VIDAS® NEPHROCLEAR Reference Interval Study

Cohort A

Inclusion Criteria:

- a) Apparently healthy adults (age ≥ 21 years); b) Provide written informed consent for
study (AST-017) participation

Exclusion Criteria:

- a) Any known or suspected acute illness or condition - including acute infections - at
the time of enrollment or within the previous 30 days; b) Any known or suspected
significant new onset or chronic morbid medical condition such as: Active cancer
Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) Chronic
coagulation abnormality Chronic obstructive pulmonary disease (including emphysema,
chronic bronchitis, and asthma) Chronic pancreatitis Chronic renal insufficiency
Congestive heart failure Coronary artery disease Diabetes mellitus (Type 1 or Type 2)
Gout Hyper- or hypothyroidism Hyperlipidemia (includes hypercholesterolemia)
Hypertension Immunocompromised Inflammatory bowel disease (including Crohn's disease
and ulcerative colitis) Liver cirrhosis Neuromuscular disease Peripheral vascular
disease (a.k.a. peripheral artery disease) Polycystic kidney disease Rheumatoid
arthritis Systemic Lupus Erythematosus c) Trauma-related surgery within the last 6
months; d) Any surgery, hospitalization or institutionalization (such as in a nursing
home) during the previous 3 months; e) Received any blood product transfusion within
the previous 2 months; f) Pregnant women or children; g) Prisoners or
institutionalized individuals; h) Already provided a urine sample for the AST-017
study

Cohort B Inclusion Criteria Adults (age ≥ 21 years); b) One or more of the following
chronic, stable morbid conditions: Active cancer Arrhythmia (atrial fibrillation, heart
block, ventricular tachycardia) Chronic coagulation abnormality Chronic obstructive
pulmonary disease (including emphysema, chronic bronchitis, and asthma) Chronic
pancreatitis Chronic renal insufficiency Congestive heart failure Coronary artery disease
Diabetes mellitus (Type 1 or Type 2) Gout Hyper- or hypothyroidism Hyperlipidemia (includes
hypercholesterolemia) Hypertension Immunocompromised Inflammatory bowel disease (including
Crohn's disease and ulcerative colitis) Liver cirrhosis Neuromuscular disease Peripheral
vascular disease (a.k.a. peripheral artery disease) Polycystic kidney disease Rheumatoid
arthritis Systemic Lupus Erythematosus

c) Provide written informed consent for study participation.

For Cohort B subjects in the AST-017 Study:

Subjects were considered to have the above condition(s) if he/she had the diagnosis by a
healthcare professional and/or was under treatment by a healthcare professional for the
listed condition(s).

Subjects with a condition (e.g., hypertension, hypercholesterolemia) controlled by
medications were enrolled.

To be considered chronic and stable, the condition(s) must have been present for at least 1
year and without any acute change (decompensation or improvement) within the 3 months prior
to enrollment.

Exclusion Criteria

1. Any known or suspected acute illness or condition - including acute infections - at
the time of enrollment or within the previous 30 days;

2. Any new onset or unstable morbidities;

3. Trauma-related surgery within the last 6 months;

4. Any surgery, hospitalization or institutionalization (such as in a nursing home)
during the previous 3 months;

5. Received any blood product transfusion within the previous 2 months;

6. Pregnant women or children;

7. Prisoners or institutionalized individuals;

8. Already provided a urine sample for this (AST-017) study.