Test Details
Methodology
Enzyme immunoassay (EIA) with reflex to real-time PCR and Sanger sequencing
Result Turnaround Time
1 - 4 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 test is used for diagnosis and management of hepatitis C virus (HCV) infection. A positive antibody test will reflex to a quantitative PCR assay. When the quantitative viral load is >2,500 IU/mL, an additional reflex to genotyping will occur.
Special Instructions
Submit two samples, preferably one refrigerated unopened gel-barrier tube and one frozen serum/plasma pour off tube.
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Specimen Requirements
Specimen
Serum
Volume
3 mL
Minimum Volume
1.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or serum transfer tube
Collection Instructions
Two samples must be submitted.
Antibody test: If tube other than a gel-barrier tube is used, transfer separated serum to a plastic transport tube.
PCR test: Centrifuge sample within 24 hours of collection. Transfer serum/plasma to a screw-cap polypropylene transport tube. Ship frozen (preferred). Plasma from a PPT can be frozen and shipped in situ. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit a separate frozen specimen for each test requested.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | Antibody test: 14 days PCR test: 24 hours |
| Refrigerated | Antibody test: 14 days PCR test: 72 hours |
| Frozen | Antibody test: 14 days PCR test: 6 weeks |
Storage Instructions
Antibody test: refrigerated (preferred)
PCR test: frozen (preferred)
Causes for Rejection
Gross hemolysis, obvious microbial contamination, and/or received outside of specimen and/or storage and/or labeling requirements; heat-inactivated samples; cadaveric samples
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 144127 | HCV Antibody Cascade(PCR/Geno) | 40726-2 | 144035 | HCV Ab | 13955-0 | |
| Order Code | 144127 | |||||
| Order Code Name | HCV Antibody Cascade(PCR/Geno) | |||||
| Order Loinc | 40726-2 | |||||
| Result Code | 144035 | |||||
| Result Code Name | HCV Ab | |||||
| UofM | ||||||
| Result LOINC | 13955-0 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 144030 | Interpretation: | 144030 | Interpretation: | 13955-0 | |
| Reflex 1 | ||||||
| Order Code | 144030 | |||||
| Order Name | Interpretation: | |||||
| Result Code | 144030 | |||||
| Result Name | Interpretation: | |||||
| UofM | ||||||
| Result LOINC | 13955-0 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| Reflex 2 | 550352 | HCV RNA (International Units) | 550353 | HCV RNA (International Units) | IU/mL | 11011-4 |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550338 | |||||
| Result Name | Hepatitis C Quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Reflex 2 | ||||||
| Order Code | 550352 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550353 | |||||
| Result Name | HCV RNA (International Units) | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| Reflex 2 | 550352 | HCV RNA (International Units) | 550354 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550338 | |||||
| Result Name | Hepatitis C Quantitation | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11011-4 | |||||
| Reflex 2 | ||||||
| Order Code | 550352 | |||||
| Order Name | HCV RNA (International Units) | |||||
| Result Code | 550354 | |||||
| Result Name | HCV log10 | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 38180-6 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550339 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550339 | |||||
| Result Name | HCV log10 | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 38180-6 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550314 | Test Information: | 19147-8 | |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550314 | |||||
| Result Name | Test Information: | |||||
| UofM | ||||||
| Result LOINC | 19147-8 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550396 | Interpretation: | 62365-2 | |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550396 | |||||
| Result Name | Interpretation: | |||||
| UofM | ||||||
| Result LOINC | 62365-2 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 550553 | HCV RT-PCR, Quant (Non-Graph) | 550394 | HCV Genotype | N/A | |
| Reflex 2 | 144052 | HCV Genotyping, Sequencing | 144054 | Hepatitis C Genotype | 92731-9 | |
| Reflex 1 | ||||||
| Order Code | 550553 | |||||
| Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
| Result Code | 550394 | |||||
| Result Name | HCV Genotype | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Reflex 2 | ||||||
| Order Code | 144052 | |||||
| Order Name | HCV Genotyping, Sequencing | |||||
| Result Code | 144054 | |||||
| Result Name | Hepatitis C Genotype | |||||
| UofM | ||||||
| Result LOINC | 92731-9 | |||||