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Inflammadry

Manufactured by Quidel
Sourced in United States

InflammaDry is a rapid in-vitro diagnostic test that detects the presence of matrix metalloproteinase-9 (MMP-9), an inflammatory marker, in human tear fluid. The test is designed to provide a qualitative result indicating the presence or absence of MMP-9 in the sample.

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8 protocols using inflammadry

1

Comprehensive Ocular Surface Examination Protocol

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Our standard ocular surface examination included, in the order performed, (1) qualitative assessment of ocular surface matrix metallopeptidase 9 (MMP-9) (InflammaDry, Quidel), rated as none, mild, moderate, and severe based on the intensity of the pink stripe; (2) tear break up time (TBUT, seconds); (3) conjunctivochalasis (absent or present) in each area of the lower eyelid (temporal, central, nasal) based on the obliteration of the tear film by conjunctivae in the region of interest16 (link); (4) corneal staining graded to the National Eye Institute scale17 (link); (5) pain rating 15 seconds after a drop of topical anesthesia (proparicaine) placed in each eye, rated on a 0 to 10 NRS; and (6) anesthetized tear production at 5 minutes (Schirmer test).
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2

Quantifying Eye Symptoms with Validated Questionnaires

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To quantify eye symptoms, patients completed two validated questionnaires: the Dry Eye Questionnaire 5 (DEQ5) which assesses the frequency and severity of dryness and discomfort and the Ocular Surface Disease Index (OSDI), which assesses for spontaneous and evoked eye pain, visual complaints, and impact of symptoms on activities of daily living. Ocular surface assessments included a qualitative measurement of matrix metalloprotease 9 (MMP-9) via Inflammadry (Quidel), tear film break up time (lower values indicate faster break up of tears) and tear production (mm wetting at 5 minutes) via Schirmer strips (a lower score indicates less production).”
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3

Comprehensive Dry Eye Evaluation Protocol

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All patients underwent a DE assessment that included measurement of both eyes, in the order performed: (1) InflammaDry (Quidel, San Diego), graded as none, mild, moderate, severe based on the color of the pink line; (2) CD around the eyelash roots graded as 0=none; 1=mild; 2=moderate; 3=severe; (3) eyelid vascularity, graded as 0=none; 1=mild; 2=moderate; 3=severe engorgement; (4) meibomian gland inspissation, graded as 0=none; 1=mild ; 2=moderate; 3=severe; (5) palpebral conjunctival hyperemia, graded as 0=none; 1=mild to moderate; 2=severe; (6) TBUT (5 mL fluorescein placed, three measurements taken in each eye and averaged); (7) corneal staining graded to the National Eye Institute (NEI) scale, five areas of cornea assessed (score 0–4 in each)28 (link); (8) Schirmer’s testing with anesthesia graded as mm of wetting after 5 minutes; and (9) meibum quality, graded as 0 = clear; 1 = cloudy; 2 = granular; 3 = toothpaste; 4 = no meibum extracted.
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4

Quantifying Ocular Biomarkers with Immunoassay and Osmolarity

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The MMP-9 immunoassay kit (InflammaDry) was purchased from Quidel Corporation (San Diego, CA, USA). The TearLab osmolarity system was purchased from TearLab Corporation (San Diego, CA, USA). Lot numbers used in the experiments were 1,801,207, 1,803,262, 1,804,133, 1,804,023, 805,149, and D613208 (in sample collectors), D631402, 1,805,241, 1,806,129 (in test cassettes), and 160634AA, 180148AA, 180270AA, 180232AA (in buffer vials). The active form of recombinant human MMP-9 (rhMMP-9, activated by 1 mM p-aminophenylmercuric acetate) was purchased from BioLegend® (550502, San Diego, CA, USA). According to the manufacturer's manual, this recombinant protein (> 95% purity) originates from the supernatant of 293E cells and is expressed with a C-terminal 8His tag and a linker sequence. Serial dilution of 100 μg/ml rhMMP-9 with phosphate buffered saline (PBS) produced samples containing 12.5, 25, 50, 100, 200, 500, and 1,000 ng/ml of active rhMMP-9. Reference standard control solutions (100 ± 2, 290 ± 2, and 500 ± 2 mOsm/L) for osmolarity were purchased from Precision Systems Inc. (Natick, MA, USA).
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5

Evaluating Ocular Surface Changes

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The main outcomes included corneal sensitivity measured with the handheld Luneau Cochet-Bonnet esthesiometer (CBE, Luneau ophthalmologia, Chartes Cedex, France), tear film break-up time (TBUT), Schirmer’s score, corneal fluorescein staining (0–5 Oxford scale), matrix metalloproteinase 9 level (MMP-9, InflammaDry®, Quidel, San Diego, CA, USA) and best-corrected visual acuity (BCVA). All patients underwent slit lamp and Keratograph 5M (Oculus, Germany) using fluorescein staining to assess the ocular surface changes in the treatment course. Complications were considered as a new development or a progression of epithelial defects. This study was approved by the University of Miami Institutional Review Board. The protocols and methods used also complied with the standards set forth by the Declaration of Helsinki.
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6

Point-of-Care MMP-9 Immunoassay for Tear Analysis

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The test for tear MMP-9 was performed with the point-of-care MMP-9 immunoassay (InflammaDry; Quidel, San Diego, CA, USA) according to the manufacturer's instructions for use.22 (link),23 (link) Brief, the operator gently dabbed the sample collector in multiple areas along the palpebral conjunctiva until the sampling fleece was saturated with tears. Next, the sample collector was assembled to the test cassette, and then the test pad was dipped in a buffer solution for 20 seconds for activation. After 10 minutes, the red test line in a readout window was read. Density evaluation of the red test line was performed on the basis of the five-scale grading system composed of grade 0 (i.e., negative), grade 1 (i.e., trace), grade 2 (i.e., weak positive), grade 3 (i.e., positive), and grade 4 (i.e., strong positive).24
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7

Retrospective Study of Dry Eye

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We conducted a retrospective study of 25 individuals who were screened with the DE Questionnaire-5 (DEQ-5, a validated survey that assesses the intensity and frequency of dryness and discomfort over a 1-month recall, range: 0 - 22)[24 (link)] and underwent bilateral MMP-9 (InflammaDry, Quidel, San Diego, United States) testing at a GVHD clinic approximately 100 days after HCT (D + 100). The University of Miami Institutional Review Board allowed the retrospective evaluation of charts (20200357), and the research was conducted in accordance with the Declaration of Helsinki.
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8

Comprehensive Ocular Surface Assessment

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Ocular surface testing in the order performed included: Inflammadry (Quidel, San Diego, CA) assessment of ocular surface inflammation (graded as absent or present and if present, qualitatively scored as mild, moderate or severe based on intensity of pink stripe, range 0-3), eyelid margin parameters (anterior blepharitis, vascularity, Meibomian gland plugging, range for all 0-3), tear film break up time (TBUT) (average of 3 measures in each eye), and corneal fluorescein staining assessed to the National Eye Institute (NEI) scoring scale (range 0-15).41 (link) After 10 μl of proparacaine 0.5% was placed in the inferior fornix and excess fluid gently removed, Schirmer strips were placed in the outer 1/3 of the lower conjunctiva and the length of wetting after 5 minutes was recorded. Meibomian gland atrophy (range 0-4)42 and meibum quality (0=clear liquid, 1=white liquid, 2=granular, 3=toothpaste, 4=no visible meibum extracted) were then assessed.
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