CLIA, short for Clinical Laboratory Improvement Amendments, is a federal regulatory body that oversees laboratory processes and testing on humans. It also grants waivers for testing that may be done in-office. There are hundreds of CLIA waived tests utilized by different specialties to provide better care, and it is important that these tests be performed correctly, by trained personnel, and in an environment where good laboratory practices are followed. CLIA registered practices are overseen by the CLIA regulatory body.
In the eye care industry, the newest test to obtain a CLIA waiver is called InflammaDry (March 2014), which is good news for those suffering with dry eye. InflammaDry is an immunoassay test that detects elevated levels of matrix metalloproteinase 9 (MMP9), an inflammatory marker that is typically elevated in patients with ocular inflammation associated with dry eye. It can also be elevated in other disease processes and we expect it to be approved for other diseases such as seasonal allergic conjunctivitis and chemical/contact conjunctivitis. The test requires only a small sample of tears and takes less than 2 minutes to perform. Results are available within ten minutes, allowing a treatment plan to be established on a patient’s initial visit (as compared to waiting for lab results).
There are a number of other tests utilized in eye care that are CLIA-waived and can be performed in-office including:
- RPS Adeo Detector – infectious agent antigen detection for adenovirus (pink eye)
- Tear Osmolarity – tear salt concentration for dry eye testing (elevated osmolarity correlates well with dry eyes)
- Tear lactoferrin – elevated in evaporative dry eye
- Tear IgE (immunoglobulin E) – elevated in allergy mediated inflammation
Other in-office tests often used by your eye doctor include Hemoglobin A1c for eye care practices related to diabetic eye disease, and light microscopes to differentiate fungal versus bacterial eye infections.
The advantages to all these tests are that they can provide a more accurate assessment and rapid diagnosis, usually right in the office. For example when using these tests, your doctor is able to diagnose your red eye as pink eye (non- responsive to antibiotics) versus a bacterial virus. If viral in etiology you will be better served with a treatment plan that avoids antibiotics. It also saves patients money since the in office test costs about $15, typically far less expensive than antibiotics.
For allergy cases, in-office testing allows the doctor to rule out infectious disease and prescribe anti-inflammatories or allergy medication. Both prevent the inadvertent use (or overuse) of antibiotics.
Individual practices must apply for and obtain a CLIA lab license prior to performing these tests. They must also follow particular guidelines and record keeping when performing them. Most insurances cover these tests when used for a specific diagnosis; a practice cannot bill Medicare or insurances without first being CLIA- approved practice. There are over 400 different CLIA waived tests and over 25 branches of medicine are affected.
Dr. Evans is the founding owner of Evans Eye Care in Palm Desert and can be reached at (760) 674.8806 or online at www.evanseyecare.com.