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RPS INFLAMMADRY DETECTOR™PACKAGE INSERT

NOTE: Do not discard this Package Insert. There is only one Package Insert per dispenser box. Additional copies of the Package Insert can be downloaded at: http://www.RPSdetectors.com/downloads/

Results in 10 minutes

Right DiagnosisRight Treatment

Right Now™

INTENDED USEThe RPS InflammaDry Detector is

a rapid, immunoassay test for the

visual, qualitative in-vitro detection

of elevated levels of the MMP-9

protein in human tears to aid in the

diagnosis of patients with Dry Eye

disease. This test is intended for

professional use in an office, clinic or

hospital in conjunction with other

methods of clinical evaluation.

Store between 77ºF/25ºC and

39ºF/4ºC. For in-vitro diagnostic

use. Not to be taken internally.

Keep out of reach of children.

SUMMARY AND EXPLANATION OF THE TEST

Dry Eye, or Dysfunctional Tear Syndrome, as defined by the Dry Eye WorkShop (DEWS) is a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability, with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface [1].

Dry Eye is an extremely common condition that is often under-diagnosed. Dry Eye may range in severity from episodic symptoms of ocular discom-fort to a chronic condition requiring therapeutic intervention. Inflammatory mechanisms are believed to be an underlying cause of chronic Dry Eye. Cur-rently, the diagnosis of Dry Eye is based upon a clinical exam and supported by some ancillary testing.

The clinical diagnosis of Dry Eye includes utilizing a combination of symptoms and signs [1]. Typically, physicians ask patients to report on the presence of burning, stinging, pain, light sensitivity and fluctu-ating vision. The Ocular Surface Disease Index (OSDI) was developed to target and quantify the most common symptoms associated with Dry Eye. This is the standard instrument used in screening patients with dry eyes for therapeutic Dry Eye studies [1].

The clinical signs of Dry Eye include corneal staining and reduced tear break up time (TBUT). In many cases, a Schirmer Tear Test is performed to confirm the presence of reduced tear production [1]. Other Dry Eye tests that measure tear osmolarity or lacto-ferrin are also available, however these lack sensi-tivity and are not routinely used.

Dry Eye involves the relationship between the amount of tears produced, rate of tear evapora-tion, and the presence or absence of inflammation. Matrix metalloproteinases (MMP) are proteolytic enzymes that are produced by stressed epithelial cells on the ocular surface. MMP-9, in particular, is a nonspecific inflammatory marker that has consistently been shown to be elevated in the tears of patients with dry eyes [5-20]. Studies have demonstrated that greater levels of MMP-9 are present in patients with more severe dry eyes and that the levels correlate with clinical exam find-ings [6]. Identifying the presence of ocular surface inflammation through objective measures can signif-icantly impact the treatment algorithm for Dry Eye.

MMP-9 in TearsMMP-9 is a nonspecific inflammatory marker that has consistently been shown to be elevated in the tears of patients with dry eyes. The normal levels of MMP-9 (ng/ml) in human tears range from 3 ng/ml to 40 ng/ml [5-10].

Elevated MMP-9 levels in patients with moderate to severe Dry Eye disease correlate with clinical exam findings. Altered corneal epithelial barrier function is the cause for ocular irritation and visual morbidity in Dry Eye disease. MMP-9 appears to play a physiological role in regulating corneal epithelial desquamation. The increased MMP-9 activity in dry eyes may contribute to deranged corneal epithe-

III. ASSEMBLING THE DETECTOR

1. Locate the Test Cassette (B) with the Test Cassette Body (D) and the Protective Cap (F). The opened Test Cassette should be used within one (1) hour.

2. Assemble the test by gently placing the Sampling Fleece (C) of the Sample Collector (A) into the Sample Transfer Window (G) of the Test Cas-sette Body (D).

3. Press firmly where indicated until the test feels secure. A double-click means the test is properly assembled.

IV. RUNNING THE TEST

1. Open the Buffer Vial (I). Remove the Protective Cap (F) from the test. Do not allow any portion of the test besides the Absorbent Tip (E) to touch the Buffer Vial (I).

