Upload
miranda-taylor
View
214
Download
1
Tags:
Embed Size (px)
Citation preview
Bacterial Testing of Bacterial Testing of Platelet Components: Platelet Components:
2008 Update2008 Update
William B. Lockwood, PhD, MDWilliam B. Lockwood, PhD, MDClinical ProfessorClinical Professor
Department of Pathology & Laboratory MedicineDepartment of Pathology & Laboratory MedicineUniversity of LouisvilleUniversity of Louisville
Director, Transfusion Services & Tissue/Bone BankDirector, Transfusion Services & Tissue/Bone BankUniversity of Louisville HospitalUniversity of Louisville Hospital
Director, Transfusion Services, Tissue/Bone Bank & Director, Transfusion Services, Tissue/Bone Bank & Coagulation LabCoagulation Lab
Norton Hospital & Kosair Children’s HospitalNorton Hospital & Kosair Children’s HospitalLouisville, KentuckyLouisville, Kentucky
[email protected]@gwise.louisville.edu502-852-5857502-852-5857
2SCACM Conference Jan. 20, 2009
ObjectivesObjectives Describe the current FDA Describe the current FDA
regulations and accreditation regulations and accreditation agency standards for testing agency standards for testing platelet collections for bacterial platelet collections for bacterial contaminationcontamination
Compare & contrast 3 methods Compare & contrast 3 methods of bacterial detection in platelet of bacterial detection in platelet collectionscollections
Describe a validation plan for Describe a validation plan for use of non-FDA approved use of non-FDA approved bacterial detection methodsbacterial detection methods
PACE Program Number: PACE Program Number: 362-001-362-001-
0909
SCACMSCACM is approved as a provider is approved as a provider of continuing education of continuing education programs in the clinical programs in the clinical laboratory sciences by the laboratory sciences by the ASCLS P.A.C.E. Program.ASCLS P.A.C.E. Program.
3SCACM Conference Jan. 20, 2009
Whole Blood Collection SetWhole Blood Collection Set ca. 1900ca. 1900
Whole Blood Glass BottleWhole Blood Glass Bottle ca. 1940ca. 1940
TODAY!TODAY!
4SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Known to occur since 1900 when Known to occur since 1900 when using vented glass bottles for using vented glass bottles for whole blood collectionwhole blood collection
Continued with advent of plastic Continued with advent of plastic blood containers in 1950sblood containers in 1950s
Platelets stored refrigerated had Platelets stored refrigerated had less of a contamination problem, less of a contamination problem, but were not efficacious on but were not efficacious on transfusion*!transfusion*!*Murphy S, Gardner FH. NEJM 1969;380:1094-98
5SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Additional studies on platelet storage Additional studies on platelet storage medium, storage temperature, pH, type medium, storage temperature, pH, type of agitation, volume of platelets in of agitation, volume of platelets in container and size of container, plastic container and size of container, plastic used for platelet bag from 1960s-1980sused for platelet bag from 1960s-1980s
Changes included:Changes included: Gentle horizontal agitation Gentle horizontal agitation Room temperature (RT) storage- 3 days to 5 Room temperature (RT) storage- 3 days to 5
days (1981); 5 days to 7 days (1984)days (1981); 5 days to 7 days (1984) Reduction from 7 day to 5 day RT storage Reduction from 7 day to 5 day RT storage
(1986)*(1986)**Shiffer CA et al. Blood 1986;67:1591-94
6SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
US Food & Drug Administration US Food & Drug Administration (FDA) via blood regulatory (FDA) via blood regulatory department Center for Biologics department Center for Biologics Evaluation & Research (CBER) held Evaluation & Research (CBER) held industry workshops in 1995 & 1999 industry workshops in 1995 & 1999 to discuss platelet bacterial to discuss platelet bacterial contaminationcontamination
Literature continues to report Literature continues to report increasing platelet bacterial increasing platelet bacterial contamination (BaCon study of contamination (BaCon study of American Red Cross Blood Services)American Red Cross Blood Services)
7SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Bacterial contaminated blood Bacterial contaminated blood components cause of >10% components cause of >10% (77/694) of recipient fatalities (77/694) of recipient fatalities reported to FDA from 1985-1999*reported to FDA from 1985-1999*
11stst multicenter study of bacterial multicenter study of bacterial contamination of blood contamination of blood components published by components published by American Red Cross** American Red Cross**
*Workshop on bacterial contamination of platelets.Bethesda: FDA, Center for Biologics Evaluation and Research,September 24, 1999. Available from http://www.fda.gov/cber/minutes/workshop-min.htm.
