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RAPID TESTS: ENACHECK |
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>REF. |
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Packaging |
CE mark |
Sensitivity |
Specificity |
Total running time |
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| ENACHECK |
5453 |
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25 tests / kit |
CE mark |
92,5 % |
98 % |
2 h. |
- FORMAT: S: stick; D: device; M: midstream,
- All the tests are packaged in individual, aluminium, hermetic pouch.
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ENACHECK |
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Immuno-line assay based on recombinant antigens for the determination of antibodies against extractable nuclear antigens of auto-immune diseases (collagenosis) in human serum or plasma.
This line-assay is designed as confirmatory assay in order to distinguish between rheumatic diseases caused by autoimmune disorders and those of other origin.
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- Quality system certified ISO 9001 and ISO 13485.
- Specificity : 98%.
- Sensitivity : 92.5%.
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| - PACKAGING : |
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| - EFFICIENT : |
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- Simple : Unitary tests.
- Fast : Results in 2 hours.
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| - PRACTICAL : |
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- Realizable over serum.
- Traceability : possible filing of the strip.
- Objective reading: Comparison of the color’s intensity with an integrated cut-off.
- Long shelf life: 12 months.
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After incubating the test strips with human serum or plasma for 1 hour, unbound antibodies are removed with washing buffer. After a second incubation with anti-human IgG conjugated with horseradish peroxidase and adding TMB as the chromogenic substrate, specifically bound antibodies are detected. Unspecifically bound antibodies are removed in between by washing steps. The test principle allows the allocation of the reactivity for the different antigens.
Every test strip has two bands beyond the printed number :
1. Reaction control band : should be stained very strong and indicates a correct incubation and staining.
2. "Cut off"-control band : allows the interpretation of the reactivity.
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ENACHECK
PROCEDURE
INTERPRETATION
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