2. Immerse the Absorbent Tip (E) into the Buffer Vial (I) for a minimum of 20 seconds.

3. Remove the Absorbent Tip (E) from the Buffer Vial (I), replace the Protective Cap (F) and place the test horizontally on a flat surface for 10 minutes.

V. READING AND INTERPRETING THE RESULTS

NOTE: Do not interpret the test before completing 10 minutes of development time. A purple fluid wave may be observed moving across the Result Window (H) while the test is running.

Once the background within the Result Window (H) is white and 10 minutes have elapsed, the test may be accurately read. If there is a streaky-fluid wave in the background after 10 minutes, allow an additional 5-10 minutes of running time prior

to interpretation. The test should be read within 12 hours of test completion. After this period of time, it is possible that the results may change. Accurate visual interpretation requires examina-tion under brightly lit conditions.

The results of the test are indicated through two lines, which appear in the Result Window (H): the Result Line and the Control Line. The Control Line appears as a BLUE line in the Control Zone. The Control Line indicates the correct application and performance of the test and must appear for the test to be valid.

INVALID RESULT

If a BLUE line does not appear, the test may be invalid. Re-immerse the Absorbent Tip (E) into the Buffer Vial (I) for an additional 10 seconds. If a BLUE line still does not appear, the test must be discarded and the subject retested by resampling the eye using a new RPS InflammaDry Detector kit. Do not report an invalid test result to your patient. Although the test requires only 10μL of fluid, if a second sampling is needed, repeat dabs may reveal reduced eye fluid available for collecting an adequate sample. Each additional sampling may reduce or alter the MMP-9 antigen load transferred to the test. If a second sampling is needed, the sample may be repeated one hour later.

NEGATIVE RESULT

Only a BLUE line appears in the Control Zone. A negative result should be reported as negative for the presence of MMP-9 < 40 ng/ml.

POSITIVE RESULT

The presence of both a BLUE line in the Control Zone and a RED line in the Result Zone indicate a positive result. An uneven or incomplete RED line is due to an uneven distribution of eye fluid on the Sampling Fleece (C). Even if the RED line is faint in color, incomplete over the width of the test strip, or uneven in color, it must be interpreted as positive. A positive result indicates the presence of MMP-9 > 40 ng/ml.

Absorbent Tip (E)with Protective Cap (F)

Sample TransferWindow (G)

TestCassetteBody (D)

Result Window (H)

Absorbent Tip (E)with Protective Cap (F)

Sample TransferWindow (G)

TestCassetteBody (D)

Result Window (H)

I. PREPARING THE TEST

1. Check the expiration date on all packaging. Make sure there is no damage to the foil pouches. Do not use if foil pouches are damaged.

2. Tear open each foil pouch at the indicated perfora-tion (J) and remove the contents. Do not touch the Sam-pling Fleece (C) to any surface except the collection site (conjunctiva) and the Sample Trans-fer Window (G) on the Test Cassette Body (D).

II. TAKING A SAMPLE

1. Locate the Sampling Fleece (C) on the underside of the Sample Collector (A).

2. No anesthetic should be applied to the eye for at least 10 minutes prior to collecting a sample. Gently lower the patient’s lower eyelid to expose the palpebral conjunctiva.

Gently dab the Sampling Fleece (C) in multiple locations along the inside of the lower eyelid (palpe-bral conjunctiva) 6-8 times and then allow it to rest against the conjunctiva for an additional 5 seconds. This will moisten the Sampling Fleece. Do not use a dragging motion when collecting the sample.

Upon saturation with tear fluid the fleece will glisten. Based on tear volume and composition, the fleece may appear white or patchy pink in color.

Sampling Fleece (C)

Sampling Fleece (C)

Sampling Fleece (C)

Absorbent Tip (E)with Protective Cap (F)

Sample TransferWindow (G)

TestCassetteBody (D)

Result Window (H)NEGATIVERESULT

POSITIVERESULT

INVALIDRESULT

lial barrier function, increased corneal epithelial desquamation and corneal surface irregularity [17]. The RPS InflammaDry Detector detects elevated levels of MMP-9 ≥ 40 ng/ml in tears to confirm the diagnosis of Dry Eye disease.

PRINCIPLES OF THE PROCEDURE

The RPS InflammaDry Detector utilizes Direct Sampling Micro-Filtration technology. MMP-9, if present in the tear sample, is captured between MMP-9 specific monoclonal and polyclonal anti-bodies at concentration greater than 40 ng/ml.

