GUIDELINES FOR CLINICAL SPECIMEN SPECIFICATION, PACKAGING AND SHIPPING

TEST REQUEST FORM (TRF)

For clinical services that requires clinical report,

1.1 Customer must fill and submit TRF and consent form with each specimen.

TRF must have below information along with signed consent form for clinical services:

  1. Patient full name (Last Name, First Name)
  2. Date of Birth
  3. Hospital ID/ Patient ID
  4. Gender
  5. Date of collection
  6. Time of collection
  7. Source of specimen
  8. Identity (Initials) of the person collecting the sample
  9. Name and address (if different than the receiving laboratory) of the physician, legally authorized person ordering the test, or name and address of the laboratory referring the specimen
  10. Test requested
  11. Clinical history or any clinical report has to be attached if available
  12. Ethnicity of the patient

For clinical services that requires fastq data,

1.2 Customer must fill and submit Sample Submission for each batch of specimen.

The metadata form can be filled if patient details are available.

Sample submission must include below information:

  1. Patient full name (Last Name, First Name or sample code given by client)/Patient ID
  2. Client details
  3. Sample type
  4. Concentration (ng/ul) (Only for extracted DNA)
  5. A260/230 ratio (Only for extracted DNA)
  6. A260/280 ratio (Only for extracted DNA)
  7. Vol (ul/ml)

The test request form should be filled legibly in English language only.

If the test request form is not submitted with the mentioned guidelines, the samples will be rejected.

PROPER LABELLING OF TUBES

Each Sample tube must be labelled with at least two identifiers.

Patient full name (Last Name, First Name) (Written exactly as it appears on the test request form) is a mandatory identifier.

The second identifier can be:

  1. Date of birth
  2. Hospital number
  3. Social security number
  4. Requisition number
  5. Accession number
  6. Unique random number
  7. Sample ID of sending organization

Specimens collected for laboratory testing must be labelled legibly using a permanent marker and in English language only.

Improperly labelled specimens will be rejected

SAMPLE SPECIFICATIONS

Samples must follow the Specifications mentioned below:

Type Whole Blood Extracted DNA (EDTA-Blood)*
Volume Adults:
Minimum 3ml Peripheral blood
Pediatric:
Minimum 3ml Peripheral Blood, but can accept 1.5ml if required
Minimum 50µL Extracted DNA in 1.5ml Microcentrifuge tube
Concentration Minimum 50ng/µL (Fluorometric assay)
Total concentration:
>2.5 µg in Nuclease free water or TE buffer
0.5X Tris EDTA (TE) buffer (pH- 8):
5mM Tris, 0.5mM EDTA
Quality Not hemolyzed or clotted A260/280 Ratio:1.6 – 2.0
A260/230 Ratio: 2.0 – 2.2
Integrity (Checked on 0.8% Agarose gel)- Intact DNA
Container EDTA Vacutainer (Purple Tube)
(K2EDTA is preferred salt over K3EDTA)
1.5ml Sterile DNAse RNAse Free Microcentrifuge tube
Storage and Stability 2-8° C up to 48 hours after Collection -20° C for 1 week after Extraction
Shipping Condition Refrigerated (2-8° C) If extracted in Nuclease free water:
Refrigerated (2-8° C)
If Extracted in TE buffer:
Frozen (-20° C)

*AGMX only accepts isolated or extracted DNA for which extraction or isolation is performed in an accredited laboratory.

PACKAGING & SHIPPING

  • Make sure that the tubes are properly closed and sealed with at least five layers of parafilm before they are dispatched
  • Make sure samples are not in direct contact with dry ice or ice bags. Sample should be wrapped in paper or filter paper to prevent direct contact with ice
  • Samples must be individually packed in “Specimen Bag” and related TRF and other documents for that sample must be in a separate pouch

1. Freezing Condition    

DNA samples can be transported Frozen in Dry Ice (if transportation will take more than 2 days) Alternatively, if transportation will take less than 2 days, DNA samples can be transported with gel packs (Gel packs must be pre-frozen at -20 °C for 24 hours prior to use).

Packing procedure:

  • Remove all contents of transport box
  • Break dry ice into small pieces and place at bottom of the box
  • Place samples sealed in Zip lock bag over the dry ice
  • Place perforated sponge over the samples
  • Close the Thermocol lid
  • Seal the cardboard box and transport to laboratory immediately
  • Indicate Frozen Samples in Dry Ice on cardboard box

Box Guidelines for Dry Ice Shipments:

  • 1.5 to 2 Kgs Dry-ice for 1 to 2 days shipment
  • 2 to 2.5 Kgs Dry ice for 2 to 3 days shipment
  • Box size – 10″ x 12 “

2.Refrigerated Condition

Samples can be transported at refrigerated condition with gel packs (Pre-frozen at 0 °C for 24 hours prior to use).

Packing procedure:

  • Remove all contents of Transport box.
  • Place a frozen gel pack at bottom of Thermocol box
  • Place a layer of perforated sponge over the pre-frozen gel pack.
  • Place specimens sealed in a zip lock bag over the perforated sponge.
  • Cover specimens with second layer of perforated sponge
  • Place another pre-frozen gel pack over the samples.
  • Place unperforated sponge and close Thermocol lid.
  • Seal the cardboard box and transport to laboratory immediately.
  • Indicate ‘Refrigerated Samples’ on cardboard box.

Note: In case a transport bag is being used, place pre-frozen gel packs in the pockets of the bag and ziplocked samples to be placed in the center of the bag.

Samples transport box should be shipped at below address:

Agiomix FZ. LLC.

Warehouse Complex, Block D,

Dubai Science Park, Al Barsha South, Dubai

United Arab Emirates

Contact No: +97144224601

SPECIMEN ACCEPTANCE AND REJECTION CRITERIA:

Specimen Acceptance Criteria Specimen Rejection Criteria
Labeled sample with patient and test details Unlabeled / Mislabeled sample
Sample matches with the TRF If sample does not Match with the TRF
Proper and non-leaking Specimen container Improper, broken or Leaking Specimen container
Sample received at appropriate time after collection Prolonged transport time, esp. if the samples are not preserved at 2-8 C
Sample temperature is as specified at the time of receipt Sample temperature is not as specified at the time of receipt
Specimen suitable for request Specimen unsuitable for request
Not hemolyzed or clotted Hemolyzed or clotted specimen/ unsuitable for request
Extracted DNA purity acceptance ratio: A260/280 1.6 – 2.0 Any value outside the acceptance ratio
Extracted DNA purity acceptance ratio: A260/230 2.0– 2.2 Any value outside the acceptance ratio
Intact genomic DNA Degradation of DNA below 500 bp is not acceptable
Extracted DNA concentration greater than 2.5 µg in Nuclease free water or TE buffer DNA concentration less than recommended will result in compromised data output