Frequently Asked Questions

The following documentation must be in place before NSWHSB can accept samples for processing/storage:
a. Ethics approval for the study: the investigator’s team must send a copy of the current ethics approval letter to NSWHSB
b. Fully executed agreement between NSWHSB and the investigator’s organisation
c. Study-specific standard operating procedure (SOP) must be approved by the investigator’s team.

One of the steps in the ‘study set-up’ process, is creating a study-specific standard operating procedure (SOP) that describes how all samples that arrive at the NSWHSB will be received, processed (if applicable) and stored. SOPs are drafted by the NSWHSB laboratory team and must be approved by the study investigator or delegate before any samples are received at NSWHSB. A final copy of the approved SOP is sent to the investigator’s team. Any changes (other than formatting/corrections) must be approved by the investigator’s team.
The SOP version number is recorded in the reports linked to each sample so any changes to the SOP are traceable.
Standard SOP templates are available online at: https://biobank.health.nsw.gov.au/researchers/biobanking-services/

The access/retrieval process and required notice period is as described in the relevant agreement (e.g. service agreement) between the investigator’s organisation and the NSW Health Statewide Biobank (NSWHSB). In general, the steps are as follows:
a. The investigator’s team notifies the NSWHSB that they intend to retrieve samples.
b. Using the most recent study report provided by the NSWHSB, the investigator’s team completes a ‘retrieval form’ which includes a list of sample barcodes for retrieval
c. The retrieval request is approved in writing (e.g. email) by an appropriate person in the investigator’s team. The retrieval must be approved in writing (e.g. email) by:
i. The collection custodian: the person who signed the agreement or is named as the ‘client representative’ in the agreement.
ii. The study principal investigator (PI): the person named in the current ethics approval letter for the study
iii. A person delegated by collection custodian or the study PI.
d. When the retrieval is approved by the investigator’s team, NSWHSB will conduct the retrieval and notify the investigator team when the samples are ready for pick-up/shipment.
e. The investigator’s team will arrange pick-up / shipment of the retrieved samples.

A report will be made available to the investigator/investigator’s team listing the samples received and stored at the NSWHSB. In general, for studies in the actively adding samples to the collection, NSWHSB generates a report weekly. The investigator’s team access the reports via a link (provided by NSWHSB) to the secure file transfer platform, Sharepoint.

Data fields recorded for all samples processed at the NSW Health Statewide Biobank (NSWHSB) include:
a. Date/time received at NSWHSB
b. Date/time processing start
c. Protocol version used for processing
d. Primary container (e.g. EDTA tube)
e. Primary sample type (e.g. whole blood)
f. HIL index (if plasma/serum)
g. Cell count (if PBMC isolation)
h. Secondary sample type (e.g. whole blood/plasma/red cells/buffy coat)
i. Secondary sample volume
j. Secondar sample container barcode
k. Date/time storage
l. Storage temperature

Yes, frozen samples can be stored at -80°C or liquid nitrogen at the NSW Health Statewide Biobank.
There are several of storage options available and they vary in price. An outline of the options and information that would be required by the investigator team is below.
a. Do you have an electronic inventory (e.g. Excel) for your samples? For ‘bulk’ storage receipt, an electronic inventory (e.g. Excel) is required that includes the following as a minimum:
- A unique box ID (that matches the physical label on the box)
- A unique sample ID (that matches the physical label or barcode on the sample container) – applicable if you’re requesting ‘sample-level’ inventory checking (more info is below about sample-level vs box-level)
- The location within the box – applicable if you’re requesting ‘sample-level’ inventory checking
b. When you want to access the samples, will you request an entire box or will you want individual samples retrieved from different boxes? This information will allow the NSWHSB team to quote for ‘box-level’ storage prices or ‘sample-level’ prices.
c. For box-level inventory checks, the lab team checks that a box is received and the label on the box matches the inventory provided. When you want to retrieve samples, an entire box would be requested and prepared for shipment. Note: an inventory of the box contents would not be maintained.
d. For box-level, NSWHSB would request information about the size of the boxes to check that they fit the freezer racks. If you use any non-standard boxes, our lab team might ask you to send them an example.
e. For sample-level inventory checks, on arrival, the NSWHSB lab team would check the box inventory as well as the samples within the box. When you want to retrieve samples, you may request individual samples and the lab team would remove the samples from the original box and prepare them for shipping. For sample level inventories, NSWHSB would need to know:
- How the sample/cryovials are labelled because there are different prices depending on the labelling. The options are: barcoded on bottom/scannable cryovials; or printed labels on the side; or hand-written labels.
- The size of the cryovials (e.g. 1mL, 2ml etc).

