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WARNINGS AND PRECAUTIONS
1.
This kit is for in vitro diagnostic use only. For professional use only.
2.
All reagents of this test kit which contain human serum or plasma have been tested and confirmed negative for
HIV I/II, HBsAg and HCV by FDA approved procedures. All reagents, however, should be treated as potential
biohazards in use and for disposal.
3.
Before starting the assay, read the instructions completely and carefully. Use the valid version of instructions for use
provided with the kit. Be sure that everything is understood.
4.
The microplate contains snap-off strips. Unused wells must be stored at 2 °C - 8 °C in the sealed foil pouch and
used in the frame provided.
5.
Pipetting of samples and reagents must be done as quickly as possible and in the same sequence for each step.
6.
Use reservoirs only for single reagents. This especially applies to the substrate reservoirs. Using a reservoir for
dispensing a substrate solution that had previously been used for the conjugate solution may turn solution colored.
Do not pour reagents back into vials as reagent contamination may occur.
7.
Mix the contents of the microplate wells thoroughly to ensure good test results. Do not reuse microwells.
8.
Do not let wells dry during assay; add reagents immediately after completing the rinsing steps.
9.
Allow the reagents to reach room temperature (21 °C - 26 °C) before starting the test. Temperature will affect the
absorbance readings of the assay. However, values for the patient samples will not be affected.
10. Never pipet by mouth and avoid contact of reagents and specimens with skin and mucous membranes.
11. Do not smoke, eat, drink or apply cosmetics in areas where specimens or kit reagents are handled.
12. Wear disposable latex gloves when handling specimens and reagents. Microbial contamination of reagents or
specimens may give false results.
13. Handling should be done in accordance with the procedures defined by an appropriate national biohazard safety
guideline or regulation.
14. Do not use reagents beyond expiry date as shown on the kit labels.
15. All indicated volumes have to be performed according to the protocol. Optimal test results are only obtained when
using calibrated pipettes and microtiter plate readers.
16. Do not mix or use components from kits with different lot numbers. It is advised not to exchange wells of different
plates even of the same lot. The kits may have been shipped or stored under different conditions and the binding
characteristics of the plates may result slightly different.
17. Avoid contact with Stop Solution containing 0.5 M H
18. Some reagents contain Proclin 300, BND and/or MIT as preservatives. In case of contact with eyes or skin, flush
immediately with water.
19. TMB substrate has an irritant effect on skin and mucosa. In case of possible contact, wash eyes with an abundant
volume of water and skin with soap and abundant water. Wash contaminated objects before reusing them. If
inhaled, take the person to open air.
20. Chemicals and prepared or used reagents have to be treated as hazardous waste according to the national
biohazard safety guideline or regulation.
21. For information on hazardous substances included in the kit please refer to Safety Data Sheets.
Safety Data Sheets for this product are available upon request directly from DRG.
Version 10.0
2017/05 - vk
Leptin Sandwich ELISA EIA-2395
SO
. It may cause skin irritation and burns.
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