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Details

How Supplied
Single use test kit (x 20/carton) containing:, Pouched Sterile Sample Collector, Pouched Test Cassette, Buffer Vial containg Sodium Azide.
Dosing
ECP use only. Four-step process: Collect sample, assemble test, run test, read results. ECPs are highly recommended to receive one-to-one instruction before initially using test. Also see manufacturer's literature. "If drops are used, wait 2 hours before collecting a tear sample. (Testing) should be performed PRIOR to instilling ocular anesthetic, topical dyes, or performing Schirmer testing. Once opened, the test cassette should be used within 1 hour".
Formulation
See above and manufacturer's literature.
Contact Lens Use
See note 1.
Indications
Dry Eye. Ocular surface inflammation related to Dry Eye and elevated levels of MMP-9. Differential diagnosis of EDE/ADE. " ....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 help in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation".
Contra-Indications/Cautions
Hypersensitivity to product/class/component. "1. For in vitro diagnostic use only. 2. Keep the test cassette and sample collector in their foil pouches until just before use. 3. The Dacron® material used in the sampling fleece may cause allergic reactions for some people. 4. Do not use past the expiration date. 5. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. Proper handling and disposal methods should be established according to local, state, and federal regulations. 6. Wear disposable gloves while handling samples and wash hands after the test is complete. 7. (All components) are single use items. Do not reuse with multiple specimens. 8. .... do not interpret the test result if you have color-impaired vision. 9. Result interpretation requires a brightly lit environment. 10. Do not use the same .... test kit on more than one patient (or eye). 11. Slit-lamp biomicroscopy is required to eliminate patients with active intraocular inflammation. Avoid direct contact with the liquid buffer". ECP/HCP to read and understand all accompanying product information before first use.
Adverse Reactions
"The Dacron® material used in the sampling fleece may cause allergic reactions for some people". Also see manufacture's Safety Data Sheet. If irritation occurs, persists or increases, discontinue use and assess eye. If vision changes or irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP.
Legal Category
CE (Medical Device)
Notes

1. Data on use with CLs in situ not available at this time, therefore advised CLs be removed before commencement of test - 22/06/15.

2. All users are advised to be familiar with all product literature before use.

3. THIS PRODUCT MUST ONLY BE ADMINISTERED TO A PATIENT BY AN APPROPRIATELY TRAINED QUALIFIED ECP.

4. Because products are regularly improved and change, product data and advice may occasionally change. As a result, EDDB recommends that you and your patient always read the product label and Patient Information Leaflet carefully before using any products. Please do not solely rely on the information provided on this website. Because of this, EDDB is unable to accept liability for any inaccuracies or incorrect information contained on this site.

Product information

Not every product may be listed, or have full data. Every effort is being made to fill in the gaps as soon as possible. It will continue to grow in breadth and depth as data arrives and products are released, almost on a daily basis. Endeavours will be made to include information on 'retailers' drops such as Sainsbury's, Superdrug etc, so you can have data available when your patient tells you they are using Tesco Allergy Drops (Sodium Cromoglicate) and asks "can I use it with my contact lenses?". If you would like to propose products for the database, have any ideas, suggestions, would like to provide missing data or see any factual inaccuracies please email adpconsultancy@gmail.com