REAGENTS AND MATERIAL

Materials ProvidedThe RPS InflammaDry Detector kit includes two foil pouches containing the following materials:

The Protective Cap (F) protects the Absorbent Tip (E) from unintended physical damage.

The Sample Collector (A) is a separately packaged sterile component that can be assembled easily onto the Test Cassette Body (D). Additionally, the Test Cassette Body (D) guarantees correct sample transfer onto the lateral flow assay strip.

Materials Not Provided• Timer • Gloves • Quality Control materials (see section on external controls)

WARNINGS AND PRECAUTIONS

1. For in-vitro diagnostic use only.2. Keep the Test Cassette and Sample Collector in their foil pouches until just before use.3. The Dacron material used in the Sampling Fleece may cause allergic reactions for some people.4. Do not use the RPS InflammaDry Detector past the expiration date.5. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. Proper handling and disposal methods should be established according to local, state and federal regulations.6. Wear disposable gloves while handling samples and wash hands after the test is complete.7. Both the RPS InflammaDry Detector and the Buffer Vial provided are single use items. Do not

TEST PROCEDURE

reuse with multiple specimens.8. The RPS InflammaDry Detector requires a visual readout. Do not interpret the test result if you have color-impaired vision.9. Result interpretation requires a brightly lit environment.10. Do not use the same RPS InflammaDry Detec-tor on more than one patient.

STORAGE AND STABILITY

Store the RPS InflammaDry Detector between 77ºF/25ºC and 39ºF/4ºC. Both the RPS InflammaDry Detector and the Buffer are stable until the expira-tion dates marked on their outer packaging and containers.

Sample Collector (A)

Test Cassette (B)

Buffer Vial (I)

Sample Collector (A)

Test Cassette (B)

Buffer Vial (I)

Study Normal Average Standard Upper Range Controls MMP-9 Levels Deviation of MMP-9

1 18 23.61 ng/ml 17.4 ng/ml 41 ng/ml 2 16 8.39 ng/ml 4.70 ng/ml 13 ng/ml 3 17 7.2 ng/ml 2.1 ng/ml 9 ng/ml 4 10 10.5 ng/ml 0.2 ng/ml 11 ng/ml 5 20 6.9 ng/ml 1.4 ng/ml 8 ng/ml 6 28 22.7 ng/ml 14 ng/ml 37 ng/ml

Total/ 109 13.2 ng/ml ~ 40 ng/ml Avg/Range

Normal Levels of MMP-9 in Tears

RPS INFLAMMADRY DETECTOR™PACKAGE INSERT

7 8 9 10 11 12

to the test strip, it causes enhanced MMP-9 binding and an apparent false positive result.• Alcon, Alcaine• Alcon, Tobra Dex• Alcon, Econopred• Alcon, Vigamox• Alcon, Pataday• Alcon, Nevanac• Alcon, Travatan• Alcon, Systaine• Alcon, Azopt• Allergan, Refresh Liquigel• Allergan, Alphagan• Allergan, Zymar• Allergan, Refresh Tears• Allergan, Elastat• Allergan, Lumigan• Allergan, FML• Allergan, Optive• Allergan, Combigan• Allergan, Acular LS• Allergan, Pred Forte• Amo, Blink Tears• AVS, Thera Tears• Bausch & Lomb, Lotemax• Bausch & Lomb, Alrex• Bausch & Lomb, Zylet• Falcon, Polymyxin B Sulfate• Falcon, Timolol• Falcon, Gentamycin Sulfate• Inspire, AzaSite• Ista, Xibrom• Medpoint, Optivar• Merck, Trusopt• Novartis, GenTeal• Novartis, Voltaren• Novartis, Zaditor• Pfizer, Visine• Pharmacia, Xalatan• Sigma-Aldrich, Human IgA (1 mg/ml)• Sigma-Aldrich, Human Lactoferrin (1 mg/ml)• Sigma-Aldrich, Transferrin (1 mg/ml)• Vistakon, Betimol• Vistakon, Quixin• Vistakon, Iquix• Wilson, Proparacaine

NOTE: Certain medications may cause erroneous results if used immediately before taking a sample. It is recommended that no topical medications, except ocular anesthetic, should be used within 30 minutes prior to collecting a sample. No anes-thetic should be applied to the eye for at least 10 minutes prior to collecting a sample.

