Chapter 07

C h a p t e r

7

Blood Component Collection

by Apheresis 䊱 James W. Smith, MD, PhD, and Edwin A. Burgstaler, MT(ASCP), HP

hemapheresis, or any of the various terms used are derived from the Greek aphairos, meaning “to take from.” Both centrifugal- and membranebased apheresis techniques were under development in the late 19th and early 20th centuries. By the 1970s, multiple technologies had begun to develop for the separation of blood components from donors or patients.

The status of donor apheresis at present parallels the evolution in technology. In the United States, centrifugal technology has been developed primarily for apheresis applications. Other parts of the world, primarily Europe and Japan, have seen in addition the development of membrane filtration technology for some donor procedures.

The development of automated, online, centrifugal technologies was linked with the development of the first devices to allow donor apheresis in large-scale applications.

Early device developments allowed the donation of platelets, plasma, and granulocytes. As the technology continued to develop, equip-

A

PHERESIS, PHERESIS,

ment, disposables, and software programs became increasingly sophisticated for the separation of these products as well as other components. The collection of various combinations of products by apheresis is now possible (see Table 7-1). This chapter discusses the technology and instrumentation used in the collection of these products, with special consideration given to the regulatory aspects involved with donors, products, testing, and other requirements specifically related to apheresis. 䊳

CO M P O N E N T CO L L E C T IO N Collection of components by apheresis follows many of the same rules and guidelines that apply to whole blood donation. For instance, like whole blood donors, donors who are to undergo a procedure involving apheresis must be given information so that their consent to donate is informed. Although apheresis collection and preparation processes differ from those used for whole-blood-derived compo-

James W. Smith, MD, PhD, Associate Medical Director, Oklahoma Blood Institute, Oklahoma City, Oklahoma, and Edwin A. Burgstaler, MT(ASCP), HP, Apheresis Research and Development, Mayo Clinic, Rochester, Minnesota The authors have disclosed no conflicts of interest.

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TABLE 7-1. Components That Can Be Collected from Various Instruments Instrument

GRAN

PLT

Fenwal ALYX Fenwal Amicus

X

cRBC

2-RBC

X

X

PLASMA

cPLASMA X

X

X

Fenwal Autopheresis C

X

Fresenius AS104

X

Gambro (COBE) Spectra

X

X

X

Gambro Trima V-4

X

X

X

X

Gambro Trima Accel

X

X

X

X

Haemonetics Cymbal Haemonetics MCS+ LN9000

X X

X

Haemonetics MCS+ LN8150

X X

X

Haemonetics PCS-2

X X

GRAN = granulocytes; PLT = plateletpheresis (single, double, triple); cRBC = concurrent 1-unit RBC; 2-RBC = double unit of RBCs; PLASMA = 1-unit plasma; cPLASMA = concurrent plasma; concurrent = more than one product can be collected; V-4 = software version 4.

nents, the storage conditions, transportation requirements, and some quality control steps are the same for both. Yet another similarity is that the facility must maintain written procedures and protocols for all types of collections used and must keep records for each procedure as required by AABB Standards for Blood Banks and Transfusion Services.1(pp79-81) The circumstances unique to apheresis collection are addressed in the sections that follow.

Platelets Apheresis platelet collections are used to obtain platelets from volunteer donors, from patients’ family members, or from donors with HLA- or platelet antigen-compatible phenotypes. Apheresis procedures are by design intended to collect large numbers of platelets from an individual, thereby providing a more consistent product with fewer donor exposures for the patient. AABB Standards requires that

an apheresis platelet component contain at least 3 × 1011 platelets in 90% of sampled units.1(p36) With newer technology and more efficient processes, higher yields of platelets may be obtained from one donor, and the original apheresis unit may be split into multiple units, each of which must meet minimum standards. Some instruments are programmed to calculate the yield from the donor’s hematocrit, platelet count, height, and weight. For alloimmunized patients who are refractory to random allogeneic platelets, platelets from an apheresis donor selected on the basis of a compatible platelet crossmatch or matched for HLA antigens may be the only way to achieve a satisfactory posttransfusion platelet increment. In the United States, the use of apheresis platelets has been steadily increasing over the past 25 years. It is estimated that 79% of therapeutic platelet doses transfused in the United States are apheresis platelets.2

