Model Number

BJC O 234

Materials provided
. H pylori test kit contains following items to perform the assay;
1) . H pylori test device
2) Assay diluent : 4 ml/vial
3) Instructions for use
3 Precautions
. H pylori test devices should be stored at room temperature The test device is sensitive to humidity and as well as to heat Perform the test immediately after removing the test device from the foil pouch Do not use it beyond the expiration

4 Specimen collection and storage

1) [whole blood ] Collect the whole blood using the suitable anti-coagulant
2) [serum or plasma] Centrifuge whole blood to get plasma or serum specimen
3) If specimens are not immediately tested they should be refrigerated at 2 ~ 8? For storage periods greater than three days, freezing is recommended They should be brought to room temperature prior to use
4) Specimens containing precipitate may yield inconsistent test results Such specimens must be clarified prior to assaying
5) The whole blood may be used for testing immediately or may be stored at 2 ~ 8? up to three days

5 Warnings
1) For in vitro diagnostic use only
2) Do not eat or smoke while handling specimens
3) Wear protective gloves while handling specimens Wash hands thoroughly afterwards
4) Avoid splashing or aerosol formation
5) Clean up spills thoroughly using an appropriate disinfectant
6) Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container
7) Do not use the test kit if the pouch is damaged or the seal is broken

6 Procedure of the test
1) Remove the test device from the foil pouch, and place it on a flat, dry surface
2) Add 10 L of serum, plasma or 20 L whole blood to the sample well (S), and then add 3 drops of assay diluent
3) Then add 3 drops of the assay diluent As the test begins to work, you will see purple color move across the Result Window in the center of the test device
4) Interpret test results within 10 minutes Do not interpret after 20 minutes

Caution: The above interpreting time is based on reading the test results at room temperature of 15 to 30 degrees C If your room temperature is significantly lower than 15 degrees C, then the interpreting time should be properly increased