Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Selected rows are included for illustration purposes only, in order to save space. The LOINC code, if included, should be provided by the testing laboratory. The sponsor applicant may also include the method used for testing if it is of interest.   

The biomarkers were categorized using LBCAT and LBSCAT. These categories were based on the scientific classification of the type of  biomarker and the associated constituent being evaluated by the biomarker test. Other categorization may be done by the sponsorapplicant, based on the study design. These may include using Biomarker of Tobacco Exposure, Biomarkers of Harm or Potential Harm, Biomarkers of Compliance, etc. The LBSCAT can be used to provide the type of markers (e.g., Tobacco Alkaloid, Polynuclear Aromatic Hydrocarbons, Tobacco Specific Nitrosamines) or the health impact of the biomarker (e.g., cancer, cardiovascular disease, respiratory effects, reproductive problems, or addiction).

Total Nicotine equivalents (TNE-7) were calculated by the sponsor applicant based on the data below and represented in an ADaM dataset. Total Nicotine equivalents are the sum of nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates. Other estimates of TNE can be used and are typically denoted using terms like TE-2, TE-3. For example TE-2 is the sum of cotinine + 3'-hydroxycotinine.  

...