No, the NSW Health Statewide Biobank (NSWHSB) does not currently offer blood collection services onsite. However, NSWHSB is part of NSW Health Pathology which has collection sites throughout NSW. NSWHSB is connected to the NSW Health Pathology collection sites via a non-urgent courier network. The NSW Health Pathology courier network is not suitable for any urgent transport or transport of samples that must be processed/stored within a specified time-frame.
A list of NSW Health Pathology collection centres is available here: https://pathology.health.nsw.gov.au/contact-us/locations-services/find-a-collection-centre/

There are many options available for sample collection and transport of those samples to the NSW Health Statewide Biobank (NSWHSB) for processing/storage. The best option for your study will depend on the participant cohort, the method of recruitment to the study (e.g. face to face or online recruitment) and the type of sample being collected. Some options for sample collection include:
1. The participant self-collects a sample (e.g. saliva, feces) in a collection kit and sends it to the NSWHSB (e.g. via post)
2. Investigator team collects the sample and sends it to NSWHSB
3. Study participant receives a form (e.g. blood collection form) and attends a collection centre. The collection centre organises transport (e.g. courier) to NSWHSB:
a. NSW Health Pathology collection centre
b. Private collection centre
NSWHSB is connected to the NSW Health Pathology collection sites via a non-urgent courier network. The NSW Health Pathology courier network is not suitable for any urgent transport or transport of samples that must be processed/stored within a specified time-frame.
A list of NSW Health Pathology collection centres is available here: https://pathology.health.nsw.gov.au/contact-us/locations-services/find-a-collection-centre/

Yes, the main activity of the laboratory staff at the NSWHSB is processing samples. Some standard processing protocols include:
a. Blood fractionation (plasma, buffy coat, red blood cells, serum etc)
b. Blood spot cards
c. Isolation of peripheral blood mononuclear cells (PBMCs)
d. Aliquoting of other fluids such as urine, saliva etc
e. Processing samples in kits (e.g. saliva, faeces) as per manufacturer’s recommendations
f. Processing whole blood collected in specialised tubes (e.g. PAXgene, Tempus, Streck) as per manufacturer’s recommendations
g. DNA extraction
h. RNA extraction
A list of services and prices can be found here: https://biobank.health.nsw.gov.au/researchers/biobanking-services/
A list of standard procedures can be found here: https://biobank.health.nsw.gov.au/researchers/biobanking-services/

The -80°C freezers at the NSWHSB are connected to back-up generator power and the temperatures are monitored 24/7. The generators are managed by a hospital-based 24-hour response team with 24-hour refuelling capabilities. Liquid nitrogen vapour phase freezers are connected to piped liquid nitrogen with an automated filling function. The robotic freezer, the Brooks BioStore II, has liquid nitrogen back-up which is activated automatically in the event of a power failure.
Various best practice guidelines recommend storing a collection in different storage units and at different locations; ideally, the different storage locations would be on separate electricity grids.
Therefore, although the NSWHSB has significant safety measures in place, the best practice is to split collections among different sites and therefore NSWHSB recommends storing a portion of the collection at NSWHSB.

The ISBER best practices includes information about factors when considering whether or not to purchase a robotic storage unit. ISBER members may access the best practice document on the ISBER website at: www.isber.org.
More information is outlined in the paper ‘Automated Sample Storage in Biobanking to Enhance Translational Research: The Bumpy Road to Implementation’ https://pmc.ncbi.nlm.nih.gov/articles/PMC6962113/

No, not necessarily. Samples processed at the NSW Health Statewide Biobank (NSWHSB) are typically stored in barcoded cryovials that are compatible with the robotic freezer, the Brooks Biostore II. Typically samples in these barcoded cryovials will temporarily be stored in a mechanical freezer until they are moved to the robotic freezer.
All labware must pass validation before being stored in the robotic freezer. Samples processed and stored outside the NSWHSB may be stored in labware that hasn’t been validated so these samples may be stored in standard mechanical -80°C freezers.
Cryovials or containers with labels added to the container cannot be placed in the BioStore II because the labels interfere with the robotic mechanisms of the freezer.