**Kuehnert MJ, et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion 2001;41:1493-99
8SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
BaCon studyBaCon study 23,711,169 RBCs23,711,169 RBCs 1,804,725 single 1,804,725 single
donor platelets donor platelets (SDP)(SDP)
1,033,671 Pooled 1,033,671 Pooled platelets (WBDP)platelets (WBDP)
9SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Transfusion-transmitted bacteremia rates:Transfusion-transmitted bacteremia rates: SDP= 1:100,000SDP= 1:100,000 WBDP= 1:100,000WBDP= 1:100,000 RBC= 1:8,000,000RBC= 1:8,000,000
10SCACM Conference Jan. 20, 2009
1:100,000 1:1,000,000 Incidence rate
Bacterial vs. Virus: Infectious risk in the blood supply
HIV
Hepatitis C
HTLV 1/2
Bacteria - Platelets
Bacteria - Red Cells
West Nile Virus
Hepatitis B
HIV Ab1985
P 241996
HIV PCR2000
HCV Ab1990
HCV PCR2000
HTLV 1/21989
WNV NAT2003
HBsAg1971
Anti HBsAg 1987
1:2,000
1:20,000
No PracticalScreening Tests
CurrentlyAvailable
No PracticalScreening Tests
CurrentlyAvailable
Source: Ilert WE, et al. Transfusion Medicine 1995, 5:57-61 Brecher et al. Clinical Microbiology Reviews, 2005, 195-204
11SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Sources of Bacterial ContaminationSources of Bacterial Contamination
Skin Surface ContaminationPhlebotomy CoreDonor BacteremiaContainers and DisposablesEnvironment
12SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood ComponentsORGANISMS INVOLVEDORGANISMS INVOLVED
ExogenousExogenous
Staphylococcus Staphylococcus epidermidisepidermidisStaphylococcus aureusStaphylococcus aureusDiphteroids sppDiphteroids sppMicrococcus sppMicrococcus sppPseudomonas sppPseudomonas sppBacillus cereusBacillus cereusPropionibacterium Propionibacterium acnesacnesFlavobacterium sppFlavobacterium spp
Normal skinNormal skin
13SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood ComponentsORGANISMS INVOLVEDORGANISMS INVOLVED
EndogenousEndogenous
OsteomyelitisOsteomyelitisStaphylococcusStaphylococcusS. cholera suisS. cholera suis
Staphylococcus Staphylococcus sppspp TeethTeeth Streptococcus Streptococcus viridansviridans
SerratiaSerratialiquefaciensliquefaciens
YersiniaYersiniaenterocoliticaenterocolitica IntestinesIntestinesSalmonella sppSalmonella spp
Campylobacter Campylobacter sppspp
14SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Prevention and Detection OptionsPrevention and Detection Options• Donor screening – not feasible except Donor screening – not feasible except for arm screening. Can’t detect for arm screening. Can’t detect asymptomatic bacteremic donorsasymptomatic bacteremic donors• Arm Preparation-Limited effectiveness Arm Preparation-Limited effectiveness of arm scrubof arm scrub• Better phlebotomy methods and initial Better phlebotomy methods and initial blood diversionblood diversion• Bacterial contamination testing offers Bacterial contamination testing offers best confirmatory optionbest confirmatory option
• Pathogen Inactivation--INTERCEPTPathogen Inactivation--INTERCEPT
15SCACM Conference Jan. 20, 2009
FDA RegulationsFDA Regulations
FDA is silent about Whole-blood FDA is silent about Whole-blood Derived Platelets (WBDP) bacterial Derived Platelets (WBDP) bacterial testing guidelines [FDA guidelines are testing guidelines [FDA guidelines are recommendations but are not legally recommendations but are not legally binding until published as a Code of binding until published as a Code of Federal Regulations (CFR)]Federal Regulations (CFR)]
HOWEVER- establishments requesting HOWEVER- establishments requesting a Biological License Application (BLA) a Biological License Application (BLA) or Supplement (BLS) must follow the or Supplement (BLS) must follow the Title 21 CFR Parts 200 and 600Title 21 CFR Parts 200 and 600
16SCACM Conference Jan. 20, 2009
FDA RegulationsFDA Regulations
Part 200 relates to Good Manufacturing Part 200 relates to Good Manufacturing Practice, current (cGMP) of biologicsPractice, current (cGMP) of biologics
Part 600 relates to blood components - Part 600 relates to blood components - safety, quality, purity, potency, safety, quality, purity, potency, identificationidentification Part 640- plateletsPart 640- platelets Subsections itemize various manufacturing Subsections itemize various manufacturing
