Point-of-care diagnostic tools are entering the market at an unprecedented rate, but it can be difficult for practitioners to determine whether these tools will have a positive impact on their practice environment. In my experience, patients feel secure receiving medical care from a practice that offers cutting-edge diagnostic technologies. These devices can be integrated seamlessly into a clinical practice and allow eye care professionals to deliver more accurate diagnoses. I believe that these tools set my practice apart from competitors by building patient confidence in my care, which, in turn, yields repeat patients and increases referrals.
THREE DIAGNOSTIC TESTS
AdenoPlus. A diagnostic test that aids in the rapid differential diagnosis of acute conjunctivitis (AdenoPlus; Nicox) is the first in the latest generation of point-of-care diagnostic tools. The examiner swabs the interior fornix with a pad on the sample collector to absorb the tear film. Then, the sample collector is placed into the test, and the absorbent pad is placed in a vial of fluid that is included with the test. The fluid travels up the pad, through the tear sample, and into the indicator window. The indicator will then reveal a blue line, which is the control, and a red line if the patient has tested positive for adenoviral conjunctivitis. The test, which can be done by a technician during a work-up, takes less than 1 minute to perform and produces a result in 10 minutes or less. This is an important diagnostic tool because it can clarify the root cause of the tearing, red eye, which can be extremely difficult to diagnose accurately. Research has shown that acute conjunctivitis is misdiagnosed approximately 50% of the time when clinicians assess signs and symptoms alone.1-3
Doctor’s Allergy Formula. Another diagnostic advance in ocular allergy is an emerging technology designed to help eye care practitioners discover allergens that are producing allergic conjunctivitis (Doctor’s Allergy Formula; DrsAllergy.com.). The examiner dips an applicator into a series of wells, each containing a separate antigen—60 in all. These applicators, now loaded with antigen at the tip, are then used to make a gentle impression on the skin of the forearm without breaking the skin. Within 10 minutes, an allergen road map is produced, which allows the practitioner to discover which of the 60 possible allergens the patient is sensitive to. Because allergens vary by geographic location, the test is customized to contain the antigens that are common in the physician’s specific region. This test not only helps determine the cause of the patient’s allergy but can also help to rule in or out allergy as a possible contributor to the patient’s ocular surface disease symptom complex.
Positive results give patients clarity about what they should avoid in their lives to help reduce their symptomatology. I have found this diagnostic tool extremely helpful, especially during allergy season, when patients are often miserable and in search of answers to their ocular allergy questions.
Sjö. An advanced diagnostic test for Sjögren syndrome (Sjö; Nicox; not available in Europe) has been developed to detect this debilitating autoimmune disease years earlier than traditional testing methods. Emerging research on Sjögren syndrome indicates that it may be the underlying cause of dry eye disease in one in 10 patients.4
Because a patient’s dry eye symptoms may be rooted in a more serious, progressive autoimmune disease such as Sjögren syndrome, eye care professionals should serve as the first line of defense by identifying the disease at its earliest stage. In this way, ophthalmologists can provide more targeted therapeutic management, referrals to other health care specialists, and the best quality of care possible.
In the past, biomarkers used to detect Sjögren syndrome were only 40% to 60% sensitive and specific, and diagnosis usually occurred after patients were in the advanced stages.5 Now, the Sjö diagnostic test includes the traditional assays for SS-A, SS-B, antinuclear antibody, and rheumatoid factor, and three new proprietary biomarkers—salivary gland protein-1, carbonic anhydrase-6, and parotid secretory protein—in order to detect the disease much earlier than the traditional biomarkers and with greater specificity and sensitivity.5
By identifying affected patients early, physicians can work to prevent many of the painful and irreversible systemic effects of Sjögren syndrome, including the destruction of the lacrimal and parotid glands due to inflammation.
The in-office test kit, provided to US practices at no cost, includes all of the supplies and literature needed to collect a specimen and ship it to the laboratory (Immco Diagnostics). Administering the test is easy. The examiner uses the included lancet to perform a simple finger prick and gathers the blood drops on a specimen collection card. The test request form, patient’s insurance information, and specimen collection card are shipped via FedEx to the testing laboratory to be processed.
The laboratory communicates results to the office via e-mail or fax within 1 week of receiving the specimen.
If the test positively detects early Sjögren syndrome, I refer the patient to a rheumatologist, and both ocular and systemic treatment can begin. A technician can easily perform the diagnostic test for Sjögren syndrome, and it does not disrupt the flow of my practice. It is an important advance in the fight against this debilitating autoimmune disease.
Doctors often complain that their practice workload is too heavy to implement point-of-care diagnostic testing. They may also feel as though their clinical judgment is good enough that they do not need to rely on diagnostic testing.
However, I would argue that emerging technologies can make doctors more accurate diagnosticians, especially in a busy practice where it is sometimes easy to gloss over findings. In turn, patients view practices that implement point-of-care diagnostic testing as sophisticated and state of the art, which pays dividends in the community and when building a reputation with patients. In my experience, all of the tests reviewed in this article can be seamlessly integrated into the flow of a busy practice, especially because technicians can perform them. The tests also all have billable insurance codes that are reimbursable by the US Medicare system and other insurance companies. These premium capabilities can set a practice apart from those that do not use these diagnostic tools.
A number of different forces are going to spur further growth in point-of-care diagnostics. First, patients want better, faster, and more accurate care. Second, reimbursable diagnostics cost far less than a misdiagnosis that leads to multiple trips to the doctor’s office and ineffective, wrongly prescribed medications.
Two new point-of-care diagnostic tests are in development: an ocular test for herpes simplex virus and an immunoglobulin E allergy tear test that will be linked to the AdenoPlus.
Jodi I. Luchs, MD, is Codirector, Department of Refractive Surgery, North Shore/Long Island Jewish Health System in Great Neck, New York; an Assistant Clinical Professor at Hofstra University School of Medicine in Hempstead, New York; and the Director of Clinical Research and the Director of Cornea and External Diseases at South Shore Eye Care in Wantagh, New York. Dr. Luchs states that he has no financial interest in the products or companies mentioned. He may be reached at tel: +1 516 785 3900; e-mail: firstname.lastname@example.org.
- O’Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009;25(8):1953-1961.
- Leibowitz HM, Pratt MV, Flagstad IJ, et al. Human conjunctivitis. Arch Ophthalmol. 1976;94:1747-1749.
- Stenson S, Newman R, Fedukowicz H. Laboratory studies in acute conjunctivitis. Arch Ophthalmol. 1982;100:1275-1277.
- Liew M, Zhang M, Kim E, et al. Prevalence and predictors of Sjögren’s syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012;96:1498-1503.
- Shen L, Suresh L, Lindemann M, et al. Novel autoantibodies in Sjogren’s syndrome. Clin Immunol. 2012;145(3):251-255.