Alliance Biorepository and Laboratory Closures and Limited Operations
Last Updated: April 1, 2020
Please see detailed instructions by study below. Please click on the link below and download the document that lists study, collection time points, specimen type, COVID-19 response for Kits and Shipments.
Updated: March 19, 2020
Due to institutional, state, and federal measures to limit person-to-person contact and the spread of COVID-19 virus, Alliance Biorepositories and some Assay Labs will be closing and/or limiting activities due to limited staffing. Please visit this page frequently to see updates regarding kit requests and biospecimen submission for all Alliance trials. Note that the Alliance Biospecimen Coordinating Center (i.e. BioMS and BioMS HelpDesk) will still operate normally through phone and email communication. Please contact the BioMS HelpDesk with any questions related to these policies and procedures.
- Effective March 20, 2020, the Alliance Pharmacokinetics Lab at the University of Pittsburgh will significantly reduce its sample processing capacity. The following Alliance studies normally require sites to ship blood specimens directly to the University of Pittsburgh and will be affected: A021602, A171601 and A221701. Please follow these new procedures:
- A021602-PP1 & A171601-PP1: there is no change to the blood collection and/or processing procedures. However, please hold all shipments to the Alliance Pharmacokinetics Lab at the University of Pittsburgh until further notice from the Alliance. If you are unable to hold biospecimens at your site, contact the assay lab at PITT-PK@upmc.edu
- A221701-PP1: If a site has a -80oC freezer available, please store the whole blood collected in EDTA tubes at -80oC after blood draw. Please hold any shipment to the Alliance Pharmacokinetics Lab at the University of Pittsburgh until further notice from the Alliance. Please do NOT freeze glass EDTA tubes. Collect blood in plastic EDTA tubes or transfer whole blood into suitable cryovials before freezing. Label each individual tube with the patient study number, patient initials, and date and time of collection. This is extremely important if collecting and batch shipping tubes from multiple study participants. If a site does not have a -80oC freezer available, please proceed with shipment per protocol. However, please send an email to inform PITT-PK@upmc.edu of this shipment before you submit the samples.
- Please contact relevant Alliance study Protocol Coordinators and/or Dr. Yujia Wen firstname.lastname@example.org with any questions regarding the sample submission changes for these protocols.
- Effective March 20, 2020 (this applies to any biospecimen collected after March 19, 2020) all Alliance Biorepositories (MAYO, WUSTL, OSU, HEME) will be providing limited services (kit distribution and biospecimen receipt) on ALL Alliance trials.
- The following specimens SHOULD NOT BE SHIPPED AT THIS TIME:
- Paraffin tissue blocks, stained slides, and unstained slides, unless needed for integral, prospective (“real time”) assays or pathology review, for patient eligibility or arm stratification. These ‘stable’ and ‘non-urgent’ specimens will be requested and should be sent when operations return to normal.
- Frozen tissue or biofluids (serum, plasma, urine, CSF, feces) that are already being processed and frozen on site and that can be reliably stored at -80 degrees at the local site. These will be requested and sent when operations return to normal.
- Specimen collections that may be deferred to a later collection time point.
- e.g. collection of EDTA blood tube at ‘baseline’ or ‘screening’ for isolation of constitutional (‘germline’) DNA.
- Any other biospecimen that requires immediate receipt and processing but is not required for a specified integral or integrated correlative science assay. In these cases, the site (rather than the biorepository) may be able to process and store specimens at the clinical site. Some examples include:
- PaxGene Tubes: May be frozen, stored frozen, and eventually shipped frozen to the biorepository.
- Streck Tubes: Centrifugation, plasma removal, stored frozen
- EDTA Tubes for ‘Buffy Coat’: Centrifugation, buffy coat removal, stored frozen.
If you are able to perform these functions, please contact the HelpDesk for processing SOPs that may not already be available in the Correlative Science Manual (CSM).
- The following specimens SHOULD BE SHIPPED AT THIS TIME:
- Any specimen required for integral, prospective (“real time”) assays or pathology review, for patient eligibility or arm stratification.
- Any specimen that requires immediate receipt and processing by the biorepository AND is part of a ‘mandatory’ collection or a collection that is specified as part of an integrated correlative science study.
- Any specimen that requires immediate shipping, receipt, and processing at a laboratory other than an Alliance biorepository, and the destination laboratory is currently still open to accept and process specimens (other laboratory closing and limitations will be listed on this page).
- Any specimen that is processed and frozen at the site but for which there is not appropriate storage facilities (i.e. intermediate term -80 degree storage).
- If you are uncertain as to whether to SHIP or HOLD a biospecimen, please contact the BioMS HelpDesk by phone or email.
- Biospecimen distributions from the Alliance biobanks to research laboratories for non-integral biomarker studies (integrated / retrospective and secondary use correlative science studies) are suspended until further notice.
- Distribution of biospecimen COLLECTION KITS will be made on a limited basis.
- Kit request and shipment times will be significantly delayed. Kits may only ship out once per week.
- Kits may only be requested for collections that are mandatory or required for trial correlative science (see above).
- Availability of kit ordering will be restricted in BioMS. If you are not able to find a kit that you normally request on the BioMS kit request page, that means that the kit will not be available for shipment.