DEVICE FOR SAMPLE COLLECTION AND RAPID IMMUNOLOGICAL IDENTIFICATION OF BIOLOGICAL SPECIMENS

A PATENTED SELF-CONTAINED SOLID PHASE COLORIMETRIC IMMUNOASSAY FOR THE RAPID IDENTIFICATION OF BIOLOGICAL ANALYTES IS PROPOSED FOR USE IN MICROGRAVITY ENVIRONMENT. THIS SIMPLE TO USE NONINSTRUMENTED DEVICE CAN DETECT AS FEW AS 2 X 10(3) GROUP A STREPTOCOCCI IN LESS THAN 5 MINUTES. THE TEST DEVICE IS COMPRISED OF A TUBE WHICH HAS A DACRON SWAB FOR SAMPLE COLLECTION, A SERIES OF CHAMBERS CONTAINING LYOPHILIZED EXTRACTION AND COLLOIDAL GOLD IMMUNOREAGENTS, RECONSTITUTION BUFFER, AND A REACTION ZONE ON A FIXED MEMBRANE. EACH SINGLE USE TEST CAN BE STORED AT ROOM TEMPERATURE. THE SWAB IS USED TO COLLECT A BIOLOGICAL SPECIMEN. AFTER SAMPLE COLLECTION, THE SWAB IS RETURNED TO THE DEVICE AND PUSHED FORWARD INTO AND THROUGH REAGENT CHAMBERS. AFTER 1 TO 5 MINUTES, THE SWAB IS PUSHED FURTHER INTO THE TUBE DEVICE WHERE THE REACTANTS DIFFUSE FOR AT LEAST 1 MINUTE INTO A CAPTURE MEMBRANE. THE MEMBRANES ARE THEN OBSERVED WITH THE NAKED EYE FOR THE PRESENCE OF ANALYTE INDICATED BY DEVELOPMENT OF A RED SPOT. NO WASHING, ADDITIONAL STEPS, ORREAGENTS ARE REQUIRED. THIS TEST SHOULD BE FUNCTIONAL IN A MICROGRAVITY ENVIRONMENT BECAUSE ALL TRANSFER REACTANTS IS ACCOMPLISHED BY MOVEMENT OF THE SWAB AND DIFFUSION. THIS TUBE DEVICE IS DESIGNED FOR TESTING BY UNTRAINED PERSONNEL.