C8.1(ii) The Laboratory should use standard taxonomy for referring to Specimens in reports. Appendix A Template for Molecular testing validation for an in-house assay (Informative) Whilst validation must be performed in accordance with the Requirements for the below is a template Development and Use of In-house in-Vitro Diagnostic Devices (IVDs), that may be useful for the technical aspects of validation. Assay validation will be performed in two major steps: 1) Developmental Validation: this addresses specificity, sensitivity, accuracy, bias, precision, positives and false negatives. Appropriate controls should be determined and reference databases used should be documented. once a method has been developed and initially validated, it may 2) Operational Validation: be transferred to the Laboratory as an operational method for implementation. Operational validation is accumulation of test data during testing to demonstrate that the established method(s) and procedure(s) are carried out within predetermined limits in that Laboratory. This includes quality control, competency assessment of personnel, proficiency testing and instrument calibration. 1. Developmental Validation 1.1 Description of Test Note: Appropriate personal protective equipment (PPE) and environmental containment conditions must be used when working with infectious organisms. 1.2 Test Method Protocol 1.2.1 Primers and Probes: Primers and Probe Sequence Working Concentration Reference 1.2.2 Mastermix: All reagents must be stored and used according to the manufacturer’s instructions. Component No Concentration Volume / Vol / working run reaction Reaction mix
C8.1(ii) The Laboratory should use standard taxonomy for referring to Specimens in reports. Appendix A Template for Molecular testing validation for an in-house assay (Informative) Whilst validation must be performed in accordance with the Requirements for the Development and Use of In-house in-Vitro Diagnostic Devices (IVDs), below is a template that may be useful for the technical aspects of validation. Assay validation will be performed in two major steps: 1) Developmental Validation: this addresses specificity, sensitivity, accuracy, bias, precision, positives and false negatives. Appropriate controls should be determined and reference databases used should be documented. 2) Operational Validation: once a method has been developed and initially validated, it may be transferred to the Laboratory as an operational method for implementation. Operational validation is accumulation of test data during testing to demonstrate that the established method(s) and procedure(s) are carried out within predetermined limits in that Laboratory. This includes quality control, competency assessment of personnel, proficiency testing and instrument calibration. 1. Developmental Validation 1.1 Description of Test Note: Appropriate personal protective equipment (PPE) and environmental containment conditions must be used when working with infectious organisms. 1.2 Test Method Protocol 1.2.1 Primers and Probes: Primers and Probe Sequence Working Concentration Reference 1.2.2 Mastermix: All reagents must be stored and used according to the manufacturer’s instructions. Component No Concentration Volume / reaction Vol / working run Reaction mix
Reqmts%20Microb%20Nuc%20Acids%202013.docx