The Alethia Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used to aid the user in detecting unexpected conditions that may lead to test errors.