pISSN 2234-3806eISSN 2234-3814
| Category | Elements |
|---|---|
| Test request information |
Reason for test request or test indication Clinical diagnosis or relevant clinical information Medication history Demographic data (e.g., age, sex, ethnicity) |
| Test information |
Type of specimen Names of the gene(s) analyzed Regions of target gene(s) included in the test (target alleles and/or variants) Test method: Assay principle Indicate whether a laboratory-developed or commercially available kit was used, and whether the test was performed within the laboratory or by a referral laboratory Test limitations: Mention whether there are clinically significant genotypes that the test method cannot detect Note any specific characteristics or limitations based on the test method |
| Test results |
Types of detected genetic variants, corresponding alleles, and genotype results: Describe genetic variants using standard nomenclature Indicate whether the patient is heterozygous or homozygous for the variant Provide the type of variant discovered Relevant reference literature: when available, include allele frequency data in the target population/ethnicity Description of expected phenotype: phenotype conversion |
| Interpretation and recommendation |
Brief explanation of important drugs associated with the target gene Discussion of the relevance of the results to the test indication Description of the drug response related to the variants identified (e.g., sensitivity or resistance to chemotherapy) If applicable, any cautions related to result interpretation If applicable, recommendations for additional testing Clinical application considerations, such as dose adjustment or the use of alternative drugs based on genotype Citation of the appropriate references and publications associated with interpretation and recommendation |
| Additional elements required in the final report format |
Interpretation and (electronic) signature of the laboratory director on the final report Name and address of the laboratory, patient name, unique patient identifier, and date of birth (or age) Include the name of the requesting physician and the affiliated institution; for requests from different institutions, add the name or contact information of the requesting organization Date of specimen receipt and date of result report |
| Name of the testing personnel and (electronic) signature of the laboratory director who interpreted the results | For tests referred from other laboratories, documentation must indicate the referral along with the (electronic) signature of the laboratory director from the requesting institution |
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