Helps identify inflammation
Detects elevated MMP-9, an inflammatory marker often elevated in the tears of patients with dry eye disease.
In-Office Procedures · Diagnostic Test
InflammaDry In-office MMP-9 test for dry eye.
InflammaDry is a simple in-office test that detects elevated levels of MMP-9, an inflammatory marker that is often elevated in the tears of patients with dry eye disease. It is a rapid, CLIA-waived immunoassay that gives a visual result from a tear sample in 10 minutes.
10 minTime to result
40 ng/mLMMP-9 clinical cutoff
98%Negative agreement
80.3%Positive agreement
How it works
How InflammaDry works
A tear sample is collected directly onto the sampling fleece and run on a lateral flow immunoassay using direct sampling microfiltration technology. MMP-9 is captured between two antibodies, and a two-color line result shows whether elevated MMP-9 is present.
Results in 10 minutes
A simple four-step process gives a result during the same visit.
CLIA-waived
Designed for point-of-care use in the eye care office.
No extra equipment
Ready to use immediately, with no refrigeration or reader required.
What is in the test
Each test combines a sterile sample collector, a test cassette and a buffer.
- CLIA-waived point-of-care test
- Results in 10 minutes
- No refrigeration required
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Sample collector
Sterile collector with a contoured end and a Dacron sampling fleece for direct tear collection.
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Test cassette
Lateral flow immunoassay strip in a plastic cassette using direct sampling microfiltration technology.
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Two-color readout
A blue control line confirms a valid test. A red test line with the blue line is positive; a blue line alone is negative.
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External controls
Positive and negative controls verify test performance and support operator training.
The test
Testing workflow
InflammaDry fits into the dry eye work-up and should be run before anesthetic, dyes or Schirmer testing.
Sample
Tear fluid collected directly from the eye with the sterile sampling fleece. No pipetting or additional equipment.
Time to result
A simple four-step process gives a visual result in 10 minutes.
CLIA-waived
For prescription use at point-of-care sites. Run external controls with each new lot, each new shipment and every 30 days.
Order 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.
Common questions about InflammaDry
What does InflammaDry detect?
Elevated levels of MMP-9, an inflammatory marker that is often elevated in the tears of patients with dry eye disease. The clinical cutoff is 40 ng/mL.
How long does the test take?
Results are available in 10 minutes.
Is InflammaDry CLIA-waived?
Yes. It is a CLIA-waived test intended for prescription use at point-of-care sites.
How should the test be stored?
At 4°C to 25°C (39°F to 77°F). No refrigeration is required, and the test and buffer are stable until the expiration date on the packaging.
How often should external controls be run?
With each new lot, each new shipment and every 30 days.
When should the test be run during the exam?
Before instilling ocular anesthetic or topical dyes and before Schirmer testing. If any topical medication has been applied to the eye, wait at least 2 hours before collecting a sample.
Add MMP-9 testing to your dry eye work-up
A 10-minute, CLIA-waived test that identifies elevated MMP-9 in the tears of patients suspected of having dry eye.
InflammaDry MMP-9 Test is a trademark of QuidelOrtho. Review the full manufacturer instructions for use, including all warnings, precautions and contraindications, before use. Individual results vary.
