Test Id : HDVQU
Hepatitis D Virus RNA Detection and Quantification, Real-Time RT-PCR, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detection of hepatitis D virus (HDV) for diagnosis of acute or chronic hepatitis D
Determine HDV RNA level in serum to monitor progression and response to antiviral therapy for chronic hepatitis D
Highlights
This molecular test detects and quantify hepatitis D virus (HDV) RNA present in serum of individuals suspected or known to have acute or chronic hepatitis D. It also serves to confirm the diagnosis of chronic hepatitis D in individuals with positive HDV total antibodies in serum.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis D: Diagnostic Testing Algorithm.
Method Name
A short description of the method used to perform the test
Real-Time, Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Hepatitis D virus
HDV
HDV PCR
HDV Qualitative
HDV Quantification
HDV Quantitative
HDV RNA Detection
HDV RNA Qualitative
HDV RNA Quantification
HDV RNA Quantitative
HDV RT-PCR
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis D: Diagnostic Testing Algorithm.
Specimen Type
Describes the specimen type validated for testing
Serum SST
Ordering Guidance
This test should be requested for all individuals who are newly confirmed to be positive for hepatitis B virus surface antigen (HBsAg) or HDV total antibodies in serum.
Shipping Instructions
1. Freeze serum immediately, and ship specimen frozen on dry ice.
2. If shipment will be delayed for more 24 hours, freeze serum at -20 to -80 degrees C (up to 35 days) until shipment on dry ice.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2.2 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
1.0 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 35 days | ALIQUOT TUBE |
| Refrigerated | 5 days | ALIQUOT TUBE |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detection of hepatitis D virus (HDV) for diagnosis of acute or chronic hepatitis D
Determine HDV RNA level in serum to monitor progression and response to antiviral therapy for chronic hepatitis D
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis D: Diagnostic Testing Algorithm.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Infection with the hepatitis delta virus (HDV) always occurs in association with hepatitis B virus (HBV) infection, where it may occur either as acute co-infection or acute super-infection superimposed upon existing chronic hepatitis B. HDV is an RNA virus that requires the presence of HBV for viral replication.
Diagnosis of acute HBV-HDV co-infection and HDV super-infection depends upon the presence of HDV antigen (HDV Ag) and HDV RNA in serum or plasma, with or without the presence of HDV-specific total antibodies, in addition to detectable hepatitis B virus surface antigen (HBs Ag), HBV e antigen, and/or HBV core total antibodies. Individuals with acute HBV-HDV co-infection will have detectable HBV core IgM antibody, which is absent in those with HDV super-infection with pre-existing chronic hepatitis B.
In acute co-infection, HDV Ag and HDV RNA appears early after HBs Ag becomes detectable and then both disappear with convalescence, while both markers persist in HDV superinfection that frequently leads to chronic HBV-HDV co-infection. HDV total antibodies persist in both resolved and chronic co-infection.
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.
Undetected
Interpretation
Provides information to assist in interpretation of the test results
Quantification range of this assay is 20 to 2,000,000 IU/mL (1.30 log to 6.30 log IU/mL), with a limit of detection (based on a 95% detection rate) of 4.17 IU/mL (0.62 log IU/mL).
An "Undetected" result indicates that hepatitis D virus (HDV) RNA is not detected in the serum specimen (see Cautions). Repeat testing in 1 to 2 months is recommended for those at risk of HDV infection. The limit of detection (based on a 95% detection rate) for this assay is 4.17 IU/mL.
A result of "<20 IU/mL" indicates that the HDV RNA level present in the serum specimen is below 20 IU/mL (1.30 log IU/mL), and the assay cannot accurately quantify the HDV RNA present below this level.
A quantitative value (reported in IU/mL and log IU/mL) indicates the HDV RNA level (ie, viral load) present in the serum specimen.
