APOL1 Genotype, Varies

Clinical Use

Use

This test is intended to determine an individual's APOL1 genotype, specifically the G1 and G2 alleles, which are associated with an increased lifetime risk of chronic kidney diseases when two risk alleles are present. It is not useful for clinical management nor for determining eligibility for kidney allografts on its own; results must be interpreted in the context of clinical findings, family history, and other data. The assay cannot detect all variants, and may miss rare alleles, so interpretation should consider potential false negatives or positives. In certain scenarios, such as after blood transfusion or hematopoietic stem cell transplantation, donor DNA may interfere with results, and additional testing or a pretransplant DNA specimen may be needed.

Special Instructions

Not provided.

Limitations

This assay does not detect all APOL1 variants; rare alleles may lead to false‑negative or false‑positive results. It cannot determine phasing of alleles (cis/trans). Absence of risk genotype does not rule out risk of chronic kidney disease. Donor DNA (e.g., from blood transfusion or hematopoietic stem cell transplant recipients) may alter results; maternal contamination studies recommended for cord blood testing. Results should not alone determine eligibility for donation or transplant and must be considered with clinical context.

Test Details

New York Approved