regulations, - source, donor suitability, collections, regulations, - source, donor suitability, collections, QCQC
QC elements- platelet count of donor, donor weight, QC elements- platelet count of donor, donor weight, pH at pH at outdate (≥6.2),outdate (≥6.2), sterility testingsterility testing, etc, etc
Manufacturer’s requirements for automated plateletpheresis Manufacturer’s requirements for automated plateletpheresis collectioncollection
17SCACM Conference Jan. 20, 2009
FDA RegulationsFDA Regulations Revised regulation effective in 2008 (1Revised regulation effective in 2008 (1stst
was in 1988, draft in 2005!!)was in 1988, draft in 2005!!) “ “Revisions to the Requirements Applicable to Revisions to the Requirements Applicable to
Blood, Blood Components and Source Plasma”*Blood, Blood Components and Source Plasma”* Pertains to those establishments that want to Pertains to those establishments that want to
license their blood componentlicense their blood component THEREFORE, FDA regulates platelet THEREFORE, FDA regulates platelet
“manufacturing” through the BLA/BLS!!“manufacturing” through the BLA/BLS!! Also, approval of manufacturer’s devices Also, approval of manufacturer’s devices
through Pre-Market Approval through Pre-Market Approval 510(k)510(k) application regulates equipment used in application regulates equipment used in all phases of blood component all phases of blood component productionproduction
*Federal Register: August 16, 2007 (Volume 72, Number 158)
18SCACM Conference Jan. 20, 2009
CAP Accreditation CAP Accreditation ChecklistChecklist
11stst accreditation group to require accreditation group to require bacterial testing of platelets!bacterial testing of platelets!
CAP Checklist - 2002CAP Checklist - 2002 Phase I deficiencyPhase I deficiency Revised 12/29/2004 to Revised 12/29/2004 to Phase IIPhase II
deficiencydeficiency
19SCACM Conference Jan. 20, 2009
CAP Accreditation CAP Accreditation Checklist 2008Checklist 2008
TRM.44955 Phase IIPhase II N/A YES NO
Does the laboratory have a validated system to detect the presence of bacteria in platelet components?
NOTE: For random donor platelets, any of the following testing methods satisfy this checklist question: detection of decreased pH or glucose by analytic instrument or dipstick; gram stain; acridine orange stain. Though of low sensitivity, these methods may detect units that are heavily contaminated by bacteria. Culture or FDA-approved commercial detection systems have greater sensitivity. The swirling technique is not recommended because of its very low sensitivity.
20SCACM Conference Jan. 20, 2009
CAP Accreditation CAP Accreditation Checklist 2008Checklist 2008
Two commercial systems have been cleared by the FDA for in-process quality control culturing of platelet units; one detects the growth of bacteria by their generation of CO2, and the other detects growth by their consumption of O2. Another system has been cleared for bacterial detection by fluorescent staining. If this testing is performed by the supplier of platelet components, the transfusion service can satisfy this checklist requirement by having an agreement with the supplier to notify the transfusion service if any units suspected of containing bacteria have been transferred to the transfusion service.
21SCACM Conference Jan. 20, 2009
AABB AccreditationAABB Accreditation AABB Standards for Blood Banks & AABB Standards for Blood Banks &
Transfusion Services, 23Transfusion Services, 23rdrd ed, ed, Effective May 1, 2004Effective May 1, 2004 Implement standard 5.1.5.1:Implement standard 5.1.5.1:
The blood bank or transfusion service shall have The blood bank or transfusion service shall have methods to limit and detect bacterial methods to limit and detect bacterial contamination in all platelet components. contamination in all platelet components. Standard 5.6.2 appliesStandard 5.6.2 applies
Standard 5.6.2- Protection Against Standard 5.6.2- Protection Against Contamination:Contamination:The venipuncture site shall be prepared so as to The venipuncture site shall be prepared so as to
minimize risk of bacterial contamination. Green minimize risk of bacterial contamination. Green soap shall not be used.soap shall not be used.
