NIDS® Rapid Bio-Threat Assay FAQs
Comparison of NIDS® Multiplex Handheld BW Assays with Other Lateral Flow Assays (LFAs)
|High dose Hook Effect causes false negatives||No||Yes|
|Multiple dilutions to avoid false negatives||No||Yes|
|True multiplex on a single strip||Yes||No|
|Handheld assays needed per sample||1||3+|
|On-site biological waste management||Low||High|
|Handheld reader to eliminate human to human variations||Yes||No|
|Room temperature stability||Yes||No|
|3rd Party evaluations with live agents by DoD/US Army||Yes||No|
Who uses the NIDS® Rapid Bio-Threat Assay?
ANP Technologies, incorporated in April 2002 was founded to support the Defense Industry and has provided research and development (R&D) services as well as functionalized nano-material based products to address market needs associated with biological and chemical defense and homeland security of the United States Government. We have been the R&D laboratory for the Joint Service Agent Water Monitor (JSAWM) program since July of 2002. Currently the NIDS® Rapid Bio-Threat 2-Plex Assay is fully fielded in the Joint Chemical Biological Radiological Agent Water Monitoring (JCBRAWM) test kit of the United States Army. The NIDS® Rapid Bio-Threat 5-Plex Assay is under limited fielding by the Department of Defense. We have also utilized our technology platform for commercial applications and currently have a NIDS® 5-Plex 4 Bio-Threat Assay that is commercially available. The NIDS® Rapid Bio-Threat Assays are also being used by many first-responders and emergency health professionals.
Is your product protected under the SAFETY Act?
The SAFETY Act, or Support Anti-terrorism by Fostering Effective Technologies Act, provides broad liability protections, caps and other incentives for qualified entities that sell, use, integrate or deploy anti-terrorism and terrorism mitigation products and services. We have submitted an application for our NIDS® Rapid Bio-Threat Assay to be SAFETY Act designated.
Have the NIDS® Rapid Bio-Threat Assays undergone independent 3rd party evaluations?
Yes, they have been independently evaluated by U.S. Army laboratories. Please click here for a complete list of 3rd party evaluation reports.
What biothreat targets are detectable using the NIDS® Rapid Bio-Threat Assay?
The NIDS® Handheld Bio-Threat/Biowarfare Assays are sold in four different 5-Plex combinations each testing for five different biothreat targets simultaneously:
The NIDS® 5-Plex 1 detects B. anthracis, Ricin toxin, Botulinum toxin, SEB toxin and F. tularensis.
The NIDS® 5-Plex 2 detects Brucella melitensis, Vaccinia, C. Burnetii, Y. pestis and Venezuelan Equine Encephalitis (VEE).
The NIDS® 5-Plex 3 detects Brucella melitensis, Vaccinia, C. Burnetii, Y. pestis and V. cholera.
The NIDS® 5-Plex 4 detects B. anthracis, F. tularensis, Y. pestis, SEB toxin and Vaccinia.
How long is the time-to-result for the NIDS® Rapid Bio-Threat Assay?
When running a NIDS® Rapid Bio-Threat Assay, a control line should appear at the top of the results window indicating that the assay has operated correctly. If there is any biothreat target antigen present in the sample above the limit of detection, a line will also appear in the appropriate target zone for that biothreat agent. The NIDS® Rapid Bio-Threat Assay yields results within 15 minutes. Yet in instances where there is a high concentration of biothreat target antigen, a result can be ascertained sooner.
What is the Hook Effect?
The Hook Effect is the occurrence of a false negative result on a lateral flow assay in the presence of high antigen concentrations. When the Hook Effect occurs, the antigen in the sample is in excess of both the detector and capture antibodies and this unlabeled antigen binds to the capture antibodies preventing antibody sandwich formation and producing a false negative result. The Hook Effect has extremely negative implications and could result in mass casualties.
Why doesn’t the NIDS® Rapid Bio-Threat Assay suffer from the Hook Effect?
The NIDS® technology uses a proprietary antibody nanomanipulation technique that optimally orients capture antibodies so that there are ample biosensing regions available for antigen binding and sandwich formation even in the presence of high antigen concentrations. The NIDS® Rapid Bio-Threat Assays have yet to be overwhelmed at high concentrations.
How does the NIDS® Rapid Bio-Threat Assay differ from traditional handheld assays?
The NIDS® Rapid Bio-Threat Assay is a multiplexed immunoassay that allows a user to screen for multiple biothreat targets using only one sample resulting in lessened time and materials costs. Because the NIDS® Handheld Assays do not suffer from the Hook Effect, there is no need to test various sample dilutions. Using a traditional Department of Defense handheld assay, the user would need to use 40 single-target assays and 4 mL of sample solution to test the entire 10 target panel that the NIDS® Rapid Bio-Threat Assay can test using 2 assays and 0.2 mL of sample. The NIDS® Rapid Bio-Threat Assay decreases operational complexity, consumable costs, and waste.
What is the shelf life of the ANP BW lateral flow assay?
The NIDS® Rapid Bio-Threat Assays were subjected to an accelerated aging study at 70oC in sealed desiccated foil pouches and were subsequently tested with blank buffer solution and with the individual target antigen species at their specified DLs. All antigen species were detected at the specified detection limits and no false positive results were observed with blank solution. A long term room temperature shelf life study has confirmed the accelerated aging results. The shelf life of the NIDS® Rapid Bio-Threat Assay is 2 years from the date of manufacture at room temperature (23°C) based on these studies.
Why are the NIDS® 3000 Bio-Threat Assays more cost effective?
As previously demonstrated, the number of test tickets is reduced threefold, significantly decreasing the logistic burden and waste disposal. By using only two 5-plex tickets, the cost per test sample is reduced by at least threefold.
Can I use the NIDS® 3000 Bio-Threat Assays beyond their expiration date?
Using the NIDS® Rapid Bio-Threat Assays beyond their expiration date is not recommended. Accelerated and long-term stability and storage studies were conducted to determine the shelf life of the product. Eventually, the components of the NIDS® Rapid Bio-Threat Assays will degrade even if stores under optimal conditions. To ensure accurate test results, users should use NIDS® Rapid Bio-Threat Assays by their posted expiration date.
Why use the NIDS® 3000 Stand Alone Reader IV (SAR IV)?
The NIDS® 3000 SAR IV is an advanced handheld reader device that is recommended for the evaluation of all NIDS® Handheld Assays. The NIDS® 3000 SAR IV eliminates inter-personnel differences when visually reading assays and is as accurate as a trained human eye. When accompanied by the NIDS® SAR IV PC Software, the NIDS® 3000 SAR IV also has data storage and management capabilities as well as chain of custody evidence for each test result. Furthermore, the ruggedized reader allows the user to perform accurate reads under low-visibility and/or high-stress conditions commonly encountered in field use.