Sentosa SA HHV6 Quantitative PCR Test
Quantifying disease constellations for diagnosis
HHV-6 belongs to the Betaherpesvirinae subfamily and to the Roseolovirus genus. The virion particle has the typical structure of a herpesvirus, with a central core containing the viral DNA, a capsid, and a tegument layer that, in turn, is surrounded by a membrane.
HHV-6 is the virus that most commonly causes the childhood disease roseola. It includes 2 genetically distinct forms: HHV-6A and HHV-6B. HHV-6B has been associated with a variety of viral illnesses, including exanthema subitum (roseola infantum), mononucleosis syndromes, focal encephalitis, and pneumonitis. Infection in adults is seen primarily in immunocompromised hosts who have undergone solid-organ or stem cell transplantation or in those with HIV infection.
The Sentosa SA HHV6 Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of Human Herpesvirus 6 (HHV6) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum and cerebrospinal fluid (CSF) samples, Sentosa® SX Virus Total Nucleic Acid Kit v2.0 is used for DNA extraction; and for human EDTA whole blood samples, Sentosa® SX Whole Blood Kit is used for DNA extraction.
The Sentosa® SA HHV6 Quantitative PCR Test is intended for use in the detection and quantitation of HHV6 DNA from symptomatic patients as an aid in HHV6 diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with HHV6 infection. The results from the Sentosa® SA HHV6 Quantitative PCR Test must be interpreted within the context of all relevant clinical and laboratory findings.
- Combination of various sample materials in one run (EDTA plasma, serum, CSF), increases efficiency when detecting different conditions
- Fast turn-around time by simultaneous testing (< 4 hrs for 22 samples), allowing for timely medical decision making
- Broad linear range and low limit of detection, aids medical decision making and accurate treatment
- Combination of up to four tests from a single clinical sample in one run, increases laboratory efficiency and decreases time to result by up to 75%, generating relevant data efficiently
| Attribute | Value |
|---|---|
| Analytical Sensitivity (95% CI) | 150 copies/mL |
| Analytical Reactivity | All relevant genotypes was confirmed by database alignment |
| Analytical Specificity | No cross-reactivity with 13 pathogens tested |
| Clinical Sensitivity | 95.2% |
| Clinical Specificity | 81.6% |
| Linear Range | 300 copies/mL to 1.2 x 107 copies/mL |
| Reproducibility | 98.25% |
| Sample Type(s) | EDTA plasma/serum, CSF, Whole Blood |
PRODUCT FLYERS
| Immunosuppression Flyer | RUO | EN |
| Product | Pack Size | Item Number |
|---|---|---|
| Sentosa SA HHV6 PCR Test (4x24) RUO | 4x24 | 300185 |
| Sentosa SA HHV6 PCR Test (4x48) RUO | 4x48 | 300674 |
| Sentosa SA HHV6 Quantitation Controls (4x2) RUO | 4x2 | 300179 |
| Sentosa SA HHV6 Quantitation Standards (2x13) RUO | 2x13 | 300181 |
| Sentosa SX Whole Blood Kit (4x24) RUO | 4x24 | 300253 |
| Sentosa SA HHV6 Controls Set (8x3) RUO | 8x3 | 300689 |
| Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) RUO | 4x24 | 300044 |
For availability in your country, please contact your Vela Diagnostics sales representative.
