Sentosa SA ZIKV RT-PCR Test

Determination of Tropical Infections

DESCRIPTION

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.

WORKFLOW

FEATURES AND BENEFITS

  • Detection limit (3 x 103 copies/mL) enables detection of samples with low viral load
  • Analytical performance with 82 zika virus strains detected and no cross-reactivity with 44 pathogens (including dengue and chikungunya)
  • 24 samples per reaction for detection of Zika virus
  • Time to results in ~ 3 hours
  • Only 250 μL of sample input needed

SPECIFICATIONS

AttributeValue
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)

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SA ZIKV RT-PCR Test (IUO) 4x24 300615
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (IUO) 4x24 300353

For availability in your country, please contact your Vela Diagnostics sales representative.

  • This test has been authorized bFDA under an EUA for use by authorized laboratories
  • This test has not been FDA cleared or approved;
  • This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.