage of using a “CLIA Waived” test is that it “waives” you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).
CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets. However CLIA-Waived tests can still be sold to them as if they were not Waived at all. As distributors typically sell to multiple end user markets, having a selection of CLIA-Waived tests is advantageous as it avoids limiting their sales avenues.
Additional information on CLIA can be found at http://www.fda.gov/cdrh/clia/cliaWaived.html.
For state by state reimbursement fee schedule go to www.cms.hhs.gov.
How ALFA Can Help?
At Alfa Scientific, our key area of focus is in Drugs of Abuse Testing. As such, we have several “novel” products which would be of interest to any distributor competing in the Drugs of Abuse market.