Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts

The objective of this study is to collect blood specimens from pediatric (>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.

Inclusion criteria

• Over 90 days of age.
• Clinical suspicion of acute bacterial or viral infection.
• Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
• Current disease duration ≤ 7 days.

Exclusion criteria

• Previously enrolled
• Insufficient sample volumes obtained

• For the adult and pediatric populations, < 1.2 mL serum volume
• Sample handling errors
• Another unrelated episode of febrile infection within the past 2 weeks
• Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
• ≥48 hours of oral antibiotic treatment
• ≥12 hours of intravenous\\intramuscular antibiotic treatment
• Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
• A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
• Active inflammatory disease (e.g., Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE], Juvenile Idiopathic Arthritis [JIA], Rheumatoid Arthritis [RA], Kawasaki, other vasculitis)
• Major trauma and\\or burns in the last 7 days.
• Major surgery in the last 7 days
• Congenital immune deficiency (CID)
• Acquired immune deficiency\\modulation state including

• Active malignancy treated within last 6 months
• Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

i. Administration of P.O.\\IV\\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. Asplenia, sickle cell disease

• Indwelling central venous catheter
• Cystic Fibrosis
• Pregnancy - self-reported or medically known
• Other severe illnesses that affect life expectancy and quality of life such as:

• Severe psychomotor retardation
• Congenital metabolic disorder
• End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)