User manual DROP TEST KFT DIAGNOSTIC RAPID

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Manual abstract: user guide DROP TEST KFT DIAGNOSTIC RAPID

Detailed instructions for use are in the User's Guide.

[. . . ] This kit can be used only for preliminary diagnostic. If the sample shows a positive reaction, a control examination must be conducted in an authorised laboratory. [. . . ] We recommend to execute a new test. Caution!When determining the time of reading, consider that room temperature is between 15 and 30°C. If the room temperature is much more under 15°C, the time of reading must be increased accordingly. After utilisation, put the needle and the test cassette back into the bag and treat it as hazardous waste!INFORMATION We compared the accuracy of this kit with that of anti-HIV-1/2 ELISA tests. The results have shown 100% (600/600) of sensibility and 99, 094% (5205/ 5208) of accuracy. Interpretation of the result, limits of the test: a positive result may signal the appearance of HIV infection. Consult your physician since positive results must be confirmed in every case with an examination conducted in the indicated laboratory. The final diagnosis can be established only on the basis of the laboratory examination!It must be mentioned that a positive result may be obtained not only due to HIV infection but also due to the presence of so-called , , cross-reagent" antibodies (they can appear mainly as a result of other virus infections or diseases of immunologic origin). It is also important to know that a negative result does not exclude the possibility of HIV infection since antibodies appear in the blood only after a certain period of time (from 3 weeks to 3 months). Therefore if infection is suspected, it is strongly recommended to repeat the test every week, or to execute the test every month if your lifestyle is accompanied with the danger of infection. [. . . ] Expiry date: Number of items This product is in compliance with the European IVD directive no. 98/79/EC Temperature limitation Do not throw it into the rubbish bin! [. . . ]

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