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APOL1 Testing: G1 and G2 alleles
Clinical Genetic Test
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offered by
Iowa Institute of Human Genetics
View lab's test page
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GTR Test Accession: Help GTR000558473.5
REPRODUCTIVE HEALTHURINARY SYSTEM DISEASE
Last updated in GTR: 2021-07-08
View version history
Last annual review date for the lab: 2024-07-16 LinkOut
At a Glance
Test purpose: Help
Risk Assessment
Conditions (1): Help
Focal segmental glomerulosclerosis
Genes (1): Help
APOL1 (22q12.3)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Bi-directional Sanger Sequence Analysis
Target population: Help
The APOL1 test is a genotyping test which detects variants …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for management
Ordering Information
Offered by: Help
Iowa Institute of Human Genetics
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Mycah Kimble, BA, Administrator
iihg@uiowa.edu
319-335-3688
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
This test must be ordered by a health care provider. Please note patients are not permitted to order the test.

UIHC health care providers should complete a requisition form and place a miscellaneous testing order in Epic titled 'APOL1 test'. This is a send out test.

Health …
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Order URL
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
Bi-directional Sanger Sequence Analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Risk Assessment
Clinical utility: Help
Guidance for management
View citations (1)
  • Determining the risk status of patients, especially the African-American and Caribbean population, including: Those with kidney disease believed to be due to hypertension, FSGS, SLE, membranous GN or HIV; Patients being considered for kidney donation; Determining carrier status in a family member related to an APOL1 carrier.

Target population: Help
The APOL1 test is a genotyping test which detects variants that comprise the G1 (NM_001136540:c.1024A>G, p.Ser342Gly and NM_001136540:c.1152T>G, p.Ile384Met) and G2 (NM_001136540:c.1160_1165delATAATT) risk alleles. The APOL1 test can be ordered by a physician as a tool in the counseling, evaluation and management of their patients. The African-American population has a … View more
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
The APOL1 genotype assay has been limited to the evaluation of known variants within exon 6 of the APOL1 gene. Additional APOL1 gene variants will not be identified. Variants in other genes are not detectable with this assay. Rare sequence variants within primer sites may lead to erroneous results. This … View more

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Research:
Is research allowed on the sample after clinical testing is complete? Help
Research is not performed after clinical testing is complete
Recommended fields not provided:
Clinical validity, Will the lab re-contact the ordering physician if variant interpretation changes?, Sample negative report, Sample positive report
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Thirty-two samples collected either through IIHG research projects or through IIHG clinical testing services were included in the validation of the APOL1 Genotyping Test. Three variants which comprise the G1 and G2 risk alleles are detected. Any participants were not restricted based on age of onset or based on race … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Inter-Laboratory
VUS:
Laboratory's policy on reporting novel variations Help
The APOL1 genotype assay has been limited to the evaluation of known variants within exon 6 of the APOL1 gene. Additional APOL1 gene variants will not be identified. Variants in other genes are not detectable with this assay. Rare sequence variants within primer sites may lead to erroneous results. This … View more
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.