22SCACM Conference Jan. 20, 2009
AABB Accreditation con’tAABB Accreditation con’t
Standard 5.1.5.1.1 (Standard 5.1.5.2, 25Standard 5.1.5.1.1 (Standard 5.1.5.2, 25thth ed, 2008)ed, 2008) When a true-positive result is obtained and an When a true-positive result is obtained and an
appropriate specimen is available, additional appropriate specimen is available, additional testing to identify the organism shall be performed. testing to identify the organism shall be performed. Additional testing and follow-up shall be defined. Additional testing and follow-up shall be defined. Standards 5.2.2 and 7.1 to 7.1.4 apply.Standards 5.2.2 and 7.1 to 7.1.4 apply.
Standard 5.2.2: Donor Notification of Standard 5.2.2: Donor Notification of Abnormal Findings and Test Results Abnormal Findings and Test Results (Standard 5.2.3, 25(Standard 5.2.3, 25thth ed, 2008) ed, 2008)
Standards 7.1-7.1.4: NonconformancesStandards 7.1-7.1.4: Nonconformances
23SCACM Conference Jan. 20, 2009
AABB Accreditation con’tAABB Accreditation con’t
Standard 5.6.6.1 (25Standard 5.6.6.1 (25thth ed, 2008) ed, 2008)Blood collection containers with draw Blood collection containers with draw
line (inlet) diversion pouches shall be line (inlet) diversion pouches shall be used for any collection of platelets, used for any collection of platelets, including whole blood from which including whole blood from which platelets are made.platelets are made.
24SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Bacterial detection tests•3 devices are cleared for quality control monitoring of platelet collection process of leukoreduced platelets
BioMeriuex BacT/ALERT®BioMeriuex BacT/ALERT®Pall eBDSPall eBDShemoSystems Scansystem™hemoSystems Scansystem™
•Other non approved and non validated methods are also being used to meet the AABB standard for bacterial detection
25SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
FDA concerns with bacterial FDA concerns with bacterial detection as currently applied detection as currently applied ((Vostal JG, Jan. 28, 2005 CBER workshop))• Test performance characteristics unknown• Use of non-validated tests (glucose and pH by Use of non-validated tests (glucose and pH by dipstick, swirling)dipstick, swirling)• Non-standardized methodology even with Non-standardized methodology even with culture-based devicesculture-based devices• Potential for excessive false positives or negatives • Less reliable methods are used on whole blood derived platelets creating a two tiered safety system for apheresis and whole blood derived platelets
26SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood ComponentsBlood Components
Manual tests- validation required Manual tests- validation required for pH & glucosefor pH & glucose pHpH
GlucoseGlucose
SwirlingSwirling
27SCACM Conference Jan. 20, 2009
28SCACM Conference Jan. 20, 2009
Devices approved for QC detection Devices approved for QC detection of platelet bacterial of platelet bacterial contamination- contamination- Pall BDSPall BDS
29SCACM Conference Jan. 20, 2009
Pall eBDSPall eBDS Sample set/Oxygen Sample set/Oxygen
AnalyzerAnalyzer Sterile weld platelet Sterile weld platelet
component to setcomponent to set Fill pouch with ~3 mL Fill pouch with ~3 mL
of productof product Disconnect sample Disconnect sample
pouch from set and pouch from set and incubate at 35°C for incubate at 35°C for 24-30 hrs24-30 hrs
Measure the OMeasure the O22 content content in the air above the in the air above the plasma sample with plasma sample with insertion of analyzer insertion of analyzer probe into pouchprobe into pouch
LED display will read LED display will read PASS or FAILPASS or FAIL
30SCACM Conference Jan. 20, 2009
Pall eBDSPall eBDS
Pall Medical eBDS Brochure, 2004
31SCACM Conference Jan. 20, 2009
BioMeriuex BioMeriuex BacT/ALERT®BacT/ALERT®
Colorimetric Colorimetric technology/Sensor technology/Sensor Culture bottlesCulture bottles COCO22 release causes release causes
sensor bottle to turn sensor bottle to turn yellowyellow
Instrument measures Instrument measures & detects color & detects color change, analyzes change, analyzes data to determine data to determine positivity, alerts positivity, alerts when positive culturewhen positive culture
32SCACM Conference Jan. 20, 2009
hemoSystems hemoSystems Scansystem™Scansystem™