No, unfortunately labelling cryovials is not a service offered. When samples are processed at the NSWHSB, the samples are stored in barcoded containers such as barcoded cryovials such FluidX or LVL cryovials. The specifications of the FluidX cryovials are: tri-coded Tube, external thread, 2D code on base, 1D linear barcode and human readable number on side.
Barcoded cryovials are used because they are compatible with instruments such as the robotic -80°C freezer, cryovial de-cappers and liquid handlers. Attaching labels results in incompatibility issues with the instruments.

Samples processed at NSWHSB are typically stored in barcoded containers such as barcoded cryovials such FluidX or LVL cryovials. The specifications of the FluidX cryovials are: tri-coded Tube, external thread, 2D code on base, 1D linear barcode and human readable number on side. Typical cryovial sizes used at NSWHSB are 0.5 mL, 1.0 mL, 1.9 mL and 3.8 mL.
The barcoded cryovials used because they enable accurate tracking and are compatible with instruments such as the robotic -80C freezer, cryovial de-cappers and liquid handlers. Attaching labels results in incompatibility issues so additional labels are not used.

Unfortunately the NSW Health Statewide Biobank (NSWHSB) is not currently the owner/custodian of any sample collection.
NSWHSB offers biobanking services to ethically approved studies. The investigators of each studies are the custodians of the samples and therefore, the investigators make decisions about access.
The NSWHSB manages a biobank certification program which includes a biobank locator at: https://nsw.biobanking.org/locator The locator lists biobanks and includes details about the types of samples available as well as contact information.
In the future, when resourcing is available, NSWHSB aims to collect, process and store samples that are under the custodianship of NSW Health Pathology.

The NSW Health Statewide Biobank offers the following ultra-low temperature storage options:
a. -80◦C storage:
a. Mechanical -80◦C freezers
b. Robotic -80◦C freezer: Brooks BioStore II
b. Vapour phase liquid nitrogen (LN) to cryovats for -196◦C

The NSW Health Statewide Biobank (NSWHSB) supports a number of clinical trials that have requirements that must align with other national and international processing laboratories. The NSWHSB will review the requirements and determine whether or not the requirements are feasible. If the requirements are feasible, the NSWHSB laboratory team would draft a study-specific SOP that would be sent to the investigator’s team for review. The NSWHSB generated SOP is needed because it includes information specific to the NSWHSB laboratory and equipment. Reviewing the NSWHSB SOP provides an opportunity for the investigators to review and process and determine whether the necessary requirements are met.

The NSWHSB standard procedure for isolation of PBMCs is the EasySepTM method using the EasySepTM Direct Human PBMC Isolation Kit. The EasySepTM method is compatible with automation. Due to the large number of PBMCs processed at NSWHSB, manual protocols such as density-gradient separation cannot be performed. NSWHSB have validated that the EasySepTM method is comparable to a commonly used density-gradient separation method and have shown equivalent yields and viability. Further, the EasySepTM method removes red blood cells and granulocytes resulting in a purer product.
A publication outlining the procedure is available at: https://www.jove.com/t/66887/isolating-human-peripheral-blood-mononuclear-cells-from-buffy-coats
Video of the EasySepTM procedure: https://app.jove.com/b/66887/high-throughput-pbmc-isolation-using-immunomagnetic-beads
The standard procedure template is available here: https://biobank.health.nsw.gov.au/researchers/biobanking-services/
The resulting PBMCs can be prepared at a fixed concentration if desired. Additionally, NSWHSB offer a range of cryopreservation mediums including Cryostor10, 10% DMSO in FBS or 10% DMSO or 10% DMSO, 20% FBS in RPMI.
NSWHSB can also isolate other human cell types such as eosinophils, B, T, NK, etc using various EasySepTM kits. Please email [email protected] if you would like to discuss these capabilities further.

No, the NSW Health Statewide Biobank does not have a preferred manufacturer or vendor for collection kits. The NSW Health Statewide Biobank (NSWHSB) doesn’t purchase collection kits. Such kits are purchased by the investigator’s team and provided to their study participants (in person or via mail).
Collection kits are usually designed to allow participants to self-collect the samples, which may result in higher participation compared to studies which require participants to visit a blood collection centre.
NSWHSB generally follows the manufacturer’s instructions when the processing and storage of the samples. Most collection containers may be frozen but for long-term storage, most manufacturers recommend storing multiple aliquots in cryovials.

