• Pall provides all the necessary components for testing and data logging results:
  • Pall eBDS oxygen analyzer with bar code scanner.
  • Helmer incubator and agitator (various sizes available).
  • Sampling stand.
  • Pall Data (data management software).

Unsurpassed Sensitivity and Specificity

• Ten organisms were selected for determining the performance characteristics of the Pall eBDS:
  • 96.6% of all samples tested for bacteria immediately after inoculation and sampling tested positive when sampling occurred immediately following inoculation. See Table 1 below.
  • 100% of all samples tested positive when sampling occurred after a 24-hour incubation at room temperature. See Table 2 below.
  • No false positives were detected in the control samples. [Field data reported to date has shown an average false positive rate of 1/1,554 (0.064%), and a true positive rate of approximately 1/5,100 (0.02%).]

Single Point Detection Provides Test of Record Prior to Transfusion

• Pall eBDS provides a clear pass/fail readout for each unit tested, and establishes a test of record.
• No further monitoring of the unit is necessary once test is complete.

Easy to Use with Minimal Platelet Loss

• Pall eBDS has been designed to support blood bank cGMP, and easily integrates into routine practice.
• A single use, closed system designed to minimize false positives from outside contaminants.
• Rapid read system provides pass/fail results in approximately 30 seconds. No interpretation is necessary.
• Minimal platelet loss of approximately 4 mL per sample.

Sensitive*
Table 1 illustrates that 96.6% of all samples tested positive when sampling occurred immediately following inoculation.

Table 2 illustrates that 100% of all samples tested positive when sampling occurred after a 24-hour incubation at room temperature.

Specific
No false positives were detected in the control samples.

1. Lee JH. In: Bacterial Contamination of Platelets Workshop, Bethesda, September 24, 1999. (Cited May 3, 2000.) Available from
http://www.fda.gov/cber/minutes/bact092499.pdf

* Sensitivity varies depending on the bioburden and duration of incubation prior to sampling.

Table 1. Performance Summary with Sampling Taken at the Time of Inoculation

	Bacteria Level Immediately After Inoculation and Sampling (Sample Time = 0 hrs)				Number Detected out of Total Tested
	< 5 CFU/mL	6-15 CFU/mL	16-50 CFU/mL	> 51 CFU/mL	(Detection with sampling at 0 hrs)
S. epidermidis	4	1			5 of 5
S. agalactiae	5	4	2		11 of 11
S. aureus		5	4		9 of 9
P. aeruginosa		11			8 of 11
S. choleraesuis	4	2	5		11 of 11
E. coli	1	6			7 of 7
E. cloacae		6			6 of 6
B. cereus	2	6	4		12 of 12
K. pneumoniae	3	7	1		11 of 11
S. marcescens		5			5 of 5
TOTAL	19	53	16	0	85 of 88 (96.6%)

Table 2. Performance Summary with Sampling Taken 24 Hours After Inoculation
(Number of Bacteria Detected with 24 Hour Incubation)

The Pall eBDS novel approach to detection measures the oxygen content of air within the sample pouch as a surrogate marker for bacteria. The Pall eBDS Oxygen Analyzer is used to measure the percent of oxygen in the headspace gas of the sample pouch. If bacteria are present in the platelet sample collected, an increasing amount of oxygen is consumed through the metabolic activity and proliferation of the bacteria in the sample during incubation, resulting in a measurable decrease in oxygen content of the plasma as well as the air within the sample pouch.

Pall eBDS Sample Set
Enhances bacteria recovery and improves oxygen sampling.

Incubator and Agitator

• Platelet agitation accelerates bacteria growth and oxygen equilibration between the headspace air and fluid.
• Sizes available to accommodate all levels of production.
• Advanced electrical control system assures accurate and consistent incubation temperatures regardless of atmospheric conditions.
• An integrated chart recorder is included in all models to provide continuous monitoring of incubation temperature for added operational assurance.

Pall eBDS Oxygen Analyzer

• Rapid throughput - approximately 30 seconds to obtain a reading.
• Automatic data entry - generates data string for electronic capture.
• Sample Pass or Fail displays - no interpretation necessary.
• Added security levels - passcode entry required to access set up menus.
• Requires no preventive maintenance - instrument is calibrated annually.
• Automatic hourly baseline confirmation - provides quality assurance.
• Four barcode scanning input options - User ID, Lot Number, Product Code, Donation ID; any or all of the fields may be selected for use.
• Barcode symbology recognition - prevents incorrect barcode entry (ISBT128 Codabar, USS Codabar).
• PC handshake feature verifies that a PC with data collection software remains connected to the Analyzer. An alarm will display if disconnected, thereby ensuring data will not be lost.
• Includes Oxygen Sampling Stand, a device that holds the sample pouch upright and secure during oxygen measurement.
• Two RS-232 ports - for connection to a barcode scanner and computer.

Pall Data

A software package that captures the output from the Pall eBDS Oxygen Analyzer and allows the information to be queried into a user-defined report.

1. Sterile connect the Pall eBDS Sample Set to the platelet product. Refer to Performance Data for optimal sampling time.
2. Fill sample pouch with approximately 3 mL of platelet product.
3. Disconnect the sample pouch from the Pall eBDS Sample Set and incubate pouch at 35 °C for 24 to 30 hours.
4. At the desired time following incubation, measure the oxygen content in the air above the plasma in the sample pouch using the Pall eBDS Oxygen Analyzer.
5. The LED display on the oxygen analyzer will then read either "Pass" or "FAIL".
6. Results are captured electronically and a report can be printed or exported.

• Pool and Store Platelets – Augmenting Quality Platelet Supply To Meet Transfusion Requirements
• Bacterial Detection and Extended Platelet Storage: The Next Step Forward (Transfusion, December 2005)
• Pall eBDS - 6 Steps to Bacteria Detection
• Pall eBDS Bacteria Detection System Brochure

• An Acrodose^SM Platelet
• Collecting and Processing: Leukotrap® RC PL and Leukotrap PL Systems
• Pooling and Storing: Acrodose™ PL System

For the full story, go to A New Platform for Platelet Transfusion Safety.