1. Age: Adults: ≥ 18 years (75%-80% in total); Pediatrics: newborn- 18 years (20-25% in total)
2. Weight: Pediatrics: Weight of at least 1500 g (3.3 pounds [lb])
3. Blood volume: Blood volume collected must not exceed 5% of the total blood volume of the subject in a 24 hours period or 2.5% of total blood volume for a single blood draw
4. Subject Type:
a. Subjects whose medical history indicates that their lab values will be within the normal measuring interval for the respective capillary analytes (apparently healthy)
b. Subjects with various conditions or diseases indicating that their lab values will be outside the normal range for the respective capillary analytes (unhealthy)
5. The subjects, legal guardians and/or legally authorized representative (if applicable) provided a signed informed consent prior to any study-specific procedure
6. At least two (2) adequate puncture sites
Inclusion- Venous samples
1. Age: Adults: ≥ 18 years (75-80% in total); Pediatrics: 2 years – 18 years (20-25% in total)
2. Blood volume: Blood volume collected must not exceed 5% of the total blood volume of the subject in a 24 hours period or 2.5% of total blood volume for a single blood draw
3. Subject Type:
a. Subjects whose medical history indicates that their lab values will be within the normal measuring interval for the respective venous analytes (apparently healthy)
AND/OR
b. Subjects with various conditions or diseases indicating that their lab values will be outside the normal range for the respective venous analytes (unhealthy)
4. The subjects and/or legal guardians, legally authorized representative (if applicable) provided a signed informed consent prior to any study-specific procedure
5. At least one adequate venipuncture site
Exclusion- Both Capillary and Venous samples
A subject will not be eligible for the study if any of the following criteria apply:
1. For serum tubes only: subjects currently receiving >325 mg/day of Aspirin (i.e. acetyl salicylic acid) and/or other anticoagulation therapy (e.g. heparin, warfarin).
Note for >325 mg/day Aspirin: Subjects can be enrolled if a washout period of at least 4 days is completed prior to screening.
2. The subject and/or legal guardian or legally authorized representative is unwilling or unable to provide informed consent.
3. Inadequate capillary and venous blood collection sites (sites infected, scarred, bruised, …) that does not allow a proper sample collection according to the puncture site evaluation.
4. History of any illness or condition that, in the opinion of the Principal Investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
5. Disqualified by the treating physician.
