access memed bv assay clinical study collection protocol - infectious adult and pediatric cohorts

Conditions: Infection, Bacterial; Infection Viral

Summary: 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)