1. The kits are intended for professional use only. Users should have a thorough understanding of the protocols for the successful use of this kit.
  2. Only the test instruction provided with the kit is valid and has to be used to run the assay. Reliable performance will only be attained by strict and careful adherence to the instructions provided.
  3. Each assay was validated for certain types of sample as indicated in Intended Use (please refer to Chapter 1). Any off-label use of this kit is in the responsibility of the user and the manufacturer cannot be held liable.
  4. The principles of Good Laboratory Practice (GLP) must be followed.
  5. In order to reduce exposure to potentially harmful substances, wear lab coats, disposable protective gloves and protective glasses where necessary.
  6. All kit reagents and specimens should be brought to room temperature and mixed gently but thoroughly before use. Avoid repeated freezing and thawing of reagents and specimens.
  7. The microplate contains snap-off strips. Unused wells must be stored at 2 °C to 8 °C in the sealed foil pouch with desiccant and used in the frame provided.
  8. Duplicate determination of sample is recommended to be able to identify potential pipetting errors.
  9. Once the test has been started, all steps should be completed without interruption. Make sure that the required reagents, materials and devices are prepared ready at the appropriate time.
  10. Incubation times do influence the results.
  11. All wells should be handled in the same order and time intervals.
  12. To avoid cross-contamination of reagents, use new disposable pipette tips for dispensing each reagent, sample, standard and control.
  13. A standard curve must be established for each run.
  14. If controls are included in the kit, they should be included in each run and should fall within established confidence limits. The confidence limits are listed in the QC-Report provided with the kit.
  15. Do not mix kit components with different lot numbers within a test.
  16. Do not use reagents beyond expiry date as shown on the kit labels.
  17. If the plate is incubated overnight in a fridge, a constant temperature and uniformly cooling of the whole plate should exist.
  18. For information on hazardous substances included in the kit please refer to Safety Data Sheet (SDS). The Safety Data Sheet for this product is made available directly on the website of the manufacturer or upon request.
  19. If expected reference values are reported in the test instruction they are only indicative. It is recommended that each laboratory establishes its own reference intervals.
  20. The results obtained with this test kit should not be taken as the sole reason for any therapeutic consequence but have to be correlated to other diagnostic tests and clinical observations.
  21. Kit reagents must be regarded as hazardous waste and disposed of according to national regulations.