Diagnostics image
Diagnostics image

Specification

Technical data






1. SensitivityPositive result by 0.5 ug/mL of T. rubrum dried fungus body.
2. Specificity, reactivity and cross-reactivityThe dermatophyte species on nail shows positive result, the other one shows regative results.
3. RepeatabilitySame results by 5 times.
4. Interference by antifungal materialsRepresentative antifungal materials does not interferen the test result.
5. StabilityStable 36 months at 30 deg. No lot-to-lot variation.

Clinical Performance data

Clinical data

High accuracy

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


Strip, Al pouch Strip

10 strips are included in one box. All the strips are packed by Al-Pouch (left).


Extraction Buffer: 1 bottle (7 mL)


Extraction Buffer

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


Test Tube

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


Stir rod

10 stir rods are included in one box. Stir rod can only be used once per one test, not re-use.


Quick Link

Certification

CE mark

EN ISO13485

Contact

Name:
JNC Corporation
TEL:
+81-3-3243-6147
email:
vethum-diag@jnc-corp.co.jp
web:
http://www.jnc-corp.co.jp/english/
Address:
Shin Otemachi Bldg., 2-1, Otemachi 2-Chome, Chiyoda-ku, Tokyo 100-8105

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