APOL1 Genotyping CTA Clinical Performance Study

Inclusion Criteria: * Study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria. * Study participant has agreed to and signed the clinical trial Informed Consent Form (inclusive of risks related to the APOL1 Genotyping CTA). * The study participant's specimen must be distributed to the device test site accompanied by a complete Test Request Form signed by the appropriate clinical trial site personnel. * All participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures. Exclusion Criteria: * Study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit 1. * The study participant has not agreed to and signed the (Clinical Trial) Informed Consent Form. * The study participant's specimen is distributed to the device test site without a complete Test Request Form. * The study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.