BioThreat Alert (BTA) Test Strips

The BTA test strip employs agent-specific antibodies to identify the potential threat. After prep, five drops of the liquid mix are added to the sample port of the test strip. The sample interacts with the reagents and moves along the test material, inside the test strip's plastic case. Lateral-flow immunochromatography then provides the results. Two solid bands, one in the control area and one in the sample area, indicate a positive result. One solid band (in the control area) indicates negative results. Any other combination of bands indicates an invalid result.

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Availability: Commercially Available

Tom O'Brien
tobrien@tetracore.com
+1 240 268 5400
9901 Belward Campus Drive, Suite 3000
Rockville, MD 20850
USA
www.tetracore.com
Manufacturer
Tetracore, Inc.
Product Name
BioThreat Alert (BTA) Test Strips
Detection Category
Biological;
Detection Principle
Immunological;
Detection Method
Lateral Flow Hand Held Immunoassay ;
Application
Emergency Response; Detection;
Equipment Type
Instrument
Product Synopsis
The BTA test strip employs agent-specific antibodies to identify the potential threat. After prep, five drops of the liquid mix are added to the sample port of the test strip. The sample interacts with the reagents and moves along the test material, inside the test strip's plastic case. Lateral-flow immunochromatography then provides the results. Two solid bands, one in the control area and one in the sample area, indicate a positive result. One solid band (in the control area) indicates negative results. Any other combination of bands indicates an invalid result.
Availability
Commercially Available
Technology Readiness Level (TRL)
9
tooltip-iconAssociated Scoring Levels4 –TRL 9, immediately available
3 – TRL 9 1-2 months delivery after order
2 – TRL 7-8
1 – <TRL 7
Supporting Documentation
Docs: Tetracore - BioThreat.pdf;
Dimensions
2.4 x 1.1 x 0.2 in (6.2 x 2.9 x 0.5 cm)
Weight
<1 lb.; 0.2 oz (7.0 g)
tooltip-iconAssociated Scoring Levels4 – <1 lb
3 – <5 Lbs.
2 – <30 Lbs.
1 – >30 Lbs.
Power Requirements
Lithium Battery; Reader: battery
tooltip-iconAssociated Scoring Levels4 – None
3 – Battery or Line Power
2 – Standard Line Power
1 – Non-Standard Line Power
Noise Produced
None
Transportability
Pocket Size
tooltip-iconAssociated Scoring Levels4 – Handheld
3 – Person-Portable
2 – Mounted
1 – Benchtop/Fixed
Operating Conditions
10 to 30°C (50 to 86°F)
Available Accessories
$5,500 reader
Data Analysis Support Equipment
Tablet
Shelf Life
<5 years; 2 years
Unit Cost
$605.00 per 25 pack, Reader (optional) $5,500.
tooltip-iconAssociated Scoring Levels4 - <$500
3 – <$10,000 per unit
2 – <$50,000 per unit
1 – >$50,000 per unit
Maintenance Cost
$24 per sample
Tested For Biological Agents
Analytes containing protein antigens including B. anthracis (Anthrax), Y. pestis (Plague), Botulinum toxin, Brucella spp., Ricin, Staphylococcal Enterotoxin B (SEB), F. tularensis (Tularemia), Abrin., Smallpox
Other Biological Targets
Not Specified
Adaptability
Yes, must work with the manufacturer to place corresponding capture ligands on the strip substrate and on the reporting antibodies, respectively.
Sample Introduction
Liquid
Sensitivity/Detection Limits
ppb; cfu/mL; ppt; Anthrax 10,000 to 1 million CFU/mL; Ricin 2 ng/mL; SEB 5 ng/mL; Smallpox 40 million CFU/mL, Plague 10,000 to 1 million CFU/mL
tooltip-iconAssociated Scoring Levels4 – Detects trace (<µg/ppm)
3 – Detects less than 1% in mixture
2 – Detects < ~10% in mixture
1 – Detects at > 10%
Known Interferents/Inhibitors
Moderate resistance, tests may be susceptible to interferents. An independent laboratory evaluation of the ability to detect anthrax spores, Botulinum A toxin, and Ricin toxin determined that (1) a mixture of 1% powdered milk, 2.75% bentonite, and 1% fumed silica could reduce sensitivity and (2) sensitivity not affected by 1% bleach.
tooltip-iconAssociated Scoring Levels4 – <1% False Positive and Negative Rate, no known Interferences
3 – <5% False Positive and Negative Rate, <5 known Interferences
2 – <10% False Positive and Negative Rate, <5 known Interferences
1 – >10% False Positive and Negative Rate, >5 known Interferences
False Positive Rates
False positives were observed in the EPA study with the BioThreat Alert® test strips with all targets tested
tooltip-iconAssociated Scoring Levels4 – <1% False Positive and Negative Rate, no known Interferences
3 – <5% False Positive and Negative Rate, <5 known Interferences
2 – <10% False Positive and Negative Rate, <5 known Interferences
1 – >10% False Positive and Negative Rate, >5 known Interferences
Response Time (Sample Application To Output)
>15 minutes; 15 to 30 minutes
tooltip-iconAssociated Scoring Levels4 – Continuous/<60 Seconds
3 – <5 minute
2 – <15 minute
1 – > 15 minutes
Alarm Capability
Visual
Software Control
On-board
Other Operational Parameters
The tests can be read visually, or with greater accuracy using the Rapid BioAlert Reader. Requires sample acquisition equipment such as spatula and pipettor for sample application.
Training Required
<1 day training
Warranties
1 year, limited
ITAR/EAR Export Regulations
No; EAR99 and ship with the no license required designation.
U.S. EAR Compliant
Yes; EAR99 and ship with the no license required designation.
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