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
4 - 7 days
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 determine the number of international units (IU) of hepatitis D virus (HDV) RNA per milliliter in serum or plasma in known HDV-positive patients.
Special Instructions
This is quantitative testing performed at Monogram Biosciences Inc.
This test currently is not approved for use in New York state. This is quantitative testing performed at Monogram Biosciences Inc. |
This is quantitative testing performed at Monogram Biosciences Inc. |
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 frozen (preferred). Serum from a plastic SST can be frozen and shipped in situ.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 3 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Storage Instructions
Frozen (preferred) or refrigerated
Causes for Rejection
Gross hemolysis, lipemia or visible microbial contamination; specimens other than serum and EDTA plasma; frozen glass tubes
References
Asselah T, Rizzetto M. Hepatitis D virus infection. N Engl J Med. 2023 Jul 6,389(1):58-70. PubMed 37407002
Gish, RG, Jacobson IM, Lim JK, et al. Prevalence and characteristics of hepatitis delta virus infection in the United States: an analysis of the all-payer claims database. Hepatology. 2024 May 1;79(5):1117-1128. Epub 2023 Nov 16. PubMed 37976395
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550653 | HDV RNA, Quantitative PCR | 95144-2 | 550654 | HDV RNA quantitation | IU/mL | 85512-2 |
| 550653 | HDV RNA, Quantitative PCR | 95144-2 | 550656 | Log10 HDV RNA | log10 IU/mL | 85513-0 |
| 550653 | HDV RNA, Quantitative PCR | 95144-2 | 550668 | Use | N/A | |
| Order Code | 550653 | |||||
| Order Code Name | HDV RNA, Quantitative PCR | |||||
| Order Loinc | 95144-2 | |||||
| Result Code | 550654 | |||||
| Result Code Name | HDV RNA quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 85512-2 | |||||
| Order Code | 550653 | |||||
| Order Code Name | HDV RNA, Quantitative PCR | |||||
| Order Loinc | 95144-2 | |||||
| Result Code | 550656 | |||||
| Result Code Name | Log10 HDV RNA | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 85513-0 | |||||
| Order Code | 550653 | |||||
| Order Code Name | HDV RNA, Quantitative PCR | |||||
| Order Loinc | 95144-2 | |||||
| Result Code | 550668 | |||||
| Result Code Name | Use | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550669 | HDV RNA, Quantitative PCR | 550658 | HDV RNA quantitation | IU/mL | 85512-2 |
| Reflex 1 | ||||||
| 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 | 550669 | HDV RNA, Quantitative PCR | 550667 | Log10 HDV RNA | log10 IU/mL | 85513-0 |
| Reflex 1 | ||||||
| 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 | |||||