risto juvonen | product manager, hidex oy, finland feedback on us etv experiences of hidex as a...

Risto Juvonen | Product manager, Hidex Oy, Finland

Feedback on US ETV

Experiences of Hidex as a vendor on evaluation of BioTox™ toxcicity test system on US ETV

Hidex OyRisto Juvonen


Agenda

Hidex Oy BioTox™ - toxicity test system US ETV - Evaluation of rapid toxicity technologies Results and comments on US ETV Conclusions


Founded 1993 by people from Wallac (PerkinElmer)Specialized in instrument design for life science research and anvironmental applicationsProducts:

Chameleon multitechnology platereaders

Trathler multilabel vial counters


BioTox™ - toxicity test system


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.


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.


BioTox™ Result evaluation

0

20

40

60

80

100

120

0 5 10 15 20 25 30

Time/ s

Lu

min

escen

ce

Reference Toxic Ntox, col Tox, col

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.


US ETV Evaluation of rapid toxicity technologies

Battelle, of Columbus, Ohio - 2003


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.


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


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


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


Outcome

Environmental Technology Verification Report and ETV Joint Verification Statement

Certificate -statement on verification of the technology

Outreach efforts of ETV, eg. conferences


Results on US ETV

&

Comments by Hidex


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


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


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?


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


Conclusions


Preliminary evaluation of tests should be considered to avoid wrong type of tests to be verified for desired interest

Technology should be commercially available

Technology


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

Samples


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

Field conditions and The importance operator expertiece


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

Costs


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

Benefit for the vendor


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?

Important questions arised


Risto JuvonenMustionkatu 2, FIN-20750 Turku, Finland

[email protected]

http://www.hidex.com/

risto juvonen | product manager, hidex oy, finland feedback on us etv experiences of hidex as a...

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