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CHAPTER 7

Blood Component Collection by Apheresis

Donor Selection and Monitoring Plateletpheresis donors may donate more frequently than whole blood donors but must meet all other donor criteria. The interval between donations should be at least 2 days, and donors should not undergo plateletpheresis more than twice in a week or more than 24 times in a year.1(p24),3 If the donor donates a unit of whole blood, or if it becomes impossible to return the donor’s red cells during plateletpheresis, at least 8 weeks should elapse before a subsequent plateletpheresis procedure, unless the extracorporeal red cell volume is less than 100 mL. Platelets may be collected from donors who do not meet these requirements only if the component is expected to be of particular value to a specific intended recipient and if a physician certifies in writing that the donor’s health will not be compromised by the donation. Donors who have taken antiplatelet medications within specific intervals before donation (aspirin/aspirincontaining medications, 48 hours; Feldene, 48 hours; Plavix/clopidrogel, 14 days; Ticlid/ ticlopidine, 14 days) are deferred because apheresis platelets are often the single source of platelets given to a patient.1(p71),3 Plateletpheresis donors should meet the usual donor requirements including hemoglobin or hematocrit level. Platelet count is not required before the first apheresis collection or if 4 weeks or more have elapsed since the last procedure. If the donation interval is less than 4 weeks, the donor’s platelet count should be above 150,000/µL before subsequent plateletpheresis occurs. AABB Standards permits documentation of the platelet count from a sample collected immediately before the procedure or from a sample obtained either before or after the previous procedure.1(p25) Exceptions to these laboratory criteria should be approved in writing by the apheresis physician. The Food and Drug Administration (FDA) specifies that the total volume of plasma collected should be no

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more than 500 mL (or 600 mL for donors weighing more than 175 lb), or the volume described in the labeling for the automated blood cell separator device (this volume may be more or less than the 500-mL or 600-mL volume previously stated). The platelet count of each unit should be kept on record but need not be written on the product label.

Units containing less than 3.0 × 1011 platelets should be labeled with the actual platelet count.3 It is also possible to collect plasma concurrently with the collection of platelets. This collection is discussed further in the section about donor plasmapheresis. With regard to donor reactions, vasovagal and hypovolemic reactions are rare in apheresis donors but may occur. Paresthesias and other reactions to citrate anticoagulant are common. (Reactions are discussed with those for whole blood in Chapter 27.) Serious reactions occur less often among apheresis donors than among donors of whole blood.

Laboratory Testing Tests for ABO group, for Rh type, for unexpected alloantibodies, and for markers for transfusion-transmitted diseases must be performed by the collecting facility in the same manner as for other blood components.

Each unit must be tested unless the donor is undergoing repeated procedures to support a specific patient, in which case testing for infectious disease markers needs to be repeated only at 30-day intervals.

If red cells are visible in a product, the hematocrit should be determined. FDA guidelines and AABB Standards 1(pp45-46) require that if the component contains more than 2 mL of red cells, a sample of donor blood for compatibility testing must be attached to a container.

In some instances it may be desirable for the donor plasma to be ABO-compatible with the recipient’s red cells (eg, if the recipient is a child or an ABO-mismatched allogeneic pro-

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genitor-cell transplant recipient). In the United States, to be considered leukocytereduced, apheresis platelets must contain fewer than 5 × 106 leukocytes per product, and platelets must meet the specifications of the apheresis device manufacturer. In Europe, the guideline for leukocyte-reduced components is fewer than 1 × 106 white cells per unit.

2.

Record-Keeping Complete records must be kept for each procedure. All adverse reactions should be documented along with their investigations and follow-ups. Records of all laboratory findings and collection data must be periodically reviewed by a knowledgeable physician and must be found to be within acceptable limits. FDA guidelines require a review at least once every 4 months.3 Facilities must have policies and procedures in place to ensure that donor red cell loss during each procedure does not exceed acceptable limits.

3.

4.

