Donor Stds handout by dandanhuanghuang

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									                           BLOOD COLLECTION AND DONOR STANDARDS


I. Donor Selection

     A. Registration includes:

          1. Date and time of donation

          2. Full legal name and name(s) used for any previous donations. Many donor centers
             require a government-issued photo ID.

          3. Contact information: address, telephone number; used to notify donor if testing
             reveals ineligibility or a need for deferral.

          4. Age: > 16 years old; no upper age limit

               a. Must be in accordance with local laws

               b. Autologous donations - evaluated on a case by case basis to determine safety

          5. Reasons for previous deferrals, if any

     B. Donor interview:

          1. Conducted to elicit information concerning donor suitability. Both the health and
             safety of the donor and the recipient are taken into consideration.

          2. The interview is conducted in a private setting. All information obtained during the
             interview is kept confidential.

               a. May be conducted face to face

               b. Donor may complete a health history questionnaire via computer

          3. Donor education:

               a. Consent to donate: The blood collection center must inform the donor of the risks
                  associated with the collection process and explain the testing conducted on the
                  product. The donor should be given an opportunity to ask questions.

               b. Educational material on signs and symptoms associated with human
                  immunodeficiency virus (HIV) infections and AIDS, including:

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                     1) High risk activities for HIV transmission
                     2) Importance of refraining from donating blood if engaged in these activities
                     3) Other sources for HIV testing

               c. Information on other infectious diseases transmitted through blood transfusion.

               d. Donor must confirm that they have:

                     1) Read the educational materials
                     2) Provided accurate information during the donor interview

          4. Medical history: The FDA has approved a “Uniform Donor History Questionnaire”
             to obtain health history that may indicate the donor is not suitable for donation at that
             time. Each donor center may choose to use the “Uniform Donor History
             Questionnaire”, or design its own questionnaire. The following information is
             obtained:

               a. General wellness at time of donation; asked to protect both donor and recipient

               b. Determination of time elapsed since last donation [i.e. donation interval]; asked to
                  protect the donor

                     1)   Whole blood donation – 8 weeks
                     2)   Apheresis RBC collection (2 units) – 16 weeks
                     3)   Infrequent plasmapheresis – 4 weeks
                     4)   Frequent plasmapheresis, plateletpheresis or leukapheresis – at least 2 days, no
                          more than 2 times/week, and no more than 24 times/year.

               c. Current medications, both prescription and over the counter; asked to protect the
                  recipient from infections and other complications.

                     -    Medication Deferral List – Determine if the donor has ever taken any
                          medications on this list and defer as indicated.

               d. Vaccinations; asked to prevent the recipient from infections due to live attenuated
                  viruses

               e. Receipt of human blood/organs/tissues; asked to protect recipient from infectious
                  diseases transmitted by blood

               f. History of viral hepatitis or HIV; asked to protect recipient from hepatitis and/or
                  HIV


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               g. Potential exposure to hepatitis or HIV; asked to protect recipient from hepatitis
                  and/or HIV

               h. Risk of Creutzfeldt-Jakob Disease (CJD); asked to protect recipient from CJD.

                i. History of other diseases transmissible by blood; asked to prevent infection of
                   recipient.

                     1)   Exposure to/history of malaria
                     2)   Chagas’ disease
                     3)   Babesiosis
                     4)   History of Leishmania or travel to Iraq
                     5)   West Nile virus

               j. Question concerning other emerging diseases may be added as warranted – must
                  stay abreast of current events, and follow FDA guidelines.

               k. Questions regarding travel history to determine potential exposure to various
                  infectious diseases

     C. Physical exam

          1. General appearance - if donor appears ill, or under the influence of drugs or alcohol,
             or extremely nervous - defer donation for present

          2. Weight:

               a. 10% of blood volume can be donated without donor suffering the effects
                  of hypovolemia. AABB Standards states that 10.5 mL/kg donor weight
                  (including samples for testing) is the maximum amount of whole blood that can
                  be safely collected.

               b. >110 lbs (50 kg) person may donate maximum 525 mL (450 ± 45 mL +
                  30 mL for testing)

               c. < 110 lbs may donate as little as 300 mL- units labeled as “low volume
                  unit: ____ mL”

               d. < 300 ml drawn - anticoagulant must be reduced proportionately:

