The UCSF AIDS Specimen Bank (ASB) observes the following requirements concerning the depositing, processing, storage, and withdrawal of specimens:
- Proposal: The depositor (investigator) must submit in writing a formal proposal to the UCSF AIDS Specimen Bank for the use of the repository and processing services. The proposal must contain the following information: purpose of study; number of patients and visits; defined diagnoses, where applicable; name of study, where applicable; amount and specimen type to be collected; name, telephone, fax, and e-mail of contact person(s) (Project manger or coordinator of the study); and CV of the investigator.
- CHR Approval: Studies without UCSF CHR approval will not be accepted. A copy of the approved consent form must contain a section in which the patient is made aware that their specimens will be stored at the UCSF AIDS Specimen Bank and that the patient has the right to have all specimens removed and destroyed upon their request. A copy of the approval letter, consent form, and approved protocol must be sent to the ASB for review.
- Funding: There are two main methods for reimbursing the ASB:
- A recharge account may be set up for charging personnel, supplies, and other expenses generated by a project. The UCSF DPA and Fund numbers to which all expenses related to the project will be charged for each fiscal year must be provided to the ASB director prior to acceptance of the project.
- The AIDS Specimen Bank may be included in a federal- or state-funded grant with a budget that has been approved by the granting agency. In such a case, the ASB is assigned its own DPA/Fund, and the Department of Orofacial Sciences will help to administer the grant funds awarded to the bank.
- Deposit Form: The depositor agrees to use the AIDS Specimen Bank deposit form for each specimen. The ASB data manager will contact the PI or study coordinator to design a deposit form specific to their study.
- Storage: Specimens will be kept in storage until the study has terminated. If an investigator intends to keep the specimens for a period of time past the study’s termination date, then the investigator will be charged a monthly storage fee. If funds are not available to pay for long-term storage, arrangements must be made to have all specimens removed from the ASB and shipped to a facility designated by the investigator or, alternately, disposed of at the expense of the investigator. The ASB will not release the last vial of any depositor’s specimen. The depositor will be notified if there is a request for a specimen that has only one vial left in storage.
- Identifiers: Specimens will be assigned an AIDS Specimen Bank accession number (example: AS99-0100). No personal identifiers will be used.
- Hours of Operation: Monday–Friday, 8:00 AM to 5:00 PM
Deliveries: All specimens must arrive for processing no later than 3:00 PM Monday–Thursday, by noon Fridays. Notices will be sent via e-mail informing all clients of pending holidays and required dates and time for delivery of specimens to accommodate for the bank’s closure.
- If there is a request for the use of a depositor’s specimens, the ASB director(s) will contact for permission the investigator(s) who deposited the requested specimens in the bank. If the investigator approves, specimens will be released.
- The requestor must provide the ASB with an IRB approval number and a copy of their approved protocol for working with the requested specimens.
- The depositing investigator may request that they (and others) be included as co-author(s) if a published paper or presentation is made based on the use of their specimens and data.
- Once the ASB receives all pertinent data (study name, patient study numbers, date of collection, specimen type, address of facility where specimens will be shipped), we will normally process the order within three weeks; more time may be needed, depending on the size of the order. Note: Rush orders will be charged a higher fee.
- All specimens will be identified by an ASB accession number (example: AS99-0100) placed on the vial.
- A member of the ASB staff will contact the facility receiving requested specimens to inform them when to expect arrival of a shipment. For Federal Express shipments, the airbill number will be provided. The recipient must call the ASB by 4:00 PM to inform them whether an expected package has arrived. If it has not, the ASB will place a tracer on the package.
- Results generated by the use of ASB specimens to be published in a paper or presented as a poster, oral presentation, or abstract must acknowledge the UCSF AIDS Specimen Bank. The ASB must be sent a copy of the written work.
- If an investigator requests to have specimens sent to a prescribed laboratory and there are remaining samples left at the laboratory, the ASB has the right to refuse to store the “used” specimens.
Specimen Return Policy
Returned specimens are defined as clinical and biological specimens originally processed at the UCSF AIDS Specimen Bank (ASB) or ARI Laboratory of Clinical Virology (LCV), removed and shipped to an external laboratory or testing facility and returned to the primary processing laboratory.
- The specimen return policy must be in accordance with the appropriate ASB and LCV laboratory standard operating procedures (SOP) and by agreement with the laboratory directors and the ARI Cores Advisory Committee.
- The external testing/storage facility must supply sufficient documentation and SOP before specimens are returned to the ASB or LCV to assure compliance with minimum acceptable standards in specimen handling and operations as follows:
- All storage equipment housing the specimen(s) was monitored daily and demonstrated performance within the established tolerance limits.
- All specimens were sub-aliquoted under sterile conditions.
- All pipette tips that accessed the specimens were sterile and used for a single specimen. d.All personnel responsible for handling the specimens have been trained in good laboratory practices and sterile technique.
- The requesting PI(s) will be financially responsible for each specimen being returned at a cost determined by the receiving laboratory (ASB or LCV) and agreed to in advance. Where appropriate, this fee will include labor for all associated communication and administrative efforts, shipping, inventory, data entry, relabeling, and restocking.
- The requesting PI(s) will be responsible for any associated monthly storage fees in accordance with standard laboratory rates.
- Specimens must be of minimum volume for reasonable and adequate subsequent testing.
Table 1 – Acceptable minimum volumes for return specimens
Specimen Type Amount Whole Blood 200 μl Blood Plasma 200 μl Blood Serum 200 μl CSF 200 μl Body Fluids: Genital, saliva, urine, etc. 200 μl Solid Tissue Any amount PBMC, cells (cryopreserved in DMSO)* 500 μl, 2-5 million cells PBMC, dry pellet Not accepted if thawed
* Accepted at the ASB or LCV with pre-approval of laboratory director based on the number of specimens and specimen integrity.
- If returned specimens are subsequently sent out to other entities, a disclaimer must accompany these specimens informing investigators that the specimens have been previously shipped, stored, and potentially thawed, sub-aliquoted, and refrozen outside the primary processing/storage facility.
- The following information must accompany specimens upon return: a.An electronic file identifying each specimen's accession number(s), draw date, primary tissue type (e.g., EDTA plasma) and location within a freezer box b.Verification by the external laboratory that each specimen vial contains the minimum acceptable volume specified above. Anything less than this minimum volume must be discarded prior to returning samples to the ASB or LCV, except in cases where there is mutual agreement between the requesting PI(s) and the accepting laboratory c.Documentation stating the number of thaws per specimen
- Depending on the volume of requests or number of returned samples for any one particular request, additional fees may be necessary to absorb increased storage costs.