No, the NSW Health Statewide Biobank doesn’t provide DNA/RNA sequencing services however NSWHSB can extract nucleic acid from human specimens (whole blood, buffy coat etc) for sequencing by another provider. NSWHSB offers high throughput nucleic acid extractions using the QIAsmphony platform. Quality control measures can be performed using a nanodrop and/or tapestation.

Some resources for researchers/biobankers setting up their own biobank include:
a. Template standard operating procedures (SOPs): https://biobank.health.nsw.gov.au/standard-operating-procedures/

b. The NSW Health Biobank Certification program which includes education and useful tools: certification program
c. Other useful websites and resources include:
a. The International Society for Biological and Environmental Biorepositories (ISBER). ISBER members may access the best practice document on the ISBER website at: www.isber.org.
b. SOPs from the Biospecimen Pre-analytical Variable (BPV) Standard Operating Procedures Library: https://biospecimens.cancer.gov/programs/bpv/bpv_sops.asp
c. National Centre Institute (USA) Biospecimen Research Database with a ‘search SOPs’ function: https://brd.nci.nih.gov/brd/sop-search
d. Biobank Research Centre (Canada): https://www.biobanking.org/

The processing time requirements will depend on the type of collection container and the downstream use of the samples. In general, the quicker a sample is processed the better and the more aliquots the better (to minimise the need for freeze/thaw events in the future). NSWHSB recommends that investigators consult with the downstream users of the samples and best practice documents such as the ISBER best practices. ISBER members may access the best practice document on the ISBER website at: www.isber.org.
For all samples processed at the NSW Health Statewide Biobank (NSWHSB), the date/time of collection, the date/time of receipt at NSWHSB and the date/time of storage/freezing is recorded. Study investigators are given the option to instruct NSWHSB to:
a. process and store all samples received or
b. dispose (do not process) any samples that arrive at NSWHSB more than X (e.g. 48 hours) after the time of collection.

Deciding the type and number of samples to collect is challenging. The NSW Health Statewide Biobank recommends consulting the downstream users of the samples and best practice guidelines such as the ISBER best practices. ISBER members may access the best practice document on the ISBER website at: www.isber.org.
In general, various types of samples should be collected and stored in multiple aliquots to maximise the types of samples available and minimise the number of freeze/thaw events. The NSW Health Statewide Biobank recommends considering specialised tubes such as PAXgene, Streck, Tempus and/or collection kits (e.g. saliva/feces collection kits) which contain stabilizers.

When making decisions about the type of samples, the NSW Health Statewide Biobank recommends referring to best practice guidelines or documents such as the ‘Best Practices: Recommendations for Repositories’ available through the International Society for Biological and Environmental Biorepositories (ISBER). ISBER members may access the best practice document on the ISBER website at: www.isber.org.

The best transport temperature depends on the sample container and the downstream use of the sample. A general consideration is that a warm transport / storage temperature may result in degradation. However, cold temperatures may result in changes in the metabolic and/or molecular profiles that may negatively impact some downstream analysis.
In addition, in some cases a specific period of time and/or transport at room temperature is recommended. For example, whole blood in SST tubes must stand for a specific period at room temperature to facilitate clotting prior to centrifugation and transport of whole blood for PBMC isolation is recommended to be room temperature.

NSW Health Pathology collection centres do not stock specialised research blood collection tubes. As such, to enable blood collection into specialised tubes, the typical process is as follows:
a. The investigator team provides a ‘kit’ to the participant which includes the blood collection form and specialised blood tube in a biohazard bag
b. The participant brings the ‘kit’, which includes the specialised tube to the NSW Health Pathology collection centre
c. Blood is drawn into the specialised tube
d. The blood sample in sent to the NSW Health Statewide Biobank for processing/storage

Yes, this may be possible depending on the size of the collection, the temperature requirements and whether the study-specific ethics approval allows storage at NSWHSB. However, best practice guidelines general recommend storing collections in different storage units (e.g. different freezers) and on multiple sites, preferable sites on different electrical grids.
Therefore, the NSWHSB recommends storing only a portion of a collection onsite.

The NSW Health Statewide Biobank (NSWHSB) does not provide any diagnostic/clinical testing services. However, as NSWHSB is part of NSW Health Pathology, a participant may attend a NSW Health Pathology collection centre with a clinical request form (to cover the clinical testing) and a research request form. The clinical bloods will be processed as all standard testing is performed. The research bloods may be transported to the NSWHSB for processing/storage.

