Test Details
Methodology
The HDV RNA Quantitative assay is an in vitro reverse transcription-quantitative polymerase chain reaction (RT-qPCR) laboratory developed test for the quantification of HDV RNA from human serum or EDTA-plasma.
Result Turnaround Time
3-12 days (Note: Reflex testing to HDV RNA is done only if HDV antibody results are positive; turnaround times will vary accordingly)
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This assay is used to identify active hepatitis D virus (HDV) infection and to quantitate the HDV viral load by determining the number of international units (IU) of HDV RNA per milliliter in serum or plasma in known HDV antibody-positive patients.
Special Instructions
Note: You must order Hepatitis D Virus (HDV) Antibody, IgG and IgM [144012] along with this Reflex Hepatitis D Virus (HDV) RNA, Quantitative PCR offering. Without Hepatitis D Virus (HDV) Antibody, IgG and IgM [144012], this reflex HDV RNA, Quantitative will not be performed.
Limitations
Assay range: 20–2,000,000 IU/mL
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Serum or EDTA-plasma
Volume
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Serum gel-barrier tube or lavender-top (EDTA) tube
Collection Instructions
Centrifuge whole blood sample within 24 hours of collection. Transfer EDTA plasma to a screw-cap polypropylene transport tube. Ship refrigerated (preferred).
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 3 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Storage Instructions
Refrigerate.
Causes for Rejection
Gross hemolysis, lipemia or visible microbial contamination; specimens other than serum and EDTA plasma; frozen glass tubes
References
European Association for the Study of the Liver. EASL Clinical Practice Guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-460. Epub 2023 Jun 24. PubMed 37364791
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. PubMed 29405329
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550672 | HDV RNA Quant Reflex | 550676 | HDV RNA Quant Reflex Trigger | N/A | ||
| Order Code | 550672 | |||||
| Order Code Name | HDV RNA Quant Reflex | |||||
| Order Loinc | ||||||
| Result Code | 550676 | |||||
| Result Code Name | HDV RNA Quant Reflex Trigger | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550653 | HDV RNA, Quantitative PCR | 550654 | HDV RNA quantitation | IU/mL | 85512-2 |
| Reflex 2 | 550669 | HDV RNA, Quantitative PCR | 550658 | HDV RNA quantitation | IU/mL | 85512-2 |
| Reflex 1 | ||||||
| Order Code | 550653 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550654 | |||||
| Result Name | HDV RNA quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 85512-2 | |||||
| Reflex 2 | ||||||
| Order Code | 550669 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550658 | |||||
| Result Name | HDV RNA quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 85512-2 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550653 | HDV RNA, Quantitative PCR | 550654 | HDV RNA quantitation | IU/mL | 85512-2 |
| Reflex 2 | 550669 | HDV RNA, Quantitative PCR | 550667 | Log10 HDV RNA | log10 IU/mL | 85513-0 |
| Reflex 1 | ||||||
| Order Code | 550653 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550654 | |||||
| Result Name | HDV RNA quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 85512-2 | |||||
| Reflex 2 | ||||||
| Order Code | 550669 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550667 | |||||
| Result Name | Log10 HDV RNA | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 85513-0 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550653 | HDV RNA, Quantitative PCR | 550656 | Log10 HDV RNA | log10 IU/mL | 85513-0 |
| Reflex 1 | ||||||
| Order Code | 550653 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550656 | |||||
| Result Name | Log10 HDV RNA | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 85513-0 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550653 | HDV RNA, Quantitative PCR | 550668 | Use | N/A | |
| Reflex 1 | ||||||
| Order Code | 550653 | |||||
| Order Name | HDV RNA, Quantitative PCR | |||||
| Result Code | 550668 | |||||
| Result Name | Use | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||