RevoDx Epstein-Barr Virus qPCR Kit
Intended Use
RevoDx Epstein-Barr Virus qPCR Kit is an in vitro nucleic acid amplification test for quantification of Epstein-Barr Virus (EBV) DNA in human serum or plasma (EDTA) or cerebrospinal fluid (CSF) specimens using BIO-RAD CFX96 or Tianlong Gentier 96 Real-Time PCR Detection System for amplification, detection and analysis.
Negative results do not preclude Epstein-Barr Virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
RevoDx Epstein-Barr Virus qPCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.:
Instruments
The RevoDx Epstein-Barr Virus qPCR Kit is to be used with BIO-RAD CFX96 and Tianlong Gentier 96 Real-Time PCR Detection Systems. But the RevoDx Epstein-Barr Virus qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX.
Features
- Ready-to-use kit
- Quantification Standards ranging from 1 x 104 IU/mL to 1 x 107 IU/mL
- Exogenous internal control
- The Limit of Detection (LoD) value is 86 IU/mL
- Linear range is between 97 IU/mL and 1 x 109 IU/mL
- Diagnostic specificity is ≥ 99 %
- Whole system failure rate is ≤1 %
- CE-IVD marked
Ordering Information