REFERENCES

[1] Definition and Classification of Dry Eye. Report of the Diagnosis and Classification Subcommittee of the Dry Eye Work Shop (DEWS). Ocular Surface 2007;5:75-92.

[2] Market Scope. Report on the Global Dry Eye Market. St. Louis, Mo: Market Scope, July 2004.[3] Multi-sponsor surveys, Inc. Gallup study of dry eye sufferers. Princeton, NJ, 2006.[4] Schaumberg, DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA 2001;286:2114-2119.[5] Acera A, Rocha G, Vecino E, Lema I, Durán JA. Inflammatory markers in the tears of patients with ocular surface disease. Ophthalmic Res. 2008 Oct; 40(6):315-21.[6] Chotikavanich S, de Paiva CS, Li de Q, Chen JJ, Bian F, Farley WJ, Pflugfelder SC. Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci. 2009 Jul; 50(7):3203-9.[7] Solomon A, Dursun D, Liu Z, Xie Y, Macri A, Pflug-felder SC. Pro- and anti-inflammatory forms of inter-leukin-1 in the tear fluid and conjunctiva of patients with dry-eye disease. Invest Ophthalmol Vis Sci. 2001 Sep; 42(10):2283-92.[8] Leonardi A, Brun P, Abatangelo G, Plebani M, Secchi AG. Tear levels and activity of matrix metal-loproteinase (MMP)-1 and MMP-9 in vernal kerato-conjunctivitis. Invest Ophthalmol Vis Sci. 2003 Jul; 44(7):3052-8.[9] Lema I, Sobrino T, Durán JA, et al. Subclinical keratoconus and inflammatory molecules from tears. Br J Ophthalmol. 2009 Jun;93(6):820-4.[10] Honda N, Miyai T, Nejima R, et al. Effect of latanoprost on the expression of matrix metallopro-teinases and tissue inhibitor of metalloproteinase 1 on the ocular surface. Arch Ophthalmol. 2010 Apr;128(4):466-71.[11] Hadassah J, Bhuvaneshwari N, Rao U, Sehgal PK. Evaluation of succinylated collagen bandage lenses in corneal healing by the expression of matrix met-alloproteinases (MMP-2 and MMP-9) in tear fluid. Ophthalmic Res. 2009; 42(2):64-72.[12] Sobrin L, Liu Z, Monroy DC, Solomon A, Selzer MG, Lokeshwar BL, Pflugfelder SC. Regulation of MMP-9 activity in human tear fluid and corneal epithelial culture supernatant. Invest Ophthalmol Vis Sci. 2000 Jun; 41(7):1703-9.[13] Afonso AA, Sobrin L, Monroy DC, Selzer M, Lokeshwar B, Pflugfelder SC. Tear fluid gelatinase B activity correlates with IL-1alpha concentration and fluorescein clearance in ocular rosacea. Invest Ophthalmol Vis Sci. 1999 Oct; 40(11):2506-12.[14] Oh JY, In YS, Kim MK, Ko JH, Lee HJ, Shin KC, Lee SM, Wee WR, Lee JH, Park M. Protective effect of uridine on cornea in a rabbit dry eye model. Invest Ophthalmol Vis Sci. 2007 Mar; 48(3):1102-9.[15] Pflugfelder SC, de Paiva CS, Tong L, Luo L, Stern ME, Li DQ. Stress-activated protein kinase signaling pathways in dry eye and ocular surface disease. Ocul Surf. 2005 Oct; 3(4 Suppl):S154-7.[16] Luo L, Li DQ, Corrales RM, Pflugfelder SC. Hyper-osmolar saline is a proinflammatory stress on the mouse ocular surface. Eye Contact Lens. 2005 Sep; 31(5):186-93.[17] De Paiva CS, Corrales RM, Villarreal AL, Farley WJ, Li DQ, Stern ME, Pflugfelder SC. Corticosteroid and doxycycline suppress MMP-9 and inflammatory

QUALITY CONTROL

The RPS InflammaDry Detector has built-in proce-dural controls (see below). For daily quality control, RPS recommends documenting that these inter-nal procedural controls were checked for the first sample tested each day.