                     1) volume to draw = (donor’s weight in kg/50kg) x 450 mL
                     2) amount of anticoagulant needed = (volume to draw / 100) x 14
                     3) amount of anticoagulant to remove = 63mL - amount of anticoagulant
                        needed
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          3. Oral temperature - not greater than 37.5oC (99.5F)

          4. Blood pressure - no greater than 180/100 mmHg

          5. Pulse - 50-100 beats per minute (bpm), without irregularities
             - <50 bpm acceptable if donor is an athlete

          6. Hemoglobin >12.5 g/dl or hematocrit >38%. Acceptable methods include (but are not
             limited to):

               a. Copper sulfate method: Relies on the density of a blood drop relative to copper
                  sulfate (1.053 sp. gr.). Density is proportional to hemoglobin content.

               b. Hemocue- photometric hemoglobin determination that uses reagent-coated
                  microcuvettes

               c. Spun hematocrit

          7. Skin lesions - skin at site of venipuncture or anywhere else is examined for:

               a. Signs of drug use

               b. Unusually extensive rash - acne or psoriasis

               c. Boils, wounds, severe skin infections

               d. Purplish-red or hemorrhagic nodules suggestive of Kaposi’s sarcoma (associated
                  with HIV infection)

     D. Records from current donation must be compared with and linked to any previous
        donations made at that collection facility to ensure that products are not made from
        unsuitable donors.


II. Blood Collection
    - Aseptic method using a sterile, closed system and a single venipuncture

     A. Materials - sterile, single-use, disposable

     B. Containers

          1. FDA approved

          2. Pyrogen-free and sterile, colorless, transparent and single use
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Blood Collection and Donor Standards - Handout
          3. Contain anticoagulant

          4. Allow O2 and CO2 exchange

          5. Durable to withstand shipping conditions and processing, such as irradiation; most are
             made from PVC plastic.

          6. May have leukoreduction filters and/or satellite bags attached. If platelets are to be
             manufactured from a whole blood collection, an in-line diversion pouch must be used.

     C. Donor Identification

          1. Essential at each step in the collection process to assure traceability from donor
             registration to final disposition of each component made from that collection.

          2. Each donor is assigned a unique donor identification number (DIN) for each donation.
             The primary collection container, all satellite containers, specimens for testing, donor
             records and any component prepared from that collection are each labeled with the
             DIN.

     D. Selection and Preparation of venipuncture site:

          1. Apply tourniquet or blood pressure cuff. Palpate for well anchored vein.
             Select venipuncture site. Release tourniquet or deflate cuff.

          2. Scrub venipuncture site for 30 seconds with 0.7% aqueous solution of
             iodophor compound.

          3. Starting at intended puncture site and moving outward in a concentric spiral, apply
             10% PVP-iodine.

          4. Let stand for 30 seconds. Cover with sterile gauze until venipuncture performed.

          5. Alternate arm prep methods are allowed for donors with allergies to iodine. The use
             of green soap is not an acceptable alternative.

     E. Collection

          1. Confirm donor identity and verify DIN on collection bag and paperwork.

          2. Clamp line between needle and collection bag shut.

          3. Inflate blood pressure cuff or reapply tourniquet.

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          4. Perform 2-step venipuncture (Insert the needle under the skin at the venipuncture site,
             then advance the needle into the vein.). Once the needle is in position, tape in place.
             Cover venipuncture site with sterile gauze. Release clamp.

          5. Instruct donor to open and close fist periodically throughout donation.

          6. Mix blood with anticoagulant periodically throughout collection. Monitor
             volume collected.

          7. Observe donor carefully throughout collection for adverse effects of donation.

          8. Clamp tubing near the venipuncture site. Release cuff or tourniquet. Collect properly
             labeled specimens for testing.

          9. Remove needle from the donor’s arm. Instruct donor to elevate arm and apply
             pressure to gauze at venipuncture site for a minimum of two minutes.

