Updated joint MicroVal / AOAC RI validation studies
Background
Last year AOAC RI and MicroVal received applications from manufacturers
interested in simultaneous method evaluations with both organizations.
Subsequently, they decided to take a pragmatic approach to accommodate
the manufacturers by combining the requirements for a MicroVal (basis EN
ISO 16140) certificate and an AOAC RI (Performance Tested MethodsSM)
review. It is important for each organization to maintain and fulfill
its own requirements with respect to the reviews, policies and
procedures, fees etc, but also to design a validation study protocol
that meets both AOAC and MicroVal requirements.
Current situation
Two pilot validation studies were initiated in 2009. Due to the fact
that it is learning curve for both organizations it took more time than
we could anticipate. However, the first joint AOAC RI / MicroVal studies
are finished. This means that the validation study manuscripts for the
test kits have been reviewed and are certified as AOAC Performance
Tested MethodsSM. However for MicroVal this only means that the Method
comparison studies have successfully been completed. In fact for
MicroVal we are halfway through the process and after the
Interlaboratory studies (ILS) have been completed successfully, the
certificates can be granted.
The two test kits that have been evaluated are:
- Hyserve, Compact Dry X-SA - Enumeration Staphylococcus aureus
- Greenlight(tm) Model 960 from Luxcel Biosciences Ltd.
- For AOAC RI: these two test kits are approved as Performance Tested MethodsSM.
- For MicroVal: only the Method Comparison studies have successfully been completed.
Hopefully the ILS studies will soon also be successfully completed. Thereafter the MicroVal Certification Body will be able to grant the certificates.
Benefit for test kit manufacturers
For the manufacturer, users and official control, a joint validation
study means that there is one validation study protocol that meets both
organizations' requirements. Although this validation will be somewhat
more extensive, the overall result is beneficial for all parties. One
validation study protocol meeting both organizations' requirements is
advantageous for the manufacturer, since it is less expensive and more
efficient than two individual validation studies.
In short:
- Harmonized, cooperative validation with MicroVal and AOAC Research Institute
- One data set - two certificates
- Use of MicroVal approved laboratories
Combined validations MicroVal / AOAC
AOAC and MicroVal received applications from manufacturers wishing to have approvals/certificates simultaneously for both organizations. Subsequently, both decided to take a pragmatic approach to accommodate the wishes of the manufacturers to combine a MicroVal (basis EN ISO 16140) certificate as well as AOAC approvals (Official Methods of Analysis and/or Performance Tested Methods). It is important for both organizations that their own requirements with respect to the procedures, rules, fees etc, remain fulfilled, but also to design a protocol that suits both AOAC and MicroVal requirements.
For the manufacturer, users and official control, this means that there will be one validation that meets both requirements. Although this validation will be somewhat more extensive, the overall result is beneficial for all parties. One validation meeting both requirements is advantageous for the manufacturer, since it is less expensive and more efficient than two separate validations.
In the spring of 2009 two pilot validation studies were initiated. Hopefully at the MicroVal symposium 12 November 2009 the first result of a combined study will already be visible in a AOAC PTM approval, which will be followed by the MicroVal certificate beginning of 2010 when the Interlaboratory study has been finished.
In short:
- Harmonized, cooperative validation with MicroVal and AOAC
- Integrated reviewers
- One data set - two certificates
- Use of MicroVal approved laboratories