Plasma Apheresis devices can be used to collect plasma as transfusable Fresh Frozen Plasma (FFP) or for Source Plasma for subsequent manufacturing. The FDA has provided guidance with regard to the volume of plasma that is allowed to be collected using automated devices. The distinction is made between infrequent plasmapheresis, in which the donor undergoes plasmapheresis no more frequently than once every 4 weeks, and serial plasmapheresis, in which the donation is more frequent than once every 4 weeks. For donors in infrequent plasmapheresis programs, donor selection and monitoring requirements are the same as those for whole blood donation.

For serial plasma collection using either automated instruments or manual techniques, the following principles apply4: 1. Donors must give consent for the procedure, and they must be observed closely during the

5.

6.

procedure. Emergency medical care must always be available.

Red cell losses related to the procedure, including samples collected for testing, must not exceed 25 mL/week so that no more than 200 mL of red cells are removed in 8 weeks. If the donor’s red cells cannot be returned during an apheresis procedure, hemapheresis or whole blood donation should be deferred for 8 weeks.

For manual collection systems, a mechanism must exist to ensure safe reinfusion of the autologous red cells. Before the blood container is separated from the donor for processing, there should be two separate, independent means of identification, so that both the donor and the phlebotomist can ascertain that the contents are those of the donor. Often, the donor signature is one identifier along with a unique identification number.

In manual procedures for donors weighing 110 to 176 lb, no more than 500 mL of whole blood should be removed at one time or no more than 1000 mL during a session or within a 48-hour period. The limits for donors who weigh >176 lb are 600 mL and 1200 mL, respectively. For automated procedures, the allowable volume has been determined for each instrument by the FDA. At least 48 hours should elapse between successive procedures. Donors should not undergo more than two procedures within a 7-day period. However, exceptions are permissible when plasma is expected to have special therapeutic value for a single recipient.

At the time of initial plasmapheresis and at 4-month intervals for donors undergoing serial (large-volume) plasmapheresis (donors undergoing plasmapheresis more often than once every 4 weeks), serum or plasma must be tested for total protein and for serum protein electrophoresis or for quantitative immunoglobulins. Results must be within normal limits. This requirement applies to donors undergoing large-volume plasma col-

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CHAPTER 7

Blood Component Collection by Apheresis

lections, where the total annual volume of plasma collected exceeds 12 L (14.4 L for donors weighing more than 175 lb) or if the donor is a frequent (more often than once every 4 weeks) plasma donor.

7. A qualified licensed physician, knowledgeable about all aspects of hemapheresis, must be responsible for the program.

Red Blood Cells and Multicomponent Donations Both AABB standards and FDA guidance documents address the removal of red cells by automated apheresis methods. The guidance document issued in 2001 by the FDA finalized recommendations for RBCs to be collected by automated apheresis. The guidance document5 included the use of automated apheresis equipment that involved collection protocols for the following: 䊳 䊳 䊳 䊳

A single unit of RBCs and plasma A single unit of RBCs and platelets A single unit of RBCs, platelets, and plasma A double unit of RBCs only

The guidance document notes FDA regulations requiring that equipment perform in a manner for which it was designed for collecting or processing blood and blood components. Standard operating procedures, including a device manufacturers’ instructions for use and maintenance of current records, are described.

Donor Selection and Monitoring The FDA requires that an adequate hemoglobin level should be determined by a quantitative method for predonation hemoglobin or for hematocrit of donors undergoing double RBC collection. Donors of small stature and minimum weight criteria, as established by the FDA in device operator’s manuals, should be further evaluated. Those donors must meet all appropriate FDA criteria for allogeneic or

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autologous whole blood donation. Donors giving a single unit of RBCs with platelets or plasma, or both, should be deferred for at least 8 weeks. The exception to this deferral is when a donor serves as a plateletpheresis donor or a donor of platelets with plasma byproducts within 8 weeks, if the extra-corporeal red cell volume of the procedure is less than 100 mL. Donors should be deferred for at least 16 weeks after a double RBC donation. If an apheresis procedure is discontinued before completion and if absolute red cell loss is <200 mL, the donor may return to donate within 8 weeks if all donor eligibility criteria are met.

If there is a second red cell loss of <100 mL during a subsequent donation within 8 weeks, the donor should be deferred for 8 weeks. If the total absolute red cell loss within 8 weeks is >300 mL, the donor should be deferred for 16 weeks from the date of last red cell loss.

