National Referral Laboratory

Specimen Collection & Sample Packaging

Contents

• General sample packaging requirements
  • General requirements
  • Notes for dry ice
  • Marking and labelling the package
  • Additional requirements for International specimens
  
  
• Specimen collection and packaging
  • EDTA whole blood (lysosomal enzyme analysis)
  • Peripheral blood leucocyte pellets
  • Plasma (VLCFA analysis only)
  • Plasma or serum (specific component analysis, eg, transferrin isoforms, chitotriosidase)
  • EDTA Whole blood (DNA/molecular analysis)
  • Skin biopsy for fibroblast culture
  • Cultured cells (skin fibroblasts, amniocytes, chorionic villus cells)
  • Chorionic villus biopsies
  • Whole amniotic fluid
  • Urine (specific component analysis)
  • Freeze-dried urine (MPS or oligosaccharide analysis)
  • Urine on filter paper (MPS or oligosaccharide analysis)
  • Frozen tissue
  • Cell-free amniotic fluid (7-dehydrocholesterol analysis)
  
  
• IATA Packaging Instruction 650

General sample packaging requirements

All biological specimens shipped to the laboratory MUST be packaged in containers that comply with IATA Regulation 650. Local freight agents will be able to assist with this. Basically, the packaging has to be strong enough to survive the rigours of freight shipment. Polystyrene boxes alone are NOT acceptable. However, they may enclosed in a strong outer container.

If the specimen does not need to be frozen, it is only required that the specimens are well insulated from temperature extremes. However, any patient material shipped from hot climates should have a cooling block, pre-chilled to 4 degrees celcius, present in the inner container. Do NOT place the patient material in direct contact with the coolant.

Special notes for DRY ICE

If dry ice is required to keep the specimen frozen, sufficient must be added to last the duration of the journey to the laboratory.

Note: NEVER pack specimens that must not be frozen in a container of dry ice, no matter how well the specimen appears insulated from the dry ice. It is virtually assured that everything inside a package of dry ice will be frozen on arrival in the laboratory

Where dry ice is used, there must be a method for release of carbon dioxide gas from the outer container (ie, a 'bleed' hole, about 3 - 4mm in diameter). Containers must NOT be sealed tightly.

The package should also have a 'Dangerous Goods - Miscellaneous' label attached to the outside of the package (even if the weight of the dry ice is less than 2kg. Appropriate labels may be purchased from either HazPak Pty Ltd, CSIRO-AAHL or Proscience Pty Ltd (SAFPAK).

Marking and labelling the package

The outside of the container should be marked as follows:

1. the full name and address of both the shipper and the consignee,
   
2. the consignee's telephone number
   
3. the words "Diagnostic specimen - not restricted, packed in compliance with IATA Packaging Instruction 650",
   
4. if dry ice is present, a 'Dangerous Good - Miscellaneous" label must be placed on the package and you must include the line "per UN 1845-9 III, 'x' kg dry ice" at the end of the statement in part 3.

The air waybill should contain this identical information and additionally, the 'Nature and Quantity of Goods" box of the airwaybill must show the text "DIAGNOSTIC SPECIMENS" (see the IATA Regulation 650)

Further requirements for International specimens

If the samples are of international origin, place a copy of the Department’s Permit to Import Quarantinable Material on the outside of the package so that Australian Quarantine Officers can locate it. A copy of this permit is available by facsimile on request.

It is also essential that you notify us regarding the incoming package prior to consignment. Please follow our instructions for the Transport of International Specimens.

Specific sample collection and packaging requirements

EDTA whole blood for lysosomal enzyme analysis

• For most purposes, 10 mL blood collected in to EDTA (Sequestrene) is adequate.
• In general, use no coolant but insulate well from temperature extremes. If the sample is despatched from a hot climate, include a cooling pack, prechilled to 4 degrees celcius, together with the samples in the container. Never place whole blood specimens in close contact with a frozen ice pack.
• Whole blood must be scheduled to arrive in the laboratory within 24 - 36 hours of collection. Longer delays may mean that insufficient leucocytes are isolated.
• Do not consign whole blood on Fridays.
• Should you wish to send blood from overseas, we recommend that you contact the laboratory to discuss the best possible options.

  Important points

  • Blood must be drawn with a minimum of trauma and be well mixed (but not shaken) with the EDTA. Partially clotted samples are of little value.
  • Do not use plasma separators.
  • Do not collect blood into containers that use plastic mixing beads.
  • Do not pack the blood in direct contact with pre-frozen ice-packs or other frozen patient specimens.
  • Do NOT consign blood in any container that also contains dry ice, no matter how well insulated it may appear to be; for example, do not place blood in an insulated container, then place this inside another containing dry ice.