          10. Seal tubing. Discard needle in puncture proof container.

          11. Strip tubing to allow anticoagulant to mix with blood. Allow tubing to refill. Make
              segments to be used in compatibility testing.


III. Post Phlebotomy Care

     A. Instructions to donor include:

          1. Eat or drink something - more fluids than usual in next 4 hours

          2. Do not smoke for 30 minutes

          3. If bleeding occurs, raise arm and apply pressure

          4. If feeling faint or dizzy, lie down or sit with head between knees

          5. Should be cautioned about returning to high risk occupations, no strenuous activity

          6. Do not leave collection facility until released by staff member

     B. Possible adverse reactions include:

          1. Fainting

          2. Hyperventilation
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          3.    Bruising or hematoma at phlebotomy site

          4. Nausea and vomiting

          5. Arterial puncture

          6. Nerve damage

          7. Convulsions

          8. Serious cardiac difficulties


IV. Processing Requirements

     A. Donor facility

          1. Required tests

               a. ABO/Rh, including weak D - donors who test positive for the weak D antigen are
                  considered Rh Positive

               b. Unexpected antibodies, if donor has a history of transfusion or pregnancy. If
                  antibody screen is positive, no plasma components are manufactured from that
                  donor.

               c. Infectious disease testing: Testing conducted for various antigens and antibodies
                  of transfusion-transmitted diseases. Nucleic Acid Testing (NAT) is used to detect
                  HCV, HIV, and WNV RNA. For NAT, individual donor’s plasma or pools of
                  plasma from several donors may be tested.

               d. The donor must be notified of any medically significant abnormal findings
                  detected during the pre-donation evaluation or as a result of unit testing.




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Blood Collection and Donor Standards - Handout
                                                           Required Donor Tests

                     Disease                     Test(s)              Method of testing                  Estimated US
                                                                                                         Transmission
                                                                                                         Risk
                     Hepatitis B                 Hepatitis B          Enzyme-linked                      1:220.000
                                                 surface antigen      Immunosorbent assay
                                                 (HbsAg)              (ELISA) or
                                                                      Chemiluminescent
                                                                      immunoassay(ChLIA)

                                                 Anti-HBc             enzyme immunoassay
                                                                      (EIA) or ChLIA
                     Hepatitis C                 Anti-HCV             ELISA or                           1:1,800,000
                                                                      Recombinant
                                                                      immunoblot assay
                                                                      (RIBA)

                                                 HCV RNA              Transcription-
                                                                      mediated
                                                                      amplification (TMA)
                                                                      or polymerase chain
                                                                      reaction (PCR)
                     HIV                         Anti-HIV-1/2         ChLIA, EIA, indirect               1:2,300,000
                                                                      immunofluorescence
                                                                      (IFA) or Western Blot

                                                 HIV-1 RNA      TMA or PCR
                     HTLV I/ II                  Anti-HTLV I/II ChLIA or EIA                             1:2 ,993,000

                     West Nile                   WNV RNA              TMA or PCR                          1:4,570,000*
                     Virus
                     Syphilis                    Treponema            RPR, FTA                           Rare – no
                     (Treponema                  pallidum                                                cases reported
                     pallidum)                   antibody                                                since the 1960s
                                                                                                         See note
                                              Adapted from the AABB Technical Manual, 16th ed., 2008.
                               *From “A Compendium of Transfusion Practice Guidelines”, American Red Cross 1sr Ed., 2010.


                     Note: Treponema spirochete does not ordinarily survive more than 72 hours at
                     4oC. Transmission requires blood to be drawn during brief period of
                     spirochetemia. A syphilis test (STS) continues to be positive long after the brief
                     period of infectivity.