Protocol deviations, when they occur, are recorded in the study dataset and are included in the regular reports received by the investigator’s team. Any protocol deviation resulting in loss of a sample is managed via the NSW Health Pathology incident management platform IMS+ and the investigator team is notified of the issue and any actions resulting from the relevant root cause analysis.

No. the participant ID is generated by the investigator’s team.

Research best practices generally recommend that the priority in sample labelling is maintaining participant privacy and confidentiality. Therefore, no potentially identifiable information should form part of a specimen ID or any label on the specimen.
When the NSW Health Statewide Biobank (NSWHSB) processes samples, in general samples are aliquoted into barcoded cryovials. No additional labels are attached to the cryovials because additional labelling interferes with instruments such as the liquid handler and robotic freezer.

A few things should be considered when deciding whether or not to freeze the original blood collection tube (e.g. EDTA tube):
a. Blood collection tubes may not have been tested at ultra low temperatures: check with the manufacturer. Note: some manufacturers have reported that a tube of particular size / type has been tested while others have not.
b. Collection centres may stock multiple brands and sizes of the collection tubes. Variability may be reduced if:
i. the investigator’s team performs the blood collection using a single brand and size of blood tube that has been confirmed suitable for the intended storage temperature.
ii. the investigator’s team provides a ‘kit’ to the participant to take the collection centre. The ‘kit’ would include a single brand and size of blood tube that has been confirmed suitable for the intended storage temperature.
c. It is generally considered best practice to store multiple aliquots of a sample to minimise freeze/thaw events.
d. Blood tubes are typically larger than storage containers such as cryovials, so will take up a larger storage space and incur higher storage fees.
e. Tracking blood tubes is a manual process compared to barcodes/scannable cryovials, increasing the cost of inventory checking and increasing the time needed for retrievals.

The NSW Health Statewide Biobank (NSWHSB) is located at Level 1, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown NSW 2050.
Meeting specific time requirements is challenging particularly if samples will be collected in multiple locations. Some options for consideration include:
a. Use of specialised tubes/collection containers that stabilize the sample, allowing longer transit times (e.g. Tempus, PAXgene, Streck Omnigene kits) and transport samples to NSWHSB for processing
A. Pros
i. No cost of private couriers
ii. Consistent processing
iii. Increased sample integrity / utility
B. Cons
i. Cost of specialised tubes/containers
ii. Investigators/investigator’s staff will need to give out ‘kits’ to their participants (e.g. at the time of the consent, investigator’s team gives participant ‘kit’ which includes the specialised tube and the Research/Pathology Request Form)
iii. Participant must bring specialised tube/kit to collection site (as these tubes/kits are not available routinely at collection centres

Please ask our team.

The expertise and training of the NSWHSB laboratory team is focused on receiving, processing and storing samples. NSWHSB leave shipments and required documentation for transport overseas to the couriers.
The agreements between the investigator’s team and NSWHSB outline the responsibilities of both parties and in general, it is the investigator’s responsibility to:
• Manage the shipment including supply of the packaging (e.g. eskies), labels, refrigerant (e.g. dry ice) if required, temperature probes (if required), shipping documentation apart from the packing list and any correspondences with courier
• Select a courier appropriate for the samples and required transport conditions.
• Select a courier that will supply the packaging, labels and refrigerant (e.g. dry ice, temperature probes) and will prepare all required documentation (customs declaration etc) apart from the packing list.

No, the NSW Health Statewide Biobank (NSWHSB) does not necessarily have to be named in an ethics approval application or consent document, unless the ethics committee requires it. The use of the NSWHSB should not be in conflict with the application. It is the responsibility of the investigator to ensure that a studies ethics application / approvals permits the use of service providers such as the NSWHSB.
An SSA for NSWHSB is usually not required because the support services provided by NSWHSB are covered by a service agreement. In cases where a research collaboration agreement is appropriate with NSW Health Pathology (e.g. the investigators are NSW Health Pathology staff), an SSA may be appropriate.

Planning and sustainability is challenging in an environment where research funds are limited.

The NSW Health Statewide Biobank (NSWHSB) operates through a partial cost recovery model, recovering around 10-20% of the cost spent. NSWHSB maintains low fees in relation to the operating costs in order to support as many research projects as possible. Therefore, the NSWHSB is not able to waive the fees for individual clients.

Unfortunately, NSWHSB is not able to accept donations of collections, as this would rely on NSWHSB staff to act as the collection custodian and drive the research use of these samples. NSWHSB aims to support all collections equally, by working with individual research custodians, and not becoming custodians ourselves.