Peripheral blood leucocyte pellets

• Prepare 2 pellets from 10 mL EDTA blood (see Method Sheets for instructions).
• Once prepared, the cells are stable for about a week at -20 degrees Celsius (or below).
• Consign on sufficient dry ice to last the entire transit time to the laboratory.
• Consign the samples by courier to arrive within 24 - 48 hours.

Plasma for very long chain fatty acid analysis (VLCFA) only

• 2 - 3 mL serum or heparinised/EDTA plasma.
• Keep frozen until consigned.
• For short transit times (eg overnight), package with a pre-frozen ice pack.
• For longer transit times, add 1:100 (by volume) of sodium azide (1g/3mL water) as a preservative. Consign by courier to arrive within 48 hours.
• VLCFA in plasma are also stable frozen on dry ice.

Plasma or serum for specific component analysis (eg, 7-dehydrocholesterol, transferrin isoform, chitotriosidase or amino acid analysis)

• 2 - 3 mL serum or EDTA/heparinised plasma (NB. Presently, serum or heparinised plasma is required for transferrin isoform analysis, EDTA plasma is NOT suitable)
• Keep frozen until consigned.
• Consign on sufficient dry ice to last the entire transit time to the laboratory.
• Consign by courier to arrive within 24 - 48 hours.

Whole blood for DNA preparation and molecular analysis

• 10 mL blood collected in to EDTA (Sequestrene) is adequate.
• If very long chain fatty acid analysis is also required, separate the plasma and cells by centrifugation. Keep both plasma and cells and freeze separately.
• For short transit times (eg overnight), package the blood with a pre-frozen ice pack.
• For longer transit times, consign the blood on sufficient dry ice to last the entire transit time.

Skin biopsy for fibroblast culture and storage

• The skin biopsy can be taken after a local anaesthetic, preferably not from the groin region due to the increased risk of fungal infection.
• The biopsy should be full thickness and about 2-3mm in diameter. Biopsies MUST include the dermis; shallow or conical biopsies that fail to reach the dermis are not satisfactory.
• The biopsy can be placed in any sterile container of culture medium (Basal Eagle’s Medium, Ham’s F10, ‘viral transport medium’), but not in saline.
• It can be stored overnight in a refrigerator at 4 degrees C.
• Label the package DO NOT FREEZE.
• Consign in a well insulated container with NO coolant to arrive within 24 - 48 hours. Note that, if sending from a laboratory outside of Australia, the maximum shipping time for this sample is 5 days. We strongly recommend that you contact the laboratory before transporting the sample.

Cultured cells (skin fibroblasts, amniocytes, chorionic villus cells, etc)

• The day prior to shipment, subculture the cells into 2 small flasks using standard tissue culture protocols such that the cells are about 40-50% confluent.
• Leave in an incubator (37 degrees C and 5% CO2 in air) overnight.
• Fill the flask completely with the usual tissue culture medium which has been equilibrated with 5% CO2 in air.
• Cap firmly and tape the lid with water proof tape (wind the tape in a clockwise direction)
• Package the flasks in a well insulated container, but use NO coolant. Never pack growing cells in or near a container of dry ice.
• Label the package STORE AT ROOM TEMPERATURE.
• Consign by courier to arrive in the laboratory within 24 - 48 hours. Note that, if sending from a laboratory outside of Australia, the maximum shipping time for this sample is 5 days. We strongly recommend that you contact the laboratory before transporting the sample.

Chorionic villus biopsies

• As large a biopsy as practicable.
• If a second specimen is collected, it should be place in a second container and labelled as such.
• Keep the biopsy under sterile conditions.
• The biopsy should be placed in Chang’s or other high quality tissue culture medium. Saline is NOT acceptable.
• The specimen should be cleaned and dissected in the institution of origin.
• Package the flasks in a well insulated container but use NO coolant. Never pack biopsies for cell growth in or near a container of dry ice.
• Label the package STORE AT ROOM TEMPERATURE.
• Consign by courier to arrive in the laboratory within 24 - 48 hours. Note that, if sending from a laboratory outside of Australia, the maximum shipping time for this sample is 5 days. We strongly recommend that you contact the laboratory before transporting the sample.

Whole amniotic fluid for cell culture

• As large a volume as practicable.
• If a second specimen is collected, it should be place in a second container and labelled as such.
• Keep the fluid under sterile conditions
• Package the specimen in a well insulated container but use NO coolant. Never pack amniotic fluid containing cells for culture in or near a container of dry ice.
• Label the package STORE AT ROOM TEMPERATURE.
• Consign by courier to arrive in the laboratory within 24 - 48 hours. Note that, if sending from a laboratory outside of Australia, the maximum shipping time for this sample is 5 days. We strongly recommend that you contact the laboratory before transporting the sample.