Scansystem Platelet Scansystem Platelet Kit/Scansystem Kit/Scansystem AnalyzerAnalyzer After sample processing in After sample processing in
platelet kit, bacteria are platelet kit, bacteria are stained with a green stained with a green fluorescence and retained fluorescence and retained on the surface of a on the surface of a dedicated membrane dedicated membrane (platelets are aggregated (platelets are aggregated and lysed)and lysed)
Membrane is inserted in Membrane is inserted in analyzer and scanned by analyzer and scanned by an Argon laseran Argon laser
Each fluorescent spot on Each fluorescent spot on the membrane will be the membrane will be detected and analyzeddetected and analyzed
Analyze 3 platelet Analyze 3 platelet components (SDP, WBDP)components (SDP, WBDP)
33SCACM Conference Jan. 20, 2009
hemoSystems hemoSystems Scansystem™Scansystem™
Scansystem™ Brochure accessed at www.hemosystem.com
34SCACM Conference Jan. 20, 2009
Preparing Platelets for Preparing Platelets for CultureCulture
Sterile Connection DeviceSterile Connection Device
35SCACM Conference Jan. 20, 2009
Connecting Platelets to Connecting Platelets to Syringe SetSyringe Set
36SCACM Conference Jan. 20, 2009
Tubing from syringe setTubing from syringe set
Tubing from platelet bagTubing from platelet bag
37SCACM Conference Jan. 20, 2009
Aliquoting Platelet SampleAliquoting Platelet Samplefrom Transfusion Bagfrom Transfusion Bag
(Suspected Transfusion Reaction(Suspected Transfusion Reaction))
Syringe setSyringe set
SDPSDP
Transfusion setTransfusion set
38SCACM Conference Jan. 20, 2009
Aliquoting Platelet SampleAliquoting Platelet Samplefor Bacterial Detection for Bacterial Detection
TestingTesting
39SCACM Conference Jan. 20, 2009
Aliquoting Platelet SampleAliquoting Platelet Samplefor Bacterial Detection for Bacterial Detection
TestingTesting
40SCACM Conference Jan. 20, 2009
Inoculating Culture Bottle Inoculating Culture Bottle (pediatric size)(pediatric size)
41SCACM Conference Jan. 20, 2009
Sterile Connection PortSterile Connection Port
42SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood Components-2008Blood Components-2008
ARC Study of ARC Study of bacterial bacterial contamination before contamination before & after & after implementation of implementation of sample diversion sample diversion pouch (Pall Acrodose pouch (Pall Acrodose with eBDS) with eBDS)
Prestorage pooling of Prestorage pooling of WBDP with culture WBDP with culture testingtesting
Jan 2003-December Jan 2003-December 20062006
Benjamin RJ, et al. Transfusion 2008;48:2348-55
43SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood Components-2008Blood Components-2008
Benjamin RJ, et al. Transfusion 2008;48:2348-55
44SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood Components-2008Blood Components-2008
Benjamin RJ, et al. Transfusion 2008;48:2348-55
45SCACM Conference Jan. 20, 2009
Bacterial Contamination of Bacterial Contamination of Blood Components-2008Blood Components-2008
Benjamin RJ, et al. Transfusion 2008;48:2348-55
PSP=prestorage pooled WBDP
46SCACM Conference Jan. 20, 2009
47SCACM Conference Jan. 20, 2009
Blood Transfusion Safety-Blood Transfusion Safety-FDA Blood Transfusion Fatality FDA Blood Transfusion Fatality
ReportReport
http://www.fda.gov/Cber/
48SCACM Conference Jan. 20, 2009
Why test at point of issue ?
Wide variation in durationof Lag Phase
Wide variation in rateof log Phase Growth
Source: Goodnough LT et al. NEJM 1999, Klein et al.JAMA, vol 274, issue 1368 –1373, November 1,2005, Goodman et al. Bacterial Contamination of blood Components: Risk, Strategy and regulation, Hematology 2003
49SCACM Conference Jan. 20, 2009
New FDA Approved Device New FDA Approved Device for Transfusion Servicesfor Transfusion Services
The Abbott Verax The Abbott Verax Platelet PGDPlatelet PGD®® Test Test
A rapid, qualitative A rapid, qualitative immunoassay for the immunoassay for the detection of Aerobic detection of Aerobic and Anaerobic; Gram-and Anaerobic; Gram-positive and Gram-positive and Gram-negative bacteria in negative bacteria in leukocyte reduced leukocyte reduced apheresis platelets apheresis platelets (SDP) (SDP)
~30 minute TAT~30 minute TAT SDP must have SDP must have
undergone QC culture undergone QC culture by blood supplier!!by blood supplier!!
