Smartpractice Denmark Aps

Smartpractice Denmark Aps Drugs

• T.r.u.e. Test Thin-laye...
  

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  T.r.u.e. Test Thin-layer Rapid Use Patch Test

  

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  T.R.U.E. TEST contains three adhesive panels consisting of 35 allergen and allergen mix patches and a negative control. See Description (11) for allergen types and amounts.

  2.1 Application Instructions

  T.R.U.E. TEST should only be applied to healthy skin. Test sites should be free of scars, acne, dermatitis, or other conditions that may interfere with test result interpretation. Avoid application of T.R.U.E. TEST panels to recently tanned or sun-exposed skin because this may increase the risk of false negatives. Avoid patch testing on patients for three (3) weeks after ultraviolet (UV) treatments, heavy sun, or tanning bed exposure. Avoid using alcohol or other irritating substances on the skin prior to testing. Avoid excessive sweating during the testing period to maintain sufficient adhesion to the skin. Avoid excessive physical activity to maintain sufficient adhesion and to prevent actual loss of patch test material. Avoid getting the panels and surrounding area wet.

  If excessive body hair exists at the test site, remove with an electric shaver (do not use razors). Very oily skin may be cleaned with mild soap and water prior to testing.

  T.R.U.E. Test panels should be applied as follows:

  Figure 1 Figure 2 Figure 3 Figure 4 Peel open the package and remove the test panel (Figure 1). Remove the protective plastic covering from the test surface of the panel (Figure 2). Be careful not to touch the test substances. Position test Panel 1.2 on the patient's back as shown in Figure 3. Allergen number 1 should be in the upper left corner. Avoid applying the panel on the margin of the scapula or directly over the midline of the spine. Ensure that each patch of the allergen panel is in contact with the skin by smoothing the panel outward from the center to the edge (as illustrated for Panel 3.2 in Figure 3). With a medical marking pen, indicate on the skin the location of the two notches on the panel (as illustrated for Panel 3.2 in Figure 4). Repeat the process with test Panel 2.2. Position the test Panel 2.2 beside Panel 1.2, on the left side of the patient's back so that the number 13 allergen is in the upper left corner. Apply test Panel 2.2 five (5) cm from the midline of the spine (Figure 3). Repeat the process with Panel 3.2 positioning the panel on the right side of the patient's back so that the number 25 allergen is in the upper left corner. Apply test Panel 3.2 five (5) cm from the midline of the spine. (Figure 3) If needed, hypoallergenic surgical tape, appropriate for patch testing, may be used for increased adhesion around the outside edges of the panels.

  2.2 Timing of Test Readings

  Schedule patients to return approximately 48 hours after patch test application to have the panels removed. Prior to removal of the panels, use a medical marking pen to remark the notches found on the panels. The patch test reaction on the patient's skin may be evaluated at 48 hours, but an additional reading(s) at 72 and/or 96 hours is necessary. Late positive reactions may occur 7 to 10 days after application of the panels. Patients should be advised to report these reactions to you. Late positive reactions, occurring more than 14 days after application of the panels, may be indicative of active sensitization [see Warnings and Precautions (5.2)].

  2.3 Interpretation Instructions

  An identification template is provided for each of the three (3) panels for quick identification of any allergen that causes a reaction. To assure correct positioning, marks on the skin made with the medical marking pen should correlate with the notches on the template. The interpretation method, similar to the one recommended by the International Contact Dermatitis Research Group, is as follows:

  ? Doubtful reaction: faint macular erythema only + Weak positive reaction: non-vesicular with erythema, infiltration, possibly papules ++ Strong positive reaction: vesicular, erythema, infiltration, papules +++ Extreme positive reaction: bullous or ulcerative reaction - Negative reaction IR Irritant reaction: Pustules as well as patchy follicular or homogeneous erythema without infiltrations are usually signs of irritation and do not indicate allergy.

  Itching is a subjective symptom that is expected to accompany a positive reaction.

  False Negatives

  False negative results may be due to insufficient patch contact with the skin and/or premature evaluation of the test. Repeat testing may be indicated. The effect of repetitive testing with T.R.U.E. TEST is unknown [see Warnings and Precautions (5.9)].

  False Positives

  A false positive result may occur when an irritant reaction cannot be differentiated from an allergic reaction. A positive test reaction should meet the criteria for an allergic reaction. If an irritant reaction cannot be distinguished from a true positive reaction or if a doubtful reaction is present, a retest may be considered. The effect of repetitive testing with T.R.U.E. TEST is unknown [see Warnings and Precautions (5.9)].

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