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Frequently Asked Questions About T.R.U.E. TEST 1. Can T.R.U.E. TEST be used safely on patients who are allergic to natural rubber latex? YES! There is no natural rubber latex in T.R.U.E. TEST allergens, components or packaging. Therefore it is safe to use on patients who are allergic to natural rubber latex. 2. How should T.R.U.E. TEST be handled and stored? When does T.R.U.E. TEST product expire? Is there an MSDS for T.R.U.E. TEST? Refrigerate T.R.U.E. TEST; do not freeze. T.R.U.E. TEST is temperature sensitive and should be stored in between 36ºF (2ºC) and 46ºF (8ºC). If T.R.U.E. TEST is not refrigerated for 4 hours or more, it should be discarded. T.R.U.E. TEST product will be delivered with an expiration date of 8 months or longer; expiration dates are stamped on each box. As an FDA-regulated biologic, no MSDS is required. For more information, click here. 3. Can T.R.U.E. TEST be used in children? The safety and efficacy of T.R.U.E. TEST use in children is unknown, and pre-market approval testing of excluded patients under the age of 16. As a result, using T.R.U.E. TEST in children is considered an off-label use of T.R.U.E. TEST in the United States. For more information, click here. 4. Can T.R.U.E. TEST be used in patients using immunosuppressive therapies? Overall, it is best to avoid systemic immunosuppressive steroids prior to and during patch testing for optimal test results. The effect of systemic antihistamines during patch testing with T.R.U.E. TEST is essentially unknown, as is the effect of systemic cyclosporin administration. In general, the use of topical steroids or immunosuppressants at or near potential test sites should be avoided for at least 1 week prior to patch testing. For more information, click here. 5. Can T.R.U.E. TEST be used in women who are pregnant or breast-feeding? The safety and efficacy of T.R.U.E. TEST in women who are pregnant or breast-feeding is unknown, and pre-market clinical trials of T.R.U.E. TEST excluded pregnant women. T.R.U.E. TEST has been assigned a pregnancy Category C level of fetal risk by the Food and Drug Administration. Therefore, T.R.U.E. TEST should only be used in pregnant women if clearly needed, and when the potential benefit justifies any potential fetal risk. For more information, click here. 6. Can patients react to the components in T.R.U.E. TEST tape or adhesive? The tape and adhesive used in T.R.U.E. TEST is equivalent to that in hypoallergenic surgicala tape. Irritant reactions do occur, but not frequently. Allergic reactions to the tape or adhesive are considered rare. For more information, click here. 7. How can T.R.U.E. TEST panel adherence problems be prevented? T.R.U.E. TEST panels generally adhere well. Problems can occur with: 1) excess hair, skin oil or dermatitis at the test site; 2) patient physical activity level; 3) patient perspiration; and 4) climatic extremes, such as high humidity or heat. If needed, hypoallergenic surgical tape may be used around the outside edges of the panels. For more information, click here.