A result of ">2,000,000 IU/mL" indicates that the HDV RNA level present in the serum specimen is above 2,000,000 IU/mL (6.30 log IU/mL), and this assay cannot accurately quantify the HDV RNA present above this level.
An "Inconclusive" result indicates that the presence or absence of HDV RNA in the serum specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to reverse transcription-polymerase chain reaction inhibition. Submission of a new specimen for testing is recommended.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay is optimized for the detection and quantification of hepatitis D virus (HDV) genotypes 1 to 8, but due to unexpected mismatches between the polymerase chain reaction assay primers and unusual or rare HDV target sequences, some serum specimens may yield "Undetected" results despite the presence of HDV RNA. Therefore, results should be interpreted with caution, considering the patient's risk factors for HDV infection, the analytical sensitivity of the assay, and possible geographic origin of the infecting HDV strain. Follow-up HDV RNA testing is recommended for patients with initially "Undetected" HDV RNA test results but at high risk for or suspected to have chronic hepatitis D.
In immunocompetent individuals, undetectable HDV RNA results indicate only the absence of HDV RNA in the serum specimen tested but do not exclude the diagnosis of HDV infection, given the relatively short duration of viremia (2 to 8 weeks after infection) in these individuals. Immunocompetent individuals with HDV infection would be expected to have repeatedly positive HDV-specific IgG and total antibody test results.
Heparinized or visibly lipemic serum specimens may result in reduced assay sensitivity, with possible false-negative or under-quantified HDV RNA test results.
Due to differences in design and analytical performance for different assays detecting and quantifying HDV RNA in human serum, serial testing of HDV viral load in a given patient over time should be performed using the same molecular assay.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Negro F. Hepatitis D virus coinfection and superinfection. Cold Spring Harb Perspect Med. 2014;4(11):a021550. Published 2014 Nov 3. doi:10.1101/cshperspect.a021550
2. European Association for the Study of the Liver. EASL Clinical Practice Guidelines on hepatitis delta virus. J Hepatol. 2023;79(2):433-460. doi:10.1016/j.jhep.2023.05.001
3. Umukoro E, Alukal JJ, Pak K, Gutierrez J. State of the art: Test all for anti-hepatitis D virus and reflex to hepatitis D virus RNA polymerase chain reaction quantification. Clin Liver Dis. 2023;27(4):937-954. doi:10.1016/j.cld.2023.05.008
4. Asselah T, Rizzetto M. Hepatitis D Virus Infection [published correction appears in N Engl J Med. 2023 Oct 12;389(15):1444. doi: 10.1056/NEJMx230006.]. N Engl J Med. 2023;389(1):58-70. doi:10.1056/NEJMra2212151
Method Description
Describes how the test is performed and provides a method-specific reference
This assay utilizes the real-time polymerase chain reaction (PCR) with TaqMan probe chemistry with the RealStar HDV RT-PCR Kit 1.0 (altona Diagnostics GmbH, Hamburg, Germany) for qualitative and quantitative detection of hepatitis D virus (HDV) RNA in human serum. Testing involves 3 major processes with the ELITe InGenius integrated system: automated extraction and purification of viral and internal control (MS2 phage) RNA, reverse transcription of HDV RNA target sequence and MS2 RNA to generate complementary DNA (cDNA), PCR amplification, and real-time detection of amplified products with fluorescent dye-labeled oligonucleotide probes. This assay amplifies a conserved sequence located between two autocatalytic sites in the HDV genome, with simultaneous detection and quantification of the target-specific amplified products and the MS2 (internal control) sequence. The assay is calibrated to the First World Health Organization International Standard for HDV RNA, PEI code 7657/12, and test results are reported in IU/mL.(Package insert: RealStar HDV RT-PCR Kit 1.0. Altona Diagnostics GmbH; 05/2018)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Varies (once per week)
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87523
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HDVQU | HDV RNA Detect / Quant, S | 85512-2 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 621375 | HDV RNA Detect / Quant, S | 85512-2 |