BADD™ Biowarfare Agent Detection Devices
The AdVnt Biowarfare Agent Detection Devices are lateral flow immunoassays (LFA) for the detection of specific biothreats. These devices test for one biological agent at a time. Each test comes with an all-in-one swab kit that contains a swab, sample buffer, and pipette/dropper tube. Following sampling, the test is initiated by adding five or six drops (~0.2 mL) of sample to the sample inlet window. Results can be seen in 15 minutes. However, with concentrated samples a positive result may be obvious after only 3 minutes.
One line in the control zone indicates the agent was not detected, two lines (one in the control zone and one in the test zone) indicate the agent was detected. The absence of a control line indicates the assay is invalid and any positive or negative test result must be disregarded.
The management system governing the manufacture of this product is ISO 9001:2008-certified (specifies the requirements of a quality management system) and ISO 13485:2003-certified (specifies the requirements of a quality management system for medical devices). This product has received a “Certified” classification (consistently proven effectiveness, with high confidence of enduring effectiveness) by DHS as part of its Support Anti-terrorism by Fostering Effective Technologies (SAFETY) Act of 2002 (www.safetyact.gov).
The BADD™ screening device is a simple-to-use, environmental test for the rapid, qualitative detection of specific biological weapon threats in powders or liquids. The BADD™ screening devices provide a preliminary analytical result. Confirmation should be made by a more specific method, such as cell culture with PCR verification.
Performance specifications for AdVnt's BADD screening assay's are:
|Threat||Legal||Limit of Detection|
|Anthrax||Bacillus anthracis||1.5X10^4 - 8.3X10^8/mL (strain dependent)|
|Ricin Toxin||Ricinus communis||10 ng/mL|
|Botulinum Toxin||Clostridium botulinum||33 ng/mL(BoNT A) 500 ng/mL(BoNT B)|
|Plague||Yersinia pestis||1.0X10^5 CFU/mL|
|SEB||Staphylococcus aureus||10 ng/mL|
(Bacillus anthracis strains: Vollum, Ames, Sterne & New Hampshire)
Made in the U.S.A./ BADD's Commodity Jurisdiction Determination, by Department of State, is not subject to ITAR jurisdiction. The Department of Commerce advises the item is classified as EAR99.