Scotia Rapid Test FDA Approval

On 16 January 2004 US FDA approved the recommendations of the Interstate Shellfish Sanitation Conference (ISSC), and has incorporated the Scotia Rapid Test for PSP into the US National Shellfish Sanitation Program.

Summary of ISSC Committee Report by the Lab Methods Review (LMR) Committee:

….Recommend to Task Force I to adopt as a Type IV method with the following restrictions:

(i) Method can be used to determine when to perform a mouse bioassay in a previously closed area.

(ii) A negative result can be substituted for a mouse bioassay to maintain an area in the open status.

(iii) A positive result can be used for a precautionary closure.

(iv) Use of the Scotia PSP test must be based on the currently approved procedure for PSP toxin extraction. No other extraction procedures have been validated and approved for use under the NSSP, including those provided by Scotia Rapid Testing Ltd.

For more details of the approval please click here

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