Description
InflammaDry® MMP-9 Test – CASE (8 x 20-Packs, 160 Tests)
CLIA-Waived In-Office Tear Testing for Ocular Surface Inflammation
Product Summary
The InflammaDry® case pack contains 8 individually boxed 20-test kits for a total of 160 tests. It is the standard order for a dedicated dry eye clinic, a multi-doctor office, or a group distributing diagnostic stock across locations. Same test, same CLIA-waived status, at a lower cost per box than ordering kits individually.
InflammaDry® is a rapid immunoassay for the visual, qualitative detection of elevated MMP-9 in human tears. It 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.
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
Why Buy the Case
- Lower Cost Per Box – Better unit economics than ordering 20-packs individually
- One Purchase Order – A single order and a single receiving event for 160 tests
- Distribute Across Locations – Each 20-test kit is separately boxed and can be sent to a satellite office without breaking a kit
- Covers a Full Protocol – 160 tests supports bilateral testing on roughly 80 new dry eye workups, or a baseline plus follow-up protocol on roughly 40 patients
- Fewer Supply Interruptions – Practices that stock deeper are less exposed to constrained periods
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.
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.
What's in the Case
8 boxes, each containing:
- (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
Case total: 160 sample collectors, 160 test cassettes, and 160 buffer vials.
Specifications
- Manufacturer – QuidelOrtho
- Manufacturer Catalog Number – RPS-ID-20-U (8 kits per case)
- Dry Eye Rescue SKU – RX-4101
- 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 Case – 160 (8 kits x 20 tests)
- 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
- Rotate stock so the earliest expiration date is used first, and confirm case dating supports your expected 160-test burn rate
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). A case-buying practice testing year round should plan on multiple control sets per year to keep its QC log current.
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 20-Pack (RX-4100) – The same test in a single 20-test kit for lower-volume practices
- Quidel InflammaDry® Control Set (DER5444) – 1 positive control, 1 negative control, and diluent, required for routine quality control
