|1. Sensitivity||Positive result by 0.5 ug/mL of T. rubrum dried fungus body.|
|2. Specificity, reactivity and cross-reactivity||The dermatophyte species on nail shows positive result, the other one shows regative results.|
|3. Repeatability||Same results by 5 times.|
|4. Interference by antifungal materials||Representative antifungal materials does not interferen the test result.|
|5. Stability||Stable 36 months at 30 deg. No lot-to-lot variation.|
Clinical Performance data
In 222 patients (at 11 centers) suspected of having tinea unguium on visual inspection, a sample was collected from a foot or hand nail according to the guidelines for diagnosis and treatment of cutaneous fungal infection. The sample was crushed into 3 pieces and subjected to measurement with this kit, direct microscopy and PCR (only samples for which the results of this kit and direct microscopy were inconsistent), respectively. Sample collection, direct microscopy, this kit and PCR were performed by different persons under blinded conditions.
Comparison between the results of Diafactory Tinea Unguium and PCR incorporating direct microscopy Analyses were performed on 222 patients. In 5 patients in whom the results of this kit and direct microscopy were inconsistent and PCR could not be performed because the amount of sample was insufficient, the result of direct microscopy was used.
Contents per One box
Test Strip: 10 strips
10 strips are included in one box. All the strips are packed by Al-Pouch (left).
Extraction Buffer: 1 bottle (7 mL)
Each test requires 0.25 to 0.5 mL of extraction buffer. 7 mL of one bottle is sufficient to carry out 10 tests in one box.
Test Tube: 10 tubes
10 test tubes are included in one box. Test tube can only be used once per one test, not re-use.
Stir Rod: 10 rods
10 stir rods are included in one box. Stir rod can only be used once per one test, not re-use.