Description
InflammaDry® MMP-9 Test – 20-Pack
CLIA-Waived In-Office Tear Testing for Ocular Surface Inflammation
Product Summary
InflammaDry® is a rapid immunoassay for the visual, qualitative detection of elevated MMP-9 in human tears. It is CLIA-waived, requires no instrumentation, and delivers a readable result in 10 minutes, so you can confirm or rule out ocular surface inflammation while the patient is still in the chair.
Each kit contains 20 complete tests. Staff can collect and activate the test during pretesting, and you read the result during the exam, which means MMP-9 testing adds objective data to a dry eye workup without adding a second visit.
Key Features & Benefits
- CLIA-Waived – Performed in-office under a Certificate of Waiver, no send-out required
- Results in 10 Minutes – Diagnose and discuss treatment within the same visit
- Detects MMP-9 at or above 40 ng/mL – Objective evidence of ocular surface inflammation
- No Capital Equipment – No reader, no centrifuge, no per-test instrument cost
- No Anesthetic Required – Tear sample collected with a gentle sampling fleece
- Two-Color Read – Simple visual interpretation with a built-in control line
How It Works
Matrix metalloproteinase-9 (MMP-9) is a proteolytic enzyme produced by stressed corneal epithelial cells. It is consistently elevated in the tears of patients with dry eye disease and is associated with tear film instability and epithelial barrier disruption.
Symptoms and clinical signs frequently disagree in dry eye. A tear biomarker result gives you a third data point that is independent of both, helping you separate inflammatory from non-inflammatory presentations. A positive result supports anti-inflammatory therapy. A negative result redirects you toward evaporative, aqueous-deficient, or neuropathic pathways.
When to Use
- To confirm ocular surface inflammation in a suspected dry eye workup
- To establish a pre-treatment baseline before starting anti-inflammatory therapy
- To document response by retesting after a therapeutic course
- To support medical necessity with an objective, dated in-office result
- To strengthen patient education and improve acceptance of a longer treatment plan
How to Use
- Collect the sample. Gently pull down the lower eyelid to expose the palpebral conjunctiva. Dab the sampling fleece 6 to 8 times along the conjunctiva, releasing the lid between dabs, then rest the fleece against the conjunctiva for 5 additional seconds.
- Assemble the test. Seat the sample collector into the test cassette body to transfer the sample.
- Activate the test. Immerse the absorbent tip in the buffer vial for at least 20 seconds.
- Develop and read. Lay the cassette flat for 10 minutes. Once the result window background is white and 10 minutes have elapsed, the test may be read accurately. Read within 6 hours.
- Do not test within 20 minutes of Schirmer testing.
Plan for roughly 2 minutes of chair time to collect and activate, plus a 10 minute development window that runs in parallel with the rest of your exam.
Reading the Result
- Positive – Blue control line plus a red result line. MMP-9 detected at or above 40 ng/mL
- Negative – Blue control line only. MMP-9 below 40 ng/mL
- Invalid – No blue control line. Repeat with a new test and a new sample
Any visible red line, however faint, is a positive result.
Test Kit Includes
- (20) Individually packaged sample collectors
- (20) Individually packaged test cassettes
- (20) Buffer vials – Buffered salt solution with sodium azide preservative
- Package insert with complete instructions for use
Specifications
- Manufacturer – QuidelOrtho
- Manufacturer Catalog Number – RPS-ID-20-U
- Dry Eye Rescue SKU – RX-4100
- Analyte – Matrix metalloproteinase-9 (MMP-9)
- Positivity Threshold – 40 ng/mL
- Sample Type – Tear fluid from the palpebral conjunctiva
- Time to Result – 10 minutes
- CLIA Complexity – Waived
- Positive Agreement – 80.3%
- Negative Agreement – 98%
- Format – Single-use lateral flow immunoassay cassette
- Tests Per Kit – 20
- Equipment Required – None
- Regulatory – For in vitro diagnostic use. Prescription only
Storage & Handling
- Store between 39°F and 77°F (4°C to 25°C). No refrigeration required
- Single-use only – Do not reuse any test component
- Do not use past the expiration date printed on the packaging
- Bring refrigerated or cold-shipped stock to room temperature before running a test
Quality Control
QuidelOrtho specifies external control testing with each new lot, each new shipment, and every 30 days. Controls are sold separately as the Quidel InflammaDry® Control Set (SKU DER5444). Practices billing this test should keep a current control set on hand and log results.
Coding & Reimbursement
InflammaDry is generally reported with CPT 83516 plus the QW modifier for CLIA-waived status, and laterality modifiers (RT and LT) when both eyes are tested. Your practice must have a CLIA Certificate of Waiver on file before performing or billing waived testing.
Coverage for tear biomarker testing varies by payer and by MAC jurisdiction, and some carriers list it as non-covered for dry eye evaluation. Confirm current policy and the Clinical Laboratory Fee Schedule rate for your state before billing. This information is provided as a reference and is not a guarantee of payment.
Important Considerations
MMP-9 is a general marker of ocular surface inflammation and is not specific to dry eye disease. Results are intended to be used alongside your clinical examination and should not be the sole basis for a treatment decision.
- Very low tear volume in severe aqueous deficiency can produce a false negative
- Recent ocular surgery, active infection, and certain topical medications can produce a false positive
- Refer to the package insert for the complete list of limitations
You Might Also Like
- InflammaDry® MMP-9 Test CASE (RX-4101) – 8 kits, 160 tests, at a lower cost per box for high-volume and multi-location practices
- Quidel InflammaDry® Control Set (DER5444) – 1 positive control, 1 negative control, and diluent, required for routine quality control
