Product Name
HCV Genotyping Detection Kit (Fluorescence PCR)
Packaging Size
20 tests/kit
50 tests/kit
Intended Use
This kit is used for genotyping detection of hepatitis C virus (HCV) subtypes 1b, 2a, 3a, 3b and 6a in clinical serum/plasma samples of hepatitis C virus (HCV). It aids in diagnosis and treatment of HCV patients.
Epidemiology
Hepatitis C virus (HCV) belongs to the family flaviviridae, and its genome is a single positive strand RNA, which is easily mutated. The virus exists in the hepatocytes, serum leukocytes and plasma of infected persons. HCV genes are susceptible to mutation and can be divided into at least 6 genotypes and multiple subtypes. Different HCV genotypes use different DAAs treatment regimens and courses of treatment. Therefore, before patients are treated with DAA antiviral therapy, the HCV genotype must be detected, and even for patients with type 1, it is necessary to distinguish whether it is type 1a or type 1b.
Features
Multiplex PCR Amplification Technology
Internal control: Fully monitor the experimental process to ensure the quality of experiments.
High sensitivity: 200 IU/mL
High specificity: No cross-reactivity with common pathogens for more accurate results.
Channel
FAM: Type 1b, Type 2a
ROX: Type 6a, Type 3a
VIC/HEX: Internal Control, Type 3b
Real Time Isothermal Amplification
| Step |
Cycles |
Temperature |
Time |
Collect Fluorescent Signals or Not |
| 1 |
1 cycle |
50℃ |
20 mins |
No |
|
|
95℃ |
4 mins |
No |
| 2 |
5 cycles |
95℃ |
15 secs |
No |
|
|
54℃ |
20 secs |
No |
|
|
72℃ |
30secs |
No |
| 3 |
40 cycles |
95℃ |
15secs |
No |
|
|
60℃ |
45secs |
Yes |
Technical Parameters
| Storage |
≤-18℃ In dark |
| Shelf-life |
9 months |
| Specimen Type |
Serum, Plasma |
| Ct |
≤36 |
| CV |
≤5.0％ |
| LoD |
200 IU/mL |
| Specificity |
Use this kit to detect other virus or bacterial samples such as: human cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, hepatitis B virus, hepatitis A virus, syphilis, human herpes virus type 6, herpes simplex virus type 1, simplex Herpes virus type 2, influenza A virus, Propionibacterium acnes, Staphylococcus aureus, Candida albicans, etc. The results are all negative. |
| 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 |
Specification
|
Quantity |
Component Description |
| 20 tests/kit |
50 tests/kit |
| HWTS-HP004A |
HCV Reaction Buffer 1 |
560μL/vial |
1.4mL/vial |
1 vial |
Contains HCV type 1b primers, fluorescent probes, RT-PCR mix, Taq enzyme, etc |
| HCV Reaction Buffer 2 |
560μL/vial |
1.4mL/vial |
1 vial |
Contains HCV type 2a/6a and internal control primers, fluorescent probes, RT-PCR mix, Taq enzyme,etc |
| HCV Reaction Buffer 3 |
560μL/vial |
1.4mL/vial |
1 vial |
Contains HCV type 3a/3b primers, fluorescent probes RT-PCR mix, Taq enzyme,etc. |
| HCV Enzyme Mix |
120μL/vial |
300μL/vial |
1 vial |
Reverse transcriptase,Taq enzyme, etc. |
| HCV Positive Control |
400μL/vial |
1mL/vial |
1 vial |
Diluted samples of inactivated pseudoviruses of different types |
| HCV Internal Control |
100μL/vial |
250μL/vial |
1 vial |
Inactivated internal control pseudovirus diluted samples |
| HCV Negative Control |
400μL/vial |
1mL/vial |
1 vial |
DNase/RNase free H2O |
References
[1] Victoria González, Meissiner Gomes-Fernandes, Elisabet Bascunana et al. Accuracy of a commercially available assay for HCV genotyping and subtyping in the clinical practice[J]. Journal of Clinical Virology, 2013(58): 249~253.
[2] Syria Laperche, Francoise Lunel , Jacques Izopet et al. Comparison of Hepatitis C Virus NS5b and 5’Noncoding Gene Sequencing Methods in a Multicenter Study[J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2005(43): 733~739.
[3] Donald G. Murphy, Bernard Willems, Marc Deschenes et al. Use of Sequence Analysis of the NS5B Region for Routine Genotyping Hepatitis C Virus with Reference to C/E1 and 5’Untranslated Region Sequences[J]. OURNAL OF CLINICAL MICROBIOLOGY, 2007(45):1102~1112.
[4] Kathryn J. Rolfe, Graeme J.M. Alexander, Tim G. Wreghitt et al. A real-time Taqman method for hepatitis C virus genotyping[J]. Journal of Clinical Virology, 2005(34): 115~121.