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

The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.

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.

Eligibility Criteria:
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

  1. Active malignancy treated within last 6 months
  2. 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:

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