If an apheresis procedure is discontinued and the absolute red cell loss is >200 mL but <300 mL, the donor should be deferred for 8 weeks. If an apheresis procedure is discontinued and total absolute red cell loss is >300 mL, the donor should be deferred for 16 weeks.

Saline infusion is used to minimize volume depletion. The procedure is limited to persons who are larger and have higher hematocrits than current minimum standards for whole blood donations (for males: minimum weight 130 lb, height 5′ 1″ ; for females: minimum weight 150 lb, height 5′ 5″ ; minimum hematocrit 40% for both genders).

Quality Control Issues The FDA has promulgated quality control (QC) programs for RBC units collected by apheresis. There are two phases, as follows: Phase I QC—consists of 100 consecutive RBC units that are tested to determine the expected or target RBC volume in accordance

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with the specifications set forth in the device operator’s manual. Target values are compared with the actual values to determine product acceptability. After the completion of satisfactory QC, which includes having at least 95% of the units meet product specifications, the establishment may proceed to Phase II. Phase II QC—consists of monthly testing of a representative sample of the manufactured product. This testing includes a requirement that each month a minimum of 50 units is tested for each collection center. At least one unit from a single-RBC protocol or both units from a double-RBC protocol device used at the center should be included. At least 95% of the products tested should meet product specifications as described in the device operator’s manual.

Record Requirements Blood establishments must update their blood establishment registrations and product listing forms. Implementation of automated RBC collection is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product. Blood establishments that are approved to manufacture RBCs with one manufacturer’s device and that wish to change to another manufacturer’s device must submit a supplement and must receive approval before distribution of the product manufactured on the new device. A number of records are described that must be available for FDA inspection in relation to RBC or multicomponent collection. These records and forms include those addressing donor consent, donor eligibility, product collection, and QC for the product.

Granulocytes The use of granulocyte transfusions has been controversial for a number of years. Analysis of randomized controlled trials of granulocyte transfusions has indicated that an adequate

dose (>1 × 1010 granulocytes/day) and crossmatch compatibility (no recipient antibodies to granulocyte antigens) have a major bearing on effectiveness. Recently, there has been renewed interest in granulocyte transfusion therapy because much greater cell doses may be obtained from donors who have received recombinant colony-stimulating factors.

Agents Administered to Increase Yields A daily dose of at least 1 × 1010 granulocytes is necessary to achieve a therapeutic effect. To collect this number of cells, one must administer drugs or sedimenting materials to the donor. The donor’s consent must include specific permission for any of these drugs or sedimenting agents to be used.

HY D ROX YE T HY L ST A RCH . A common sedimenting agent, hydroxyethyl starch (HES), causes red cells to aggregate, thereby sedimenting more completely. Sedimenting agents enhance granulocyte harvest and result in minimal red cell content in the final product.

Because HES can be detected in donors as long as a year after infusion, AABB Standards1(p28) requires facilities performing granulocyte collections to have a process to control the maximum cumulative dose of any sedimenting agent administered to the donor in a given interval. HES is a colloid, which acts as a volume expander. Donors who receive HES may experience headaches or peripheral edema because of expanded circulatory volume.

Corticosteroids can double the number of circulating granulocytes by mobilizing granulocytes from the marginal pool. The common protocol is to use 60 mg of oral prednisone as a single or divided dose before donation in order to collect significant numbers of granulocytes with minimal systemic steroid activity. Another protocol uses 8 mg of oral dexamethasone.

Donors should be questioned about relevant

CORTICOSTEROIDS.

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Blood Component Collection by Apheresis

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medical history or symptoms (hypertension, diabetes, cataracts, or peptic ulcer) before they use systemic corticosteroids.

INST R U ME NT S A N D SY STE M S FO R DONOR APHERESI S COLLECTI ONS

Recombinant hematopoietic growth factors, specifically granulocyte colony-stimulating factor (G-CSF), can effectively increase granulocyte yields. Hematopoietic growth factors given alone can result in collection of up to 4 to 8 × 1010 granulocytes per apheresis procedure. Typical doses of G-CSF are 5 to 10 μg/kg given 8 to 12 hours before collection. Preliminary evidence suggests that in-vivo recovery and survival of these granulocytes are excellent and that growth factors are well tolerated by donors.

