Blood sample for infectious disease tests - Qualification.
Blood samples of potential deceased donors for tissues and cells are taken to minimise the risk of transmitting infectious diseases to other recipients.Collection of the blood samples for testing are taken no longer than 24 hours after death and it is recognised the volume of blood, colloids and crystolloids infused prior to death may affect the test results. A standardised formula (e.g. Europe, USA) is available in this healthcare sector to determine the acceptability of a blood sample for infectious marker testing, when infusions have taken place. The algorithm is based on values related to blood volume, plasma volume and the volumes of blood, colloid and crystalloid infused within the 48 hours prior to death.
This evaluation process is sometimes referred to as the "Plasma (Blood) Dilution Evaluation". A review of MedCalc does not appear to include this formula and if others are interested I would be happy to provide further details of the formula and some associated references.
Regards Mike Cox.
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Stefan Poniatowski commented
I think this would be really helpful, not least as it saves carrying another piece of paper around to handle a referral. I imagine many donation centres would find it useful and accessible. Fully support it.
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Scott Brubaker commented
Where it describes this at the end:
The post-transfusion/infusion sample is not acceptable if the answer to
either D or E is “Yes”,
(In the latter case use a pre-transfusion/infusion sample or reject the
potential donor of human tissues/cells).Maybe it should state this:
The post-transfusion/infusion sample is not acceptable if the answer to
either D or E is “Yes”,
(In the latter case, use a pre-transfusion/infusion sample, locate a
different sample and apply this algorithm, or reject the potential donor
of human tissues/cells).Rationale: multiple samples collected at different times could be found and a few can be evaluated until you find one that qualifies.
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Jill Shepherd commented
The formula addresses most of the relevant EUTCD requirements and in correct timeframes. One aspect of EUTCD 2006/17/EC requiring a calculation that may still need to be addressed is from Annex II section 2:
‘Tissue establishments may accept tissues and cells from donors with plasma dilution of more than 50 % only if the testing procedures used are validated for such plasma or if a pre-transfusion sample is available.’
Perhaps this point is addressed elsewhere on the actual App?
I hope you find this helpful. -
Deirdre Fehily commented
This would be very useful for all those co-ordinators working on donor referrals often on their own during the night! I can see it being used by the many tissue donation programmes across Europe.
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Ted Eastlund commented
Good idea, including a method for calculating total blood and plasma volume based on weight and height. This might be used over 30,000 times a year for each of the tissue donors in the USA plus more that are rejected
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Crystal Blackwell commented
I think this could be a very handy app for the folks in the field to have at their fingertips.
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Scott Brubaker commented
This is very useful for folks to use "in the field" - check it out!
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Thanks for all this info, awesome!
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Michael Cox commented
Further details are now added to the forum for viewpoints.
Clinical use:
To minimize risk to recipients, a blood sample of a deceased donor of tissues or cells is collected and tested for communicable disease. It is recognized the volume of blood, colloids and crystalloids infused prior to death may affect these test results and an algorithm is used to determine the acceptability of a blood sample for infectious marker testing.PRELIMINARY QUESTIONS FOR DETERMINING IF A DONOR SPECIMEN IS ADEQUATE FOR INFECTIOUS DISEASE TESTING.
Question 1
Has the donor had a transfusion or infusion?
• If the answer is no, then test the blood specimen
• If the answer is yes, then ask question 2Question 2
Is the donor more than twelve years old?
• If the answer is no, then ask question 2a
• If the answer is yes, then ask question 3Question 2a
Is there a recent pre-transfusion/infusion blood specimen available for the donor who is twelve years of age or younger?
• If the answer is no, then apply the algorithm worksheet
• If the answer is yes, then test the pre-transfusion/infusion blood specimen that is availableQuestion 3
Is there a recent pre-transfusion/infusion blood specimen available for the donor who is more than twelve years of age?
• If the answer is yes, then test the pre-transfusion/infusion blood specimen
• If the answer is no, then ask Question 4Question 4
Has blood loss occurred?
• If the answer is no, then test the blood specimen
• If the answer is yes, then ask Question 5Question 5
Are any of the following conditions exceeded?
• 2000 mL of blood or colloid given to the donor within the past 48 hours;
• 2000 mL of crystalloids within the last hour; or
• 2000 mL total of any combination of blood and colloid within past 48 hours, and crystalloid in the past hour
• If the answer is no, then test the blood specimen
• If the answer is yes, then apply the algorithm worksheetAlgorithm (Worksheet).
Donor ID: _________________
Date of sampling: ________________
Time of sampling (00.00): ________________
Donor Weight (kg): _________________Blood Volume (BV) = donor’s weight (kg) ÷ 0.015 = ____ ml
or (BV) = donor’s weight (kg) x 70 mL/kg = ____ mLPlasma Volume (PV) = donor’s weight (kg) ÷ 0.025 = ____ mL
or (PV) = donor’s weight (kg) x 40 mL/kg = ____ mLA. Total Volume of Blood transfused/48 hours *
A1. Volume of RBCs transfused/48 hours ____ mL
A2. Volume of Whole blood transfused/48 hours ____ mL
Total volume (A = A1 + A2) ____ mL
(Enter “zero” if not transfused).B. Total Volume of Colloid infused/48 hours *
B1. Volume of Dextran ____ mL
B2. Volume of plasma ____ mL
B3. Volume of platelets ____ mL
B4. Volume of albumin ____ mL
B5. Volume of hetastarch ____mL
B6. Volume of other ____ mL
Total volume (B = B1 to B6) ____ mL
(Enter “zero” if not infused).C. Total Volume of Crystalloid Infused/1 hour *
C1. Volume of saline ____ mL
C2. Volume of Dextrose in water ____ mL
C3. Volume of Ringer’s lactate ____ mL
C4. Volume of other ____ mL
Total volume (C = C1 to C4) ____ mL
(Enter “zero” if not infused).
Determination of Sample Acceptability for Infectious Disease Tests:
Calculate both D and E below.
D. Is the sum of B + C greater than PV? Yes or No.
E. Is the sum of A + B + C greater than BV? Yes or No.The post-transfusion/infusion sample is acceptable for testing where the answer to both D and E are “No”,
The post-transfusion/infusion sample is not acceptable if the answer to either D or E is “Yes”,
(In the latter case use a pre-transfusion/infusion sample or reject the potential donor of human tissues/cells).
* before death or sample collection, whichever comes first.References
1. Directive 2006/17/EC of 8th February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for donation, procurement and testing of human tissues and cells. Official Journal of the European Union, L38/40 09/02/2006.
2. Guidance for Industry: Eligibility determination for donors of human cells, tissues and cellular and tissue based products (HCT/Ps), FDA, Center for Biologics Evaluation and Research, August 2007.
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf
3. Chopek, M.M., Protein and Biochemical Changes During Plasma Exchange. Therapeutic Hemapheresis: A Technical Workshop Presented by the Committee on Technical Workshops, American Association of Blood Banks 1980; 1980:13-52.
4. Hemodilution-an overview of current canadian practices, Cell and Tissue Banking, 2: 41-44.2001.