AS 4659.3:2015 pdf free download – Guide to determining the equivalence of food microbiology test methods Part 3: Confirmation tests

AS 4659.3:2015 pdf free download – Guide to determining the equivalence of food microbiology test methods Part 3: Confirmation tests.
AS 4659.3 sets out a protocol that may be used to determine whether an alternate method will yield a result equivalent to an Australian Standard. food microbiology method (AS 5013 series), for confirmation tests using a pure culture.
As this Standard deals with pure cultures, the matrix will have no bearing on the validation of a particular test kit.
2 REFERENCED DOCUMENTS
The following documents are referred to in this Standard:
AS
5013 Food microbiology (series)
3 DEFINITIONS
For the purpose of this Standard the definitions below apply:
3.1 Alternate method
The method for which equivalence is to be determined.
3.2 Equivalent
A determination according to this Standard, that two methods (the reference and atternate methods) give results that are not statistically different when confirming cultures.
3.3 False negative
When the alternate method yields a negative result the reference method yields a positive result.
3.4 False positive
When the alternate method yields a positive result hut the reference method yields a negative result.
NOTE: A ‘false positive may be a true positive which was not detected by the rcfcrcnce method. Such occurrences need to be carefully vcrificd. For thc purpose of this Standard thcy will bc considered falsc positives because the guidc is aimed at demonstrating the equivalence of the two methods.
3.5 Reference method
The Australian Standard method against which the alternate method will be compared.
3.6 Target organism
The genus, species, antigenically, toxicologically or physiologically defined group of organisms which the reference method is designed to detect.
4.7 Acceptance criteria
The alternate method will only be accepted if B + C = 0.
NOTE: If B or C is greater than zero then equialence of the alternate method has not been adequately demonstrated. An explanation should be sought for the discrepancy. It may lie in the choice of Lest organism. thc pcrthrmancc of a critical step in the alternate method or some other factor. Once the reason is determined, the procedure may be repeated. after redefining the test organisms where necessary, to fulfil the requirement that B = 0.
5 REPORT
The report should contain the following information:
(a) All details necessary for identification of sample types.
(b) Reference to this Standard (i.e. AS 4659.3) and other appropriate Australian Standards.
(c) Reference to the alternative method.
(d) Each step of the method above reported in full.
(e) The results obtained.
(f) Date of testing.
(g) Any circumstances that may have influenced the result.