The following is a list of equipment that is available for use in the United States for the respective blood components collected by automated techniques. A brief description is given for each instrument; more detailed information can be found in other resources.6,7 [Note: The CS-3000 and CS-3000+ (Fenwal, Lake Zurich, IL) have not been included because the company has discontinued the sale of these devices in the United States (although disposables are still available at the time of this writing). The devices are capable of collecting platelets, concurrent plasma, and granulocytes.]

Laboratory Testing

Plasma

GROW T H FA C T OR S .

Testing for ABO and Rh, for alloantibodies, and for infectious disease markers is required on a sample drawn at the time of phlebotomy.

Red cell content in granulocyte products is inevitable; the red cells should be ABOcompatible with the recipient’s plasma. If more than 2 mL of red cells are present, the component should be crossmatched. Both Rh compatibility and HLA compatibility are recommended.

Storage and Infusion Granulocyte function deteriorates rapidly during storage, and concentrates should be transfused as soon as possible after preparation.

AABB Standards mandates a storage temperature of 20 to 24 C for no longer than 24 hours.1(p66) Agitation during storage is undesirable. Irradiation is required for immunodeficient recipients and is indicated for nearly all recipients because the primary diseases are likely to include deficiencies in their immune systems. Use of a microaggregate or leukocyte reduction filter is contraindicated.

The Autopheresis C (Baxter Healthcare, Deerfield, IL) is an instrument designed to collect plasma only.8 It uses a rotating cylindrical filter to separate the plasma from the cellular elements of blood. Because of the high efficiency of the rotating filter, a small filter is used and the extracorporeal volume (ECV) of the system is approximately 200 mL. The Autopheresis C is a single-access system, and saline replacement can be administered. The Autopheresis C is considered an open system, and it can collect several units of plasma.

B A X T E R AU T O P H E RE S I S C .

The PCS-2 (Haemonetics, Braintree, MA) is designed specifically for plasma collection.8 The PCS-2 is a simplified version of the MCS Plus. The PCS2 uses a blow-molded (grenade-shaped) centrifuge bowl to separate plasma from the cellular elements. Depending on the degree of cell reduction required, one of three versions of the PCS-2 bowl can be used: standard, filter core, and high-separation core. The standard bowl uses centrifugal force to remove the plasma from the top of the bowl. To increase

HAEMONETICS PCS-2.

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cell reduction, the filter core and high-separation core bowls allow plasma to pass through the core, one covered with a filter membrane (it has the highest cell reduction but has not been released in the United States at this time).9-11 The ECV of the PCS-2 is variable depending on the hematocrit of the donor, ranging from 491 mL (38% hematocrit) to 385 mL (50% hematocrit). The PCS-2 is a single-access system and saline replacement can be administered. It is considered an open system. The PCS-2 can collect several units of plasma.

Plasma can be collected as a concurrent product during collection of apheresis platelets or automated RBCs. The amount that can be collected is determined by the volume of platelets, RBCs, or both, that are being collected and by the maximum volume that can be removed from the donor. Equipment capable of concurrent plasma collection includes Haemonetics MCS+ LN9000, Haemonetics MCS+ LN8150, Fenwal Amicus, Fenwal ALYX, Gambro (COBE) Spectra (Gambro, Lakewood, CO), Gambro Trima, and Gambro Trima Accel.

Platelets FE NW A L AM I C U S . The Amicus is capable of collecting single, double, or triple apheresis platelets as well as concurrent plasma and RBCs (single-access kit only), depending on the donor’s size, platelet count,6,12-14 and hematocrit. The Amicus uses a double compartment belt wrapped around a spool and centrifugal force to separate the platelets. The platelets accumulate in the collection chamber and are transferred to the final collection bags at the end of the procedure. The Amicus is capable of single- or double-access procedures. The ECV of the double-access kit is 210 mL and the single access kit is 209 mL plus the whole-blood bag (adjustable). Consistent leukocyte reduction is accomplished without external filtration.