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          2. Optional tests – Local policy may indicate performance, however these tests are not
             required by FDA or AABB Standards

               a. Trypanosoma cruzi (Chagas’ disease) – many donor centers routinely test for this
                  parasite

               b. CMV

               c. EBV

               d. Others as indicated by local policy

          3. Final product label requirements – Must comply with the “Uniform Labeling of Blood
             and Blood Components” using ISBT 128 or the 1985 Uniform Labeling Guidelines
             established by the FDA.

               a. The following information must be on the product label:

                     1) Proper name of component

                     2) Unique DIN that relates unit and all components to donor

                     3) Volume of blood collected, amount and type of anticoagulant used; volume of
                        components other than cryo, on container

                     4) Expiration date; if less than 72 hours until expiration, expiration time must be
                        included

                     5) Required storage temperature

                     6) ABO/Rh and interpretation of unexpected antibody test

                     7) Reference to Circular of Information

                     8) Instructions to transfusionist: Warning that product may transmit infectious
                        disease, “Rx only”, “Properly identify intended recipient”

                     9) Donor classification, e.g., volunteer, autologous

                     10) Name and address of collecting facility

               b. The DIN, ABO/Rh, component code (RBCs, platelets, etc), and collection facility
                  identification must be in both eye-readable and barcode format.

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               c. Any handwritten modifications to the label must be made in permanent, moisture
                  –proof ink, and be clearly legible.

               d. Once labels have been affixed to the unit, there is a verification step that ensures
                  that the correct ABO/Rh, expiration date, and component label have been placed
                  on the product.

          4. Records

               a. Current ABO/Rh test results must be compared with donor’s historical type.
                  Discrepancies must be resolved before the product is distributed. Confirm the
                  correct ABO/Rh label is on the unit.

               b. Records on donors are reviewed to ensure units from unsuitable donors are never
                  released. This does not take the place of place of infectious disease testing.

               c. Must be possible to trace any unit (and any components made from that unit) from
                  the original source (donor) to final disposition, indefinitely.

               d. Look-back process

                     1) A method to identify patients who have received products from donors with a
                        disease that is transmitted by blood or from donors who are in a high risk
                        category concerning such a disease.

                     2) The patient and/or patient’s physician is notified of the possible risk of
                        infection. Testing services and counseling may be provided.

                     3) Any product from the donor that remains in inventory should be quarantined
                        or discarded.

          5. Storage and shipment - Storage devices are equipped to monitor the temperature
             continuously, and record the temperature at least once every 4 hours. An audible
             alarm alerts technologists to temperatures that are out of acceptable range.

               a. Refrigerators: 1-6oC, with fans to insure temperature maintained
                  throughout

               b. Freezers: -18oC or colder for FFP and Cryo, -65oC or colder for frozen RBCs

               c. Platelets: 20-24oC with continuous gentle agitation

               d. Transportation - all components must be transported in a manner that will insure
                  maintenance of the following temperatures:
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Blood Collection and Donor Standards - Handout
                     1) Red blood cells: 1-10oC on wet ice
                     2) Platelets: 20-24oC
                     3) Frozen components: -18oC or colder on dry ice

     B. Transfusion service

          1. Must confirm ABO group of all red blood cell-containing units and Rh type of Rh
             Negative RBC-containing units

          2. Request form - order from physician for a specific number of components. May
             request special unit attributes such as leukoreduced, irradiated, fresh, etc.

          3. Check records for patient’s history

          4. For red blood cell-containing units:

                     a. Testing of recipient blood using a positively identified sample from recipient

                     b. ABO/Rh and unexpected antibody test on recipient

                     c. Crossmatch using suspension of donor RBCs and recipient’s plasma/serum (or
                        electronic XM)

          5. Selection of blood and components for transfusion (e.g., ABO compatible, antigen
             negative, special attributes, expected date of transfusion)

          6. Label requirements - unit tag securely attached to container includes: 2 unique patient
             identifiers, donor identification number (DIN), and interpretation of compatibility
             tests

          7. Inspection of product prior to transfusion - inspected immediately before issue from
             the laboratory for signs of bacterial contamination (abnormal color, hemolysis, clots)
              or breech of the hermetic seal

          8. Retention of sample - a sealed sample of each donor’s and recipient’s blood shall be
             stored at 1-6oC for at least 7 days after transfusion

          9. Records - must be maintained for a minimum of 5 years or as required by applicable
             state and federal law

          10. Reissue of blood - blood returned to the laboratory will not be reissued unless:

               a. Container closure has not been disturbed (i.e. the ports have not been “spiked”)

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               b. Product has been maintained within the acceptable temperature range

               c. At least one sealed segment of integral donor tubing has remained attached to the
                  container for RBC containing units.

               d. The unit has been visually inspected and found satisfactory for reissue.


