1 LABORATORY TESTING: ITS ROLE IN DIAGNOSING AND MANAGING OCULAR DISEASE Tammy Pifer Than, MS, OD, FAAO UAB School of Optometry Birmingham, AL [email protected]Nothing to Disclose Getting the Job Done... External Lab Testing PCP External laboratory In-office sampling is it ok? Before You Order Tests... good case hx narrow ddx avoid “shot gun” approach comprehensive ocular exam If You Order Tests... interpret Laboratory Tests and Diagnostic Procedures 6 th edition – 12/2012 Chernecky and Berger – includes Herbal interactions communicate treat refer Getting the Job Done... In Office Lab Testing Point-of-Care
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LABORATORY TESTING: ITS ROLE IN DIAGNOSING AND MANAGING OCULAR
Combined results from 7 eye care meetings held in 2013n = 649
In the works…
FST-100Foresight Biotherapeutics
0.1% dexamethasone and 0.4% povidone-iodine
Phase II trial
AL-46383A (N-chlorotaurine)Aganocide compound
Phase II trial
Doxovir
What’s Up and Coming?
www.clinicaltrials.govThe Food and Drug Administration
Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007
The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices
Dry Eye Disease and MMP‐9
Matrix metalloproteinases (MMP) are proteolyticenzymes that are produced by stressed epithelial cells on the ocular surface1
MMP‐9 in Tears
Non‐specific inflammatory marker
Normal range between 3‐41 ng/ml
More sensitive diagnostic marker than clinical signs1
Correlates with clinical exam findings1
Ocular surface disease (dry eye) demonstrates elevated levels of MMP‐9 in tears1
[1] Chotiakavanich S, de Paiva CS, Li de Quan, et al. Invest Ophthalmol Vis Sci 2009; 50(7): 3203‐3209.
Dry Eye Disease and MMP‐9
Increased concentrations of MMP‐9 can be found in other diseases or conditions, including:
Ocular rosacea
Meibomian gland disease
Sjögren’s syndrome
Corneal ulcers
Corneal erosions
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InflammaDry® Limit of Detection
Normal levels of MMP‐9 in human tears ranges from 3‐41 ng/ml
NEGATIVE TEST RESULTMMP‐9 < 40 ng/ml
POSITIVE TEST RESULTMMP‐9 ≥ 40 ng/ml
InflammaDry 4‐Step Process
* Release the lid after every 2‐3 dabs. Allow the sampling fleece to rest along the conjunctiva for 5 seconds.
*
Reimbursement Strategy
CPT Code 83516 – Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
$15.46
CLIA Waived Status
2/27/2014
Traditional Understanding of Sjögren’s
Sjögren’s is a chronic, systemic, progressive autoimmune inflammatory disease
Characterized by the immune‐mediated (lymphocytic) destruction of the lacrimal and salivary glands
Early hallmark symptoms include dry eyes and dry mouth
Recent evidence suggests that all layers of tear film can be affected
Traditional Understanding of Sjögren’s
Primary Sjögren’s
Disease presents alone
• Secondary Sjögren’s
Subsequent to another autoimmune condition (e.g. rheumatoid arthritis)
It currently takes 4.7 years to receive an accurate diagnosis
Systemic effects are seen in 30‐70% of patients
Myths of Sjögren’s
“All Sjögren’s patients are identified and diagnosed”
“There are only a few patients in my practice”
“Nothing can be done for the patients if they are diagnosed”
“Sjögren’s Syndrome does not have serious long‐term consequences, it is just a nuisance”
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Sjögren’s Syndrome and Non‐Hodgkin’s Lymphoma
Solans‐Laque R, et al, Seminars Arthritis Rheum, 2011
Lymphoma risk
~10% at 15 years
Risk with time
Ioinnidis et al, Arthritis Rheum, 2002
Primary SS
20% deaths due to lymphoma
Mortality in pSS
Ioinnidis et al, Arthritis Rheum, 2002
723 patients studied in Greece
1 in 5 deaths of pSS patients due to lymphoma
Early detection is key!
Markers for Sjögren’s
• The classical serological markers for Sjögren’s are anti‐Ro/SS‐A and anti‐La/SS‐B antibodies• Other antinuclear antibodies (ANA) and rheumatoid factors (RF) are also included as the more common serological markers detected
• The combined serology sensitivity and specificity of the classical markers is around 40‐60%• None of the currently recommended serology tests diagnose Sjögren’s early in the disease progression
• In approximately 20‐30 % of cases no classic Sjögren’santibodies are found
New Markers
Salivary Gland Protein 1 (SP‐1) Submandibular and lacrimal glands
Carbonic Anhydrase 6 (CA6) Involved in buffering capacity of saliva
Submandibular and parotid glands
Parotid Secretory Protein (PSP) Involved with binding and helping to clear various infections
The Specifics
No CLIA waiver
Saturate at least 3 of 5
CPT 36416Collection of blood by capillary blood
specimen (e.g. finger, heel, ear stick)
Insurance Info
Call FedEx
IMMCO Lab Only
OR…
Microbiology
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Cultures and Sensitivities
specimen preparation is important no anesthetic – if possible sterile swab plate onto culture media culturette media:Thioglycolate brothBlood agarChocolate agarSaboraud’s agar
Transport Media
Amies media without charcoalHigher yield than other media
Comparable to plates
Subconjunctival Hemorrhage
Historyfrequency
medications
activity
Examination
Subconjunctival Hemorrhage
Idiopathic Valsalva maneuver HTN, DM Von Willebrand’s Disease 1-2%
Severe hepatic disease Leukemia Vitamin K deficiency AIDs
Subconjunctival Hemorrhage
Blood pressure CBC with differential PT (prothrombin time) PTT (partial thromboplastin time) INR (international normalized ratio)
Prothrombin Time (PT)
prothrombin:vitamin-K dependent glycoprotein produced
by liverneeded for firm fibrin clot formation
PT – measures time for clot formationreagent tissue thromboplastin and calcium
are added to citrate plasma
avoid coffee and alcohol for 24 hours before test ↓ time
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Prothrombin Time (PT)
each lab has normal value normal range is 2 secs Adult 12-14 sec International Normalized Ratio (INR)standardizes PT resultsINR = (Patient’s PT in seconds)ISI
Mean normal PT in secondsISI = international sensitivity indexNormal 0.9 – 1.3Coumadin therapy
Partial Thromboplastin Time (PTT) evaluates how well coagulation
sequence is functioning time for recalcified, citrate plasma takes
to clot after partial thromboplastin is added
Activated PTTcommercial activating materials used to
standardize the testcurrent method of the test
Standardized times reported by each lab< 35 seconds
Coagulation Studies
recurrent subconjunctivalhemorrhages
non-traumatic hyphema
± artery or vein occlusion
pre-op ocular surgery
To Treat or not to Treat.
34 YOWF
CC: HAs, double vision, dizzy
OHx: no trauma, LEE – long time ago
MHx: Voltaren, Zantac
Magnetic Resonance Venography(MRV)
Emerging imaging toolVeins of abdomen, pelvis, thorax and
extremities
Duplex sonography hindered by acoustic access
DVTNew gold standard
Cerebral Venous Sinus Thrombosis
Causes increased intracranial pressure
Can be life-threatening
Should be a DDX for every case of IIH
CVST9-26% of patients
Reference Lin A, Foroozan R, et al, Occurrence of cerebral venous
sinus thrombosis in patients with presumed idiopathic intracranial hypertension. Ophthalmology 1996; 113(12);2281-84.