Pro-Strip Rapid Screening System | AdVnt Biotechnologies, LLC

General Description
Pro-Strips were introduced in 2006 and are certified and designated by the DHS Safety Act. Pro-Strips is the first HHA designed to detect and identify multiple bio-threat agents using one sample. No additional collection kits or expensive readers are required. Each test is packaged in a protective, foil pouch then placed alongside 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.
Features include:

Results in as little as 3 minutes
Excellent detection capabilities
No cross-reactivity to dozens of near neighbor strains including bacillus thuringensis and bacillus globigii
No Cross-reactivity to common household substances such as flour, yeast, baby powder, sugar, etc.
Cost Effective

Technical Description
AdVnt’s Bio-Warfare agent detection systems come in the form of a immunochromatogarphy assay, designed to provide a quick presumptive identification of selected biological warfare agents. Polyclonal antibodies are used because of their superior sensitivity. Monoclonal antibodies are used for their high degree of specificity and sensitivity. These “capture” antibodies are able to grab onto to portion of an antigen with their antigen binding sites
Detector antibodies conjugate to colloidal gold allowing for visualization of the antibody. The capture antibodies are what make up the “T” or test line on the ticket. The collected agents are first introduced into a buffer solution that allows for transport across a wicking pad. As the sample makes its way across the pad it comes into contact with the antispecies line to indicate the test is working properly, then makes contact with the antibodies on the test line. If the antibodies bind with the sample the test line will indicate a positive result.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
1 sample, <10 tests/sample per run
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

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

Tier Selection