The Gambro (COBE) Spectra is capable of collecting single, double, or triple apheresis platelet units as well as concurrent plasma, depending on the size, and platelet count of the donor.6,12,15-17 It uses a dual-stage (different radius) channel to collect leukocyte-reduced platelets. Leukocyte reduction to less than 5 × 106 White Blood Cells (WBCs) can be obtained in approximately 85% of the collections for software versions less than 5.0.18 Software versions 5.0 and 7.0 increased the consistency of obtaining products containing <1.0 × 106 WBCs by using the Leukocyte Reduction System (LRS), which uses a cone in the centrifuge and saturated, fluidized, particle-bedfilter technology to remove residual WBCs leaving the second stage of the channel.6,12,15-17 The Spectra is capable of single- or doubleaccess procedures. The ECV of the singleaccess kit is 361 mL, and the double-access kit is 272 mL. Note that the Spectra is being replaced by the more efficient Gambro Trima or Trima Accel.7 G AM B RO ( CO B E ) SP E C T R A .

The Gambro Trimas were designed as automated donor collection machines for platelets, plasma, and RBCs only. The Gambro Trima (Version 4) uses a smaller, modified, dualstage channel and LRS cone to consistently collect leukocyte-reduced platelets (<1.0 × 106 WBCs). To increase platelet yields, the Trima Accel (Versions 5.0, 5.01, and 5.1) uses a single-stage, donut-shaped channel and larger LRS cone to consistently collect leukocytereduced platelets.19 The Trimas use singleaccess kits only. The ECV of the Trimas is 182 to 196 mL. The Trimas are capable of collecting single, double, or triple units of apheresis platelets as well as concurrent plasma and RBCs, depending on donor size, platelet count, and hematocrit.13,19,20 GAMBRO TR I MA AN D TR IMA ACCEL .

H A E M O N E T I C S M C S + L N 9 0 0 0 . The Haemonetics MCS+ LN9000 system is capable of several different apheresis procedures includ-

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Blood Component Collection by Apheresis

ing apheresis platelet collection. It uses the Latham conical bowl, plasma-controlled hematocrit, and plasma surge technique to build up the platelets and float them off the bowl with rapid plasma infusion. Although this technique results in leukocyte-reduced platelets, the use of an online leukocyte reduction filter ensures consistency in leukocyte reduction.6,21-24 The LN9000 uses a single-access kit, and the ECV is variable from 480 mL (38% hematocrit) to 359 mL (52% hematocrit).

The LN9000 is capable of collecting single, double, or triple units of apheresis platelets as well as concurrent plasma, depending on donor size and platelet count.6,21-24

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As previously mentioned, the Trima can collect a single unit of RBCs concurrently with platelets.7,20,26 There is also a kit to collect a double unit of RBCs with or without concurrent plasma, depending on the donor’s size and hematocrit. The Trima uses the single-stage channel for the double-RBC collection, and saline is returned to the donor during the collection. The addition of the preservative solution and the leukocyte reduction by filtration are performed manually and offline after the collection is complete, for both the single and double units of RBCs. G A M B R O TR I M A A N D TR I M A A C C E L .

The Cymbal is a collection system that uses an expanding, variable-volume bowl; has a small ECV; and collects a double-RBC product.28 HA E M O NE T I CS CY M B A L .

Red Blood Cells The Fenwal ALYX was developed as an automated, double-RBC collection system only. Recently, it has been approved to also collect concurrent plasma.

The ALYX uses a rigid, cylinder-shaped chamber in the centrifuge to separate the plasma from the cells. The plasma is collected in one bag with the red cells in a separate bag.

During reinfusion, the plasma and saline are returned to the donor. When collection is complete, the ALYX automatically adds the preservative solution and pumps the red cells through an online leukocyte-reduction filter into the final storage bags. The ALYX uses a single-access kit only, and the ECV is approximately 110 mL. The ALYX is capable of collecting 2 units of RBCs or 1 unit of RBCs and concurrent plasma, depending on donor size and hematocrit.7,24-26

FE NW A L A LY X .

FE NW A L AM I C U S . As mentioned previously, the Fenwal Amicus can collect a single unit of RBCs concurrently with plateletpheresis, but only with the single-access kit.7,27 The preservative solution and leukocyte reduction by filtration are performed manually and offline after the collection is complete.