Urine for specific component analysis (eg mucopolysaccharides, organic acids, acylcarnitines)

• Collect 20-30mL urine with no preservative.
• Keep frozen at -20 degrees Celsius (or below) until shipment.
• Consign on sufficient dry ice to last the entire transit time to the laboratory.
• Consign the samples by courier to arrive in the laboratory within 24 - 48 hours.

Preparation of lyophilised (freeze-dried) urine for mucopolysaccharide or oligosaccharide analysis

• Measure and record the volume (about 20-30mL) and the creatinine concentration.
• Shell freeze the urine in a plastic tube and freeze dry.
• After lyophilisation, the urine is stable indefinitely at ambient temperature.

Preparation of urine on filter paper for mucopolysaccharide or oligosaccharide analysis

• Full instructions for the preparation of urine on filter paper is given in the file Urine.pdf
• In summary:
  • Measure and record the creatinine concentration of an early morning urine sample
  • Spot and dry 10-20mL of the sample onto Whatman 3MM paper (spot 5mL, dry paper, spot next 5mL on top, etc), recording the volume dried on to the paper.
  • Keep the area to a minimum. Allow the urine to dry at room temperature - do not use heat or expose to direct sunlight.

Frozen tissue

• Freshly collected tissue should be snap-frozen
• Store at -80 degrees Celsius until shipment
• Tissue must be sent frozen on sufficient dry ice
• Consign the package for delivery within 24 -48 hours

Cell-free amniotic fluid for metabolite analysis (eg, 7-dehydrocholesterol)

• About 2-3 mL amniotic fluid is required
• Remove amniotic cells by centrifugation
• Store at -70 degrees Celsius until shipment
• For short transit times (eg overnight), package the cell-free amniotic fluid with a pre-frozen ice pack
• For longer transit times, consign the amniotic fluid on sufficient dry ice to last the entire transit time.
• Consign the package for delivery within 24 -48 hours.

IATA Packing Instruction 650

Operator Variations: SK-03, TN-03

General Requirements

Shippers of biological products and diagnostic specimens where a relatively low probability exists that infectious substances are present (diagnostic specimens being transported to undergo routine screening tests or for the purpose of initial diagnosis may be considered to fall under this category) must comply with these Regulations. The shipper must also ensure that shipments are prepared in such a manner that they arrive at their destination in good condition and that they present no hazard to persons or animals during shipment. The packaging must include:

650(a) inner packaging comprising

a leak-proof primary receptacle(s) - for biological products the maximum quantity must not exceed 20 mL, and for diagnostic specimens the maximum quantity must also not exceed 20 mL; a water-tight secondary packaging - the maximum quantity per outer packaging for biological products must not exceed 20 mL when fragile primary receptacles are used, or 20 mL when other than fragile primary receptacles are used. The maximum quantity per outer packaging for diagnostic specimens must not exceed 500 mL; an absorbent material - must be placed between the primary receptacle and the secondary packaging.

If multiple primary receptacles are placed in a single secondary packaging they must be wrapped individually to ensure that contact between them is prevented.

The absorbing material, for example cotton wool, must be sufficient to absorb the entire contents of all primary receptacles.

650(b) an outer packaging of adequate strength for its capacity, weight and intended use.

The completed package must be capable of withstanding at least a 1.2 m drop test on a hard unyielding surface without release of its contents.

Packages consigned as freight must be at least 100 mm (4 in) in the smallest overall external dimension.

An itemised list of contents must be enclosed between the secondary packaging and the outer packaging.

Each package and the "Nature and Quantity of Goods" box of the air waybill must show the text "BIOLOGICAL PRODUCTS" or "DIAGNOSTIC SPECIMENS" (as applicable)" - NOT RESTRICTED, PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650".

A Shipper's Declaration for Dangerous Goods is not required.

Specific Requirements

Although exceptional cases (for example, the shipment of whole organs) may require special packaging, the great majority of biological products and diagnostic specimens can and must be packaged according to the following guidelines.

Substances shipped at ambient temperatures or higher: Primary receptacles include those of glass, metal or plastic. Positive means of ensuring a leak-proof seal, such as heat seal, skirted stopper or metal crimp seal must be provided. If screw-caps are used, these must be reinforced with adhesive tape.

Substances shipped refrigerated or frozen (wet ice, pre-frozen packs, dry ice): Ice or dry ice must be placed outside the secondary packaging(s). Interior support must be provided to secure the secondary packaging(s) in the original position after the ice or dry ice has been dissipated. If ice is used, the packaging must be leak-proof. If dry ice is used, the outer packaging must permit the release of carbon-dioxide gas. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost.

Substances shipped in liquid nitrogen: Plastic capable of withstanding very low temperatures must be used instead of glass receptacles. Secondary packaging must also withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. Requirements for shipment of liquid nitrogen must also be observed. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant used, as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost.

Lyophilised substances: Primary receptacles must be either flame-sealed glass ampoules or rubber-stoppered glass vials with metal seals.

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