Specifications include, but are not limited to: The required services are for a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified laboratory to provide polymerase chain reaction (PCR) tested COVID-19 positive specimens to the Department of State Health Services (DSHS) for next generation sequencing and variant identification. All specimens shall have been collected in Texas or from Texas residents only. Contractor shall provide up to three hundred fifty (350) PCR tests, positive COVID-19 specimens and accompanying specimen metadata on a weekly basis. Quantities are subject to change per DSHS discretion. a) COVID-19 positive specimens shall meet the following criteria: 1. PCR results must have target gene PCR cycle threshold (CT) value less than 25. 2. The only specimens that can be sequenced with CT values greater than 25 are vaccine breakthrough and reinfection cases. 3. Specimens must have been collected in TX or from TX residents and, if requested by DSHS, come from specific public health regions or zip codes. b) Specimen sources and transport medium: 1. Nasopharyngeal (NP), Oropharyngeal (OP), and Nasal swabs 2. Viral Transport Media (VTM), Universal Transport Media (UTM), Amies, or 0.85% Saline. All transport mediums not mentioned must be approved by DSHS prior to shipment. 2. Minimum volume required: 0.8 mL c) Specimen shipping and handling requirements: 1. Clinical specimens shall be kept frozen at -70 degrees Celsius and shipped packed with dry ice or cold on ice packs via FedEx overnight delivery. Specimens received by DSHS with thawed ice packs or no remaining dry ice to preserve specimen temperatures shall be considered unacceptable by DSHS. Specimens received in ambient temperatures shall be considered unacceptable by DSHS. 2. Metadata line list must be completed. All fields marked with an asterisk (*) must be filled. Required fields include name, date of birth, patient zip code, date of collection, sample type, sample source, reason for sequencing, original purpose of sampling, and original sample ID. 3. Label specimens with two unique identifiers excluding date of collection. The identifiers on the tubes must match those entered on the metadata line list. 4. Maintain proper infection control when handling specimens. Guidance can be found at Center for Disease Control and Prevention (CDC). 5. Specimens shall be placed in a zip-lock biohazard bag and can be organized in tube racks or boxes. Samples should be organized in line list order. A hardcopy of the metadata line list shall be placed in the outer sleeve of the biohazard bag or must be attached to the exterior of the bag without compromise to specimen or bag. Specimens with metadata line list inside the biohazard bag shall not be accepted due to risk of contamination. Specimens shipped without a biohazard bag or metadata list shall not be accepted...
