Product Name
Hepatitis B Virus Nucleic Acid Detection Kit (Fluorescence PCR)
Packaging Size
50 tests/kit
Intended Use
This kit is used for in vitro quantitative detection of hepatitis B virus nucleic acid in human serum samples.
Epidemiology
Hepatitis B is an infectious disease with liver and multiple organ lesion caused by the hepatitis B virus (HBV). Most people experience symptoms such as extreme fatigue, appetite loss, lower limbs or whole-body edema, hepatomegaly, etc. 5% of adult patients and 95% of children patients infected from their mother cannot clean the HBV virus efficiently in persistent infection and progress to liver cirrhosis or primary liver cell carcinoma.
Features
Multiplex PCR Amplification Technology
Internal control: Fully monitor the experimental process to ensure the quality of experiments.
High sensitivity: 25IU/mL
High specificity: No cross-reactivity with common pathogens and human genome for more accurate results.
Channel
FAM: HBV-DNA
VIC (HEX): Internal reference
PCR Amplification Conditions Setting
| Step |
Cycles |
Temperature |
Time |
Collect Fluorescent Signals or Not |
| 1 |
1 cycle |
50℃ |
2 mins |
No |
| 95℃ |
5 mins |
No |
| 2 |
5 cycles |
95℃ |
15 secs |
No |
| 55℃ |
30 secs |
No |
| 72℃ |
30 secs |
No |
| 3 |
40 cycles |
95℃ |
15 secs |
No |
| 55℃ |
45 secs |
Yes |
Technical Parameters
Storage: ≤-18℃ In dark
Shelf-life: 12 months
Specimen Type: Venous blood
Ct: ≤33
CV: ≤5.0％
LoD: 25IU/mL
Applicable Instruments: It can match the mainstream fluorescent PCR instruments on the market.
ABI 7500 Real-Time PCR Systems
ABI 7500 Fast Real-Time PCR Systems
SLAN-96P Real-Time PCR Systems
QuantStudio®5 Real-Time PCR Systems
LightCycler®480 Real-Time PCR Systems
LineGene 9600 Plus Real-Time PCR Detection Systems
MA-6000 Real-Time Quantitative Thermal Cycler
BioRad CFX96 Real-Time PCR System
BioRad CFX Opus 96 Real-Time PCR System
Main Components
| Catalogue Number |
Component (50 tests/kit) |
Specification |
Quantity |
Component Description |
| HWTS-HP001A |
HBV Reaction Buffer |
1.5 mL |
1 vial |
Reaction mix containing HBV premier, probe, Taq DNApolymerase, dNTPs, MgCl2, and UNG at optimalconcentrations. |
| HBV High Positive Control |
1mL |
1 vial |
Inactivated serum from HBV positive patient |
| HBV Low Positive Control |
1mL |
1 vial |
Inactivated serum from HBV positive patient |
| HBV Negative Control |
1mL |
1 vial |
Inactivated negative human serum |
| HBV QS * 1 |
1mL |
1 vial |
Noninfectious HBV virus at defined concentrations in Human serum. Refer to the instruction in the package insert for the exact concentrations of QS. |
| HBV QS * 2 |
1mL |
1 vial |
| HBV QS * 3 |
1mL |
1 vial |
| HBV QS * 4 |
1mL |
1 vial |
| HBV Internal Control |
50μL |
1 vial |
Internal reference control plasmid |
References
[1] Ganem D, Prince A M. Hepatitis B virus infection--natural history and clinical consequences[J]. N Engl J Med, 2004,350(11):1118-1129.
[2]Madoka Kohmoto，et a1．Detection of serum hepatitis B virus DNA by real-time quantitative- polymerase chain reaction (TaqMan PCR)during lamivudine treatment：comparison with three other assays[J]．Hepatology Research，2003，26：125-133.
[3]K.S.Lole，V.A.Arankalle．Quantitation of hepatitis B virus DNA by real-time PCR using intemalamplification control and dual TaqMan MGB probes[J]．Journal of Virological Methods．2006，135：83-90.
[4]Anna SuK-LoK．Hepatitis B infection：pathogenesis and management． Journa1 of Hepatology，2000．32（Supp1 1）：577-584.