BADD Single Agent Detection Test | AdVnt Biotechnologies, LLC

General Description
BADD Single Argent Detection Test are certified and designated by DHS under the Safety Act. Pro-Strips is the first HHA designed to detect and identify multiple bio-threat agents using one sample. Each kit contains everything you need to properly perform a test. No additional collection kits, or expensive readers are required. Each test is packaged in a protective, foil pouch then placed along side our unique all-in-one buffer collection tube and instruction sheet and Chain of Custody label then sealed in a red mylar pouch which doubles as a re-sealable bio-hazard bag to aid in transportation. Our BADD line of products is the HHA of choice for inclusion in all of North America’s premiere Biological Hazmat Training Programs.
Features include:

No Electronic Readers or additional collection kits required
Results in as little as 3 minutes
Excellent detection capabilities
No cross-reactivity to dozens of near neighbor strains
No Cross-reactivity to common household substances such as flour, yeast, baby powder, sugar, etc.
Portable, easy to carry and easy to store
Cost Effective
Easily Deployable

Technical Description
AdVnt Biotechnologies BADD Single Agent Detection Test is a colloidal gold/antibody conjugate-based immunochromantography assay designed to provide a quick presumptive identification of selected biological warfare agents. Monoclonal and polyclonal antibodies are carefully selected to be used as capture antibody or detection antibody based on their superior specificity and affinity levels The sample is collected with a specially designed buffer/collection/dilution bottle that is then applied to the Pro-Strip / BADD test device to perform the detection test. The target agent in the sample serum binds first to the detection antibody that is conjugated to gold particles. The target agent – loaded gold particles diffuse through the nitrocellulose membrane and pass Test line marked “T”. There, another specific antibody is coated on membrane at this place, the target agent – gold particles were bound specifically and become visible as Test line T. The color intensity is proportional to the target agent concentration in the sample. The intensity increases during incubation time. Excess gold conjugate diffuse further over the membrane. Conjugate-specific antibodies that apply on the membrane are functioning as Control line marked “C”. Here, the residual gold conjugate is capture and formed a well visible line during the incubation time.

Evaluation Criteria

THROUGHPUT:

Between 15 and 30 minutes for detection
1 sample, single test/sample per run
Less than 32 samples every 2 hours
The system could be adapted to a semi-automated system
with some effort
Device or system is designed for a single use
0-1 solutions, buffer, eluents, and/or reagents
0 components
Less than 5 minutes is required for set-up
1-2 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a soda can
Less than 1 kg
This system is not capable of transmitting data
There is no electrical requirement

OPERATIONS:

Can be used from 4°C to 37°C
Components must be stored at room temperature (27°C)
Device or system has peak performance at normal relative humidity conditions
Between 1 to 3 years shelf life
Results can be viewed in real-time
The system is not capable of autonomy
The system does not employ any software

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive FDA approval, no current efforts at this time
Less than 100 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
10,000-100,000 CFU per mL
10-100 ng per mL
Spore lysis not necessary for detection by system

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