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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. InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.

InflammaDry™ consists of three (3) parts: a sterile Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and Buffer in a vial. The Sample Collector is used to take a sample of human tears. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the tear sample from the inside of the lower eyelid. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally, the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer vial contains a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, carries antigen through a microfiltration process to remove unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane. InflammaDry External Controls are to be used with the InflammaDry test only and are intended to verify that the test reagents are working and that the test is performed correctly. Both Negative and Positive external controls for InflammaDrv™ are supplied as lyophilized powder in small glass vials with screw caps. 200 ul of recombinant MMP-9 in Stabilizing buffer solution is quickly frozen and lyophilized under vacuum. A soft and pliable plastic dropper bottle filled with a Dl water diluent is provided with each set of external controls. The InflammaDry external controls are sold as a separate catalog item. The InflammaDry™ test is based on the principle of lateral flow immunoassays using Direct Sampling Micro-Filtration technology. Matrix metalloproteinase-9 (MMP-9) present in the tear fluid is captured between two (2) highly specific anti-MMP-9 antibodies: a monoclonal mouse anti-MMP-9 antibody and a polyclonal goat antihuman antibody. This antigen-antibody complex is captured at an immobilized Test Line. The formation of a blue color line at the control zone line with a red color line at the test zone line is considered as a positive result, a blue color line at the control zone only is considered as a negative result, if a blue color line in the control zone does not appear the test is considered invalid. The test is a disposable, rapid test requiring 10-15 minutes for a result.