| Ordering Code | 5509R |
|---|---|
| Test Name | HBV Quant. w/ Reflex to Genotype |
| Alias | Hepatitis B Virus DNA, Quantitative with Reflex to HBV Genotype |
| Preferred Specimen | Serum |
| Preferred Container | SST (Gold) |
| Optimum Volume | 4 mL |
| Collection Instructions | Draw 2 full SST tubes. |
| Handling Instructions | Separate serum from whole blood within 24 hours of collection Use only polypropylene tubes for aliquot samples DO NOT thaw once serum is frozen. |
| Transport Requirements | Oahu: Frozen Airline: Frozen |
| Specimen Stability | Refrigerated: 6 Days Frozen: 1 Month |
| Avail. Stat | NO |
| Analytic Time | Up to 7 Days |
| Methodology | Real time PCR |
Reference range(s)
The reference ranges listed below are valid on this date of May 22, 2025.
| Component | Age | Male Norm | Male Critical Low | Male Critical High | Female Norm | Female Critical High | Female Critical Low | Units | Add'l info |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis B DNA, Quant | ALL | NOT DETECTED | NOT DETECTED | The linear... Note1 |
|||||
| HBV-DNA | ALL | <10 | <10 | IU/mL | |||||
| HBV-DNA | ALL | <1.0 | <1.0 | Log IU/mL |
Note1:
The linear range for the cobas (R) HBV for a 500 uL sample processing volume for EDTA plasma and serum is from 10 IU/mL to 1.00E+09 IU/mL with an accuracy within +/-0.24 log10
The lower limit of quantification (LLoQ) is 10 IU/mL
The limit of detection (LoD) of cobas (R) HBV for 500 uL sample processing volume is 6.6 IU/mL for EDTA plasma and 3.5 IU/mL for serum. The same LoD has been verified for genotypes A through H and the predominant precore mutant
Reliable results depend on proper sample collection, storage and handling procedures. Quantitation of HBV DNA is dependent on the number of virus particles present in the samples and may be affected by sample collection methods, patient factors (i.e. age, presence of symptoms), and/or stage of infection
.