1. Feedback on US ETV
Experiences of Hidex as a vendor on evaluation of BioTox™ toxcicity test system on US ETV
Hidex Oy
Risto Juvonen
Risto Juvonen | Product manager, Hidex Oy, Finland

2. Agenda Hidex Oy BioTox™ - toxicity test system
US ETV - Evaluation of rapid toxicity technologies
Results and comments on US ETV
Conclusions
Risto Juvonen | Product manager, Hidex Oy, Finland

3. Risto Juvonen | Product manager, Hidex Oy, Finland

4. Founded 1993 by people from Wallac (PerkinElmer)
Specialized in instrument design for life science research and anvironmental applications
Products:
Chameleon multitechnology platereaders
Trathler multilabel vial counters
Risto Juvonen | Product manager, Hidex Oy, Finland

5. BioTox™ - toxicity test system
Risto Juvonen | Product manager, Hidex Oy, Finland

6. Portable Triathler™ luminometer with automatic injector+
BioTox™ luminescent bacterial reagent kit by Aboatox Oy
BioTox™ test is based on ISO standard luminescent bacteria method for screening of ecotoxicity.
Risto Juvonen | Product manager, Hidex Oy, Finland

7. BioTox™ Test principle:
Luminescencent BioTox test bacteria produce light
Toxic compounds reduce the light emission.
The changes in light output are measured
Decrease of light emission is a measure of toxicity.
Risto Juvonen | Product manager, Hidex Oy, Finland

8. BioTox™ Result evaluation
Improved ISO standard method, correcting automatically quenching caused e.g. by color and turbidity
BioTox™ system was verified through US ETV as a system measuring toxicity in drinking water.
Risto Juvonen | Product manager, Hidex Oy, Finland

9. US ETV Evaluation of rapid toxicity technologies Battelle, of Columbus, Ohio - 2003
Risto Juvonen | Product manager, Hidex Oy, Finland

10. The purpose of ETV is to provide objective and quality assured performance data on environmental technologies, so that users, developers, regulators, and consultants can make informed decisions about purchasing and applying these technologies.
Risto Juvonen | Product manager, Hidex Oy, Finland

11. Conservatives were used to preserve the samples
The main objective was to evaluate the ability of the technologies to detect certain toxins that are particularly toxic to humans
Samples tested were clear water samples spiked with the toxins and interfering compounds
Conservatives were used to preserve the samples
Risto Juvonen | Product manager, Hidex Oy, Finland

12. Performance parameters evaluated:
the ability to detect the toxicity of the contaminant present in the samples.
precision
false negative and positive rate
field portability
ease of use
throughput
Risto Juvonen | Product manager, Hidex Oy, Finland

13. Hidex participated the US ETV together with Aboatox, which is the company manfacturing the BioTox reagents
About 6 other companies
Vendors had to sign vendor agreement, provide the test systems and operator training
Risto Juvonen | Product manager, Hidex Oy, Finland

14. Outcome
Environmental Technology Verification Report and ETV Joint Verification Statement
Certificate -statement on verification of the technology
Outreach efforts of ETV, eg. conferences
Risto Juvonen | Product manager, Hidex Oy, Finland

15. Results on US ETV & Comments by Hidex
Risto Juvonen | Product manager, Hidex Oy, Finland

16. Toxicity
BioTox™ test was not responsive to most of the contaminants at the concentration level tested, indicatin false negative response.
Similar response was obtained with most of the other test systems evaluated
Only one system was reported to give response to most of the samples
Risto Juvonen | Product manager, Hidex Oy, Finland

17. Toxicity
BioTox™ test is designed to test ecotoxicity, but the focus on this evaluation was on compounds toxic to human beings
The samples tested did not necessarily represent the situation with ”real world samples”
Turbidity/colour which are typical interfering factors in real water samples was not tested at all
Risto Juvonen | Product manager, Hidex Oy, Finland

18. Field portability
System could be used in the field and the precision of the results suggests that the BioTox™ system functioned similarly at the non-laboratory and laboratory locations.
Result can be used to confirm the same regardles on the tested chemicals.
Field conditions is a question – do the test conditions represent true situation in the field?
Risto Juvonen | Product manager, Hidex Oy, Finland

19. Other factors
The system was reported to be easy-to-use after setting up the correct procedure with the vendor
Sample throughput was 50 samples per hour, which is high as expected
The comments obtained from the operatiors were valuable for Hidex to improve the operational procedure and the instructions
Risto Juvonen | Product manager, Hidex Oy, Finland

20. Conclusions
Risto Juvonen | Product manager, Hidex Oy, Finland

21. Technology
Preliminary evaluation of tests should be considered to avoid wrong type of tests to be verified for desired interest
Technology should be commercially available
Risto Juvonen | Product manager, Hidex Oy, Finland

22. Samples
Spiked water samples do not represent the situation with ”real world samples” – samples from natural sources should be considered
Conservatives used to preserve the samples may cause false positive results - big risk on response to conservatives rather than the toxin itself
Risto Juvonen | Product manager, Hidex Oy, Finland

23. Field conditions and The importance operator expertiece
What is to be considered as field conditions should be discussed
Sending the samples to laboratiories with experienced operators should be considered, rather than sending the test systems to single lab for testing
Risto Juvonen | Product manager, Hidex Oy, Finland

24. Costs
The focus, as stated also by US ETV, should be on the advantage of getting right information on available technologies for the buyers and users
The cost for the vendors must be kept low to facilitate all potential technologies to participate
Risto Juvonen | Product manager, Hidex Oy, Finland

25. Benefit for the vendor
US ETV Certificate received can be used for marketing purposes, regardless of the results! – is this desired?
Report and comments by operators gave valuable information for further product development
Increased markets and public awareness advertised by ETV as potential benefit was not realised – requires activity of the vendor and favourable results
Risto Juvonen | Product manager, Hidex Oy, Finland

26. Important questions arised
Can the users outside Europe accept technologies verfied by EU?
Can users in Europe acept technologies verified by US or other countries?
Are we going to do same work several times?
Risto Juvonen | Product manager, Hidex Oy, Finland

27. Mustionkatu 2, FIN-20750 Turku, Finland
Risto Juvonen
Mustionkatu 2, FIN Turku, Finland
Risto Juvonen | Product manager, Hidex Oy, Finland