V. Special Donor Categories

     A. Preoperative Autologous Donor

          1. Recipient serves as his own donor. Must have physician’s order for donation.

          2. Donor eligibility requirements may be altered from those used for allogeneic
             donations:

               a. Hgb. >11 g/dL Hct > 33%, copper sulfate 1.049 sp.gr.

               b. May donate more frequently. Last donation must be completed at least 72 hours
                  before date of need.

               c. Volume modifications for patients who would not be considered for allogeneic
                  donations (e.g. pediatrics)

               d. Pregnant women are allowed to donate

               e. Questions during interview should elicit any possibility of intermittent bacteremia
                  – donor deferred if potential bacteremia exists.

               f. Infectious disease standards

                     1) Testing does not need to be performed if the transfusing facility also collects
                        the unit.

                     2) If collection takes place at a facility other than the transfusing facility, the first
                        unit must be tested for infectious disease. Repeat testing is done at least every
                        30 days.

                          a) If positive, a “Biohazard” label is placed on the unit.
                          b) The transfusion service is notified of abnormal results.
                          c) The patient and patient’s physician are informed of significant abnormal
                             results.

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          3. Unit labeling must include the donor classification “Autologous”, as well as
             information that identifies the recipient and transfusing facility.

          4. Autologous units are stored in a location separate from allogeneic units.

          5. No crossover of unused autologous units into allogeneic inventory is allowed, except
             in extreme circumstances. Requires approval of Transfusion Service Medical
             Director.

          6. Pretransfusion testing of the recipient (at the transfusing facility) includes:

               a. ABO and Rh

               b. Antibody screen - allows for rapid provision of allogeneic blood, should the
                  autologous donation fail to fulfill the patient’s needs

               c. Serologic crossmatch of unit RBCs with recipient’s serum/plasma. Electronic
                  crossmatch allowed if all conditions for electronic crossmatch are met.

     B. Directed donors

          1. The recipient chooses the individuals from whom they feel comfortable receiving
             blood. These are usually family members and friends who the recipient perceives as
             “safe”.

          2. Donor selection criteria and testing is the same as for other allogeneic donors.

          3. Care must be taken to transfuse directed donor units to the intended recipient before
             transfusion of allogeneic blood.

          4. Potential Pitfalls

               a. Many directed donors are first-time donors. First-time donors have a higher rate
                  of positive infectious disease tests than repeat donors.

               b. The additional handling required during collection, transportation and storage to
                  insure these units go to the intended recipient adds to the expense of using
                  directed donors.

               c. When receiving cellular blood products from a blood relative, there is greater risk
                  of graft versus host disease in the recipient. Irradiation of the product reduces this
                  risk.


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          5. Each Transfusion Service should establish a policy addressing the “crossing-over” of
             directed donor units into the general inventory. (Is it ever allowed? At what point
             during the shelf-life of the unit?)

     C. Designated donor

          1. Blood is specifically collected for use by a particular recipient, but donor is not
             chosen by the recipient.

          2. Examples include recipients with multiple antibodies, antibodies to high prevalence
             antigens, Bombay phenotype, Rh null, or HLA matched platelets.

     D. Apheresis

          1. Method: Whole blood is removed from donor and separated into components through
             centrifugation. One or more components are collected while the remaining elements
             are returned to the donor (saline, anticoagulant, etc.)

               a. Intermittent Flow - Multiple cycles (passes) of collection, centrifugation,
                  separation, and re-infusion used to collect product.

                     1) One pass is completed before the next pass begins.

                     2) May be performed using a single venipuncture.

               b. Continuous Flow - Collection, separation and re-infusion occur simultaneously;
                  one venipuncture is used for collection and a second for re-infusion.

          2. No more than 15% of the donor’s blood volume may be extracorporeal during the
             collection process.

          3. Except when collecting red blood cells, red blood cell loss should not exceed 25 mL
             per week, including samples for testing.

          4. Before the collection, the risks of the apheresis procedure must be explained to the
             donor. The donor should be given the opportunity to ask questions before signing a
             consent form.

