Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System

This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive samples.

Inclusion Criteria:Male or female subject who is ≥18 years of ageSubject is willing and able to provide Informed Consent for study participation, prior to any study mandated proceduresFor the healthy human population: Subject is in general good health with a stable health status based on medical history, and the investigator's clinical judgment defined as:No acute medical conditions that require the use of systemic prescription medications in the last 30 days andAny chronic medical diagnoses/conditions should be stable for the last 30 days (no hospitalizations, emergency room (ER), or urgent care for condition). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 30 days before enrollment.For the symptomatic human population:Current symptoms consistent with cold, flu or other bronchial and symptomatic infections. The subject must currently (day of consent) have at least one of the following symptoms: fever, chills, chest discomfort, shortness of breath, cough, dizziness/confusion, nausea, headache, sweats, fatigue, or body aches.Exclusion Criteria:Subject has inclusion symptoms and tests positive for COVID-19.Subject has previously enrolled in this study, or subject has previously failed screening for this study.Subject has any medical or social or psychiatric condition(s) or current substance abuse that, in the opinion of the investigator, would preclude the subject's ability to provide informed consent/assent, or to comply with the study requirements.Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred or occurred within the last 30 days.Subject is a nursing home resident.Subject is a prisoner.