Procedural ControlsThe unused device has an orange line in the Control Zone. If the test runs and the reagents work, this orange line will always turn into a blue line during the test procedure. This is indicative of the function-ality of the test.

The appearance of the Control Line indicates the correct application and performance of the test. The Control Line must appear in all valid tests. If the Control Line does not appear, the test must be interpreted as invalid and has to be repeated by resampling the eye using a new RPS InflammaDry Detector kit.

A pink fluid wave is observed moving across the Result Window (H) while the test is running. Once the background within the Result Window (H) is white and 10 minutes have elapsed, the test may be accurately read. If there is a streaky-fluid wave in the background after 10 minutes, allow an additional 5-10 minutes of running time prior to interpreta-tion. The clearing of the background color from the readout window is a negative background control.

External ControlsIn addition to your facility’s standard quality control procedures, it is recommended that a positive external control be tested once with each new lot number of RPS InflammaDry Detectors. Positive external controls containing recombinant MMP-9 protein at the lower detection limit of the RPS InflammaDry Detector are available directly from RPS. For ordering external controls, please refer to the “ordering information” section of this Package Insert.

Please refer to the Package Insert for the controls for instructions on how to run the external controls. External controls will have an individual expiration date printed on each package.

Additional controls may be tested according to the requirements of local, state and federal regulations or accrediting organizations. For guidance on proper QC testing refer to CLSI document EP12-A and 42 CFR 493.1202c.

When the correct control results are not obtained, repeat the test control or contact RPS at 1.941.556.1850 before testing patients.

Any problems with the device should be reported to RPS at 1.941.556.1850 or via email at info@rpsdetec-tors.com or directly to the FDA online at www.fda.gov/medwatch.

cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. Exp Eye Res. 2006 Sep; 83(3):526-35.[18] Luo L, Li DQ, Doshi A, Farley W, Corrales RM, Pflugfelder SC. Experimental dry eye stimu-lates production of inflammatory cytokines and MMP-9 and activates MAPK signaling pathways on the ocular surface. Invest Ophthalmol Vis Sci. 2004. Dec; 45(12):4293-301.[19] Pflugfelder SC, Farley W, Luo L, Chen LZ, de Paiva CS, Olmos LC, Li DQ, Fini ME. Matrix met-alloproteinase-9 knockout confers resistance to corneal epithelial barrier disruption in experimen-tal dry eye. Am J Pathol. 2005 Jan; 166(1):61-71.[20] Li DQ, Chen Z, Song XJ, Luo L, Pflugfelder SC. Stimulation of matrix metalloproteinases by hyperosmolarity via a JNK pathway in human corneal epithelial cells. Invest Ophthalmol Vis Sci. 2004 Dec; 45(12):4302-11.

ORDERING AND CONTACT INFORMATION

Ordering Information RPS-DE – RPS InflammaDry DetectorRPS-DESTD – RPS InflammaDry Detector External Control

Contact Information and Technical Support

Rapid Pathogen Screening, Inc. 7227 Delainey Court • Sarasota, FL 34240 USA t 1-941-556-1850 • f 1-941-556-1851 info@rpsdetectors.com RPSdetectors.com

Manufacturer Rapid Pathogen Screening, Inc. 7227 Delainey Court • Sarasota, FL 34240 USA t 1-941-556-1850 • f 1-941-556-1851 info@rpsdetectors.com RPSdetectors.com

European Representative MT Promedt Consulting GmbH, Altenhofstr. 80 D-66386 St. Ingbert, Germany t 49-6894-58 10 20 • f 49-6894-58 10 21 www.mt-procons.com

US Patents 6,514,773 and 7,723,124 and other patents pending. Spec 375 Rev 0. 01/2011

Clinical results are summarized below:

Limits of DetectionThe RPS InflammaDry Detector cut-off level was determined to be 40 ng/ml through a series of dilutions of human MMP-9 in human tears.