          5. Donors should meet requirements for allogeneic donation.

          6. Donor is tested to ensure no cytopenia is developing. For example, plateletpheresis
             donors who donate more frequently than once a month must have a platelet count
             greater than 150,000/uL. The platelet count may be determined at the end of the
             previous collection or before beginning the current collection.
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          7. If the donor is being pheresed in support of a specific patient, infectious disease
             testing is done with the first donation and every 30 days thereafter.

          8. Records must be maintained of:

               a.    Donor identity
               b.    Results of laboratory tests
               c.    Anticoagulant used
               d.    Volume of component(s) collected
               e.    Lot number of all disposables and replacement fluids
               f.    Drugs administered
               g.    Adverse donor reactions, including treatment

     E. Therapeutic apheresis

          1. Used clinically to treat a wide array of conditions

               a. Cytapheresis - Removal of specific blood cells involved in the pathogenesis of a
                     disease (e.g. polycythemia vera, sickle cell disease)

               b. Plasmapheresis

                     1) Removal of plasma in order to :

                          a) Remove soluble factors that contributes to a disease process (e.g.
                             autoantibodies, immune complexes, proteins, cholesterol)

                          b) To correct a deficiency or lack of a normal plasma constituent

                     2) Donor/patient plasma that is removed may be replaced by:

                          a)   Plasma (Thawed FFP or Plasma Cryoprecipitate Reduced)
                          b)   Albumin
                          c)   Crystalloids
                          d)   HES

                     3) Process may be referred to as a Plasma Exchange

          2. Because this is considered a medical procedure, the Joint Commission requires a
             “time-out” be called before the procedure begins. During the “time-out”, the
             following information is confirmed:

               a. Two unique patient identifiers

CLS 423 Clinical Immunohematology II                                                    Page 15 of 17
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               b. The procedure to be performed

               c. There is a written physician’s order to perform the procedure

               d. There is a physician available to respond should the patient experience an adverse
                  event.

          3.    Risks include:

               a. Hypovolemia

               b. Citrate Toxicity (hypocalcemia)

               c. Lowering of therapeutic drug levels (especially those that bind to albumin)

               d. Decrease in immunoglobulin, coagulation factors and complement levels




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Blood Collection and Donor Standards - Handout
                                                 TERMS


Capture question: Covers a broad topic. When a donor gives a positive response, more
detailed questions should be asked as follow-up.

Attention question: Designed to ensure the donor maintains focus when completing a self-
administered questionnaire. For example, when asking a gender based question, such as “In the
past 6 weeks, have you been pregnant or are you pregnant now?” a male donor should check the
“I am male” box instead of answering “Yes” or “No”. Failure to check the correct box would
indicate that the interviewer should ask additional questions, or take some follow-up action.

Follow-up question: Designed to capture detail when a positive or inappropriate response was
given. Documentation of the response to the follow-up question should include whether the
donor is eligible to donate, or is deferred.

Temporary Deferral: Donor is ineligible to donate for a limited time period.

Permanent Deferral: Donor will never be eligible to donate allogeneic blood.

Indefinite Deferral: Donor is ineligible to donate allogeneic blood, according to current
regulations. It is possible that future changes to the regulations would allow these donors to re-
enter the donor population.

ISBT: International Society of Blood Transfusion. This organization has developed an
international standard for blood and blood component barcode labels (ISBT 128).

Codabar: A barcode system used by some donor centers and transfusion services that have not
yet converted to ISBT 128 barcodes.

Window period: The time between contracting a disease and the detection of that disease.

Screening tests: Screening tests for infectious diseases are used for initial testing because they
are easier to perform than confirmatory tests, can test large numbers of specimens, and are more
cost effective. They are highly sensitive (few false negatives), but are not as specific as the
confirmatory tests (higher rate of false positives).

Confirmatory tests: When a screening test for an infectious disease is positive, these highly
specific tests are run to validate the initial screen results. Confirmatory tests are usually more
labor intensive and may require subjective interpretation, which makes them more expensive to
run.



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Blood Collection and Donor Standards - Handout

								
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