Sentosa® SQ HCV Genotyping Assay v2.0
Sequence and genotype Hepatitis C virus (HCV) samples
The Sentosa SQ HCV Genotyping Assay v2.0 is a next-generation sequencing (NGS)-based test intended for viral genotyping in patients diagnosed with Hepatitis C virus (HCV) infection from human plasma or serum. This test is intended to be used on the Sentosa SX101 instrument with the Sentosa SX Virus Total Nucleic Acid Plus II Kit, in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments.
Genotyping information from this test will help in management of patients with HCV. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test.
| Target Genes | Number of Amplicons | Target Genotypes and Subtypes |
|---|---|---|
| NS5B | 1 | 1a, 1b, 2, 3, 4, 5, 6 |
| NS3 | 1 | 1a, 1b |
| NS5A | 1 | 1a, 1b |
| System Control | 1 | NA |
| Total | 4 |
Targeting clinically-relevant genes:
- Genotyping based on NS5B
- Calling of resistance-associated variance based on NS3, NS5A and NS5B according to target regions of directly acting anti-viral drugs
Providing Laboratory Efficiency and Effectiveness
- Combines genotyping for genotypes 1 to 6 with variant calling for subtypes 1a and 1b in a single run
- Seamless sample traceability and network connectivity
- Automated workflow, from samples to results in two days
- Automated data analysis and result reporting on Sentosa SQ Reporter
| Attribute | Value |
|---|---|
| Sample Input | 730 μL serum or plasma |
| Sample Throughput | 15 patient samples and 1 system control |
| Mean Coverage / Target | ≥ 200 X for genotyping, ≥ 500 X for variant calling |
| Analytical Sensitivity | ≥ 1,000 HCV IU/mL for genotypes 1a, 1b, 2, 3, and 4 ≥ 2,000 HCV IU/mL for genotypes 5 and 6 |
| Analytical Specificity | No cross-reactivity with HAV, HBV, HIV, CMV, EBV, VZV, HHV1/2, Dengue virus or human genomic DNA |
| Reproducibility | 99.20% |
PRODUCT FLYERS
| Sentosa SQ HCV Genotyping Assay Flyer v2.0 | RUO | EN |
| Product | Pack Size | Item Number |
|---|---|---|
| Sentosa SQ HCV Genotyping Reagents v2.0 (4x16) RUO | 4x16 | 300393 |
| Sentosa SQ Virus Testing Solutions (4x24) RUO | 4x24 | 300775 |
| Sentosa SQ HCV Positive Control v2.0 (8) RUO | 8 | 301056 |
| Sentosa SQ HCV Positive Control v2.0 (96) RUO | 96 | 300757 |