H A E M O N E T I C S M C S + L N 8 1 5 0 . The Haemonetics MCS+ LN8150 was designed as a donor instrument only, for collection of RBCs and concurrent plasma. The MCS+ LN8150 uses the blow-molded bowl that is also used for plasma collection. The LN8150 uses a single access and the ECV is variable depending on the donor’s hematocrit, from 542 mL (38% hematocrit) to 391 mL (54% hematocrit). The LN8150 is capable of collecting a single or double unit of RBCs with or without concurrent plasma, depending on the donor’s size and hematocrit.7,26,29 The addition of preservative and the leukocyte reduction by filtration are performed manually and offline after the collection is complete.

Granulocytes The Spectra is capable of collecting granulocytes.7,30,31 It uses the donut-shaped, single-stage channel in the centrifuge to isolate the granulocytes that are continuously collected in the final storage bag. It uses a double-access kit (only), and the ECV is 285 mL.

G AM B RO ( CO B E ) SP E C T R A .

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The Fresenius AS104 is capable of collecting several products including granulocytes.7,32 The Fresenius AS104 uses a donut-shaped, single-stage channel to separate the granulocytes. The granulocytes are allowed to build up in the centrifuge and are harvested into the final collection bag intermittently. The AS104 uses a double-access kit and the ECV is 175 mL. FRE S E NI U S A S 1 0 4 .

The LN9000 can also be used to collect granulocytes. It HA E M O N E T I CS M C S + L N 9 0 0 0 .

uses the conical Latham bowl for separation, and then the buffy coat is transferred to one of two bags. The red cells are allowed to settle to the bottom of the bag before being returned to the donor. The LN9000 switches from one bag to another to return the red cells. A single- or double-access kit can be used for granulocyte collection, and the ECV is variable based on the hematocrit of the donor, from 480 mL (38% hematocrit) to 359 mL (52% hematocrit).

RE FEREN CE S 1. Price TH, ed. Standards for blood banks and transfusion services. 25th ed. Bethesda, MD: AABB, 2008.

2. Department of Health and Human Services.

2005 Nationwide Blood Collection and Utilization Survey Report. Washington, DC: DHHS, 2006:21. [Available at http://www.aabb.org.]

3. Food and Drug Administration. Guidance for industry and FDA review staff: Collection of platelets by automated methods. (December 17, 2007) Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 2007. [Available at www.fda.gov/cber/ guidelines.htm.]

4. Code of federal regulations. Title 21 CFR Part 640 Subpart G—Source Plasma. Washington, DC: US Government Printing Office, 2007 (revised annually).

5. Food and Drug Administration. Guidance for industry: Recommendations for collecting red blood cells by automated apheresis methods (January 30, 2001. Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 2001. [Available at http://www.fda. gov/cber/gdlns/rbcautoph.htm or .pdf (see also technical correction, February 13, 2001)].

6. Burgstaler EA. Current instrumentation for apheresis. In: McLeod BC, ed. Apheresis: Principles and practice. 2nd ed. Bethesda, MD: AABB Press, 2003:95-130.

7. Burgstaler EA. Blood component collection by apheresis. J Clin Apher 2006;21:142-51.

8. Hood M, Mynderup N, Doxon L. Evaluation of Haemonetics PCS-2 and Fenwal Auto-C plasmapheresis collection systems (abstract). J Clin Apher 1996;11:99.

9. Burkhardt T, Kappelsberger C, Karl M. Evaluation of a new combined centrifugation/filtration method for the collection of plasma via plasmapheresis (abstract). Transfusion 2001;41(Suppl): 50S. 10. Burnouf T, Kappelsberger C, Frank K, Burkhardt T. Protein composition and activation markers in plasma collected by three apheresis procedures. Transfusion 2003;43:1223-30.

11. Burnouf T, Kappelsberger C, Frank K, Burkhardt T. Residual cell content in plasma produced by three apheresis procedures. Transfusion 2003;43:1522-6.

12. Burgstaler EA, Pineda AA, Bryant SC. Prospective comparison of plateletapheresis using four apheresis systems on the same donors. J Clin Apher 1999;14:163-70.

13. Burgstaler EA, Winters JL, Pineda AA. Paired comparison of Gambro Trima Accel vs Baxter Amicus single-needle plateletapheresis. Transfusion 2004;44:1612-20.

