RAZOR® EX Anthrax Air Detection System

Spaulding, Usha; Christensen, Clarissa J; Crisp, Robert J.; Vaughn, Michael B.; Trauscht, Robert C; Gardner, Jordan R.; Thatcher, Stephanie A.; Clemens, Kristine M; Teng, David H.‐F.; Bird, Abigail; Ota, Irene M; Hadfield, Ted L.; Ryan, Valorie T.; Brunelle, Sharon L

doi:10.5740/jaoacint.11-521

Cited by 6 publications

(7 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Both the FilmArray ® and RAZOR have been tested in other studies, and our results are consistent with current literature. 3 , 7-9 , 11 , 12 …”

Section: Discussionmentioning

confidence: 99%

“…Importantly, the development and implementation of this test plan took into consideration prior work and also the intended application (field detection of visible suspicious powders). Our choice of B. anthracis inclusivity and exclusivity strains was guided by the existing AOAC standard for aerosol filter testing, 17 the literature, 12 , 16 and knowledge of the assays and the application. We evaluated instrument performance in the range spanned by 2 published standards: AOAC SMPR 2010.003 (0.95 lower confidence limit of POD/95% CL) and ASTM E2885-13 (0.85 lower limit of POD/80% CL), and we developed a test plan that requires a minimum of 47 samples without failure and 79 samples if there were up to 9 failures for the inclusivity, exclusivity, and powder samples.…”

Section: Discussionmentioning

confidence: 99%

“…The 5 instruments and associated B. anthracis assays that we evaluated are listed in Table 1 . Although some previous testing of the FilmArray ® has occurred for B. anthracis , Yersinia pestis, and Francisella tularensis, DNA detection 11 and some RAZOR™ EX system testing has been done for the analysis of aerosol filter extracts, 12 the previous studies were not intended to evaluate the detection of biothreats in suspicious powders. Therefore, these instruments were included in this study to provide a side-by-side comparison using the same statistically based test plan for evaluating the performance of the hand-portable PCR systems for screening powders for B. anthracis .…”

Section: Methodsmentioning

confidence: 99%

“…For example, BioFire Diagnostics reported testing 2,479 samples on a RAZOR ® EX system to gain certification as an AOAC Performance-Tested Method following the test plan outlined by AOAC Standard Method Performance Requirement (SMPR) 2010.003. 12 , 17 The assay evaluated for this previous certification is not commercially available; however, using the RAZOR ® EX Ten™10 Target Screen Kit, this testing would have cost $495,800 for the test kits alone. Biodetection technologies are rapidly advancing—for example, one of the instruments we tested (Tetracore T-COR 4™) has already been replaced by a newer model (T-COR 8™), while another has been discontinued (Smith Detection Bio-Seeq PLUS™).…”

mentioning

confidence: 99%

See 3 more Smart Citations

Evaluation of PCR Systems for Field Screening ofBacillus anthracis

Ozanich¹,

Colburn²,

Victry³

et al. 2017

Health Security

View full text Add to dashboard Cite

There is little published data on the performance of hand-portable polymerase chain reaction (PCR) systems that can be used by first responders to determine if a suspicious powder contains a potential biothreat agent. We evaluated 5 commercially available hand-portable PCR instruments for detection of Bacillus anthracis. We used a cost-effective, statistically based test plan to evaluate systems at performance levels ranging from 0.85-0.95 lower confidence bound (LCB) of the probability of detection (POD) at confidence levels of 80% to 95%. We assessed specificity using purified genomic DNA from 13 B. anthracis strains and 18 Bacillus near neighbors, potential interference with 22 suspicious powders that are commonly encountered in the field by first responders during suspected biothreat incidents, and the potential for PCR inhibition when B. anthracis spores were spiked into these powders. Our results indicate that 3 of the 5 systems achieved 0.95 LCB of the probability of detection with 95% confidence levels at test concentrations of 2,000 genome equivalents/mL (GE/mL), which is comparable to 2,000 spores/mL. This is more than sufficient sensitivity for screening visible suspicious powders. These systems exhibited no false-positive results or PCR inhibition with common suspicious powders and reliably detected B. anthracis spores spiked into these powders, though some issues with assay controls were observed. Our testing approach enables efficient performance testing using a statistically rigorous and cost-effective test plan to generate performance data that allow users to make informed decisions regarding the purchase and use of field biodetection equipment.

show abstract

“…Both the FilmArray ® and RAZOR have been tested in other studies, and our results are consistent with current literature. 3 , 7-9 , 11 , 12 …”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of PCR Systems for Field Screening ofBacillus anthracis

Ozanich¹,

Colburn²,

Victry³

et al. 2017

Health Security

View full text Add to dashboard Cite

show abstract

“…Nucleic acid amplification (NAA) tests are potentially faster and more sensitive than pathogen detection using blood culture (8). However, most commercial assays for B. anthracis, including the GeneXpert BA-plex system (9), are made to test powders, surface contamination, or environmental contamination (9)(10)(11)(12)(13). Currently available NAA assays cannot rapidly detect B. anthracis from uncultured patient blood samples with sufficient sensitivity to detect early sepsis (8,14).…”

mentioning

confidence: 99%

Rapid Detection of Bacillus anthracis Bloodstream Infections by Use of a Novel Assay in the GeneXpert System

et al. 2017

View full text Add to dashboard Cite

is a tier 1 select agent with the potential to quickly cause severe disease. Rapid identification of this pathogen may accelerate treatment and reduce mortality in the event of a bioterrorism attack. We developed a rapid and sensitive assay to detect bacteremia using a system that is suitable for point-of-care testing. A filter-based cartridge that included both sample processing and PCR amplification functions was loaded with all reagents needed for sample processing and multiplex nested PCR. The assay limit of detection (LOD) and dynamic range weredetermined by spiking DNA into individual PCR mixtures and CFU into human blood. One-milliliter blood samples were added to the filter-based detection cartridge and tested for on a GeneXpert instrument. Assay specificity was determined by testing blood spiked with non-anthrax bacterial isolates or by testing blood samples drawn from patients with concurrent non- bacteremia or nonbacteremic controls. The assay LODs were 5 genome equivalents per reaction and 10 CFU/ml blood for both the Sterne and V1B strains. There was a 6-log dynamic range. Assay specificity was 100% for tests of non- bacterial isolates and patient blood samples. Assay time was less than 90 min. This automated system suitable for point-of-care detection rapidly identifies directly from blood with high sensitivity. This assay might lead to early detection and more rapid therapy in the event of a bioterrorism attack.

show abstract