Citation:

Battelle. AN ENVIRONMENTAL TECHNOLOGY VERIFICATION (ETV) PERFORMANCE TESTING OF FOUR IMMUNOASSAY TEST KITS.

Impact/Purpose:

The overall objective of the ETV Program is to accelerate the entrance of new environmental technologies into the domestic and international marketplace by identifying the environmental performance characteristics of commercial-ready technology through the evaluation of objective and quality assured data. This provides the potential purchasers and permitters with an independent and credible assessment of what they are buying and/or permitting. The AMS Center has received funding to performance verify monitoring technologies relevant for homeland security.

Description:

The Environmental Technology Verification (ETV) Program, beginning as an initiative of the U.S. Environmental Protection Agency (EPA) in 1995, verifies the performance of commercially available, innovative technologies that can be used to measure environmental quality. The ETV provides, through a third-party, quality-assured performance data so buyers and users of environmental technologies can make informed purchase and application decisions, thus providing one path to reducing emissions and improving human health. To provide cost-effective testing, Stakeholder committees, made up of members with diverse backgrounds, provide guidance to the ETV by identifying and prioritizing environmental technologies to address present day environmental quality challenges.

The ETV Advanced Monitoring Systems (AMS) Center, one of six ETV Centers, is actively involved in verifying the performance of advanced monitoring systems available to the public for purchase. The AMS Center participates in the mission of the ETV by providing Test Plans, Protocols, conducting independent performance tests of technologies, and preparing Verification Reports and Statements describing the results of the testing. Vendors of tested technologies can use the Verification Reports for marketing purposes. All approved Verification Reports are posted on the ETV Web Site as a form of distribution. The individual verification reports and statements describe by this abstract are four Immunoassay Test Kits: ADVNT Biotechnologies' BADDTM Test Kits, Response Biomedical Corp. RAMP(R) Test Kits, Tetracore, Inc. Enzyme-Linked (ELISA) Test Kits, and Tetracore, Inc. BioThreat Alert(R) Test Kits.

The ability of the test strips to individually detect various concentrations of anthrax spores, botulinum toxin, and ricin was evaluated between January 14 and April 23, 2004, by analyzing performance test (PT) and drinking water (DW) samples. PT samples included deionized (DI) water fortified with either the target contaminant, an interferent, both, or only a cross-reactive species. Method blank (MB) samples were analyzed by both a trained technician and a non-technical/untrained, first-time user at a non-laboratory location to evaluate the test strip's performance and ease of use outside of the laboratory. PT results provided information about how well the test strips detected the presence of each contaminant at several concentration levels, the consistency of the responses, and the susceptibility of the test strips to selected interferants and cross-reactive species. Approximately 120 liters (L) of four DW samples were collected from geographically distributed municipal sources. These samples were dechlorinated with sodium thiosulfate, and then 100 L of each sample were concentrated using an ultra-filtration technique to a final volume of 250 milliliters (mL). Each DW sample (non-concentrated and concentrated) was analyzed without adding any contaminant, as well as after fortification with individual contaminants at a single concentration level to evaluate the effect of the DW matrix on the performance of the test strips. In addition to the PT and DW samples analyzed, MB samples consisting of DI water also were analyzed to confirm negative responses in the absence of contaminants and to ensure that no sources of contamination were introduced during the analysis procedures. In most cases, three replicates of each PT and DW sample were analyzed to evaluate the reproducibility of the test strip results.

QA oversight of verification testing was provided by EPA and Battelle. Battelle QA staff conducted a technical systems audit, a performance evaluation audit, and a data quality audit of 10% of the test data. The verification statement, the full report on which it is based, and the test/QA plan for this verification are all available at www.epa.gov/etv/centers/center1.html.

Record Details: