The Sentosa SA ZIKV RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from Zika virus in human specimens and is available for use in laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
The test is authorized for use with serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and/or epidemiological criteria.
The test is configured to run on the automated Sentosa SX101 real-time PCR workflow on the Sentosa SA201 real-time PCR cycler (ABI 7500 Fast DX), along with the Sentosa SX Virus Total Nucleic Acid Kit v2.0, authorized laboratories can process 22 samples per run for rapid detection of Zika virus with a turn-around time of approximately 3 hours
The Sentosa SA ZIKV RT-PCR Test is intended for use by trained research personnel. The Sentosa SA ZIKV RT-PCR Test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
|Target Gene||ZIKV MR-766 and ZIKV PRAVBC59|
|Analytical Sensitivity (95% CI)||ZIKV MR-766: 6 x 103 copies/mL
ZIKV PRAVBC59: 3 x 103 copies/mL
|Analytical Reactivity||82 zika virus strains were tested and detected|
|Analytical Specificity||No cross reactivity with 44 pathogen tested|
|Sample Type(s)||EDTA plasma, serum or urine (collected alongside a patient-matched EDTA plasma and / or serum specimen)|
|Product||Pack Size||Item Number|
|Sentosa SA ZIKV RT-PCR Test (IUO)||4x24||300615|
|Sentosa SX Virus Total Nucleic Acid Kit v2.0 (IVD)||4x24||300353|
For availability in your country, please contact your Vela Diagnostics sales representative.