Feedback on US ETV

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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
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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
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Risto Juvonen Product manager, Hidex Oy, Finland
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• 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
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BioTox - toxicity test system
Risto Juvonen Product manager, Hidex Oy, Finland
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• 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
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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
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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
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US ETV Evaluation of rapid toxicity
technologiesBattelle, of Columbus, Ohio - 2003
Risto Juvonen Product manager, Hidex Oy, Finland
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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
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• 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
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• 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
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• 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
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• 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
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Results on US ETV Comments by Hidex
Risto Juvonen Product manager, Hidex Oy, Finland
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• 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
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• 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
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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
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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
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Conclusions
Risto Juvonen Product manager, Hidex Oy, Finland
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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
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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
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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
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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
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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
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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
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• Risto Juvonen
• Mustionkatu 2, FIN-20750 Turku, Finland
• www.hidex.com
• risto.juvonen_at_hidex.com

Risto Juvonen Product manager, Hidex Oy, Finland