50SCACM Conference Jan. 20, 2009
New Device for Transfusion New Device for Transfusion ServicesServices
51SCACM Conference Jan. 20, 2009
New Device for Transfusion New Device for Transfusion ServicesServices
1. Rapid ~ 25 minutes (3 min hands on)
3. Sensitivity ~ 103 CFU/ mL
Single-use disposable testSingle-use disposable testVerax rapid Platelet PGD® Test
2. Positives typically < 10 minutes
4. Specificity > 99.7%
52SCACM Conference Jan. 20, 2009
Pan Genera Rapid Test Pan Genera Rapid Test FormatFormat
TestFeatures
2. Shared 300 uL sample addition well3. Separate GP and GN read windows
4. Procedural controls for GP & GN
ProceduralControl
ProceduralControl
1. ABS housing holding GP/GN test strips
SampleWell
Gram-NegativeRead Window
Gram-PositiveRead Window
53SCACM Conference Jan. 20, 2009
Methods ComparisonMethods ComparisonVerax PGDVerax PGD BacT/ALERTBacT/ALERT Pall eBDSPall eBDS
TechnologyTechnologyConserved Conserved
Bacterial Ag Bacterial Ag ImmunoassayImmunoassay
CultureCulture
CO2 MeasureCO2 MeasureAerobic CultureAerobic Culture
O2 measureO2 measure
Sample VolumeSample Volume 500 uL500 uL 4-20 mLs4-20 mLs 3-5 mLs.3-5 mLs.
Time to ResultTime to Result
10 – 30 min 10 – 30 min (positives (positives
typically within typically within 10 minutes)10 minutes)
24 – 96 hours24 – 96 hours 24 – 30 hours24 – 30 hours
Detect Aerobic Detect Aerobic and Anaerobic and Anaerobic
bacteria?bacteria?YesYes Yes, but time Yes, but time
variesvaries Misses AnaerobesMisses Anaerobes
Clinical Clinical SpecificitySpecificity 99.7%99.7% 99.2-99.8%99.2-99.8% ~ 99%~ 99%
Source: Abbott, Biomerieux and Pall Medical web site.
54SCACM Conference Jan. 20, 2009
Validation of Validation of Bacterial Detection Bacterial Detection
MethodsMethods pH & glucose tests are analytically pH & glucose tests are analytically
insensitive (Yomatovian R, Brecher ME. insensitive (Yomatovian R, Brecher ME. Transfusion 2005;45:647-8)Transfusion 2005;45:647-8) Validation requiredValidation required
Variable plastic bagsVariable plastic bags Variable anticoagulantsVariable anticoagulants Variable handlingVariable handling
Gram stain insensitive unless 10Gram stain insensitive unless 1066 CFU/mL CFU/mL Facilities may not have FDA approved Facilities may not have FDA approved
equipmentequipment Validate for QC useValidate for QC use
SensitivitySensitivity Types of organismsTypes of organisms Growth timeGrowth time
55SCACM Conference Jan. 20, 2009
Snyder JW, et al. BACTEC detection of bacteria in platelet pools. ASM 05-GM-A-4146; 2005
56SCACM Conference Jan. 20, 2009
SUMMARYSUMMARY Bacterial Bacterial
contamination of contamination of blood components blood components continues to pose a continues to pose a threat to transfusion threat to transfusion recipientsrecipients
Progress to prevent Progress to prevent adverse reaction to adverse reaction to blood transfusions blood transfusions due to bacterial due to bacterial contamination contamination continues to be seencontinues to be seen
Microbiologists now Microbiologists now play a major role in play a major role in this progress!!this progress!!
57SCACM Conference Jan. 20, 2009
UNIVERSITY OF LOUISVILLE MEDICAL CENTER, LOUISVILLE, KENTUCKYUNIVERSITY OF LOUISVILLE MEDICAL CENTER, LOUISVILLE, KENTUCKY
THANK YOU!!!!
THANK YOU!!!!