Cross-ReactivitiesVarious infectious ocular pathogens generated in cell culture and important ocular enzymes were applied in the laboratory to determine potential cross-reactivities:

• Staphylococcus aureus• Methicillin resistant Staphylococcus aureus (MRSA)• Moraxella catarrhalis• Haemophilus influenzae • Staphylococcus epidermis• Streptococcus pneumoniae• Pseudomonas aeroginosa• Influenza A • Influenza B “Lee”• Parainfluenza virus: 2, 3 and 4a• Rhinovirus Type 1a• Herpes Simplex 1, 2 • Coxsackie Virus B1• Echovirus: 6, 7, 9, 11 and 30• Adenovirus: 1, 3, 4, 5, 7, 11, 14, 15 and 37• Matrix metalloproteinase: 1, 2 and 3• Tissue Inhibitor of MMP: MMP-1, MMP-2

All isolates were cultured from human speci-men. The concentrations of the suspensions were between 500,000 and 1,500,000 microorganisms (virus, bacteria) per ml of supernatant. No posi-tive test lines developed, and no cross-reactivities to these species occurred when 10µl of the culture suspension was tested. No ocular enzymes caused any cross-reactivity.

INTERFERING SUBSTANCES

The following eye medications were tested for interferences with the RPS InflammaDry Detector. To check for specificity, undiluted blank medication was applied to the Sampling Fleece. Sensitivity was checked with 1:1 mixtures of recombinant MMP-9 protein in human tears at the cutoff level and the respective medication. All medications tested, except for Trusopt, exhibited no false positives or false negatives. When Trusopt is applied directly

LIMITATIONS

1. MMP-9 is a nonspecific indicator for the pres-ence of inflammation. A positive test result should not be used as the sole basis for treatment or other management decisions.

2. Patients with severe aqueous deficient dry eyes may not produce enough tears for sample collection and could yield a false negative result.

3. The RPS InflammaDry Detector should not be used within 15 minutes of performing a Schirmer Tear Test as this may stimulate degranulation of MMP-9 and cause a false positive result.

4. A recent history of ocular surgery or infection may lead to elevated levels of MMP-9 and cause a false positive result.

5. Certain medications such as topical or oral steroids, cyclosporine, tetracycline and topical azithromycin are known to inhibit metalloprotei-nase activity. Use of these medications may lead to false negative results.

6. Results obtained with this assay, particularly in the case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician.

EXPECTED VALUES

The prevalence of Dry Eye ranges from 5% to 30% in people aged > 50 years and Dry Eye is estimated to affect 21 million people in the United States [1-3]. A national survey of 2,003 individuals found that nearly 40% of Americans experience Dry Eye symptoms, which may include dryness, itching, irritation, blurred vision, sensitivity to light, foreign body sensation and excessive tearing [1,4].

The prevalence of Dry Eye increases with age and is far more common in women. Other risk factors include the use of certain medications, autoimmune inflammatory diseases, contact lens wear, LASIK and refractive surgery and menopause [1].

PERFORMANCE CHARACTERISTICS

The RPS InflammaDry Detector’s sensitivity and specificity was compared to clinical truth, as defined by commonly used dry eye diagnostic criteria, composed of a combination of necessary clinical history reflected by a high Ocular Surface Disease Index (OSDI) score ≥ 13, a positive blurred vision score, and the presence of at least two signs such as a reduced Schirmer Tear Test < 10, reduced Tear Break Up Time (TBUT) < 10, and the presence of keratoconjunctival staining. Normal healthy controls without signs and symptoms of Dry Eye were also tested and these patients had an OSDI < 1, no blurred vision, Schirmer Tear Test ≥ 10, TBUT ≥ 10, and no keratoconjunctival staining.

In two clinical sites, the RPS InflammaDry Detector was compared to clinical truth.

Clinical ExamRPS

In�ammaDry Detector

+ - + 26 1 - 4 11

Patients Reference Sensitivity Speci�city

Dry Eyes Clinical 87% (N=30) Truth (26/30) -

Normal Controls(N=12) Clinical 92% Truth - (11/12)

Total N=42

Clinical ExamRPS

In�ammaDry Detector

+ - + 26 1 - 4 11

Patients Reference Sensitivity Speci�city

Dry Eyes Clinical 87% (N=30) Truth (26/30) -

Normal Controls(N=12) Clinical 92% Truth - (11/12)

Total N=42