Flags inflammation
Picks up elevated MMP-9, an inflammatory marker frequently raised in the tears of dry eye patients.
In-office procedures · Diagnostic test
InflammaDry A 10-minute MMP-9 test, run in the exam lane.
InflammaDry is a point-of-care test that flags elevated MMP-9, an inflammatory marker frequently raised in the tears of dry eye patients. The CLIA-waived immunoassay gives a visual read in 10 minutes from a single tear sample.
10 minResult time
40 ng/mLClinical cutoff for MMP-9
98%Negative agreement
80.3%Positive agreement
How the test works
The sampling fleece picks up tears directly, and the sample runs on a lateral flow immunoassay that uses direct sampling microfiltration. Two antibodies capture MMP-9, and a two-color line readout shows whether it is elevated.
10-minute results
Four simple steps produce a result within the same visit.
CLIA-waived
Built for point-of-care use in an eye care practice.
Nothing else to buy
Ready out of the box, with no reader and no refrigeration needed.
Inside each test
Every test includes a sterile sample collector, a buffer and a test cassette.
- Point-of-care, CLIA-waived
- 10-minute results
- Stored without refrigeration
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Sample collector
A sterile collector with a contoured tip and Dacron sampling fleece that collects tears directly.
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Test cassette
A plastic cassette holding a lateral flow immunoassay strip built on direct sampling microfiltration.
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Two-color result
A blue control line means the test is valid. Red and blue lines together read positive, and blue alone reads negative.
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External controls
Positive and negative controls confirm the test is performing and help with staff training.
Where it fits in the workup
Run InflammaDry as part of the dry eye workup, before anesthetic, dyes or Schirmer testing.
Sample
Tears picked up directly from the eye by the sterile fleece. No pipettes and no extra equipment.
Time to result
Four steps and a 10-minute wait for a visual result.
CLIA-waived
Prescription use only, at point-of-care sites. Controls go in with every new lot, every new shipment and every 30 days.
Stock InflammaDry
Specifications and safety information
Technical specifications
| Sample type | Human tears |
|---|---|
| Analyte | MMP-9 (matrix metalloproteinase-9) |
| Clinical cutoff | 40 ng/mL |
| Time to result | 10 minutes |
| Result format | Visual, qualitative, two-color lines |
| Positive agreement | 80.3% |
| Negative agreement | 98% |
| CLIA status | Waived |
| Storage | 4°C to 25°C (39°F to 77°F) |
| Test kit | RPS-ID-20-U, 20 tests |
| Control kit | RPS-DESTD, 1 positive and 1 negative control |
| External controls | Each new lot, each new shipment and every 30 days |
Indications for use
InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
Warnings and precautions
- For prescription use only.
- Slit-lamp biomicroscopy is required to eliminate patients with active intraocular inflammation.
- InflammaDry requires a visual readout. Do not interpret the test result if you have color-impaired vision.
- The Dacron material used in the Sampling Fleece may cause allergic reactions for some people.
- InflammaDry should be performed prior to instilling ocular anesthetic, topical dyes, or performing Schirmer testing.
- Certain medications may cause erroneous results if used immediately before taking a sample. If ocular anesthetic or any other topical medication has been applied to the eye, wait at least 2 hrs prior to collecting a sample.
- Certain medications such as systemic immunomodulators, topical or oral steroids, cyclosporine, tetracycline and topical azithromycin are known to inhibit metalloproteinase activity. Use of these medications may lead to false negative results.
Questions doctors ask about InflammaDry
What does the test detect?
Elevated MMP-9, an inflammatory marker frequently raised in the tears of dry eye patients. The cutoff used clinically is 40 ng/mL.
How long until the result?
The result is ready in 10 minutes.
Is it CLIA-waived?
Yes. It is CLIA-waived and meant for use by prescribers at point-of-care sites.
What are the storage requirements?
Store between 4°C and 25°C (39°F to 77°F). Refrigeration is not needed, and the test and buffer stay stable until the expiration date printed on the package.
How often do external controls need to be run?
With every new lot, every new shipment and every 30 days.
At what point in the exam should it be run?
Before any ocular anesthetic, topical dye or Schirmer testing. If a topical medication has gone in the eye, allow at least 2 hours before taking the sample.
Bring MMP-9 testing into your dry eye workup
A 10-minute, CLIA-waived test showing whether MMP-9 is elevated in a patient suspected of dry eye.
InflammaDry is a trademark of QuidelOrtho. Read the complete manufacturer instructions for use, including every warning, precaution and contraindication, before use. Individual results vary.