ANNEX II SAMPLE PREPARATION AND REQUIREMENTS FOR METHODS OF ANALYSIS USED IN OFFICAL CONTROL OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND DIOXIN-LIKE PCBS IN CERTAIN FOODSTUFFS

7. SCREENING METHODS OF ANALYSIS

7.4. Specific requirements for kit based bioassays
It shall be ensured that the kit-based bioassays have sufficient sensitivity and reliability to be applied for food.
Manufacturer’s instructions for sample preparation and analyses have to be followed.
Test kits shall not be used after the expiration date.
Materials or components designed for use with other kits shall not be used.
Test kits shall be kept within the specified range of storage temperature and used at the specified operating temperature.
The limit of detection for immunoassays is determined as 3 x the standard deviation, based on 10 replicate analysis of the blank, to be divided by the slope value of the linear regression equation.
Reference standards shall be used for tests at the laboratory to make sure that the responsiveness to the standard is within an acceptable range.