14. Yockey C, Murphy S, Eggers L, et al. Evaluation of the Amicus separator in the collection of apheresis platelets. Transfusion 1999;38:848-54.

15. Perseghin P, Mascaretti L, Riva M, et al. Comparison of plateletapheresis concentrates produced with Spectra LRS version 5.1 and LRS Turbo version 7.0 cell separators. Transfusion 2000;40:789-93.

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16. Zingsem J, Glaser A, Weisbach V. Evaluation of a platelet apheresis technique for the preparation of leukocyte-reduced platelet concentrates. Vox Sang 1998;74:189-92.

17. Zingsem J, Zimmermann R, Weisbach V, et al.

Comparison of COBE white cell-reduction and standard plateletapheresis protocols in the same donors. Transfusion 1997;37:1045-9.

18. Maresh S, Randels M, Strauss R, et al. Comparison of plateletapheresis with a standard and an improved collection device. Transfusion 1993; 33:835-7.

19. McAteer M, Kagen L, Graminske S, et al. Trima Accel improved platelet collection efficiency with the merging of single stage separation technology with leukoreduction performance of the LRS chamber (abstract). Transfusion 2002;42 (Suppl):37S. 20. Elfath MD, Whitley P, Jacobson MS, et al. Evaluation of an automated system for the collection of packed RBCs, platelets, and plasma. Transfusion 2000;40:1214-22.

21. Valbonesi M, Florio G, Ruzzenenti MR, et al.

Multicomponent collection (MCC) with the latest hemapheresis apparatuses. Int J Artif Organs 1999;22:511-15.

22. Paciorek L, Holme S, Andres M, et al. Evaluation of the continuous filtration method with double platelet products collected on the MCS+ (abstract). J Clin Apher 1998;13:87.

23. Ford K, Thompson C, Mcwhorter R, et al. Evaluation of the Haemonetics MCS+ LN9000 to produce leukoreduced platelet products (abstract).

J Clin Apher 1996;11:104.

24. Rose C, Ragusa M, Andres M, et al. Evaluation of the MCS + LN9000 in-line leukoreduction filter (abstract). Transfusion 1996;36(Suppl):85.

25. Snyder EL, Elfath MD, Taylor H, et al. Collection of two units of leukoreduced RBCs from a single donation with a portable multiple-com-

26.

27.

28.

29.

30.

31.

32.

䊳

239

ponent collection system. Transfusion 2003;43: 1695-705.

Picker SM, Radojska SM, Gathof BS. Prospective evaluation of double RBC collection using three different apheresis systems. Transfus Apher Sci 2006;35:197-205.

Moog R, Frank V, Müller N. Evaluation of a concurrent multicomponent collection system for the collection and storage of WBC-reduced RBC apheresis concentrates. Transfusion 2001; 41:1159-64.

Nussbaumer W, Grabmer C, Maurer M, et al.

Evaluation of a new mobile two unit red cell apheresis system (abstract). J Clin Apher 2006; 21:20.

Smith JW. Automated donations: Plasma, red cells, and multicomponent donor procedures.

In: McLeod BC, ed. Apheresis: Principles and practice. 2nd ed. Bethesda, MD: AABB Press, 2003:143-59.

Worel N, Kurz M, Peters C, Höcker P. Serial granulocyte apheresis under daily administration of rHuG-CSF: Effects on peripheral blood counts, collection efficiency, and yield. Transfusion 2001;41:390-5.

Dale DC, Lises WC, Llewellyn C, et al. Neutrophil transfusions: Kinetics and functions of neutrophils mobilized with granulocyte colonystimulating factor and dexamethasone. Transfusion 1998;38:713-21.

Kretschmer V, Biehl M, Coffe C, et al. New features of the Fresenius blood cell separator AS104. In: Agishi T, Kawamura A, Mineshima M, eds. Therapeutic plasmapheresis (XII): Proceedings of the 4th International Congress of the World Apheresis Association and the 12th Annual Symposium of the Japanese Society for Apheresis, June 3-5, 1992, Sapporo, Japan.

Utrecht, Netherlands: VSP, 1993:851-5.

Copyright © 2008 by the AABB. All rights reserved.

Copyright Š 2008 by the AABB. All rights reserved.