Purchase Order HHSF223201111752P

THE VENDOR WILL PROVIDE THE FOLLOWING SERVICES: VIRUS PARTICLE DETECTION AND QUANTITATION BY ULTRA-CENTRIFUGATION AND THIN SECTION ELECTRON MICROSCOPY.THE END USERS LABORATORY HAS THE NEED FOR USING THIN SECTION TRANSMISSION ELECTRON MICROSCOPY TO IDENTIFY AND QUANTIFY LOW AMOUNTS OF VIRUS IN TISSUE CULTURE SUPERNATANT SAMPLES. LOW AMOUNTS OF VIRUS IN TISSUE CULTURE SUPERNATANT SAMPLES CAN BE CONCENTRATED USING ULTRACENTRIFUGATION. THIN SECTION TRANSMISSION ELECTRON MICROSCOPY (TS-TEM) METHOD CAN BE USED FOR A CONSISTENT, ACCURATE AND REPEATABLE EXAMINATION OF CULTURE SUPERNATANT SAMPLES WITH A DETECTION LIMIT OF 105PARTICLES/ML. SALIENT CHARACTERISTICSTHE FOLLOWING FOLLOWING TECHNICAL REQUIREMENTS MUST BE MET: *MATERIALS WILL BE PROVIDED BY THE FDA IN THE FORM OF CELL CULTURE SUPERNATANT (1-10ML);*THE CONTRACTOR SHALL PROCESS AND ANALYZE THE SAMPLES USING ULTRACENTRIFUGATION FOLLOWED BY THIN SECTION TRANSMISSION ELECTRON MICROSCOPY SERVICES;*THE CONTRACTOR SHALL PERFORM ULTRASTRUCTURAL EVALUATION AND QUANTIFY ANY VIRAL PARTICLES IN THE SAMPLE (DETECTION LIMIT OF 105 PARTICLES/ML);*THE CONTRACTOR SHALL PROVIDE A DATA REPORT DETAILING THE ULTRASTRUCTURAL EVALUATION OF VIRUS PARTICLES INCLUDING SIZES, TABULATION INDICATING DIFFERENT PARTICLE TYPES AND QUANTIFICATION (IF VIRUS LIKE PARTICLES ARE OBSERVED), AND PRINT AND ELECTRONIC IMAGES OF VIRUS PARTICLES TO THE INVESTIGATOR;*THE COMPLETED REPORT SHOULD BE BOTH EMAILED (PDF COPY) AND MAILED (HARD COPY) TO THE INVESTIGATOR. SCANNED IMAGES OF ANY VIRUS LIKE PARTICLES SHOULD BE PROVIDED, AND PHOTOGRAPHIC QUALITY NEGATIVES SHOULD BE RETAINED FOR AT LEAST 10 YEARS AND MADE AVAILABLE TO THE INVESTIGATOR WHEN NEEDED (RAW DATA SHOULD NOT BE DISPOSED WITHOUT CONSENT OF INVESTIGATOR ? SHOULD BE TRANSFERRED TO INVESTIGATOR FOR STORAGE);*CONTRACTOR TURNAROUND TIME FOR DELIVERABLES SHALL BE NO MORE THAN 3 WEEKS AFTER RECEIPT OF THE SAMPLES.SCOPETHE INVESTIGATOR WILL PROVIDE THE CONTRACTOR WITH THREE CELL CULTURE SUPERNATANT SAMPLES, AND THE CONTRACTOR WILL NEED TO PERFORM ULTRACENTRIFUGATION AND THIN SECTION TRANSMISSION ELECTRON MICROSCOPY SERVICES FOR VIRUS PARTICLE ULTRASTRUCTURAL EVALUATION AND QUANTIFICATION. THEY SHOULD PROVIDE A DETAILED REPORT OF THEIR FINDINGS, INCLUDING IMAGES OF ANY VIRUS PARTICLES.DELIVERABLES *DATA REPORT DETAILING THE ULTRASTRUCTURAL EVALUATION OF VIRUS PARTICLES INCLUDING SIZES;*TABULATION INDICATING DIFFERENT PARTICLE TYPES AND QUANTIFICATION (IF VIRUS LIKE PARTICLES ARE OBSERVED);*THE COMPLETED REPORT SHOULD BE BOTH EMAILED (PDF COPY) AND MAILED (HARD COPY) TO THE INVESTIGATOR. SCANNED IMAGES OF ANY VIRUS LIKE PARTICLES SHOULD BE PROVIDED, AND PHOTOGRAPHIC QUALITY NEGATIVES SHOULD BE RETAINED AND MADE AVAILABLE TO THE INVESTIGATOR WHEN NEEDED (RAW DATA SHOULD NOT BE DISPOSED WITHOUT CONSENT OF INVESTIGATOR ? SHOULD BE TRANSFERRED TO INVESTIGATOR FOR STORAGE).