Hepatitis B Virus Genotyping
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Polymerase Chain Reaction/Sequencing
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Hepatitis B Virus Genotype
HBV Genotyping FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Draw blood in lavender (EDTA) tube(s). Spin down and send 2 mL plasma frozen in a plastic vial.
Required: 1. Viral Load
2. Viral Load Date
Note: Red-top serum and serum gel tube(s) are acceptable.
Note: This test may be unsuccessful if the HBV Viral load is less than log 3.0 or 1,000 IU/mL of plasma.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Warm OK; Cold OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Plasma EDTA||Frozen (preferred)||42 days|
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Interpretive Information: Hepatitis B Virus Genotype
HBV genotype and resistance interpretation is provided by SeqHepB software from Evivar Medical. The following mutations are reported: reverse transcriptase L80I/V, Il69T, V173L, L180M, A181S/T/V, T184A/C/F/I/G/S/M/L, S202C/G/I, M204I/V, N236T, M250I/L/V; surface antigen P120T, D144A, G145R.
Both the HBV RT polymerase and the HBsAg encoding regions are sequenced. Resistance and surface antigen mutations are reported. In addition, the eight major HBV genotypes (A, B, C, D, E, F, G, and H) are identified. Mutations in viral sub-populations below 20% of total may not be detected.
This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.
Test Performed by: ARUP Laboratories
500 Chipeta Way
Salt Lake City, UT 84108
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
12 - 21 days
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|Z3195||Hepatitis B Genotype||In Process|
|Z3196||HBV Surface Antigen Mutations||In Process|
|Z3197||HBV RT Polymerase Mutations||In Process|