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Title: Experimental Design for a Sponge-Wipe Study to Relate the Recovery Efficiency and False Negative Rate to the Concentration of a Bacillus anthracis Surrogate for Six Surface Materials

Two concerns were raised by the Government Accountability Office following the 2001 building contaminations via letters containing Bacillus anthracis (BA). These included the: 1) lack of validated sampling methods, and 2) need to use statistical sampling to quantify the confidence of no contamination when all samples have negative results. Critical to addressing these concerns is quantifying the probability of correct detection (PCD) (or equivalently the false negative rate FNR = 1 - PCD). The PCD/FNR may depend on the 1) method of contaminant deposition, 2) surface concentration of the contaminant, 3) surface material being sampled, 4) sample collection method, 5) sample storage/transportation conditions, 6) sample processing method, and 7) sample analytical method. A review of the literature found 17 laboratory studies that focused on swab, wipe, or vacuum samples collected from a variety of surface materials contaminated by BA or a surrogate, and used culture methods to determine the surface contaminant concentration. These studies quantified performance of the sampling and analysis methods in terms of recovery efficiency (RE) and not PCD/FNR (which left a major gap in available information). Quantifying the PCD/FNR under a variety of conditions is a key aspect of validating sample and analysis methods, and also formore » calculating the confidence in characterization or clearance decisions based on a statistical sampling plan. A laboratory study was planned to partially fill the gap in PCD/FNR results. This report documents the experimental design developed by Pacific Northwest National Laboratory and Sandia National Laboratories (SNL) for a sponge-wipe method. The study will investigate the effects on key response variables from six surface materials contaminated with eight surface concentrations of a BA surrogate (Bacillus atrophaeus). The key response variables include measures of the contamination on test coupons of surface materials tested, contamination recovered from coupons by sponge-wipe samples, RE, and PCD/FNR. The experimental design involves 16 test runs, to be performed in two blocks of eight runs. Three surface materials (stainless steel, vinyl tile, and ceramic tile) were tested in the first block, while three other surface materials (plastic, painted wood paneling, and faux leather) will be tested in the second block. The eight surface concentrations of the surrogate were randomly assigned to test runs within each block. Some of the concentrations will be very low and may present challenges for deposition, sampling, and analysis. However, such tests are needed to investigate RE and PCD/FNR over the full range of concentrations of interest. In each run, there will be 10 test coupons of each of the three surface materials. A positive control sample will be generated prior to each test sample. The positive control results will be used to 1) calculate RE values for the wipe sampling and analysis method, and 2) fit RE- and PCD-concentration equations, for each of the six surface materials. Data analyses will support 1) estimating the PCD for each combination of contaminant concentration and surface material, 2) estimating the surface concentrations and their uncertainties of the contaminant for each combination of concentration and surface material, 3) estimating RE (%) and their uncertainties for each combination of contaminant concentration and surface material, 4) fitting PCD-concentration and RE-concentration equations for each of the six surface materials, 5) assessing goodness-of-fit of the equations, and 6) quantifying the uncertainty in PCD and RE predictions made with the fitted equations.« less
Authors:
 [1] ;  [1] ;  [2] ;  [2]
  1. Pacific Northwest National Lab. (PNNL), Richland, WA (United States)
  2. Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)
Publication Date:
OSTI Identifier:
1004540
Report Number(s):
PNNL--20060
400904120; TRN: US201104%%983
DOE Contract Number:
AC05-76RL01830
Resource Type:
Technical Report
Research Org:
Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)
Sponsoring Org:
USDOE
Country of Publication:
United States
Language:
English
Subject:
59 BASIC BIOLOGICAL SCIENCES; 99 GENERAL AND MISCELLANEOUS//MATHEMATICS, COMPUTING, AND INFORMATION SCIENCE; BACILLUS; CERAMICS; CLEARANCE; CONTAMINATION; DEPOSITION; DESIGN; DETECTION; EFFICIENCY; PERFORMANCE; PROBABILITY; PROCESSING; SAMPLING; SANDIA NATIONAL LABORATORIES Anthrax; Experimental design; False negative; Probability of correct detection.